COVID-19 Vaccine Weekly Update

Ramona Whittington

From: Roxana Cruz Sent: Tuesday, April 13, 2021 7:18 PM To: Medical Directors; Dental Directors; [email protected]; [email protected]; Myrta Garcia; Lindsay Lanagan; catherine.threatt; Abby Villafane; Lynn Roberts; [email protected]; [email protected]; Dr Flower; Vicky Jefferson, Lone Star Circle of Care Cc: Jana Eubank; Daniel Diaz; Nancy Gilliam; Shelby Tracy; Ramona Whittington; ClinicalTeam Subject: COVID-19 Vaccine Weekly Update Week 18 (04-12-2021) Attachments: nejmp2103104_AddressingVaccineHesitanceBIPOC pops.pdf; COVIDVaccineAllocation-Week18 HealthCentrs.pdf; draft-fact-sheet-providers-pi_Moderna04.2021.pdf; Moderna Provides Storage Update & Announces the U.S. FDA Authorizes Up To 15-Doses Per Vial of its COVID-19 Vaccine.pdf

Dear Fellow Directors and Vaccine Coordinators,

COVID Vaccine Allocation: Week 18 (04‐12‐2021) 33 Health center sites with 6,900 doses allocated. That brings the total DSHS Allocations to 182,665 total doses to date, since roll‐out began, including Week 18 to 268 unduplicated FQHC sites https://www.dshs.texas.gov/news/updates/COVIDVaccineAllocation‐Week18.pdf (see Attachment with Health Centers highlighted)

DSHS COVID Vaccines Total Distributed across Texas: 16,318,875. Total Reported as Administered: 11,950,969 across the state.

HRSA Health Center Vaccine Program We will continue to update the list of participating health centers (invited and participating health centers as of 4/12/2021: 34 Currently participating plus 39 invited to date.) Updates are provided for list of participating health centers on the website each week. Site‐level information is posted in the Health Center COVID‐19 Vaccine Program Online Community (VPC). For more information, visit the CDC COVID‐19 Vaccination Program Provider Requirements and Support site

URGENT Vaccine Update: Johnson & Johnson COVID 19 Vaccines We wanted to make sure you are aware of this information regarding ONLY Johnson & Johnson vaccines you may be receiving from DSHS and/or HRSA allocations. This update and this week’s allocations affect 3 of our health centers (total of 400 J&J Vaccine doses going to 4 different sites). Today, effective immediately, the US Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) are recommending a pause for the U.S. for the use of Johnson & Johnson's Covid‐19 vaccine over six reported U.S. cases of a "rare and severe" type of blood clot. Health centers administering the Johnson & Johnson vaccine should immediately STOP for the time being. If you have this vaccine in stock, please keep it in storage. Do not discard or destroy it. Press release sent out from DSHS this morning: https://www.dshs.texas.gov/news/releases/2021/20210413.aspx  The six (6) reported cases were among more than 6.8 million doses of the Johnson & Johnson vaccine administered in the United States.  None of the cases of blood clots reported at this time have occurred in Texas, where more than 500,000 doses of the Johnson & Johnson vaccine have been administered.  The pause happened because this type of blood clot (cerebral venous thrombosis) is not listed on the list of potential adverse side effects that were part of the emergency use authorization (EUA) for J&J.

1  All six cases occurred among women between 18 ‐ 48 years of age, and symptoms occurred 6 ‐ 13 days after vaccination, according to a joint statement on today (4‐13‐2021) from Dr. Anne Schuchat, principal deputy director of the CDC and Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.  "CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) tomorrow, Wednesday (04‐14‐2021) to further review these cases and assess their potential significance.” https://www.cdc.gov/media/releases/2021/s0413‐JJ‐vaccine.html  For people who have received the Johnson & Johnson shot, those who have developed severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html As it happens, according to Imelda Garcia with the Department of State Health Services (DSHS) Expert Vaccine Allocation Panel (EVAP), this week Texas allocations decreased from about 500,000 doses of the Johnson & Johnson vaccine last week (Week 17) to about 130,000 this week (Week 18) That amounts to a decrease of about 74%. This decrease was due to manufacturing shortages that occurred earlier this month. Furthermore, today DSHS/EVAP had a call with the following additional information:  No replacement or new vaccines to allocate from DSHS at this time, for Week 18.  Allocations for Week 19 will be determined this week, attempting to take into account the current situation.  Texas Military targeted calls: will be calling providers who have received any J&J vaccines to alert vaccine providers to stop vaccinating with J&J.

CDC and FDA will provided additional information and answer questions today at a media briefing at 10 AM ET here. A recording of that media call will be available on the FDA’s YouTube channel.

Guidance for providers for recently administered J&J Vaccines to identify and determine patients who need support and/or referral to hospital for evaluation Dr. Shuford provided an overview of the cause for the FDA and CDC guidance to ‘pause’ on administration of the J&J Vaccines:  6 cases with rare and severe blood clot (cerebral venous sinus thrombosis,CSVT), have occurred in women b/w 18 – 48 years old, occurring approximately 2 – 3 weeks post vaccination  Cerebral venous thromboses are rare and severe, with potential for mortality. Similar to heparin induced thrombocytopenia.  Similar syndrome seen w/Astra Zeneca (in both men and women) in Europe.  Recommendations for treatment & management, CDC Health Alert published [April 13, 2021, 1:00 PM ET]: https://emergency.cdc.gov/han/2021/han00442.asp  Primary Care providers should: o Monitor with awareness of symptoms, abdominal pain, severe headache, shortness of breath, leg pain within 3 weeks post vaccination with J&J vaccine. o Check platelet counts and evaluate symptoms for potential of coagulopathy as an adverse event linked to immunological response. o Refer to Hematology to assess for treatment.

RECOMMENDATIONS For Clinicians 1. Pause the use of the J&J COVID‐19 vaccine until the ACIP is able to further review these CVST cases in the context of thrombocytopenia and assess their potential significance. 2. Maintain a high index of suspicion for symptoms that might represent serious thrombotic events or thrombocytopenia in patients who have recently received the J&J COVID‐19 vaccine, including severe headache, backache, new neurologic symptoms, severe abdominal pain, shortness of breath, leg swelling, petechiae (tiny red spots on the skin), or new or easy bruising. Obtain platelet counts and screen for evidence of immune thrombotic thrombocytopenia. 3. In patients with a thrombotic event and thrombocytopenia after the J&J COVID‐19 vaccine, evaluate initially with a screening PF4 enzyme‐linked immunosorbent (ELISA) assay as would be performed for autoimmune HIT. Consultation with a hematologist is strongly recommended. 2 4. Do not treat patients with thrombotic events and thrombocytopenia following receipt of J&J COVID‐19 vaccine with heparin, unless HIT testing is negative. 5. If HIT testing is positive or unable to be performed in patient with thrombotic events and thrombocytopenia following receipt of J&J COVID‐19 vaccine, non‐heparin anticoagulants and high‐dose intravenous immune globulin should be strongly considered. 6. Report adverse events to VAERS, including serious and life‐threatening adverse events and deaths in patients following receipt of COVID‐19 vaccines as required under the Emergency Use Authorizations for COVID‐19 vaccines.

Additional Vaccine Updates  Pfizer and BioNTech say vaccine is 91% effective at 6 months, protects against variants ‐ Pfizer and BioNTech said their COVID‐19 vaccine remains 91.3% effective up to 6 months after administration of the second dose, according to an updated analysis of a phase 3 study. https://www.healio.com/news/infectious‐ disease/20201109/covid19‐vaccine‐more‐than‐90‐effective‐pfizer‐says  Pfizer and BioNTech announced this week that the vaccine, which has been authorized since December in the U.S. for use in people aged 16 years or older, is also protective in adolescents aged 12 to 15 years. This is not yet approved by the FDA, and the companies plan to submit that data to the FDA, and experts said it means a vaccine could be available for this age group by next school year. https://www.healio.com/news/primary‐ care/20210331/pfizer‐and‐biontech‐say‐covid19‐vaccine‐protects‐adolescents‐plan‐to‐submit‐data‐to‐fda

 Pfizer and Moderna Messenger RNA vaccines lower risk for asymptomatic infection ‐ Participants who received two doses of a messenger RNA COVID‐19 vaccine were 80% less likely to test positive for asymptomatic SARS‐ CoV‐2, according to real‐world study results published in Clinical Infectious Diseases. https://www.cdc.gov/media/releases/2021/p0329‐COVID‐19‐Vaccines.html

 Moderna Vaccine‐ Moderna Provides Storage Update & Announces the U.S. FDA Authorizes Up To 15‐Doses Per Vial of its COVID‐19 Vaccine (attachment) o The FDA has authorized the Moderna COVID‐19 Vaccine to be kept at room temperature conditions once removed from the refrigerator for administration for 24 hours, an increase from the previous 12 hours. o Additionally, a punctured vial is now useable for up to 12 hours, an increase from the previous 6 hours. o The FDA also authorized inclusion of a new vial presentation with a maximum of 15 doses of its COVID‐19 vaccine. In parallel, the FDA also authorized a maximum of 11 doses of its COVID‐19 vaccine in the current format, from the previously authorized 10 doses per vial. The Moderna COVID‐19 Vaccine now can be supplied in two vial presentations (a multiple‐dose vial containing a maximum of 11 doses or a multiple‐dose vial containing a maximum of 15 doses). o The Company expects that the 15‐dose vials will begin shipping in the coming weeks.

COVID‐19 Vaccine: “Practical Clinical Considerations”: https://www.acpjournals.org/doi/full/10.7326/M21‐1260

Upcoming TACHC Virtual Trainings:

Register HERE for the upcoming “COVID‐19 Vaccine Administration Open‐House Call”, taking place on Wednesday April 28 from 12‐1pm via Zoom. Health centers provide critical services to the most vulnerable Texans and therefore getting the vaccine directly to those patients is imperative. We also know that health centers were working with limited resources prior to the global health pandemic, and COVID has stretched staff time even more. TACHC has worked directly with DSHS to provide some solutions to the recent issues and challenges associated with COVID Vaccine reporting and administration that our health centers have been experiencing. The purpose of this Open‐House Call is to openly & safely discuss and review FAQs to help resolve these concerns. An infographic with FAQs from TACHC will also be shared during this open‐house call. All Health Center Staff who work directly with the administration and reporting of COVID‐19 vaccines are welcome to attend. Learning Objectives:

3 1. To create a safe and open forum for Health Center Staff Members to share challenges related to COVID‐19 Vaccine reporting and administration. 2. To provide resources and solutions to presented challenges through the infographic with FAQs. 3. To connect health centers with one another and DSHS as needed for ongoing technical assistance and best practice sharing.

"Trusted Messengers: Let’s Talk Vaccines" Webcast ‐ 4/30 @ 12:noon ‐1:pm Who are the “Trusted Messengers” and how do we bridge the gap with difficult conversations? This presentation will provide health center staff with an opportunity to hear from Dr. Jason McLellan, molecular biologist researcher at University of Texas, whose team was able to map the genetic code of the key spike protein, part of the COVID virus that infects human beings and the crucial element in creating a “structure‐based vaccine.” Dr. McLellan and his team at the University of Texas at Austin collaborated with the National Institutes of Health to share the spike protein model with scientists around the world to develop the vaccines and the treatment modalities. Dr. McLellan will provide science‐based 'myth‐busting' insight during his presentation. Patients 12 years and older with mild to moderate symptoms who are at risk for severe COVID‐19 disease are eligible to receive monoclonal antibody treatments provided by the federal government  A panel discussion will follow, focusing on vaccine messaging strategies with health center CMO Dr. Yvette Poindexter, faith‐based leaders, and front line workers share their views in this discussion on best practices to achieve vaccine confidence over hesitance or deliberation.  This Webinar is brought to you through TACHC’s collaboration with the U.S. Department of Housing (HUD) Southwest Region and BiGAustin (Business Investment Growth) to communicate with health center patients and link health centers to HUD partners to improve access to: COVID testing, COVID‐19 vaccines, and therapeutics (monoclonal antibody infusions). Registration link: https://www.tachc.org/Online/Events/Event_display.aspx?EventKey=TLKVACCINE&WebsiteKey=c7fdf3bd‐706d‐ 4253‐8852‐9535b5cf43c2

Therapeutics:  Patients 12 years and older with mild to moderate symptoms who are at risk for severe COVID‐19 disease are eligible to receive monoclonal antibody treatments provided by the federal government  The COVID‐19 Treatment Guidelines Panel (the Panel) recommends using one of the following combination anti‐ SARS‐CoV‐2 monoclonal antibodies to treat outpatients with mild to moderate COVID‐19 who are at high risk of clinical progression, as defined by the Emergency Use Authorization (EUA) criteria (listed in alphabetical order): o Bamlanivimab 700 mg plus etesevimab 1,400 mg (AIIa); or o Casirivimab 1,200 mg plus imdevimab 1,200 mg (AIIa). o https://www.covid19treatmentguidelines.nih.gov/whats‐new/  Treatment should be started as soon as possible after the patient receives a positive result on a SARS‐CoV‐2 antigen or nucleic acid amplification test (NAAT) and within 10 days of symptom onset.  Therapeutics Finder Map to assist physicians in locating facilities that are distributing the treatments. Physicians must contact the institutions directly to determine availability and to arrange for any infusion.

Publications & Webinars:  “Addressing Vaccine Hesitancy in BIPOC Communities — Toward Trustworthiness, Partnership, and Reciprocity” (article attached)  Clinical Leaders Peer to Peer Forum: “Building COVID‐19 Vaccine Trust for Community Health Center Patients” held on April 7, 2021 View webinar recording  Vaccine Hesitance, recommended this short video, produced by the Black Women's Health Imperative.  Subject: "When Should You Use Monoclonal Antibodies to Treat and Prevent COVID‐19? Which Ones Should You Use, and What About the Variants?" Click here to view: When Should You Use Monoclonal Antibodies to Treat and Prevent COVID‐19? Which Ones Should You Use, and What About the Variants?  “Utilizing Community Health Workers and Pharmacists to Address Health Inequities” View Recording

4  Watch COVID‐19 Vaccine Forum IV: Practical Clinical Considerations ACP and Annals of Internal Medicine hosted a panel of experts who provided unique insight and practical information related to COVID‐19 vaccines including the impact of COVID‐19 variants on vaccine efficacy; comparative effectiveness of the different vaccines; and post‐vaccine behavior recommendations. A recording of the forum, held on March 24, and a summary of key takeaways are now available. Access recording and summary.

 American Medical Association collaborated with the COVID‐19 Healthcare Coalition and others to launch the COVID‐19 Telehealth Impact Study Tune in for our free webinar on April 21 at 12:30 p.m. CST, where we will review the most recent results of this survey and the implications for telehealth’s future: https://onlinexperiences.com/scripts/Server.nxp?LASCmd=AI:4;F:QS!10100&ShowUUID=028C41F7‐2BE9‐4E53‐ 9095‐ 30491C8866F5&utm_source=Selligent&utm_medium=email&utm_term=%25m%25d%25y&utm_content=HS_E V_Wbnr_COVID_ImpctStdy_2_041221&utm_campaign=HS_EV_Wbnr_COVID_ImpctStdy_2_041221&utm_uid=2 733393&utm_effort=&utm_h=&Referrer=http%3A%2F%2Fclick.ama‐assn.org%2F

 Expert Panel: What is the State of COVID Testing in a Post‐Vaccine Environment? When vaccines are broadly implemented and SARS‐CoV‐2 positivity rates are lower, pooled testing may become more widespread as a means to prevent future outbreaks. There may also be greater adoption of serology tests to monitor people who have been vaccinated, as well as the potential for more decentralized testing. April 16, 2021 at 12:00 noon CST. REGISTER HERE

 “The Role of Community Health Centers as Public Health Emergency First Responders: One Year Into the COVID‐19” www.CDNetwork.org Tuesday April 27, 2021 11:30 am – 1:30 p.m. CSTCT Register Now!

 Immunization Videos: A new series of videos addresses adult immunization topics including several specific to COVID-19: Watch Videos. o Flu Versus COVID-19: A Contagious Conundrum o mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna) o Janssen Vaccine: A Third Vaccine in Our Fight Against COVID-19

Thank you for all of your work and continued dedication as we move through the pandemic together. ~Roxana

Roxana L. Cruz, MD , FACP Director of Medical & Clinical Affairs

Texas Association of Community Health Centers 5900 Southwest Parkway, Bldg. #3 Austin, Texas 78735 P (512) 329-5959 F (512) 329-9189 e-mail: [email protected] www.TACHC.org

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6 Texas COVID-19 Vaccine Allocation - Week of April 12 (Week 18) This list includes only first doses of vaccine. Addresses are shipping addresses, not necessarily where vaccination is occurring.

HUB PROVIDERS Moderna Pfizer J&J Total Provider Name Address City County Doses Doses Doses Doses Lhd Angelina County And Cities Health District (Re) 503 Hill St Ste 100 Lufkin ANGELINA 2,000 - - 2,000 Medical Clinic Of Muleshoe 708 S 1st St Muleshoe BAILEY 300 - - 300 A+ Life Style Medical Group 815 Hwy 71 W Bastrop BASTROP 2,000 - - 2,000 Christus Spohn Health System Beeville 1500 E Houston St Beeville BEE - 1,170 - 1,170 Lhd Bell County Public Health District (Re) 820 N 31st Street Temple BELL - 7,020 - 7,020 Samhd Main Immunizations Clinic 210 N Mel Waiters Way San Antonio BEXAR 300 12,870 1,000 14,170 University Health System - Inpatient 4502 Medical Dr San Antonio BEXAR - 19,890 - 19,890 Wellness 360 (Adult) 7703 Floyd Curl Dr San Antonio BEXAR - 7,020 2,000 9,020 Christus St Michael Health System 2600 Saint Michael Dr Texarkana BOWIE 2,000 - - 2,000 Chi St Joseph Health College Station Hospital 1604 Rock Prairie Rd College Station BRAZOS 6,100 - - 6,100 BSW Medical Center Marble Falls 810 Tx-71w Marble Falls BURNET - 1,170 - 1,170 Ut Health Rgv Multispecialty 2106 Treasure Hills Blvd Ste 1.326 Harlingen CAMERON - 1,170 - 1,170 Ccdhhs San Benito Nursing Office 1390 W Expressway 83 San Benito CAMERON 6,000 - - 6,000 CHAMBERS COUNTY HEALTH DEPT ANAHUAC 102 AIRPORT RD Anahuac CHAMBERS 1,200 - - 1,200 Baylor Scott & White Medical Center - Plano 4700 Alliance Blvd Plano COLLIN - 11,700 - 11,700 Coryell Health Medical Clinic 1507 W MAIN ST Gatesville CORYELL - 1,170 - 1,170 Coon Memorial Hospital 1411 Denver Ave Dalhart DALLAM - 1,170 - 1,170 Baylor University Med Cntr Dallas 3500 Gaston Ave Dallas DALLAS - 5,850 - 5,850 City Of Dallas 1500 Marilla St Dallas DALLAS 5,000 - - 5,000 LHD Dallas County Health And Human Services (incl. Fair Park) 2377 N Stemmons Fwy Dallas DALLAS 11,000 11,700 21,000 43,700 Parkland Hospital 5200 Harry Hines Boulevard Dallas Dallas - 12,870 - 12,870 UT Southwestern Medical Center 5323 Harry Hines Blvd Dallas Dallas - 9,360 - 9,360 Lhd Garland (City Of) Health Dept (Re) 206 Carver Dr Garland DALLAS 2,000 - - 2,000 LHD Denton County Public Health (RE) 535 S. Loop 288 Denton DENTON - 12,870 - 12,870 Medical Center Hospital 500 W 4th St Odessa ECTOR - 1,170 - 1,170 City of El Paso Fire Department 301 George Perry El Paso EL PASO 10,000 - - 10,000 University Medical Center of El Paso 4815 Alameda Ave El Paso EL PASO - 2,340 - 2,340 Baylor Scott And White Medical Center - Waxahachie 2400 N. I-35e Waxahachie ELLIS - 3,510 - 3,510 Falls Community Hospital & Clinic 322 Coleman St Marlin FALLS - 1,170 - 1,170 Tmc Bonham Hospital 504 Lipscomb St Bonham FANNIN - 1,170 - 1,170 LHD FORT BEND COUNTY HEALTH DEPARTMENT (HHS) (RE) 4520 Reading Rd Rosenberg FORT BEND - 5,850 - 5,850 University Of Texas Medical Branch Hospital 301 University Blvd Galveston GALVESTON - 8,190 - 8,190 LHD Galveston County Health District (RE) 9850 B Emmett F Lowry EXpy Texas City GALVESTON 5,000 - - 5,000 Hill Country Memorial Hospital 1020 S State Highway 16 Fredericksburg GILLESPIE - - 600 600 CHRISTUS Good Shepherd Medical Center Longview 700 E Marshall Ave Longview GREGG - 1,170 - 1,170 Chi St Lukes Health 6720 Bertner Ave Houston HARRIS - 2,340 - 2,340 HCPH Main Office 2223 West Loop South Houston HARRIS 10,000 - - 10,000 Houston Health Department Immunization Bureau 8000 N Stadium Dr Houston Harris 10,000 - - 10,000 Houston Methodist Hospital 6565 Fannin St Houston HARRIS - 17,550 2,000 19,550 Memorial Hermann Memorial City Medical Center 921 Gessner Rd Houston HARRIS 2,500 12,870 - 15,370 NRG Center One NRG Park Houston HARRIS - - 42,000 42,000 School Of Nursing - Main Building 1851 Crosspoint Ave. Houston HARRIS - - 5,000 5,000 Lhd Hays County Health Department (Re) 401 Broadway St Ste A San Marcos HAYS - 3,510 - 3,510 DHR Health 5501 South McColl Road Edinburg HIDALGO - 7,020 - 7,020 Lhd Hidalgo County Health Department (Re) 1304 S 25th Ave Edinburg HIDALGO 6,000 - - 6,000 Ut Health Rgv Employee Health Edinburg 1210 W Schunior St Edinburg HIDALGO - 2,340 - 2,340 Christus Spohn Health System Alice 2500 E Main St Alice JIM WELLS - 1,170 - 1,170 Christus Spohn Health System Kleberg 1311 General Cavazos Blvd Kingsville KLEBERG - 1,170 - 1,170 Kleberg County Sheriff's Office 1500 E King Ave Kingsville KLEBERG 1,000 - - 1,000 Lhd Paris-Lamar Co Health Dept (Re) 400 W Sherman St Paris LAMAR 500 - - 500 Emergency Hospital Systems, LLC 300 E Crockett Cleveland LIBERTY - 1,170 - 1,170 Lhd Lubbock City Health Dept (Re) 806 18th St Lubbock LUBBOCK - - 5,000 5,000 Eagle Pass Fire Department 2558 El Indio Hwy Eagle Pass MAVERICK 600 - - 600 Lhd Waco-Mclennan Co Phealth Dist (Re) 225 W Waco Dr Waco MCLENNAN - - 1,500 1,500 Providence Health - Providence Health Center 6901 Medical Pkwy Waco MCLENNAN - 2,340 - 2,340 Lone Star Community Health Center 605 S. Conroe Medical Dr Conroe MONTGOMERY 1,000 - - 1,000 LHD Corsicana-Navarro Public Health District (RE) 618 N Main Corsicana NAVARRO 1,500 - 100 1,600 Driscoll Health System 3533 S ALAMEDA ST Corpus Christi NUECES - 4,680 - 4,680 LHD Corpus Christi-Nueces County Public Health District (RE) 1702 Horne Road Corpus Christi NUECES 7,000 - - 7,000 Parker County Hospital District 1130 Pecan Dr Weatherford PARKER - 2,340 - 2,340 LHD Amarillo DOH 1000 Martin Rd Amarillo POTTER 3,000 - - 3,000 Pecos Valley Rural Health Clinic 2335 S Pigman St Pecos REEVES 800 - - 800 Lhd Nethealth (Re) 815 N Broadway Ave Tyler SMITH - 3,510 - 3,510 ATT Stadium Vx Arlington FD 620 W Division St. Arlington TARRANT 7,000 - 21,000 28,000 Tarrant Co Ph Imm Outreach 1101 S Main St Ste 1350 Fort Worth TARRANT 20,000 - 20,000 Texas Health Medical Support 1100 BRIDGEWOOD DR STE 107 Fort Worth TARRANT - 11,700 - 11,700 Lhd Abilene-Taylor County Health Department (Re) 850 N 6th St Abilene TAYLOR 1,000 - - 1,000 Shannon Pharmacy 119 E. Beauregard Ave San Angelo TOM GREEN - 2,340 - 2,340 Austin Public Health 15 Waller Street Austin TRAVIS 12,000 - - 12,000 Ut Health Austin (Dell Medical School) 1601 TRINITY ST STOP Z0200 Austin TRAVIS - 8,190 - 8,190 LHD Victoria City-CO Health Dept (RE) 2805 N NAVARRO ST # 102 Victoria VICTORIA 2,000 - - 2,000 City Of Laredo Health Department 2600 Cedar Ave Laredo WEBB 5,000 - - 5,000

ADDITIONAL PROVIDERS Moderna Pfizer J&J Total Provider Name Address City County Doses Doses Doses Doses Sycamore Medical Clinic 1021 S Sycamore St Palestine ANDERSON - - 100 100 Texas Department of Criminal Justice Powledge 1400 FM 3452 Palestine ANDERSON - - 100 100 Texas Department of Criminal Justice BETO 1391 FM 3328 Tennessee Colony ANDERSON - - 100 100 Lhd Andrews City-County Health Department (Re) 208 Nw 2nd St Andrews ANDREWS 200 - - 200 Texas Department of Criminal Justice DUNCAN 1502 S. First Street Diboll ANGELINA 100 - - 100 Abeldt's Gaslight Pharmacy, Inc. 200 Gaslight Blvd Lufkin ANGELINA 100 - - 100 Family Health Center At Elgin 711 W 10th Street Elgin BASTROP 100 - - 100 DSHSHSR 7 HQ - Temple (RE) 2408 South 37th Street Temple BELL 1,000 - 500 1,500 Lone Star Circle Of Care At Temple 2112 Sw H K Dodgen Loop Ste 110 Temple BELL 100 - - 100 Centromed Indian Creek Clinic 5439 Ray Ellison Blvd San Antonio BEXAR 500 - - 500 Conviva Greco 4360 Greco Dr San Antonio BEXAR - - 400 400 Conviva Guadalupe 1314 Guadalupe St San Antonio BEXAR - - 200 200 Conviva Legacy Place 18414 US Hwy 281 North San Antonio BEXAR - - 500 500 Conviva Live Oak 12602 Toepperwein Rd Ste 100 # 100 San Antonio BEXAR - - 400 400 Davila Pharmacy 1423 Guadalupe San Antonio BEXAR 500 - - 500 Direct Care Of Texas 18911 Hardy Oak Blvd San Antonio BEXAR 200 - - 200 DMS PHARMACY LLC 305 E. EUCLID AVENUE San Antonio BEXAR 100 - - 100 Dshs HSR 8 Hq - San Antonio (Re) 7430 Louis Pasteur Dr San Antonio BEXAR - - 1,100 1,100 Fresenius Medical Care San Antonio LLC 305 N. Frio St. San Antonio BEXAR - - 100 100 Gonzaba Medical Group Main Clinic 720 Pleasanton Rd San Antonio BEXAR - 2,340 - 2,340 Health by Design 13409 George Rd. San Antonio BEXAR - - 1,800 1,800 Marathon Petroleum HS - San Antonio 19100 Ridgewood Parkway San Antonio BEXAR 200 - - 200 MED SECURITY INC 10010 SAN PEDRO San Antonio BEXAR - - 100 100 METHODIST HOSPITAL AND METHODIST CHILDRENS HOSPITAL 770 Floyd Curl Dr San Antonio BEXAR 1,500 - - 1,500 Northeast Pediatric Assoc 18707 Hardy Oak Blvd Ste 225 San Antonio BEXAR 200 - - 200 St Lukes Baptist Hospital 7930 Floyd Curl Dr San Antonio BEXAR - 2,340 - 2,340 Start Center For Cancer Care 4383 Medical Drive San Antonio BEXAR 500 - - 500 Texas Center For Infectious Disease 2303 Se Military Dr San Antonio BEXAR 200 - - 200 Trinity University Student Health Services One Trinity Place San Antonio BEXAR - - 600 600 University Of Texas Medicine 8300 Floyd Curl Dr San Antonio BEXAR - - 100 100 University Of The Incarnate Word 2547 E Commerce St Ste 300 San Antonio BEXAR - - 100 100 University Of The Incarnate Word Health Services 4301 Broadway, Cpo #30 San Antonio BEXAR - - 500 500 UT Health San Antonio Verde Hills PCC 10350 Bandera Rd Ste 140 San Antonio BEXAR - - 100 100 UT HEALTH-GERIATRIC & SUPPORTIVE CARE CLINIC 2833 Babcock San Antonio BEXAR 100 - - 100 Vivir With Salud 8006 West Ave San Antonio BEXAR 100 - - 100 Wellmed at Southwest Military 517 SW Military San Antonio BEXAR - - 300 300 Wellmed General Mc Mullen 448 Castroville Rd. San Antonio BEXAR - - 300 300 Zarzamora Healthcare LLC 2716 SW Military Dr. San Antonio BEXAR 200 - - 200 Utmb-Angleton Danbury Campus 132 E Hospital Dr Angleton BRAZORIA - 5,850 - 5,850 BASF The Chemical Company 602 Copper Road Freeport BRAZORIA 400 - - 400 Dow Family Health Center 270 Abner Jackson Pkwy Lake Jackson BRAZORIA - - 100 100 Village Medical Shadow Creek 11619 Shadow Creek Pkwy Pearland BRAZORIA - - 100 100 Blinn College 2423 Blinn Blvd. Bryan BRAZOS 1,000 - - 1,000 Lhd Brazos County Health District (Re) 201 N Texas Ave Bryan BRAZOS 300 - - 300 Texas A And M University Student Health Center 311 Houston St College Station BRAZOS - 2,340 2,000 4,340 Brooks County Detention Center 901 CR 201 Falfurrias BROOKS - - 100 100 Family Wellness Center, P.A. 2300 U S Hwy 281 N Marble Falls BURNET 300 - - 300 Lscc Family Care Center At Marble Falls 802 Avenue J Marble Falls BURNET 100 - - 100 Brownsville Community Health Center 191 E. Price Rd Brownsville CAMERON 1,200 - - 1,200 City of Brownsville Fire Department 62 E Alton Gloor Brownsville CAMERON 6,000 - - 6,000 City of Harlingen 502 E. Tyler Harlingen CAMERON - 2,340 - 2,340 DSHS Harlingen (RE) 601 W Sesame Drive STE 100 Harlingen CAMERON 10,000 1,170 2,000 13,170 Su Clinica Women's Health Center- Harlingen 1706 Treasure Hills Blvd Harlingen CAMERON 100 - - 100 Wellmed Central Park 509 South Expressway 83 Harlingen CAMERON 100 - - 100 Sanchez Mario A Do 106 N Main St La Feria CAMERON 200 - - 200 BERG & MINIGUTTI PLLC 8000 ELDORADO PKWY McKinney COLLIN 100 - - 100 Wellpath Healthcare Collin County Detention Facility 4300 Community Ave McKinney COLLIN - - 100 100 Cigna Healthcare Of Texas Plano 1640 Dallas Pkwy Plano COLLIN - - 100 100 Fresenius West Plano 4405 Tradition Trail Plano COLLIN 200 - - 200 North Texas Hospital Physicians Group 6020 W Parker Rd Plano COLLIN 100 - - 100 COLUMBUS LOCAL PHARMACY 109 Shult Dr. Columbus COLORADO 100 - - 100 Eagle Lake Drugstore 702 S McCarty Avenue Eagle Lake COLORADO 100 - - 100 Rice Medical Associates - Eagle Lake 610 S Austin Rd Eagle Lake COLORADO - - 100 100 The Pharmacy Shop 406 Youens Drive Weimar COLORADO 500 - - 500 Youens And Duchicela Clinic 402 Youens Dr Weimar COLORADO 100 - - 100 Acacia Medical Mission 1781 E. Ammann Rd. Bulverde COMAL - - 100 100 ASPG dba CHRISTUS Promptu Urgent Care - New Braunfels 1659 W State Highway 46 New Braunfels COMAL - - 400 400 Christus Trinity Clinic Hill Country Oak Run 1850 W State Highway 46 New Braunfels COMAL - - 200 200 Conviva New Braunfels 1860 S Seguin Ave Bldg E New Braunfels COMAL - - 500 500 Medpost Urgent Care New Braunfels 160 CREEKSIDE WAY New Braunfels COMAL - - 100 100 New Braunfels Regional Rehabilitation Hospital 2041 Sundance Parkway New Braunfels COMAL - - 200 200 New Braunfels Rural Health Clinic 705 Landa St Ste C New Braunfels COMAL 100 - - 100 Resolute Health Hospital 555 Creekside Crossing New Braunfels COMAL - - 100 100 Health Hero America 244 Flightline Spring Branch COMAL_State 300 1,170 - 1,470 Carrollton Farmers Branch ISD 1445 North Perry Road Carrollton DALLAS - - 200 200 Bluitt-Flowers Clinic 303 E Overton Rd Dallas DALLAS 300 - - 300 Cooper Clinic 12200 Preston Rd Dallas DALLAS 100 - - 100 Dallas Baptist University Student Health Center 3000 Mountain Creek Pwy Dallas DALLAS - - 600 600 Lake June Medical Clinic 7716 Lake June Rd Dallas DALLAS 200 - - 200 Methodist Dallas Medical Center 1441 N Beckley Ave Dallas DALLAS - 2,340 - 2,340 Parkland Hospital System-Center for Geriatrics 2231 Butler Street Dallas DALLAS 200 - - 200 Prism Health North Texas South Dallas Health Center 4922 Spring Ave Dallas DALLAS - - 200 200 Texas Tech University Health Sciences Center 5920 Forest Park Road Dallas DALLAS 100 - - 100 Wellmed at Redbird Square 3107 Camp Wisdom Rd Dallas DALLAS - - 500 500 Metrocrest Family Medical Clinic 1 Medical Pkwy Farmers Branch DALLAS 200 - - 200 Garland Independent Pharmacy 3641 Broadway Blvd Garland DALLAS 1,500 - - 1,500 Mi Doctor #13 Grand Prairie 410 E Pioneer Pkwy Ste 300 Grand Prairie DALLAS - - 100 100 Crossover Health 3021 Gateway Drive Irving DALLAS 100 - - 100 ExxonMobil Medicine & Occupational Health 5959 Las Colinas Blvd Ste 2446 Irving DALLAS 100 - - 100 Healthcare Associates Of Irving, LLP 6161 N State Hwy 161, Suite 100 Irving DALLAS 200 - - 200 Mission East Dallas 4550 Gus Thomasson Rd Mesquite DALLAS 100 - - 100 Caring For Children Foundation Care Van 1001 E. Lookout Rd Richardson DALLAS 1,500 - - 1,500 Family Healthcare Associates Richardson 2821 E PRESIDENT GEORGE BUSH HWYRichardson DALLAS 100 - - 100 Lamesa Primary Clinic 1502 N Avenue K Lamesa DAWSON 200 - - 200 DSHS Hereford 600 N 25 Mile Ave Ste 500 Hereford DEAF SMITH 100 - - 100 Regence Health Network Inc Hereford 125 W Park Ave Hereford DEAF SMITH 100 - - 100 Trinity Apothecary 2501 E. Hebron Pkwy, Suite 100B Carrollton DENTON 100 - - 100 Horizon Medical Center 2813 South Mayhill Road Denton DENTON - - 100 100 Sridhar Iyer Md 802 N Bonnie Brae Denton DENTON 200 - - 200 SREEVANI KUNCHAM, MD., PA. 131 Degan Ave Lewisville DENTON 100 - - 100 Carrizo Springs Kidney Disease Clinic 409 South 7th Street Carrizo Springs DIMMIT - - 100 100 Eastland Memorial Hospital Po Box 897 Eastland EASTLAND - 1,170 - 1,170 Lhd Ector County Health Department (Re) 221 N Texas Ave Odessa ECTOR 100 - 100 200 Texas Tech Health Science Center 701 W 5th St Ste 1111 Odessa ECTOR 200 - - 200 Centro De Salud Familiar La Fe Inc/Adult Satellite Clinic 823 E Yandell Dr El Paso EL PASO 200 - - 200 Centro De Salud Lisbon 200 Lisbon Street El Paso EL PASO 200 - - 200 CODE 4 EMERGENCY SERVICES LLC - EL PASO 240 N MOON El Paso EL PASO 4,000 - - 4,000 Conviva Cliffside 1211B Cliff Drive El Paso EL PASO - - 100 100 Conviva Vista del Sol 10435 Vista Del Sol Dr. El Paso EL PASO 100 - - 100 Dept of Public Health-Remcon 7380 Remcon Circle El Paso EL PASO 200 - - 200 Dept Public Health-Alameda 9341 Alameda El Paso EL PASO 200 - - 200 Dept Public Health-Railroad 9566 Railroad Dr El Paso EL PASO 200 - - 200 Dept Public Health-Stanton 220 S. Stanton El Paso EL PASO 200 - - 200 El Paso County Community College 10700 Gateway Blvd. East El Paso EL PASO - - 600 600 El Paso Drive Iz Clinic El Paso Dph 5115 El Paso Dr El Paso EL PASO 200 - - 200 Henderson Health Center El Paso 721 S Mesa St El Paso EL PASO 200 - - 200 Hillrise Home Management LLC 10662 Vista Del Sol Dr. El Paso EL PASO 200 - - 200 La Fe Care Center 1505 Mescalero Dr El Paso EL PASO 200 - - 200 Life Ambulance Service Inc. 5720 Trowbridge Dr El Paso EL PASO - - 100 100 SISD Employee Health Clinic 11950 Bob Mitchell El Paso EL PASO 1,000 - - 1,000 Texas Tech University Health Sciences Center El Paso Occupational H 4801 Alberta Ave Ste A02 El Paso EL PASO - 1,170 - 1,170 The Hospitals of Providence Memorial Campus 2001 N Oregon St El Paso EL PASO - 2,340 - 2,340 The University of Texas at El Paso 500 W. University Ave El Paso EL PASO - 2,340 - 2,340 Transmountain Primary Care 13001 Eastlake Blvd Suite 105 El Paso EL PASO 200 - - 200 Umc El Paso Clinic Ysleta 300 S Zaragoza Rd El Paso EL PASO - 1,170 - 1,170 Umc Neighborhood Healthcare Center West 6600 N Desert Blvd El Paso EL PASO - 1,170 - 1,170 Umc Nhc East 1521 Joe Battle Blvd. El Paso EL PASO - 1,170 - 1,170 Wellmed Kenworthy 9999 Kenworthy El Paso EL PASO - - 100 100 Wellmed Remcon 7430 Remcon Circle El Paso EL PASO - - 1,000 1,000 Ysleta Health Center El Paso Dph 110 Candelaria St El Paso EL PASO 200 - - 200 Umc El Paso Neighborhood Health Fabens 101 Potasio Fabens EL PASO - 1,170 - 1,170 Centro De Salud Familiar La Fe 12101 Socorro Rd. San Elizario EL PASO 200 - - 200 The Prescription Shop 120 S Grand Ave Waxahachie ELLIS 100 - - 100 Erath County EMS 830 B East Rd Stephenville ERATH 1,000 - - 1,000 Tarleton State University Student Health Services 600 N. Rome Stephenville ERATH - - 200 200 Tejas Healthcare Clinic 890 E Travis St La Grange FAYETTE 100 - - 100 Ibn Sina Foundation Community Clinic 16345 S Post Oak Rd Houston FORT BEND 100 - - 100 Christ Clinic 25722 Kingsland Blvd Katy FORT BEND 100 - - 100 Kelsey-Seybold Clinic Sienna Plantation 7010 Highway 6 Missouri City FORT BEND - - 100 100 OakBend Medical Center Nursey 1705 Jackson Street Richmond FORT BEND 500 - - 500 ImmunoGenomics LLC 202 Industrial Blvd Sugar Land FORT BEND - - 100 100 Memorial Hermann Sugar Land 17500 W Grand Pkwy S Sugar Land FORT BEND - 17,550 - 17,550 SLMG SUGARLAND- INTERNAL MEDICINE AND PEDIATRICS 1327 Lake Pointe Pkwy Ste 410 Sugar Land FORT BEND - - 100 100 ST MICHAEL'S ELITE HOSPITAL 16000 SOUTHWEST FREEWAY Sugar Land FORT BEND 200 - - 200 Texas Oncology Pa Sugar Land 1350 First Colony Blvd Sugar Land FORT BEND 100 - - 100 Voss Family Clinic, PLLC 11920 S. Texas 6 STE 1500 Sugar Land Fort Bend 100 - - 100 Family Medicine Clinic - Pearsall 151 Medical Dr Pearsall FRIO - - 100 100 Hometown Healthcare - Pearsall 404 E San Marcos St Pearsall FRIO - - 100 100 Gator Hope Clinic 3800 Baker Dr Dickinson GALVESTON 300 - - 300 Texas Department of Criminal Justice Young 5509 Attwater Ave. Dickinson GALVESTON - - 100 100 Austin Teen Health Center 1514 Avenue N 1/2 Rm 172 Galveston GALVESTON 100 - - 100 Ball Teen Health Center 4115 Avenue O Ste 1016 Galveston GALVESTON 200 - - 200 Central Teen Health Center 3014 Sealy St Rm 157 Galveston GALVESTON 100 - - 100 Health by Design Valero Texas City Clinic 1301 Loop 197 S Texas City GALVESTON - - 100 100 Garza County Law Enforcement Center 412 E 15th St Post GARZA 200 - - 200 Sievers Medical Clinic 1110 Sarah DeWitt Dr. Gonzales GONZALES 500 - - 500 Dshs Pampa 121 S Gillespie St Pampa GRAY 100 - - 100 Care ATC Ruiz Foods 2300 W Morton St Denison GRAYSON 200 - - 200 Grayson County Health Department-Sherman 515 North Walnut St. Sherman Grayson - 2,340 - 2,340 Health Source Pharmacy, INC 1733 Texoma Pkwy, Sherman GRAYSON 100 - - 100 Wnj Regional Medical Center 500 N Highland Ave Sherman GRAYSON 300 - - 300 LHD Gregg County Health Department (RE) 405 E. Marshall Ave Longview GREGG 100 - - 100 City of Schertz EMS 1400 Schertz Parkway Schertz GUADALUPE 3,000 - - 3,000 Kellum Family Medicine 3401 Fm 3009 Schertz GUADALUPE - - 1,000 1,000 Guadalupe Regional Medical Center 1215 E Court Seguin GUADALUPE - - 1,000 1,000 Hansford County Hospital District (Hospital) 707 Roland St Spearman HANSFORD - - 400 400 Chevron Phillips Chemical Cedar Bayou Baytown 9500 East Freeway Baytown HARRIS 100 - - 100 Exxon Mobil Medicine And Occupational Health Baytown 5000 Bayway Dr Baytown HARRIS 1,500 - - 1,500 Clinicas Mi Doctor- #19 Bissonnet 5835 Bissonnet St Bellaire HARRIS - - 100 100 Fairfield Family Physicians 15201 Mason Rd Ste 1200 Cypress HARRIS 200 - - 200 CORE Occupational Medicine 126 W San Augustine Deer Park HARRIS 300 - - 300 Deer Park Family Clinic, P.A. 2910 Center St Deer Park HARRIS - - 100 100 Acres Home Health Center 818 Ringold St Houston HARRIS 300 - - 300 Aldine Health Center 4755 Aldine Mail Route Rd Houston HARRIS 1,500 - - 1,500 Baylor College Of Medicine 1 Baylor Plz Stop Bcm-667 Houston HARRIS - 1,170 - 1,170 Ben Taub General Hospital 1504 Taub Loop Houston HARRIS 6,000 - - 6,000 Casa De Amigos Health Center 1615 N Main St Houston HARRIS 200 - - 200 Casa El Buen Samaritano 14060 Dublin St Houston Harris 400 - - 400 Chevron Houston Medical Clinic 1400 Smith St Houston Harris 800 - - 800 CITGO 1293 Eldridge Parkway Houston HARRIS - - 100 100 Cleveland E Odom 5516 Lockwood Dr Houston HARRIS 500 - - 500 Clinicas Mi Doctor- #24 Airline 5402 Airline Dr Houston HARRIS - - 100 100 COH Northside Health Center 8523 N Arkansas St Houston HARRIS 1,200 - - 1,200 conocophillips 925 N. Eldridge Pkwy Houston HARRIS 200 - - 200 El Centro De Corazon Magnolia Clinic 7037 Capitol St Houston HARRIS - - 100 100 HEALTHCARE FOR THE HOMELESS-HOUSTON 1934 CAROLINE ST Houston HARRIS 100 - - 100 Hope Clinic West 12121 Westheimer Rd Houston HARRIS 100 - 100 200 Kelsey Seybold Clinic - Houston 1 1111 Augusta Dr Houston HARRIS 500 - - 500 Kelsey-Seybold Main Campus 2727 West Holcombe Blvd Houston HARRIS - 11,700 - 11,700 La Nueva Casa De Amigos Health Center 1809 N Main St Houston HARRIS 600 - - 600 Lbj Hospital - Harris County Hospital District 5656 Kelley St Houston HARRIS 6,000 - - 6,000 Lone Star Circle Of Care At The University Of Houston 4849 Calhoun Road Houston HARRIS 100 - - 100 Medical Clinic Of Houston - Houston - 1701 Sunset Boulevard 1701 Sunset Blvd Houston HARRIS - 2,340 - 2,340 Meyerland Kelsey-Seybold Clinic 560 Meyerland Plaza Mall Houston HARRIS 200 - - 200 NURSES NIGHT & DAY, INC 4310 AUSTIN ST Houston HARRIS 200 - - 200 Oncology Consultants, PA 2130 West Holcombe Houston HARRIS 300 - - 300 Sharpstown Health Services 6201 Bonhomme Rd Ste 300S Houston HARRIS 600 - - 600 St Johns Physician 9180 Bellaire Blvd Houston HARRIS - 1,170 - 1,170 TCH Main 6621 Fannin St Mc 22510 Houston HARRIS - 3,510 - 3,510 Texas Children's Hospital West Campus 18200 Katy Freeway Houston HARRIS - 1,170 - 1,170 TEXAS MEDICAL & GERIATRIC CENTER 2101 CRAWFORD STREET Houston HARRIS 100 - - 100 The Harris Center for Mental Health and IDD 9401 Southwest Freeway Houston HARRIS 300 - - 300 The Houston Dow Center Health Services 1254 Enclave Parkway Houston HARRIS 100 - - 100 United Memorial Medical Center 510 West Tidwell Road Houston HARRIS 2,000 2,340 500 4,840 UT MD Anderson Cancer Center 1515 Holcombe Blvd Houston HARRIS - 12,870 - 12,870 UT Physicians Multispecialty- Greens 550 Greens Parkway Ste 150 Houston HARRIS - - 100 100 Village Medical - Memorial 9055 Katy Fwy Ste 200 Houston HARRIS 100 - - 100 Wellmed East Alief 9380 W Sam Houston Pkwy Houston HARRIS - - 200 200 Kelsey-Seybold Summer Creek 8233 N Sam Houston Pkwy E Humble HARRIS 200 - - 200 Kelsey-Seybold Clinic - West Grand Parkway 2510 W. Grand Parkway N. Katy HARRIS 200 - - 200 Chevron Phillips Chemical PPC 1400 Jefferson Rd Pasadena HARRIS - - 100 100 Kelsey Seybold Clinic Pasadena 5001 E Sam Houston Pkwy S Pasadena HARRIS 200 - - 200 City Of South Houston EMS 506 Georgia South Houston HARRIS 200 - - 200 Chevron Phillips Chemical 10001 Six Pines Dr Spring HARRIS - - 100 100 Crossover Health Medical Group 28420 HARDY TOLL ROAD Spring HARRIS 200 - - 200 ExxonMobil Corporation 22777 Springwoods Village Parkway Spring HARRIS 400 - - 400 TOMAGWA HealthCare Ministries 455 School St Tomball Harris 200 - - 200 Ibn Sina Community Clinic 15132 Old Galveston Webster HARRIS 100 - - 100 University Of Texas Medical Branch - Clear Lake 200 BLOSSOM ST Webster HARRIS - 1,170 - 1,170 Ascension Seton Health Center Buda 5235 Overpass Rd Buda HAYS - - 100 100 BSWH Buda Medical Center 5330 Overpass Rd Buda HAYS 500 - - 500 CVS Pharmacy #10535 220 South FM 1626 Buda HAYS - - 2,000 2,000 Texas State University Student Health Services 298 Student Center Dr San Marcos HAYS - - 1,200 1,200 Brookshires Pharmacy 67 14100 Ranch Road 12 Unit 2a Wimberley HAYS 100 - - 100 Edinburg CISD Health Services Department 411 N 8th Ave Edinburg HIDALGO 6,000 - - 6,000 Wellmed Crossroads 1301 E Fern McAllen HIDALGO 1,000 - - 1,000 City Of Pharr Office Of Emergency Management 100 W Ferguson St Pharr HIDALGO 1,200 - - 1,200 Norma Iglesias M.D. & Associates 712 SOUTH CAGE BLVD Pharr HIDALGO 100 - - 100 IDEA Public Schools RGV HQ 2115 W Pike Blvd Weslaco HIDALGO - 1,170 - 1,170 Wellmed Weslaco 1001 James St Weslaco HIDALGO 100 - - 100 Granbury Hood County EMS Inc 2200 Commercial Ln Granbury HOOD - - 600 600 Christus Mother Frances Hospital - Sulphur Springs 115 Airport Rd Sulphur Springs HOPKINS - - 1,000 1,000 Howard County Community Health Center 1300 S Gregg St Big Spring HOWARD 300 - - 300 Texas A&M Commerce Student Health 2600 W Neal St Commerce HUNT - - 100 100 Hunt Regional Medical Center 4215 Joe Ramsey Blvd E Greenville HUNT - 2,340 - 2,340 City Drug Store of Jacksboro, Inc. 104 E Belknap St Jacksboro JACK 100 - - 100 Rogers Pharmacy #6 1013 S Wells St, Edna JACKSON 100 - - 100 Kalyan K. Rath MD 1273 S. Peachtree Jasper JASPER 100 - - 100 S And R Drug Co 1606 S Margaret Ave Kirbyville JASPER - - 100 100 Fort Davis Family Practice 1 Memorial Square 0792 Fort Davis JEFF DAVIS 100 - - 100 Baptist Hospitals of Southeast Texas 3080 College St Beaumont JEFFERSON - - 100 100 Beaumont Elite Emergency Center LLC 4004 College Street Beaumont JEFFERSON 100 - - 100 Beaumont Health Department 3040 College St Beaumont JEFFERSON 1,000 - - 1,000 Exxonmobil Medical Clinic 2250 Grove St Beaumont JEFFERSON 300 - - 300 Lamar University Student Health Center 857 E Virginia St Beaumont JEFFERSON - - 300 300 Mid Jefferson Extended Care-Beaumont 860 S. 8th St Beaumont JEFFERSON 100 - - 100 Mid Jefferson Extended Care-Nederland 2600 Highway 365 Nederland JEFFERSON 100 - - 100 Health By Design Valero Port Arthur Clinic 1801 S Gulfway Port Arthur JEFFERSON 100 - - 100 Ibn Sina Community Medical Clinic 8455 9th Ave Port Arthur JEFFERSON - - 100 100 Lhd Port Arthur City Health Dept (Re) 449 Austin Ave Port Arthur JEFFERSON - - 100 100 Med Clinic 3705 9th Ave Port Arthur JEFFERSON 100 - - 100 Gold Horses LLC 411 N King St. Alice JIM WELLS 200 - - 200 Hometown Healthcare Orange Grove 101 S Eugenia St Orange Grove JIM WELLS 100 - - 100 Burleson Public Health Authority 828 SW Alsbury Blvd Burleson JOHNSON 1,000 - - 1,000 DSHS Cleburne 108 E Kilpatrick St Cleburne JOHNSON - - 100 100 Ut Health East Texas Physicians Cedar Creek Lake Clinic 100 Municipal Dr GunBarrel City KAUFMAN 200 - - 200 BRASHEAR FAMILY MEDICAL 2801 Millennium Dr Ste B Kaufman KAUFMAN 100 - - 100 Kaufman County Detention Center 1900 E Hwy 175 Kaufman KAUFMAN - - 100 100 Terrell Fire Department 201 East Nash Street Terrell KAUFMAN 2,000 - - 2,000 Peterson Regional Medical Center - Kerrville 551 Hill Country Dr Kerrville KERR - - 500 500 TRUBI1 LLC 200 WESLEY DR UNIT A Kerrville KERR 200 - - 200 Hometown Healthcare 408 N Giraud Cotulla LA SALLE - - 100 100 Lavaca Family Health Clinic 1406 North Texana Hallettsville LAVACA - - 100 100 Davam Urgent Care 2454 E Austin St Giddings LEE 100 - - 100 Giddings State School 2261 James Turman Rd. Giddings LEE 100 - - 100 Pieratt's Pharmacy 233 S. Manse Giddings LEE 100 - - 100 Live Oak County Health Department 301 Houston St Annex Bldg Rm 10 George West LIVE OAK 100 - - 100 Health by Design Valero Three Rivers Clinic 100 W LeRoy St Three Rivers LIVE OAK - - 100 100 Maverick County Hospital District 3406 Bob Rogers Dr Ste 290 Eagle Pass MAVERICK - - 300 300 Frontera Healthcare-Brady 2205 S Bridge St Ste 300 Brady MCCULLOCH - - 100 100 Mclennan Cnty St Juve Corr Fac 116 W Burleson Rd Mart MCLENNAN - 1,170 - 1,170 Baylor Scott White Med Ctr Hillcrest 100 Hillcrest Medical Blvd Waco MCLENNAN - 1,170 - 1,170 Baylor University Student Health Services 209 Speight Ave Fl 2 Waco MCLENNAN - - 1,000 1,000 Generation Rx Inc 206 N Main West MCLENNAN 300 - - 300 Executive Medical Services, PC 8301 Mars Dr Woodway MCLENNAN - - 100 100 LHD Medina CO Health Dept (RE) 1206 15th St Hondo MEDINA 1,000 - - 1,000 Frontera Clinic-Menard 119 S. Ellis Menard MENARD - - 100 100 Marathon Health-Midland 600 W. Illinois Street Midland MIDLAND 100 - - 100 Midland Health & Senior Services 3303 W Illinois Ave Ste 22 Midland MIDLAND 200 - - 200 Topline Care Pharmaceuticals LLC 4400 W Loop 250 N Midland MIDLAND 200 - - 200 WESTEX URGENT CARE 3401 Greenbriar Drive Midland MIDLAND 200 - - 200 LHD MILAM CO HEALTH DEPT (RE) 209 S. Houston Ave Cameron MILAM 300 - - 300 Conroe Doctors Urgent Care 17002 Gleneagle Dr South Conroe MONTGOMERY 300 - - 300 Houston Methodist The Woodlands Hsptl 17201 Interstate 45 S Conroe MONTGOMERY - 5,850 - 5,850 Kelsey Seybold Clinic -Conroe 690 S. Loop 336 W Conroe MONTGOMERY - - 100 100 Montgomery County Jail 1 Criminal Justice Dr. Conroe MONTGOMERY - - 100 100 Sam Houston State University Dba Shsu Physicians 690 S Loop 336 W Ste 200 Conroe MONTGOMERY - - 100 100 Kelsey-Seybold Clinic The Woodlands 106 Vision Park Blvd Shenandoah MONTGOMERY 400 - 100 500 SPLENDORA PHARMACY 13841 HWY 59 Splendora MONTGOMERY 100 - - 100 Dshs Dumas 501 Success Blvd Dumas MOORE 100 - - 100 Nacogdoches Med Cntr Hsptl Phrmcy 4920 Ne Stallings Dr Nacogdoches NACOGDOCHES 1,400 - - 1,400 Nacogdoches Memorial Hospital 1204 N Mound St Nacogdoches NACOGDOCHES - - 300 300 Striplings Pharmacy 1205 N Mound St Nacogdoches NACOGDOCHES 100 - - 100 Brookshires Pharmacy 117 501 E Broadway St Sweetwater NOLAN 200 - - 200 CITGO Petroleum Corpus Christi 1802 Nueces Bay Blvd Corpus Christi NUECES 100 - - 100 Corpus Christi Metro Ministries, Inc 1919 Leopard St. Corpus Christi NUECES 300 - - 300 Wellmed Wooldridge 5846 Wooldridge Corpus Christi NUECES - - 100 100 Orange County Convention and Expo Center 11475 FM 1442 Orange ORANGE - - 500 500 Palo Pinto County Hospital District 400 Sw 25th Ave Mineral Wells PALO PINTO - - 100 100 Brookshires Pharmacy 8 - Carthage 412 W Panola St Carthage PANOLA 100 - - 100 Aledo Family Medicine 317 FM 1187 North Aledo PARKER - - 100 100 PECOS COUNTY MEMORIAL HOSPITAL DBA FAMILY CARE CEN 387 W IH 10 Fort Stockton PECOS - - 100 100 Livingston Pharmacy 714 West Church Street Livingston POLK 100 - - 100 Bsa Health System 1600 Wallace Blvd Amarillo POTTER - - 100 100 DSHS Amarillo 3407 Pony Express Way Amarillo RANDALL 300 - - 300 West Texas A & M University Student medical 2620 Russell Long Blvd Canyon RANDALL - - 300 300 Reagan Memorial Hospital 1300 W FAIRMONT PKWY Big Lake REAGAN - - 100 100 Wilson Drug 118 W 4th St Hearne ROBERTSON 100 - - 100 Rockwall County Health Authority 1010 W Ralph Hall Pkwy Rockwall ROCKWALL 1,000 - - 1,000 Texas Department of Criminal Justice EAST TX ISF 900 Industrial Drive Henderson RUSK - - 100 100 Shepherd Pharmacy 11011 hwy 150 Shepherd SAN JACINTO 100 - - 100 Lhd San Patricio Co Dept Of Health (Re) 313 N. Rachal Sinton SAN PATRICIO - - 100 100 DSHS PHR 4/5N HQ - Tyler (RE) 2521 W Front St Tyler SMITH 200 - 500 700 QLTC PHARMACY SOLUTIONS, LLC 4285 Chandler Highway Tyler SMITH 100 - - 100 Tyler Family Circle Of Care 2990 N Broadway Ave Tyler SMITH 100 - - 100 Tyler Family Circle Of Care - Tyler - 928 N. Glenwood 928 N Glenwood Blvd Tyler SMITH 300 - - 300 Family Health Center Llp 2768 Pharmacy Rd Rio Grande City STARR 1,000 - - 1,000 Starr County Memorial Hospital 128 N FM 3167 Rio Grande City STARR 100 - - 100 Valley Health Clinic 2542 Central Palm Drive Rio Grande City STARR 300 - - 300 Arlington Family Practice PA 2415 Matlock Rd Arlington TARRANT 300 - - 300 Clinicas Mi Doctor - Arlington 941 E Park Row Dr Arlington TARRANT - - 100 100 Dshs Hsr 2/3 Hq - Arlington (Re) 1301 S Bowen Rd Arlington TARRANT - - 1,400 1,400 General Motors Health Services 2525 East Abram St. Arlington TARRANT - - 400 400 Guardian Pharmacy 610 Magic Mile Arlington TARRANT 400 - - 400 Texas Oncology Arlington North 906 W Randol Mill Rd Arlington TARRANT 200 - - 200 Texas Oncology Arlington South 515 W Mayfield Rd Arlington TARRANT 200 - - 200 Maxhealth Family, Internal And Sports Medicine 5207 Heritage Ave Colleyville TARRANT - - 1,400 1,400 Jps Northeast Chc 3200 W Euless Blvd Euless TARRANT 1,000 - - 1,000 Clinica Mi Doctor #6 229 Ne 28th St Fort Worth TARRANT - - 100 100 James Haden, Md 1000 College Ave Fort Worth TARRANT 100 - - 100 Jps Hospital 1500 South Main St Fort Worth TARRANT - 3,510 - 3,510 Mi Doctor #7 4200 South Fwy Ste 106 Fort Worth TARRANT - - 100 100 Pcc Apc Family Medicine 855 Montgomery St Fl 3 Fort Worth TARRANT - - 300 300 Texas Rehabilitation Hospital of Fort Worth 425 Alabama Avenue Fort Worth TARRANT 100 - - 100 Zahra K Ali MD PLLC 1601 W State Highway 114 Grapevine TARRANT 300 - - 300 Abilene Christian University Medical Clinic 849 Coliseum Way Abilene TAYLOR - - 500 500 Super 1 Pharmacy 611 602 S Jefferson Ave Mount Pleasant TITUS 100 - - 100 La Esperanza Clinic Inc 1610 S Chadbourne St San Angelo TOM GREEN 100 - - 100 La Esperanza Clinic,Inc. 35 E 31st St San Angelo TOM GREEN 200 - - 200 San Angelo Health Department 2030 Pulliam St Ste 8 San Angelo TOM GREEN 200 - - 200 Austin Radiological Association 12554 Riata Vista Circle Austin TRAVIS 200 - - 200 Austin Regional Clinic - Anderson Mill 10401 Anderson Mill Rd Ste 110b Austin TRAVIS 200 - - 200 Austin Regional Clinic - Wilson Parke 11714 Wilson Parke Ave Ste 150 Austin Travis 200 - - 200 Crossover Health 6300 Bee Caves Rd Building 2 Austin TRAVIS - - 100 100 Crossover Health Medical Group 5505 West Parmer Lane Austin TRAVIS 1,000 - - 1,000 E David Pampe, Md 6012 West William Cannon Drive Austin TRAVIS 100 - - 100 Family Wellness Clinic Ut Austin School Of Nursing 2901 N Interstate 35 Ste 1.301 Austin TRAVIS 300 - - 300 Guadalupe Zamora M.D., P.A. 2100 E 6th St. Austin TRAVIS - - 100 100 Jose F Santiago M D 2624 W. William Cannon Dr. Austin TRAVIS 100 - - 100 Lone Star Circle Of Care At El Buen Samaritano 7000 Woodhue Dr Austin TRAVIS 100 - - 100 Lone Star Circle Of Care Ben White 1221 W Ben White Blvd # B100 Austin TRAVIS 100 - - 100 Lscc Fam Care Ctr Nw Fp 11111 Research Blvd Ste 320 Austin TRAVIS 100 - - 100 Red River Family Practice 900 E 30th St Austin TRAVIS 200 - - 200 Seton Medical Center Austin 1201 W 38th St Austin TRAVIS - - 2,000 2,000 Shots For Tots St Johns 7500 Blessing Ave Austin TRAVIS 300 - - 300 SHUBHA LLC DBA AURO PHARMACY 1139 W Braker Ln Austin TRAVIS 1,200 - - 1,200 Trinity Internal Medicine 313 E 12th St Ste 102 Ste 102 Austin TRAVIS 100 - - 100 Wellmed Ben White 706 W Ben White Blvd Ste A Austin TRAVIS 500 - - 500 Lone Star Circle Of Care At Jonestown 18220 Fm 1431 Ste D Leander TRAVIS 100 - - 100 Austin Regional Clinic - Manor 11300 Us Highway 290 E Ste 230 Bldg Manor TRAVIS 200 - - 200 Austin Regional Clinic - Pflugerville 15803 Windermere Dr Ste 103 Pflugerville TRAVIS 200 - - 200 Wellmed Pflugerville 2700 W Pecan Street Pflugerville TRAVIS - - 100 100 DSHS CENTRAL PHARMACY WAREHOUSE 1111 NORTH LOOP Austin TRAVIS_State 15,700 16,380 - 32,080 Texas DSHS Laboratory 1100 West 49th Street Austin TRAVIS_State - 12,870 - 12,870 Tyler County Hospital Family Medical Clinic 104 N Beech St Woodville TYLER 100 - - 100 PAM Specialty Hospital of Victoria Southeast 2701 Hospital Drive, 6th Floor Victoria VICTORIA - - 100 100 Huntsville Family Medicine - Huntsville 2 123 Medical Park Ln Ste A Huntsville WALKER 1,000 - - 1,000 North Houston Cancer Clinics 3233 Woodward Dr Huntsville WALKER 300 - - 300 Texas Department of Criminal Justice Holliday 295 IH 45N Huntsville WALKER - - 100 100 Brookshire Family Practice 4019 S Front St Brookshire WALLER - 1,170 - 1,170 Ward Memorial Hospital 406 S Gary Ave Monahans WARD - - 200 200 Brenham Drug Partners 2105 S Day Street Brenham WASHINGTON - - 100 100 La Familia Health Clinic Pllc 1105 Corpus Christi St Laredo WEBB 100 - - 100 United Independent School District 201 Lindenwood Dr Laredo WEBB 2,000 - - 2,000 Webb County Indigent Health Care 1620 Santa Ursula Ave. Laredo WEBB 300 - - 300 Alexander Pharmacy, LTD 123 Leveridge Street East Bernard WHARTON 100 - - 100 Midcoast Medical Clinic 305 Sandy Corner Rd Ste 120 El Campo Wharton 300 - - 300 LHD Wichita Falls-Wichita CO PH Dist (RE) 1700 3rd Street Wichita Falls WICHITA 700 - - 700 Midwestern State University Vinson Student Health Center 3410 Taft Blvd Wichita Falls WICHITA - - 500 500 Wilbarger General Hospital 920 Hillcrest Dr Vernon WILBARGER - - 200 200 Lyford CISD 8240 Simon Gomez Rd. Lyford WILLACY - - 100 100 Austin Regional Clinic - Cedar Park 801 E Whitestone Blvd Ste C Cedar Park WILLIAMSON 200 - - 200 Austin Regional Clinic - Georgetown 940 W University Ave Ste 101 Georgetown WILLIAMSON 200 - - 200 Lake Aire Med Ctr Sr Health Wellnes 2423 Williams Dr Ste 113 Georgetown WILLIAMSON 100 - - 100 Austin Regional Clinic - Hutto 151 Exchange Blvd Ste 500 Hutto WILLIAMSON 200 - - 200 Jarrell Medical Clinic 180 Town Center Blvd Jarrell WILLIAMSON - - 100 100 Austin Regional Clinic - Leander 901 Crystal Falls Pkwy Ste 103 Leander WILLIAMSON 200 - - 200 Wellmed Leander 601 Crystal Falls Parkway Leander WILLIAMSON - - 100 100 Austin Regional Clinic - Round Rock 940 Hesters Crossing Rd Round Rock WILLIAMSON 200 - - 200 Austin Regional Clinic - Sendero Springs 1025 Sendero Springs Dr Ste 120 Round Rock WILLIAMSON 200 - - 200 Baylor Scott And White Round Rock Family Medicine 425 University Blvd Ste 500 Round Rock WILLIAMSON 1,000 - - 1,000 Curative Medical Associates PA 1608 Royston Lane Round Rock WILLIAMSON 5,000 11,700 - 16,700 Lscc Tamu Hlth Science Ctr Family Hlth 3950 N A W Grimes Blvd # 301 Round Rock WILLIAMSON 100 - - 100 Wcchd Round Rock 355 Texas Ave. Round Rock WILLIAMSON 1,600 - - 1,600 Lone Star Circle Care Taylor Hlth Ctr 601 Mallard Ln Ste A Taylor WILLIAMSON 100 - - 100 Conviva Floresville 260 Us Highway 181 N Floresville WILSON - - 500 500 FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS) EMERGENCY USE AUTHORIZATION (EUA) OF THE MODERNA COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19)

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, MODERNA COVID-19 VACCINE, for active immunization to prevent COVID-19 in individuals 18 years of age and older.

SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults, and cases of COVID-19 that result in hospitalization or death following administration of the Moderna COVID-19 Vaccine. See “MANDATORY REQUIREMENTS FOR MODERNA COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION” for reporting requirements.

The Moderna COVID-19 Vaccine is a suspension for intramuscular injection administered as a series of two doses (0.5 mL each) 1 month apart.

See this Fact Sheet for instructions for preparation and administration. This Fact Sheet may have been updated. For the most recent Fact Sheet, please see www.modernatx.com/covid19vaccine- eua.

For information on clinical trials that are testing the use of the Moderna COVID-19 Vaccine for active immunization against COVID-19, please see www.clinicaltrials.gov.

DESCRIPTION OF COVID-19 Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus, SARS-CoV-2, that appeared in late 2019. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle and body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhea.

DOSAGE AND ADMINISTRATION

Storage and Handling The information in this Fact Sheet supersedes the information on the vial and carton labels.

During storage, minimize exposure to room light.

Revised: Mar/31/2021 1

The Moderna COVID-19 Vaccine multiple-dose vials are stored frozen between -50º to -15ºC (-58º to 5ºF). Store in the original carton to protect from light.

Do not store on dry ice or below -50ºC (-58ºF). Use of dry ice may subject vials to temperatures colder than -50°C (-58°F).

Vials may be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use.

Vials may be stored between 8° to 25°C (46° to 77°F) for a total of 24 hours.

After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36° to 77°F). Vials should be discarded 12 hours after the first puncture.

Thawed vials can be handled in room light conditions.

Do not refreeze once thawed.

Transportation of Thawed Vials at 2° to 8°C (35° to 46°F)

If transport at -50° to -15°C (-58° to 5°F) is not feasible, available data support transportation of one or more thawed vials for up to 12 hours at 2° to 8°C (35° to 46°F) when shipped using shipping containers which have been qualified to maintain 2° to 8°C (35° to 46°F) and under routine road and air transport conditions with shaking and vibration minimized. Once thawed and transported at 2° to 8°C (35° to 46°F), vials should not be refrozen and should be stored at 2° to 8°C (35° to 46°F) until use.

Dosing and Schedule The Moderna COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.5 mL each) 1 month apart.

There are no data available on the interchangeability of the Moderna COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of the Moderna COVID-19 Vaccine should receive a second dose of the Moderna COVID- 19 Vaccine to complete the vaccination series.

Dose Preparation • The Moderna COVID-19 Vaccine multiple-dose vials contain a frozen suspension that does not contain a preservative and must be thawed prior to administration. • Remove the required number of vial(s) from storage and thaw each vial before use following the instructions below.

Revised: Mar/31/2021 2

Vial Thaw in Refrigerator Thaw at Room Temperature

Maximum Thaw in refrigerated conditions Alternatively, thaw at room 11-Dose Vial between 2° to 8°C for 2 hours temperature between 15° to (range: 10-11 and 30 minutes. Let each vial 25°C for 1 hour. doses) stand at room temperature for 15 minutes before administering. Maximum Thaw in refrigerated conditions Alternatively, thaw at room 15-Dose Vial between 2° to 8°C for 3 hours. temperature between 15° to (range: 13-15 Let each vial stand at room 25°C for 1 hour and 30 doses) temperature for 15 minutes minutes. before administering.

• After thawing, do not refreeze. • Swirl vial gently after thawing and between each withdrawal. Do not shake. Do not dilute the vaccine. • The Moderna COVID-19 Vaccine is a white to off-white suspension. It may contain white or translucent product-related particulates. Visually inspect the Moderna COVID- 19 Vaccine vials for other particulate matter and/or discoloration prior to administration. If either of these conditions exists, the vaccine should not be administered. • The Moderna COVID-19 Vaccine is supplied in two multiple-dose vial presentations: o A multiple-dose vial containing a maximum of 11 doses: range 10-11 doses (0.5 mL each). o A multiple-dose vial containing a maximum of 15 doses: range 13-15 doses (0.5 mL each). • Depending on the syringes and needles used for each dose, there may not be sufficient volume to extract more than 10 doses from the maximum of 11 doses vial or more than 13 doses from the maximum of 15 doses vial. Irrespective of the type of syringe and needle: o Each dose must contain 0.5 mL of vaccine. o If the amount of vaccine remaining in the vial cannot provide a full dose of 0.5 mL, discard the vial and contents. Do not pool excess vaccine from multiple vials. o Pierce the stopper at a different site each time. • After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36° to 77°F). Record the date and time of first use on the Moderna COVID-19 Vaccine vial label. Discard vial after 12 hours. Do not refreeze.

Administration Visually inspect each dose of the Moderna COVID-19 Vaccine in the dosing syringe prior to administration. The white to off-white suspension may contain white or translucent product- related particulates. During the visual inspection, • verify the final dosing volume of 0.5 mL. • confirm there are no other particulates and that no discoloration is observed. • do not administer if vaccine is discolored or contains other particulate matter.

Revised: Mar/31/2021 3

Administer the Moderna COVID-19 Vaccine intramuscularly.

CONTRAINDICATION Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine (see Full EUA Prescribing Information).

WARNINGS Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Moderna COVID-19 Vaccine.

Monitor Moderna COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Moderna COVID-19 Vaccine.

The Moderna COVID-19 Vaccine may not protect all vaccine recipients.

ADVERSE REACTIONS Adverse reactions reported in a clinical trial following administration of the Moderna COVID-19 Vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site. (See Full EUA Prescribing Information)

Severe allergic reactions, including anaphylaxis, have been reported following administration of the Moderna COVID-19 Vaccine during mass vaccination outside of clinical trials.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Moderna COVID-19 Vaccine.

USE WITH OTHER VACCINES There is no information on the co-administration of the Moderna COVID-19 Vaccine with other vaccines.

INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS As the vaccination provider, you must communicate to the recipient or their caregiver, information consistent with the “Fact Sheet for Recipients and Caregivers” (and provide a copy or direct the individual to the website www.modernatx.com/covid19vaccine-eua to obtain the Fact Sheet) prior to the individual receiving each dose of the Moderna COVID-19 Vaccine, including: • FDA has authorized the emergency use of the Moderna COVID-19 Vaccine, which is not an FDA-approved vaccine. • The recipient or their caregiver has the option to accept or refuse the Moderna COVID-19 Revised: Mar/31/2021 4

Vaccine. • The significant known and potential risks and benefits of the Moderna COVID-19 Vaccine, and the extent to which such risks and benefits are unknown. • Information about available alternative vaccines and the risks and benefits of those alternatives

For information on clinical trials that are evaluating the use of the Moderna COVID-19 Vaccine to prevent COVID-19, please see www.clinicaltrials.gov.

Provide a vaccination card to the recipient or their caregiver with the date when the recipient needs to return for the second dose of Moderna COVID-19 Vaccine.

Provide the v-safe information sheet to vaccine recipients/caregivers and encourage vaccine recipients to participate in v-safe. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID- 19 vaccination. For more information, visit: www.cdc.gov/vsafe.

MANDATORY REQUIREMENTS FOR MODERNA COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION In order to mitigate the risks of using this unapproved product under EUA and to optimize the potential benefit of the Moderna COVID-19 Vaccine, the following items are required. Use of unapproved Moderna COVID-19 Vaccine for active immunization to prevent COVID-19 under this EUA is limited to the following (all requirements must be met):

1. The Moderna COVID-19 Vaccine is authorized for use in individuals 18 years of age and older.

2. The vaccination provider must communicate to the individual receiving the Moderna COVID-19 Vaccine or their caregiver information consistent with the “Fact Sheet for Recipients and Caregivers” prior to the individual receiving the Moderna COVID-19 Vaccine.

3. The vaccination provider must include vaccination information in the state/local jurisdiction’s Immunization Information System (IIS) or other designated system.

4. The vaccination provider is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS): • vaccine administration errors whether or not associated with an adverse event, • serious adverse events* (irrespective of attribution to vaccination), • cases of Multisystem Inflammatory Syndrome (MIS) in adults, and • cases of COVID-19 that result in hospitalization or death.

Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. Revised: Mar/31/2021 5

For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words “Moderna COVID-19 Vaccine EUA” in the description section of the report.

5. The vaccination provider is responsible for responding to FDA requests for information about vaccine administration errors, adverse events, cases of MIS in adults, and cases of COVID-19 that result in hospitalization or death following administration of the Moderna COVID-19 Vaccine to recipients.

*Serious adverse events are defined as: • Death; • A life-threatening adverse event; • Inpatient hospitalization or prolongation of existing hospitalization; • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; • A congenital anomaly/birth defect; • An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.

OTHER ADVERSE EVENT REPORTING TO VAERS AND MODERNATX, INC. Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above.

To the extent feasible, report adverse events to ModernaTX, Inc. using the contact information below or by providing a copy of the VAERS form to ModernaTX, Inc.

Email Fax number Telephone number

[email protected] 1-866-599-1342 1-866-MODERNA (1-866-663-3762)

ADDITIONAL INFORMATION For general questions, visit the website or call the telephone number provided below.

To access the most recent Moderna COVID-19 Vaccine Fact Sheets, please scan the QR code or visit the website provided below.

Revised: Mar/31/2021 6

Website Telephone number www.modernatx.com/covid19vaccine-eua 1-866-MODERNA (1-866-663-3762)

AVAILABLE ALTERNATIVES There is no approved alternative vaccine to prevent COVID-19. There may be clinical trials or availability under EUA of other COVID-19 vaccines.

FEDERAL COVID-19 VACCINATION PROGRAM This vaccine is being made available for emergency use exclusively through the CDC COVID- 19 Vaccination Program (the Vaccination Program). Healthcare providers must enroll as providers in the Vaccination Program and comply with the provider requirements. Vaccination providers may not charge any fee for the vaccine and may not charge the vaccine recipient any out-of-pocket charge for administration. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured Program for non-insured recipients). For information regarding provider requirements and enrollment in the CDC COVID-19 Vaccination Program, see https://www.cdc.gov/vaccines/covid-19/provider-enrollment.html.

Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination Program requirements are encouraged to report them to the Office of the Inspector General, U.S. Department of Health and Human Services, at 1-800-HHS-TIPS or TIPS.HHS.GOV.

AUTHORITY FOR ISSUANCE OF THE EUA The Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency that justifies the emergency use of drugs and biological products during the COVID-19 Pandemic. In response, the FDA has issued an EUA for the unapproved product, Moderna COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 18 years of age and older.

FDA issued this EUA, based on ModernaTX, Inc.’s request and submitted data.

Although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that the Moderna COVID-19 Vaccine may be effective for the prevention of COVID-19 in individuals as specified in the Full EUA Prescribing Information.

This EUA for the Moderna COVID-19 Vaccine will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the

Revised: Mar/31/2021 7 approval status of the product such that an EUA is no longer needed.

For additional information about Emergency Use Authorization, visit FDA at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy- framework/emergency-use-authorization.

COUNTERMEASURES INJURY COMPENSATION PROGRAM The Countermeasures Injury Compensation Program (CICP) is a federal program that has been created to help pay for related costs of medical care and other specific expenses to compensate people injured after use of certain medical countermeasures. Medical countermeasures are specific vaccines, medications, devices, or other items used to prevent, diagnose, or treat the public during a public health emergency or a security threat. For more information about CICP regarding the vaccines to prevent COVID-19, visit http://www.hrsa.gov/cicp, email [email protected], or call: 1-855-266-2427.

Moderna US, Inc. Cambridge, MA 02139

END SHORT VERSION FACT SHEET Long Version (Full EUA Prescribing Information) Begins On Next Page

Revised: Mar/31/2021 8

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION

MODERNA COVID-19 VACCINE

FULL EUA PRESCRIBING INFORMATION: CONTENTS* 10 DRUG INTERACTIONS 1 AUTHORIZED USE 11 USE IN SPECIFIC POPULATIONS 2 DOSAGE AND ADMINISTRATION 11.1 Pregnancy 2.1 Preparation for Administration 11.2 Lactation 2.2 Administration 11.3 Pediatric Use 2.3 Dosing and Schedule 11.4 Geriatric Use 3 DOSAGE FORMS AND STRENGTHS 13 DESCRIPTION 4 CONTRAINDICATIONS 14 CLINICAL PHARMACOLOGY 5 WARNINGS AND PRECAUTIONS 14.1 Mechanism of Action 5.1 Management of Acute Allergic Reactions 18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA 5.2 Altered Immunocompetence FOR EUA 5.3 Limitations of Vaccine Effectiveness 19 HOW SUPPLIED/STORAGE AND HANDLING 6 OVERALL SAFETY SUMMARY 20 PATIENT COUNSELING INFORMATION 6.1 Clinical Trials Experience 21 CONTACT INFORMATION 8 REQUIREMENTS AND INSTRUCTIONS FOR *Sections or subsections omitted from the full prescribing REPORTING ADVERSE EVENTS AND VACCINE information are not listed ADMINISTRATION ERRORS

______

FULL EMERGENCY USE AUTHORIZATION (EUA) PRESCRIBING INFORMATION

1 AUTHORIZED USE

Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

2.1 Preparation for Administration • The Moderna COVID-19 Vaccine multiple-dose vials contain a frozen suspension that does not contain a preservative and must be thawed prior to administration. • Remove the required number of vial(s) from storage and thaw each vial before use following the instructions below.

Revised: Mar/31/2021 9

Vial Thaw in Refrigerator Thaw at Room Temperature

2.2 Administration Visually inspect each dose of the Moderna COVID-19 Vaccine in the dosing syringe prior to administration. The white to off-white suspension may contain white or translucent product-related particulates. During the visual inspection, • verify the final dosing volume of 0.5 mL. • confirm there are no other particulates and that no discoloration is observed. • do not administer if vaccine is discolored or contains other particulate matter.

Revised: Mar/31/2021 10

Administer the Moderna COVID-19 Vaccine intramuscularly.

2.3 Dosing and Schedule The Moderna COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.5 mL each) 1 month apart.

There are no data available on the interchangeability of the Moderna COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Moderna COVID-19 Vaccine should receive a second dose of Moderna COVID-19 Vaccine to complete the vaccination series.

3 DOSAGE FORMS AND STRENGTHS

Moderna COVID-19 Vaccine is a suspension for intramuscular injection. A single dose is 0.5 mL.

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Moderna COVID-19 Vaccine.

5.2 Altered Immunocompetence Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to the Moderna COVID-19 Vaccine.

5.3 Limitations of Vaccine Effectiveness The Moderna COVID-19 Vaccine may not protect all vaccine recipients.

6 OVERALL SAFETY SUMMARY

It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) all vaccine administration errors, all serious adverse events, cases of Multi-inflammatory Syndrome (MIS) in adults, and hospitalized or fatal cases of Revised: Mar/31/2021 11

COVID-19 following vaccination with the Moderna COVID-19 Vaccine. To the extent feasible, provide a copy of the VAERS form to ModernaTX, Inc. Please see the REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details on reporting to VAERS and ModernaTX, Inc.

In clinical studies, the adverse reactions in participants 18 years of age and older were pain at the injection site (92.0%), fatigue (70.0%), headache (64.7%), myalgia (61.5%), arthralgia (46.4%), chills (45.4%), nausea/vomiting (23.0%), axillary swelling/tenderness (19.8%), fever (15.5%), swelling at the injection site (14.7%), and erythema at the injection site (10.0%).

Severe allergic reactions, including anaphylaxis, have been reported following administration of the Moderna COVID-19 Vaccine during mass vaccination outside of clinical trials.

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

Overall, 15,419 participants aged 18 years and older received at least one dose of Moderna COVID-19 Vaccine in three clinical trials (NCT04283461, NCT04405076, and NCT04470427).

The safety of Moderna COVID-19 Vaccine was evaluated in an ongoing Phase 3 randomized, placebo-controlled, observer-blind clinical trial conducted in the United States involving 30,351 participants 18 years of age and older who received at least one dose of Moderna COVID-19 Vaccine (n=15,185) or placebo (n=15,166) (NCT04470427). At the time of vaccination, the mean age of the population was 52 years (range 18-95); 22,831 (75.2%) of participants were 18 to 64 years of age and 7,520 (24.8%) of participants were 65 years of age and older. Overall, 52.7% were male, 47.3% were female, 20.5% were Hispanic or Latino, 79.2% were White, 10.2% were African American, 4.6% were Asian, 0.8% were American Indian or Alaska Native, 0.2% were Native Hawaiian or Pacific Islander, 2.1% were other races, and 2.1% were Multiracial. Demographic characteristics were similar among participants who received Moderna COVID-19 Vaccine and those who received placebo.

Solicited Adverse Reactions

Data on solicited local and systemic adverse reactions and use of antipyretic medication were collected in an electronic diary for 7 days following each injection (i.e., day of vaccination and the next 6 days) among participants receiving Moderna COVID-19 Vaccine (n=15,179) and participants receiving placebo (n=15,163) with at least 1 documented dose. Solicited adverse reactions were reported more frequently among vaccine participants than placebo participants.

The reported number and percentage of the solicited local and systemic adverse reactions by age group and dose are presented in Table 1 and Table 2, respectively.

Revised: Mar/31/2021 12

Table 1: Number and Percentage of Participants With Solicited Local and Systemic Adverse Reactions Within 7 Days* After Each Dose in Participants 18-64 Years (Solicited Safety Set, Dose 1 and Dose 2)

Moderna COVID-19 Vaccine Placeboa

Dose 1 Dose 2 Dose 1 Dose 2 (N=11,406) (N=10,985) (N=11,407) (N=10,918) n (%) n (%) n (%) n (%) Local Adverse Reactions Pain 9,908 9,873 2,177 2,040 (86.9) (89.9) (19.1) (18.7) Pain, Grade 3b 366 506 23 22 (3.2) (4.6) (0.2) (0.2) Axillary 1,322 1,775 567 470 swelling/tenderness (11.6) (16.2) (5.0) (4.3) Axillary 37 46 13 11 swelling/tenderness, (0.3) (0.4) (0.1) (0.1) Grade 3b Swelling (hardness) 767 1,389 34 36 ≥25 mm (6.7) (12.6) (0.3) (0.3) Swelling (hardness), 62 182 3 4 Grade 3c (0.5) (1.7) (<0.1) (<0.1) Erythema (redness) 344 982 47 43 ≥25 mm (3.0) (8.9) (0.4) (0.4) Erythema (redness), 34 210 11 12 Grade 3c (0.3) (1.9) (<0.1) (0.1) Systemic Adverse Reactions Fatigue 4,384 7,430 3,282 2,687 (38.4) (67.6) (28.8) (24.6) Fatigue, Grade 3d 120 1,174 83 86 (1.1) (10.7) (0.7) (0.8) Fatigue, Grade 4e 1 0 0 0 (<0.1) (0) (0) (0) Headache 4,030 6,898 3,304 2,760 (35.3) (62.8) (29.0) (25.3) Headache, Grade 3f 219 553 162 129 (1.9) (5.0) (1.4) (1.2) Myalgia 2,699 6,769 1,628 1,411 (23.7) (61.6) (14.3) (12.9) Myalgia, Grade 3d 73 1,113 38 42 (0.6) (10.1) (0.3) (0.4) Arthralgia 1,893 4,993 1,327 1,172 (16.6) (45.5) (11.6) (10.7) Arthralgia, Grade 3d 47 647 29 37 (0.4) (5.9) (0.3) (0.3) Arthralgia, Grade 4e 1 0 0 0 (<0.1) (0) (0) (0) Chills 1,051 5,341 730 658 (9.2) (48.6) (6.4) (6.0) Revised: Mar/31/2021 13

Moderna COVID-19 Vaccine Placeboa

Dose 1 Dose 2 Dose 1 Dose 2 (N=11,406) (N=10,985) (N=11,407) (N=10,918) n (%) n (%) n (%) n (%) Chills, Grade 3g 17 164 8 15 (0.1) (1.5) (<0.1) (0.1) Nausea/vomiting 1,068 2,348 908 801 (9.4) (21.4) (8.0) (7.3) Nausea/vomiting, 6 10 8 8 Grade 3h (<0.1) (<0.1) (<0.1) (<0.1) Fever 105 1,908 37 39 (0.9) (17.4) (0.3) (0.4) Fever, Grade 3i 10 184 1 2 (<0.1) (1.7) (<0.1) (<0.1) Fever, Grade 4j 4 12 4 2 (<0.1) (0.1) (<0.1) (<0.1) Use of antipyretic or 2,656 6,292 1,523 1,248 pain medication (23.3) (57.3) (13.4) (11.4)

* 7 days included day of vaccination and the subsequent 6 days. Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary). a Placebo was a saline solution. b Grade 3 pain and axillary swelling/tenderness: Defined as any use of prescription pain reliever; prevents daily activity. c Grade 3 swelling and erythema: Defined as >100 mm / >10 cm. d Grade 3 fatigue, myalgia, arthralgia: Defined as significant; prevents daily activity. e Grade 4 fatigue, arthralgia: Defined as requires emergency room visit or hospitalization. f Grade 3 headache: Defined as significant; any use of prescription pain reliever or prevents daily activity. g Grade 3 chills: Defined as prevents daily activity and requires medical intervention. h Grade 3 nausea/vomiting: Defined as prevents daily activity, requires outpatient intravenous hydration. i Grade 3 fever: Defined as ≥39.0° – ≤40.0°C / ≥102.1° – ≤104.0°F. j Grade 4 fever: Defined as >40.0°C / >104.0°F.

Table 2: Number and Percentage of Participants With Solicited Local and Systemic Adverse Reactions Within 7 Days* After Each Dose in Participants 65 Years and Older (Solicited Safety Set, Dose 1 and Dose 2)

Moderna COVID-19 Vaccine Placeboa

Dose 1 Dose 2 Dose 1 Dose 2 (N=3,762) (N=3,692) (N=3,748) (N=3,648) n (%) n (%) n (%) n (%) Local Adverse Reactions Pain 2,782 3,070 481 437 (74.0) (83.2) (12.8) (12.0) Pain, Grade 3b 50 98 32 18 (1.3) (2.7) (0.9) (0.5) Axillary 231 315 155 97 swelling/tenderness (6.1) (8.5) (4.1) (2.7) Axillary 12 21 14 8 swelling/tenderness, (0.3) (0.6) (0.4) (0.2) Grade 3b Revised: Mar/31/2021 14

Moderna COVID-19 Vaccine Placeboa

Dose 1 Dose 2 Dose 1 Dose 2 (N=3,762) (N=3,692) (N=3,748) (N=3,648) n (%) n (%) n (%) n (%) Swelling (hardness) 165 400 18 13 ≥25 mm (4.4) (10.8) (0.5) (0.4) Swelling (hardness), 20 72 3 7 Grade 3c (0.5) (2.0) (<0.1) (0.2) Erythema (redness) 86 275 20 13 ≥25 mm (2.3) (7.5) (0.5) (0.4) Erythema (redness), 8 77 2 3 Grade 3c (0.2) (2.1) (<0.1) (<0.1) Systemic Adverse Reactions Fatigue 1,251 2,152 851 716 (33.3) (58.3) (22.7) (19.6) Fatigue, Grade 3d 30 254 22 20 (0.8) (6.9) (0.6) (0.5) Headache 921 1,704 723 650 (24.5) (46.2) (19.3) (17.8) Headache, Grade 3e 52 106 34 33 (1.4) (2.9) (0.9) (0.9) Myalgia 742 1,739 443 398 (19.7) (47.1) (11.8) (10.9) Myalgia, Grade 3d 17 205 9 10 (0.5) (5.6) (0.2) (0.3) Arthralgia 618 1,291 456 397 (16.4) (35.0) (12.2) (10.9) Arthralgia, Grade 3d 13 123 8 7 (0.3) (3.3) (0.2) (0.2) Chills 202 1,141 148 151 (5.4) (30.9) (4.0) (4.1) Chills, Grade 3f 7 27 6 2 (0.2) (0.7) (0.2) (<0.1) Nausea/vomiting 194 437 166 133 (5.2) (11.8) (4.4) (3.6) Nausea/vomiting, 4 10 4 3 Grade 3g (0.1) (0.3) (0.1) (<0.1) Nausea/vomiting, 0 1 0 0 Grade 4h (0) (<0.1) (0) (0) Fever 10 370 7 4 (0.3) (10.0) (0.2) (0.1) Fever, Grade 3i 1 18 1 0 (<0.1) (0.5) (<0.1) (0) Fever, Grade 4j 0 1 2 1 (0) (<0.1) (<0.1) (<0.1) Use of antipyretic or 673 1,546 477 329 pain medication (17.9) (41.9) (12.7) (9.0)

* 7 days included day of vaccination and the subsequent 6 days. Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary). a Placebo was a saline solution.

Revised: Mar/31/2021 15

b Grade 3 pain and axillary swelling/tenderness: Defined as any use of prescription pain reliever; prevents daily activity. c Grade 3 swelling and erythema: Defined as >100 mm / >10 cm. d Grade 3 fatigue, myalgia, arthralgia: Defined as significant; prevents daily activity. e Grade 3 headache: Defined as significant; any use of prescription pain reliever or prevents daily activity. f Grade 3 chills: Defined as prevents daily activity and requires medical intervention. g Grade 3 Nausea/vomiting: Defined as prevents daily activity, requires outpatient intravenous hydration. h Grade 4 Nausea/vomiting: Defined as requires emergency room visit or hospitalization for hypotensive shock. i Grade 3 fever: Defined as ≥39.0° – ≤40.0°C / ≥102.1° – ≤104.0°F. j Grade 4 fever: Defined as >40.0°C / >104.0°F.

Solicited local and systemic adverse reactions reported following administration of Moderna COVID-19 Vaccine had a median duration of 1 to 3 days.

Grade 3 solicited local adverse reactions were more frequently reported after Dose 2 than after Dose 1. Solicited systemic adverse reactions were more frequently reported by vaccine recipients after Dose 2 than after Dose 1.

Unsolicited Adverse Events

Participants were monitored for unsolicited adverse events for up to 28 days following each dose and follow-up is ongoing. Serious adverse events and medically attended adverse events will be recorded for the entire study duration of 2 years. As of November 25, 2020, among participants who had received at least 1 dose of vaccine or placebo (vaccine=15,185, placebo=15,166), unsolicited adverse events that occurred within 28 days following each vaccination were reported by 23.9% of participants (n=3,632) who received Moderna COVID-19 Vaccine and 21.6% of participants (n=3,277) who received placebo. In these analyses, 87.9% of study participants had at least 28 days of follow-up after Dose 2.

Lymphadenopathy-related events that were not necessarily captured in the 7-day e-diary were reported by 1.1% of vaccine recipients and 0.6% of placebo recipients. These events included lymphadenopathy, lymphadenitis, lymph node pain, vaccination-site lymphadenopathy, injection-site lymphadenopathy, and axillary mass, which were plausibly related to vaccination. This imbalance is consistent with the imbalance observed for solicited axillary swelling/tenderness in the injected arm.

Hypersensitivity adverse events were reported in 1.5% of vaccine recipients and 1.1% of placebo recipients. Hypersensitivity events in the vaccine group included injection site rash and injection site urticaria, which are likely related to vaccination. Delayed injection site reactions that began >7 days after vaccination were reported in 1.2% of vaccine recipients and 0.4% of placebo recipients. Delayed injection site reactions included pain, erythema, and swelling and are likely related to vaccination.

Throughout the same period, there were three reports of Bell’s palsy in the Moderna COVID-19 Vaccine group (one of which was a serious adverse event), which occurred 22, 28, and 32 days after vaccination, and one in the placebo group which occurred 17 days after vaccination. Currently available information on Bell’s palsy is insufficient to determine a causal relationship with the vaccine. Revised: Mar/31/2021 16

There were no other notable patterns or numerical imbalances between treatment groups for specific categories of adverse events (including other neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Moderna COVID-19 Vaccine.

Serious Adverse Events

As of November 25, 2020, serious adverse events were reported by 1.0% (n=147) of participants who received Moderna COVID-19 Vaccine and 1.0% (n=153) of participants who received placebo, one of which was the case of Bell’s palsy which occurred 32 days following receipt of vaccine.

In these analyses, 87.9% of study participants had at least 28 days of follow-up after Dose 2, and the median follow-up time for all participants was 9 weeks after Dose 2.

There were two serious adverse events of facial swelling in vaccine recipients with a history of injection of dermatological fillers. The onset of swelling was reported 1 and 2 days, respectively, after vaccination and was likely related to vaccination.

There was one serious adverse event of intractable nausea and vomiting in a participant with prior history of severe headache and nausea requiring hospitalization. This event occurred 1 day after vaccination and was likely related to vaccination.

There were no other notable patterns or imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Moderna COVID-19 Vaccine.

8 REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS

See Overall Safety Summary (Section 6) for additional information.

The vaccination provider enrolled in the federal COVID-19 Vaccination Program is responsible for the MANDATORY reporting of the listed events following Moderna COVID-19 Vaccine to the Vaccine Adverse Event Reporting System (VAERS) • Vaccine administration errors whether or not associated with an adverse event • Serious adverse events* (irrespective of attribution to vaccination) • Cases of multisystem inflammatory syndrome (MIS) in adults • Cases of COVID-19 that results in hospitalization or death

*Serious Adverse Events are defined as: • Death; • A life-threatening adverse event; • Inpatient hospitalization or prolongation of existing hospitalization; • A persistent or significant incapacity or substantial disruption of the ability to conduct

Revised: Mar/31/2021 17

normal life functions; • A congenital anomaly/birth defect; • An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.

Instructions for Reporting to VAERS

The vaccination provider enrolled in the federal COVID-19 Vaccination Program should complete and submit a VAERS form to FDA using one of the following methods: • Complete and submit the report online: https://vaers.hhs.gov/reportevent.html, or • If you are unable to submit this form electronically, you may fax it to VAERS at 1-877- 721-0366. If you need additional help submitting a report, you may call the VAERS toll- free information line at 1-800-822-7967 or send an email to [email protected].

IMPORTANT: When reporting adverse events or vaccine administration errors to VAERS, please complete the entire form with detailed information. It is important that the information reported to FDA be as detailed and complete as possible. Information to include: • Patient demographics (e.g., patient name, date of birth) • Pertinent medical history • Pertinent details regarding admission and course of illness • Concomitant medications • Timing of adverse event(s) in relationship to administration of Moderna COVID-19 Vaccine • Pertinent laboratory and virology information • Outcome of the event and any additional follow-up information if it is available at the time of the VAERS report. Subsequent reporting of follow-up information should be completed if additional details become available.

The following steps are highlighted to provide the necessary information for safety tracking: 1. In Box 17, provide information on Moderna COVID-19 Vaccine and any other vaccines administered on the same day; and in Box 22, provide information on any other vaccines received within one month prior. 2. In Box 18, description of the event: a. Write “Moderna COVID-19 Vaccine EUA” as the first line b. Provide a detailed report of vaccine administration error and/or adverse event. It is important to provide detailed information regarding the patient and adverse event/medication error for ongoing safety evaluation of this unapproved vaccine. Please see information to include listed above. 3. Contact information: a. In Box 13, provide the name and contact information of the prescribing healthcare provider or institutional designee who is responsible for the report. b. In Box 14, provide the name and contact information of the best doctor/healthcare professional to contact about the adverse event.

Revised: Mar/31/2021 18

c. In Box 15, provide the address of the facility where vaccine was given (NOT the healthcare provider’s office address).

Other Reporting Instructions

Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above.

To the extent feasible, report adverse events to ModernaTX, Inc. using the contact information below or by providing a copy of the VAERS form to ModernaTX, Inc.

Email Fax number Telephone number

[email protected] 1-866-599-1342 1-866-MODERNA (1-866-663-3762)

10 DRUG INTERACTIONS

There are no data to assess the concomitant administration of the Moderna COVID-19 Vaccine with other vaccines.

11 USE IN SPECIFIC POPULATIONS

11.1 Pregnancy

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Moderna COVID-19 Vaccine during pregnancy. Women who are vaccinated with Moderna COVID-19 Vaccine during pregnancy are encouraged to enroll in the registry by calling 1-866- MODERNA (1-866-663-3762).

Risk Summary

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Available data on Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine- associated risks in pregnancy.

In a developmental toxicity study, 0.2 mL of a vaccine formulation containing the same quantity of nucleoside-modified messenger ribonucleic acid (mRNA) (100 mcg) and other ingredients included in a single human dose of Moderna COVID-19 Vaccine was administered to female rats by the intramuscular route on four occasions: 28 and 14 days prior to mating, and on gestation days 1 and 13. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study. Revised: Mar/31/2021 19

11.2 Lactation

Risk Summary

Data are not available to assess the effects of Moderna COVID-19 Vaccine on the breastfed infant or on milk production/excretion.

11.3 Pediatric Use Safety and effectiveness have not been assessed in persons less than 18 years of age. Emergency Use Authorization of Moderna COVID-19 Vaccine does not include use in individuals younger than 18 years of age.

11.4 Geriatric Use Clinical studies of Moderna COVID-19 Vaccine included participants 65 years of age and older receiving vaccine or placebo, and their data contribute to the overall assessment of safety and efficacy. In an ongoing Phase 3 clinical study, 24.8% (n=7,520) of participants were 65 years of age and older and 4.6% (n=1,399) of participants were 75 years of age and older. Vaccine efficacy in participants 65 years of age and older was 86.4% (95% CI 61.4, 95.2) compared to 95.6% (95% CI 90.6, 97.9) in participants 18 to <65 years of age [see Clinical Trial Results and Supporting Data for EUA (18)]. Overall, there were no notable differences in the safety profiles observed in participants 65 years of age and older and younger participants [see Overall Safety Summary (6.1)].

13 DESCRIPTION

Moderna COVID-19 Vaccine is provided as a white to off-white suspension for intramuscular injection. Each 0.5 mL dose of Moderna COVID-19 Vaccine contains 100 mcg of nucleoside- modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of SARS-CoV-2 virus.

Each dose of the Moderna COVID-19 Vaccine contains the following ingredients: a total lipid content of 1.93 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.31 mg tromethamine, 1.18 mg tromethamine hydrochloride, 0.043 mg acetic acid, 0.20 mg sodium acetate trihydrate, and 43.5 mg sucrose.

Moderna COVID-19 Vaccine does not contain a preservative.

The vial stoppers are not made with natural rubber latex.

Revised: Mar/31/2021 20

14 CLINICAL PHARMACOLOGY

14.1 Mechanism of Action

The nucleoside-modified mRNA in the Moderna COVID-19 Vaccine is formulated in lipid particles, which enable delivery of the nucleoside-modified mRNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an immune response to the S antigen, which protects against COVID-19.

18 CLINICAL TRIAL RESULTS AND SUPPORTING DATA FOR EUA

A Phase 3 randomized, placebo-controlled, observer-blind clinical trial to evaluate the efficacy, safety, and immunogenicity of the Moderna COVID-19 Vaccine in participants 18 years of age and older is ongoing in the United States (NCT04470427). Randomization was stratified by age and health risk: 18 to <65 years of age without comorbidities (not at risk for progression to severe COVID-19), 18 to <65 years of age with comorbidities (at risk for progression to severe COVID-19), and 65 years of age and older with or without comorbidities. Participants who were immunocompromised and those with a known history of SARS-CoV-2 infection were excluded from the study. Participants with no known history of SARS-CoV-2 infection but with positive laboratory results indicative of infection at study entry were included. The study allowed for the inclusion of participants with stable pre-existing medical conditions, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment, as well as participants with stable human immunodeficiency virus (HIV) infection. A total of 30,420 participants were randomized equally to receive 2 doses of the Moderna COVID-19 Vaccine or saline placebo 1 month apart. Participants will be followed for efficacy and safety until 24 months after the second dose.

The primary efficacy analysis population (referred to as the Per-Protocol Set) included 28,207 participants who received two doses (at 0 and 1 month) of either Moderna COVID-19 Vaccine (n=14,134) or placebo (n=14,073), and had a negative baseline SARS-CoV-2 status. In the Per- Protocol Set, 47.4% were female, 19.7% were Hispanic or Latino; 79.5% were White, 9.7% were African American, 4.6% were Asian, and 2.1% other races. The median age of participants was 53 years (range 18-95) and 25.3% of participants were 65 years of age and older. Of the study participants in the Per-Protocol Set, 18.5% were at increased risk of severe COVID-19 due to at least one pre-existing medical condition (chronic lung disease, significant cardiac disease, severe obesity, diabetes, liver disease, or HIV infection) regardless of age. Between participants who received Moderna COVID-19 Vaccine and those who received placebo, there were no notable differences in demographics or pre-existing medical conditions.

Efficacy Against COVID-19

COVID-19 was defined based on the following criteria: The participant must have experienced at least two of the following systemic symptoms: fever (≥38ºC), chills, myalgia, headache, sore throat, new olfactory and taste disorder(s); or the participant must have experienced at least one of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, or clinical or radiographical evidence of pneumonia; and the participant must have at least one Revised: Mar/31/2021 21

NP swab, nasal swab, or saliva sample (or respiratory sample, if hospitalized) positive for SARS- CoV-2 by RT-PCR. COVID-19 cases were adjudicated by a Clinical Adjudication Committee.

The median length of follow up for efficacy for participants in the study was 9 weeks post Dose 2. There were 11 COVID-19 cases in the Moderna COVID-19 Vaccine group and 185 cases in the placebo group, with a vaccine efficacy of 94.1% (95% confidence interval of 89.3% to 96.8%).

Table 3: Primary Efficacy Analysis: COVID-19* in Participants 18 Years of Age and Older Starting 14 Days After Dose 2 per Adjudication Committee Assessments – Per-Protocol Set

Moderna COVID-19 Vaccine Placebo Participants COVID-19 Incidence Participants COVID-19 Incidence % Vaccine (N) Cases Rate of (N) Cases Rate of Efficacy (n) COVID-19 (n) COVID-19 (95% CI)† per 1,000 per 1,000 Person- Person- Years Years 14,134 11 3.328 14,073 185 56.510 94.1 (89.3, 96.8)

* COVID-19: symptomatic COVID-19 requiring positive RT-PCR result and at least two systemic symptoms or one respiratory symptom. Cases starting 14 days after Dose 2. † VE and 95% CI from the stratified Cox proportional hazard model.

The subgroup analyses of vaccine efficacy are presented in Table 4.

Table 4: Subgroup Analyses of Vaccine Efficacy: COVID-19* Cases Starting 14 Days After Dose 2 per Adjudication Committee Assessments – Per- Protocol Set

Moderna COVID-19 Vaccine Placebo Age Participants COVID-19 Incidence Participants COVID-19 Incidence % Subgroup (N) Cases Rate of (N) Cases Rate of Vaccine (Years) (n) COVID-19 (n) COVID-19 Efficacy per 1,000 per 1,000 (95% Person- Person- CI)* Years Years 18 to <65 10,551 7 2.875 10,521 156 64.625 95.6 (90.6, 97.9)

≥65 3,583 4 4.595 3,552 29 33.728 86.4 (61.4, 95.2)

Severe COVID-19 was defined based on confirmed COVID-19 as per the primary efficacy endpoint case definition, plus any of the following: Clinical signs indicative of severe systemic illness, respiratory rate ≥30 per minute, heart rate ≥125 beats per minute, SpO2 ≤93% on room Revised: Mar/31/2021 22

air at sea level or PaO2/FIO2 <300 mm Hg; or respiratory failure or ARDS (defined as needing high-flow oxygen, non-invasive or mechanical ventilation, or ECMO), evidence of shock (systolic blood pressure <90 mmHg, diastolic BP <60 mmHg or requiring vasopressors); or significant acute renal, hepatic, or neurologic dysfunction; or admission to an intensive care unit or death.

Among all participants in the Per-Protocol Set analysis, which included COVID-19 cases confirmed by an adjudication committee, no cases of severe COVID-19 were reported in the Moderna COVID-19 Vaccine group compared with 30 cases reported in the placebo group (incidence rate 9.138 per 1,000 person-years). One PCR-positive case of severe COVID-19 in a vaccine recipient was awaiting adjudication at the time of the analysis.

19 HOW SUPPLIED/STORAGE AND HANDLING

Moderna COVID-19 Vaccine Suspension for Intramuscular Injection Multiple-Dose Vials are supplied as follows:

NDC 80777-273-99 Carton of 10 multiple-dose vials, each vial containing a maximum of 11 doses: range 10-11 doses (0.5 mL)

NDC 80777-273-98 Carton of 10 multiple-dose vials, each vial containing a maximum of 15 doses: range 13-15 doses (0.5 mL)

During storage, minimize exposure to room light.

Store frozen between -50º to -15ºC (-58º to 5ºF). Store in the original carton to protect from light.

Do not store on dry ice or below -50ºC (-58ºF). Use of dry ice may subject vials to temperatures colder than -50°C (-58°F).

Vials may be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use. Do not refreeze.

Vials may be stored between 8° to 25°C (46° to 77°F) for a total of 24 hours.

After the first dose has been withdrawn, the vial should be held between 2° to 25°C (36° to 77°F). Vials should be discarded 12 hours after the first puncture.

Thawed vials can be handled in room light conditions.

Do not refreeze once thawed.

Transportation of Thawed Vials at 2°C to 8°C (35°F to 46°F)

shipping containers which have been qualified to maintain 2° to 8°C (35° to 46°F) and under routine road and air transport conditions with shaking and vibration minimized. Once thawed and transported at 2° to 8°C (35° to 46°F), vials should not be refrozen and should be stored at 2° to 8°C (35° to 46°F) until use.

20 PATIENT COUNSELING INFORMATION

Advise the recipient or caregiver to read the Fact Sheet for Recipients and Caregivers.

The vaccination provider must include vaccination information in the state/local jurisdiction’s Immunization Information System (IIS) or other designated system. Advise recipient or caregiver that more information about IISs can be found at: https://www.cdc.gov/vaccines/programs/iis/about.html.

21 CONTACT INFORMATION

For general questions, send an email or call the telephone number provided below.

Email Telephone number [email protected] 1-866-MODERNA (1-866-663-3762)

This EUA Prescribing Information may have been updated. For the most resent Full EUA Prescribing Information, please visit www.modernatx.com/covid19vaccine-eua.

Moderna US, Inc. Cambridge, MA 02139

Revised: Mar/31/2021 24

Moderna Provides Storage Update & Announces the U.S. FDA Authorizes Up To 15-Doses Per Vial of its COVID-19 Vaccine

April 2, 2021

U.S. EUA label allows for vaccine vials to remain at room temperature conditions for a longer period (total of 24 hours from previous 12 hours)

Label update also allows for two vial presentations (maximum of 15 doses and maximum of 11 doses)

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr. 1, 2021-- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that based on submitted stability data, the U.S. Food and Drug Administration (FDA) has authorized the Moderna COVID-19 Vaccine to be kept at room temperature conditions once removed from the refrigerator for administration for 24 hours, an increase from the previous 12 hours. Additionally, a punctured vial is now useable for up to 12 hours, an increase from the previous 6 hours. These new guidelines are reflected in an updated Emergency Use Authorization (EUA) label. The Moderna COVID-19 Vaccine is ready for use and does not need to be diluted.

The FDA also authorized inclusion of a new vial presentation with a maximum of 15 doses of its COVID-19 vaccine. In parallel, the FDA also authorized a maximum of 11 doses of its COVID-19 vaccine in the current format, from the previously authorized 10 doses per vial. The Moderna COVID-19 Vaccine now can be supplied in two vial presentations (a multiple-dose vial containing a maximum of 11 doses or a multiple-dose vial containing a maximum of 15 doses). The Company expects that the 15-dose vials will begin shipping in the coming weeks.

“We are committed to constantly learning and improving to facilitate easier administration of our COVID-19 vaccine for medical staff and accelerate immunization programs. Thank you to the U.S. FDA and CDC for their ongoing collaboration,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We remain focused on doing all that we can to help end the COVID-19 pandemic with a vaccine.”

Moderna is continually learning, adapting and working closely with its partners and the U.S. government to identify ways to facilitate accelerated vaccine administration, address bottlenecks and accelerate production. One identified constraint on the production process has been the capacity of the fill-and-finish process. Moderna studied the possibility of adding more doses to each vial of vaccine to address bottlenecks, accelerate production and reduce the need for consumable materials that are in high demand. Moderna will continue to collaborate with its manufacturing partners and the federal government to increase the efficiency of its production process without compromising quality or safety.

About the Moderna COVID-19 Vaccine

The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the National Institutes of Health (NIH) on February 24, 2020, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of the Moderna COVID-19 Vaccine was dosed on March 16, 2020, 63 days from sequence selection to Phase 1 study dosing. On May 12, 2020, the U.S. FDA granted the Moderna COVID-19 Vaccine Fast Track designation. On May 29, 2020, the first participants in each age cohort were dosed in the Phase 2 study of the vaccine. On July 8, 2020, the Phase 2 study completed enrollment.

Results from the second interim analysis of the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were published on September 29, 2020 in The New England Journal of Medicine. On November 30, 2020, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases. On November 30, 2020, the Company also announced that it filed for Emergency Use Authorization with the U.S. FDA and a Conditional Marketing Authorization (CMA) application with the European Medicines Agency. On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has also received authorization for its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore and Qatar. Additional authorizations are currently under review in other countries and by the World Health Organization.

The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) is supporting the continued research and development of the Company’s COVID-19 vaccine development efforts with federal funding under contract no. 75A50120C00034. BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the Company for conducting the program described in the BARDA contract. The U.S. government has agreed to purchase supply of mRNA-1273 under U.S. Department of Defense contract no. W911QY-20-C-0100.

AUTHORIZED USE

IMPORTANT SAFETY INFORMATION

Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine. Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Moderna COVID-19 Vaccine. Monitor Moderna COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html). Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to the Moderna COVID-19 Vaccine. The Moderna COVID-19 Vaccine may not protect all vaccine recipients. Adverse reactions reported in a clinical trial following administration of the Moderna COVID-19 Vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site. Severe allergic reactions, including anaphylaxis, have been reported following administration of the Moderna COVID-19 Vaccine during mass vaccination outside of clinical trials. Available data on Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine- associated risks in pregnancy. Data are not available to assess the effects of Moderna COVID-19 Vaccine on the breastfed infant or on milk production/excretion. There are no data available on the interchangeability of the Moderna COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Moderna COVID-19 Vaccine should receive a second dose of Moderna COVID-19 Vaccine to complete the vaccination series. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Moderna COVID-19 Vaccine. Vaccination providers must complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words “Moderna COVID- 19 Vaccine EUA” in the description section of the report.

Click for Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information for more information.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the Company’s development of a vaccine (mRNA-1273) to protect against the SARS-CoV-2 virus, which causes COVID-19; the conditions under which the vaccine can be stored and administered; the number of doses that can be included in each vial; the timing for shipments of vials containing 15 doses; and ongoing improvements to the process for manufacturing and shipping the vaccine. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward- looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward- looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the safety, tolerability and efficacy profile of the Moderna COVID-19 Vaccine observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; the Moderna COVID-19 Vaccine may prove less effective against variants of the SARS-CoV-2 virus, or the Company may be unsuccessful in developing future versions of its vaccine against these variants; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company’s regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; Moderna may encounter delays in meeting manufacturing or supply timelines or disruptions in its distribution plans for the Moderna COVID-19 Vaccine; whether and when any biologics license applications and/or additional emergency use authorization applications may be filed in various jurisdictions and ultimately approved by regulatory authorities; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210401005986/en/

Media: Colleen Hussey Director, Corporate Communications 617-335-1374 [email protected]

Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations 617-209-5834 [email protected]

Source: Moderna, Inc. The NEW ENGLAND JOURNAL of MEDICINE

Perspective

Addressing Vaccine Hesitancy in BIPOC Communities — Toward Trustworthiness, Partnership, and Reciprocity Sandra C. Quinn, Ph.D., and Michele P. Andrasik, Ph.D.

Addressing Vaccine Hesitancy in BIPOC Communities he devastation of the Covid-19 pandemic has tions, and government that are been rippling through Black, Indigenous, and not easily overcome. Furthermore, persistent racial bias and the TPeople of Color (BIPOC) communities through- dearth of BIPOC clinicians in the out the United States. The Centers for Disease Control health care system are well documented. In a national survey of and Prevention has reported hor- BIPOC communities over receiv- 1643 adults, evenly split between rifyingly disproportionate age- ing Covid-19 vaccines, the social, Black and White respondents, adjusted rates of cases, hospital- economic, and political backdrop Quinn and colleagues examined izations, and deaths. Black helps us understand the experi- the impact of this lack of diver- Americans have had hospitaliza- ences and circumstances that feed sity on behavior with regard to tion and death rates 9 times as that hesitancy. influenza vaccination and found high as those for White Ameri- For BIPOC communities, such that perceived racial fairness in cans; American Indians and Alas- hesitancy is rooted in both the the health care setting increased ka Natives have seen 9 times as historical and contemporary con- trust in influenza vaccines and many cases and 4 times as many texts of systemic racism, margin- vaccine uptake, whereas experi- deaths as White Americans; and alization, and neglect that shape ences of discrimination in the Latinx/Hispanic Americans have daily life today. Moreover, his- health care setting decreased faced 3 times as many deaths as torical experiences with research trust, increased perceived risk of their White counterparts.1 Simul- abuses — from the U.S. Public side effects, and reduced uptake.2 taneously, the United States has Health Service Syphilis Study at Although BIPOC communities been reeling from police shoot- Tuskegee to the more recent case have important reasons to be ings, Black Lives Matter protests, in which blood samples from hesitant, increasing reports of dis- and an emboldened White suprem- members of the Havasupai Tribe parities in vaccine access through- acist movement that perpetrated were improperly used for research out the country point to broader the January 6, 2021, attack on the — have established doubt and systemic challenges, such as in- U.S. Capitol. As national surveys skepticism about the trustworthi- equitable distribution of doses, continue to report hesitancy in ness of science, research institu- failure to place clinics in sites ac-

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Questions and Answers Used in Train-the-Trainer and Community Education.*

How did these trials move so quickly? Researchers used existing clinical trial networks. Manufacturing started while the clinical trials were still underway. mRNA vaccines are faster to produce than traditional vaccines. Other sponsors use platforms that have proven successful in the development of vaccines. The studies included more participants than a typical study and disease transmission rates were high, enabling researchers to determine efficacy in a short time. The FDA and the CDC prioritized review, authorization, and recommendation of Covid-19 vaccines. Were vaccines tested on people Yes. like me? Vaccine trials included all adults >18 yr of age. It was mandated that 25% of participants in Moderna and Pfizer trials were to be >65 yr of age. It was mandated that 30% of participants in Janssen trial were to be >60 yr of age. Study participants included at least 25% of people with common health problems such as high blood pressure, diabetes, HIV, and cancer. There were no exclusions for diseases or medications, except immunosuppression. Vaccine studies did not include pregnant people. Do these vaccines work for all races/ Yes. There is strong evidence that the vaccines work well for all people, regardless of their genetic ethnic groups? background. What types of reactions have been reported after vaccination? Common reactions Sore arm, headache, aches, fever may appear within 48 hours. These are similar to reactions seen after shingles and influenza vaccines. Rare reaction: anaphylaxis Pfizer: 21 cases with 2 million doses Moderna: 10 cases with 4 million doses Janssen: There have been cases of severe allergic reactions. Current recommendation: 15 minutes of observation after injection If you have a history of severe allergies or an anaphylactic reaction to a vaccine, it’s recommended that you discuss vaccination with your provider and undergo 30 minutes of observation after receiving the vaccine. Most people with a history of allergies or anaphylaxis have received a vaccine with no issues. Should I get a vaccine now or You are not the first: >60 million U.S. residents have received Covid vaccines (>156 million globally “wait and see”? as of March 8, 2021) CDC v-safe and VAERS are monitoring safety. As of March 9, 2021, in the United States: 523,850 people have died of Covid-19, and nearly 29 million people have tested positive for SARS-CoV-2, the virus that causes Covid-19. The Pfizer and Moderna vaccines take 4–5 weeks to protect you fully (2 doses). For the Janssen single-dose vaccine, protection starts at 14 days and increases through 56 days after immunization. The new Covid-19 strains are more contagious than the old ones. Does mRNA change your DNA? No. mRNA is a signal to your cell. It stays in the outer part of the cell and does not enter the nucleus where DNA is located. The mRNA in the vaccine is present in the body for only 1–3 days; then it degrades and the immune system is primed and ready. The Janssen vaccine can stay in your body for more than a week, but it does not reproduce itself; this may lead to increased protection over time. I’ve heard that the mRNA vaccine .... No, it will not give you Covid-19. No, it does not affect women’s fertility. No, it does not contain fetal tissue, microchips, or any other devices. Which vaccine is the best? All the vaccines — Janssen, Moderna, and Pfizer — are very good at preventing severe disease, so they will greatly reduce rates of severe disease progression, hospitalization, and death. When you are offered a vaccine, you should take it. Why do I have to wear a mask after The vaccines prevent Covid-19 disease, severe disease, and death. getting immunized against We know much less about whether vaccines prevent asymptomatic infection, as this question was Covid-19? not studied. Until we know that, we must assume that vaccinated people might get Covid-19 and not know it. Masks, social distancing, handwashing are still required until we have more information.

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Questions and Answers Used in Train-the-Trainer and Community Education (Continued.)*

Is one dose of mRNA vaccine The data are very clear that for the Pfizer and Moderna vaccines, the best protection from Covid-19 as effective as two doses? disease happens after the second (booster) dose. The first dose starts the immune response, and the second dose boosts it to make high antibody levels. The Janssen vaccine is a one-shot vaccine. How long does vaccine immunity We don’t know. Covid-19 is a brand-new human disease, and we will need more time to determine to Covid-19 last? how long vaccine responses last. How will viral mutations affect As of February 2021, this is what we know: Covid-19 vaccines? Current vaccines work well against the variant originally identified in the United Kingdom. There seems to be some reduced efficacy for the variant originally identified in South Africa. Researchers will continue to monitor and test the efficacy of existing vaccines against new variants, including the variant originally identified in Brazil. The vaccines are still highly effective in preventing severe disease (reducing risk of being hospitalized, requiring supplementary oxygen, needing a ventilator) and death. The vaccines may not prevent you from getting mild symptoms, but they will prevent severe disease.

* Covid v-safe is an app that provides personalized health check-ins after you receive a Covid-19 vaccine. CDC denotes Centers for Disease Control and Prevention, FDA Food and Drug Administration, and VAERS Vaccine Adverse Event Reporting System.

cessible to BIPOC communities, However, we believe it’s time to ly nonexistent. The relationships and underinvestment in health care shift the focus from a sole empha- that do exist are generally short- providers and services in BIPOC sis on changing hearts and minds lived, often enduring only as long communities. Reliance on Web- among members of BIPOC com- as grant funding lasts. For health based vaccine-registration systems munities to ensuring that institu- care and public health institutions has disadvantaged communities tions are trustworthy, transparent, to build a reputation of trustwor- with less access to technology, and engaged with communities thiness, partnerships rooted in and real barriers such as work during the vaccine rollout. Mak- bidirectional communication, ca- obligations and limited childcare ing our institutions — particu- pacity building, and reciprocity options reduce their ability to larly health care, public health, are required. Environments that chase vaccination appointments. and government — more trust- center on relationships allow for Several systematic reviews3,4 have worthy will require listening to mutual learning, provide oppor- provided evidence that systemic community voices, preparing pub- tunities for sharing stories, en- racism and provider bias are as- lic health and health care organi- gender understanding, prepare sociated with poor patient–provid- zations to respectfully engage with organizations to respectfully en- er communication and interac- BIPOC communities, and becom- gage community members, and tions, lower quality of care, and ing more client-centered, includ- increase the capacity of all part- negative health outcomes. These ing viewing hesitancy and barri- ners in their efforts to navigate ongoing challenges prompt an ers to vaccine uptake through the institutional, organizational, and urgent need to address the ineq- eyes of members of the BIPOC community spaces. uities in access proactively to avoid community. Building relationships requires turning the vaccine rollout into A primary path toward trust actively listening to others’ stories one more example of ongoing and confidence is relationship and ensuring that all partners are unfair treatment, providing addi- building. In too many situations provided an opportunity to artic- tional evidence to confirm be- and circumstances, BIPOC com- ulate the challenges, barriers, and liefs that the U.S. health system munities are asked to “help us facilitating factors they have en- is fraught with structural racism. solve the problems in your com- countered in their work. The It is essential to remember that munity.” Long-standing and re- shared understanding and insight hesitancy doesn’t mean refusal, ciprocal relationships between gained can create a strong foun- and in fact, skepticism can be medical and research institutions dation for developing a collective protective for BIPOC communities. and BIPOC communities are large- public health response, but this

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understanding must be accompa- about the Covid-19 vaccines avail- health agencies, and communities nied by the sharing of resources. able through EUAs. Each 2-hour themselves. This is a challenge we The community engagement session included an hour of di- must meet. efforts of the COVID-19 Preven- dactic presentation covering vac- We believe that authentic com- tion Network (CoVPN), led by the cine science, safety, manufactur- munity engagement is essential to National Institute of Allergy and ing, and questions and concerns reducing vaccine hesitancy. Equal- Infectious Diseases (NIAID)-fund- frequently encountered in vaccine ly important is reframing the ed networks, provide one model discussions (see table). The first challenge of vaccine hesitancy in for community partnership. The hour concluded with an overview BIPOC communities to one of vac- CoVPN has worked to ensure that of available educational materials cine confidence. Working direct- communities have the resources and a review of navigating the ly with these communities, let us they need to make informed de- Dropbox folder. The second hour acknowledge the collective fears cisions about participation in included a panel discussion, with stemming from past government Covid-19 vaccine trials in the CoVPN subject-matter experts an- actions and research abuses and short term, and about vaccine ac- swering audience questions. engage in honest and authentic ceptability and uptake in the long From its beginning, the Biden dialogue. By doing so, we can to- term. These efforts are grounded administration has taken steps to gether issue a call for justice and in frequent and ongoing discus- begin to restore the trustworthi- meet that call by securing real sions with long-standing commu- ness of government for BIPOC access to Covid-19 vaccines to save nity partners to ensure that our communities who have suffered the lives of BIPOC Americans. understanding of community fears horribly during this pandemic. Disclosure forms provided by the au- and uncertainty is accurate and From its memorial service and the thors are available at NEJM.org. to share challenges and obstacles first presidential acknowledgment faced in our efforts and work to- of the grief experienced by so From the Department of Family Science, School of Public Health, University of Mary- gether to identify strategies for many families, to the proposed land, College Park (S.C.Q.); and the HIV overcoming them. American Rescue Plan and the Vaccine Trials Network and Vaccine and In- These partnerships facilitated reopening of enrollment in Afford- fectious Disease Division, Fred Hutchinson Cancer Center, University of Washington, the early identification of materi- able Care Act health care cover- Seattle (M.P.A.). als required for building capacity age, the administration has plant- among community members and ed seeds to grow trust, possibly This article was published on March 31, health care providers by increas- for the first time. The adminis- 2021, at NEJM.org. ing knowledge about vaccines, tration’s Executive Order on En- 1. Hospitalization and death by race/eth- clinical trials, and emergency use suring an Equitable Pandemic nicity. Atlanta: Centers for Disease Control authorizations (EUAs). These ma- Response and Recovery and the and Prevention, March 12, 2021 (https:// terials are available in multiple COVID-19 Health Equity Task www. cdc . gov/ coronavirus/ 2019 - ncov/ community/ health - equity/ racial - ethnic languages and housed in an on- Force, led by Dr. Marcella Nunez- -disparities/ infographic - cases line Dropbox folder (tinyurl.com/ Smith, have placed critical issues -hospitalization-death.html). COVID19Materials), easily acces- front and center in the adminis- 2. Quinn SC, Jamison A, Freimuth VS, An J, Hancock GR, Musa D. Exploring racial in- sible by all partners and dissemi- tration’s response, addressing sys- fluences on flu vaccine attitudes and behav- nated widely in emails and webi- temic challenges and calling for ior: results of a national survey of White and nar sessions. As new data and outreach to communities involv- African American adults. Vaccine 2017;35: 1167-74. information emerged, we identi- ing tailored communication and 3. FitzGerald C, Hurst S. Implicit bias in fied the need for train-the-train- trusted local leaders. Ensuring that healthcare professionals: a systematic review. er sessions for community health BIPOC communities have equita- BMC Med Ethics 2017;18:19. 4. Hall WJ, Chapman MV, Lee KM, et al. care navigators, clinicians, com- ble access to Covid-19 vaccines Implicit racial/ethnic bias among health care munity leaders (such as religious and that the vaccines will be ac- professionals and its influence on health care and faith leaders, advocates, and cepted when offered will take an outcomes: a systematic review. Am J Public Health 2015;105(12):e60-e76. barbers and stylists), and health enormous effort from govern- department staff. These sessions ments at all levels, health care DOI: 10.1056/NEJMp2103104

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