Overview of COVID-19 Vaccination – Feb.1, 2021 Please call or text one of the numbers below if you have any technical issues with the presentation: Jim Zieba – (317) 237-3563 Marilyn Carter – (317) 562-0895
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Eye Specialists of Indiana Overview of COVID-19 Vaccination
Brad Sutton OD, FAAO, FORS Anna Bedwell OD, FAAO, FORS Larissa Krenk, OD
IU School of Optometry Indianapolis Eye Care Center Financial disclosures
No financial disclosures for any of the authors Immune system vaccine basics
SARS-CoV-2(COVID- 19) respiratory virus contains 25 major proteins The main target for vaccine induced immune response is the glycoprotein spike
This Photo by Unknown Author is licensed under CC BY- SA-NC Immune response-immune memory
Three main cell types: 1) antibody (attacks virus outside the cell). Made by B cells 2) CD4 helper T cells (attacks virus inside the cell) 3) CD8 killer T cells (attack virus inside the cell) This Photo by Unknown Author is licensed under CC BY-NC Natural immunity after COVID-19 infection
How long does It looks like natural about 95% of immunity last infected people after infection? still have We don’t know immune for sure, memory at 6-8 but……… months MRNA vaccines are new!
New vaccine The MRNA is carried into our cells and codes technology for the spike protein. MRNA codes for Our cells then produce it, so the immune a single spike system recognizes it on protein the COVID-19 virus if we are infected No live virus, no Takes place in the deactivated cytoplasm virus Creates antibodies and T-cell response MRNA vaccines
A brief, temporary message that expires quickly Does not alter DNA MRNA vaccines
The MRNA is Often, adjuvants used to get vaccines into carried into our cells and convey cells by lipid “severity” to the nanoparticles immune system No adjuvants or Mostly taken up preservatives in Pfizer- by muscle cells BioNTech or Moderna vaccines Also by a few specialized immune cells MRNA vaccines
MRNA vaccine Other COVID-19 technology will vaccines in not work for all development viruses, but is use a viral highly likely to vector, not be used for MRNA other viruses in (Astrazeneca, the future Johnson & Johnson, etc.) Ingredients
Pfizer-BioNTech: Moderna: 1) MRNA 1) MRNA 2) 3 Lipid nanoparticles 2) 4 Lipid nanoparticles 3) Tromethamine / 3) 4 salts Tromethamine 4) Sucrose (protects hydrochloride / acetic acid the vaccine during / sodium acetate (PH freezing) buffers) 4) Sucrose
Must be stored frozen at ultra-low Stored frozen between - temperature between - 13 to 5 degrees F long 112 to -76 degrees F to term, but can be stored refrigerated (36-46 protect MRNA degrees F) up to 30 days Vaccine immunity
How long will It might be the COVID 19 same as natural vaccine immunity, much immunity last? longer than We don’t know natural yet immunity, or shorter than natural immunity So how did we get here so quickly?
No vaccines in Most vaccines human history take more than had ever been 10 years to developed and develop and put implemented in to use less than a calendar year until now Normal process
Phase 1 trial For past Phase 2 trial vaccines, followed Phase 3 trial sequentially in Approval order Large scale manufacturing Operation Warp Speed
Partnership Absolutely no between corners were cut Government and in the approval private industry process US government Up front funding spent $10 billion was key DoD, HHS, CDC, NIH, BARDA Operation Warp Speed
Funding allowed Normally, these phased trials to run massive financial risks contiguously instead of could not be taken sequentially Pfizer and Moderna Also allowed for have received EUA in manufacturing of large US, 3 other vaccines in quantities during phase 3 trials as of development in early 2021 anticipation of approval Pfizer-BioNTech was the first to market but took no government funding other than purchase orders for the vaccine EUA: Emergency Use Authorization
FDA can grant Pfizer-BioNTech: EUA issued 12-11-2020 for EUA when there age 16 and older. is a public health Approved in 55 crisis, and countries Moderna: EUA issued something is 12-18-2020 for age 18 developed that and older. Approved in has no already 37 countries approved counterpart Around the world
https://covid19.t 11 vaccines rackvaccines.org have been /vaccines/ approved in at least one country Incredibly helpful site that 78 in trials (23 tracks approvals phase 1, 35 and trials in phase 2, 20 every country phase 3) Trial Participants
Pfizer-BioNTech Moderna
21,720 vaccine 15,419 people 21,728 placebo received at least one vaccine dose (15,179 received both doses) 15,163 placebo Effectivity
Both vaccines Extremely high approximately 95% efficacy effective, and 90% (Pfizer-BioNTech) to nearly 100% (Moderna) effective at preventing severe disease Virus mutation
Can viruses Influenza mutates mutate to make easily and often vaccines less Measles, polio, and effective? Hep B for example basically have not Absolutely, but it mutated is highly variable COVID-19 virus has started to mutate Recent COVID Variants
B117 (United B1351 (South Kingdom) Africa Sept 2020 October 2020 Unusually large First case found number of recently in South mutations Carolina Detected in US P1 (Brazil) Estimated that it January 2020 could become the dominant strain by First case found March recently in Minnesota All are thought to be more contagious Risk of symptom severity and deadliness still uncertain Will the vaccines work?
B117 (United Kingdom) Moderna is Both Pfizer and developing two Moderna vaccines booster shots to fight appear to work against variants B1351 (South Africa) Both Pfizer and Moderna appears to Pfizer says it could work but “may be less effective” “adjust” its vaccine, P1 (Brazil) but it would take No strong evidence weeks Scientists seem to think it may be able to evade antibodies, making the vaccine ineffective So who should / should not get vaccinated?
No if severely allergic Studies ongoing now to any ingredients on children under 16 / No if severe allergic 18 reaction to first dose Pregnancy / breast It is an individual and feeding unknown personal decision, but these vaccines appear to be particularly safe
If already had COVID- 19 infection, should still Herd immunity requires get vaccinated, but can approximately 70% wait a while vaccination in the population Vaccination priority
CDC recommendations:
Phase 1A: Health care personnel and residents of long-term care facilities Phase 1B: People 75 and older and front-line essential workers Phase 1C:People 65-74, people 16-64 with high-risk medical conditions, other non-front- line essential workers Phase 2: all others 16+
But states decide for themselves Vaccination priority- Indiana IM Administration technique
So how are IM injections delivered? Syringe basics
1ml (TB): vaccines generally 3ML 5ML
Larger (less 1 ml common except for blood draws)
5 ml Needle basics
Bevel (angled slice) Gauge: larger number = smaller needle 19, 23, 25, 27, 30, etc. May have second # indicating length (inches):27 ½ G Needle gauges IM injection technique
Needle used only for the drawing up of a fluid can be re- capped using the “one hand scoop technique” IM injection technique
Needles that have been used on people are never re-capped before discarding them High risk of “stick” with contamination IM injection technique
All needles disposed of in a sharps container: they are now usually clear to allow for viewing contents Intramuscular injection technique
Deposits medication into muscular tissue free of major vessels and nerves Typically given in the deltoid (most vaccines) or gluteus muscles ( outer buttocks ). Sometimes the thigh (epipen) Much more rapid onset of action than subcutaneous route due to the greater blood supply of the tissue Intramuscular technique
Clean site with alcohol pad Pull skin taught Insert needle at 90-degree angle Inject medication / vaccine
Smith et al., 2000, p. 387 Injection sites Vaccination Providers
Currently Phase 1A Phase 1B and 2 will is only utilizing expand to local hospitals that were health departments prepared to and commercial administer the pharmacies vaccine to all Enrollment will be a healthcare personal phased process An email was sent based on vaccine in October by the availability IDOH asking them to enroll as vaccine providers Vaccination Providers
Physicians and facilities The IDOH has created an who routinely give online enrollment portal vaccines are enrolled in for providers that will the Vaccines For Children upload to the CDC’s (VFC) Program and record COVID-19 Vaccination administration of these Program Provider vaccines in Children and Agreement and Profile Hoosier Immunization Form Registry Program (CHIRP), Indiana’s Registered COVID-19 immunization information vaccination providers will system order COVID-19 vaccine through CHIRP What about optometrists?
If granted permission Much of the information to administer vaccines, needed to enroll is be on the lookout for similar to what is emails from the IDOH, included in enrolling for likely similar to the the VFC/CHIRP so the vaccination updates process will likely be from them that have more cumbersome for been emailed through optometrists the Indiana Link to CDC’s COVID- Professional Licensing 19 Vaccination Program Agency Provider Agreement Pay attention to and Profile Form: https://scdhec.gov/sites/default/files/ information relayed by media/document/COVID19- the Indiana Optometric Vaccination_Program_Provider_Agreem ent_and_Profile_Form.pdf Association Pfizer-BioNTech Vaccine
Suspension for IM injection Administered in two doses, 3 weeks apart 0.3 mL each Approved for ages 16+ Important Links for Providers
Fact Sheet for Videos for product Healthcare storage & handling, Providers preparation & Administering administration, and Vaccine found returning the here: thermal shipping https://www.fda container found .gov/media/144 here: 413/download https://www.cvdva ccine- us.com/product- storage-and-dry- ice Storage and Handling
Shipped in thermal shipping containers with dry ice Each vial tray contains either 25 or 95 multi- dose vials Credit: Provided/Premier Health Storage
Option 1 Option 2 Remove vial trays Use thermal and store in ultra- shipping container low freezer as temporary -112°F to -76°F storage Closed-lid vial trays Must be consistently can be at room refilled with dry ice temp for up to 5 With proper min to transfer and planning and open-lid up to 3 limiting opening of min, and then must container, dry ice remain in freezer for will need to be 2 hours before use replaced about every 5 days Storage
Do not refreeze Minimize thawed vials exposure to Do not open vial room light trays or remove Avoid direct vials until ready sunlight and for thawing ultraviolet light Thawing
Option 1 Option 2 In refrigerator At room 35°F to 46°F temperature Can be stored Up to 77°F for up to 5 days Can be stored Cartons take 2-3 for no more than hours to thaw, 2 hours fewer vials take Vials take 30 less time minutes to thaw Thawing
Plan ahead for the day or week to know how many multiple- dose vials to use Diluting Vials
ONLY Pfizer- ONLY THIS BioNTech Do not use vaccine needs to bacteriostatic be diluted 0.9% Sodium Dilutant not Chloride provided Injection or any Diluted with 1.8 other mL of 0.9% Sodium Chloride Injection, USP Step 1 Gently invert vaccine vial 10 times; do not shake Inspect liquid; Should be white to off-white suspension and may contain opaque amorphous particles Step 2 Cleanse 0.9% Sodium Chloride Injection, USP vial stopper with antiseptic swab Using aseptic technique, withdraw 1.8 mL of dilutant 3 mL syringe with 21 G needle or narrower recommended Step 3 Cleanse vaccine vial stopper with antiseptic swab Inject prepared dilutant into vaccine vial Don’t forget to equalize vial pressure by withdrawing 1.8 mL of air into syringe before removing from vial Step 4 Gently invert vial 10 times; do not shake Inspect the vaccine Record date and time of dilution on vial label Dilution
Once diluted, Diluted vaccine store between must be used 35°F to 77°F within 6 hours Any remaining vaccine must be discarded Preparation
Using aseptic technique, cleanse vial stopper with a single-use antiseptic swab Withdraw 0.3 mL of Pfizer- BioNTech vaccine Verify final dosing volume of 0.3 mL Check for discoloration or particles Preparation
Diluted vials contain up to 6 doses of 0.3 mL Regardless of type of syringe or needle Each dose MUST contain 0.3 mL of vaccine Discard remaining vaccine that will not provide a full dose Do not pool excess vaccine from multiple vials Administration
Must This information communicate to can be found recipient or here: caregiver http://labeling.p information fizer.com/ShowL consistent with abeling.aspx?id= “Fact Sheet for 14472 Recipients and Caregivers” prior to administration
Administer shot intramuscularly Watch for signs and symptoms of an acute allergic reaction Moderna Vaccine
Suspension for IM injection Administered in two doses, 4 weeks apart 0.5 mL each Approved for ages 18+ Important Links for Providers
Fact Sheet for Video for storage & Healthcare handling found Providers here: Administering https://www.moder Vaccine found natx.com/covid19v here: accine- https://www.fda.go eua/providers/stora v/media/144637/d ge-handling ownload Storage and Handling
Shipped frozen using existing shipping practices Each carton contains 10 multi-dose vials Provided/Premier Health Storage
Option 1 Option 2 Store frozen in Store original cartons refrigerated in to protect from original cartons light to protect from -13°F to 5°F light Can be stored 36°F to 46°F until expiration Can be stored date for 30 days Thawing
Option 1 Option 2 In refrigerator At room 36°F to 46°F temperature Thaw for 2 hours 59°F to 77°F and 30 minutes, Thaw for 1 hour then let stand at Unpunctured vials room temperature may be stored for for 15 minutes up to 12 hours before use Unpunctured vials can be stored up to 30 days
Do not refreeze thawed vials Preparation
Swirl vial gently Do NOT dilute after thawing vaccine and between each withdrawal; do NOT shake Preparation
Using aseptic technique, cleanse vial stopper with a single-use antiseptic swab Withdraw 0.5 mL of Moderna vaccine Preparation
Verify final dosing volume of 0.5 mL Check for discoloration or particles Vaccine is white to off-white suspension that may contain white or translucent particulates Preparation
Once punctured, Punctured record date and vaccine vials time of first use must be used on vial label within 6 hours Store between 36°F to 77°F Administration
Must This information communicate to can be found recipient or here: caregiver https://www.mo information dernatx.com/cov consistent with id19vaccine- “Fact Sheet for eua/eua-fact- Recipients and sheet- Caregivers” prior recipients.pdf to administration
Administer shot intramuscularly Watch for signs and symptoms of an acute allergic reaction CDC Dosing Updates
Four-day grace But for optimum period for giving protection, adhere the second dose to the 21-day early (Pfizer) and 28-day Second dose for (Moderna) dosing both can be given intervals up to 6 weeks after first Technically, no maximum interval between doses Comparing the Two
Pfizer-BioNTech Moderna Type mRNA mRNA Age Approved 16+ 18+ Shot Sequence 2 shots, 3 weeks 2 shots, 4 weeks apart apart Injection Type Intramuscular Intramuscular Storage Ultra-low freezer or Freezer (-13°F to 5°F) dry ice or (-112°F to -76°F) Fridge (36°F to -46°F) Diluted? YES NO Doses per vial ~6 10 Effectivity 95% 95% Comparable, but not interchangeable!
Different In “exceptional” ingredients circumstances Every effort any available should be made mRNA vaccine to use the same may be used for product for both the second dose doses! 28-42 days after first dose What’s on the horizon?
Oxford-AstraZeneca Non-replicating adenoviral vector DS-DNA not as fragile as RNA Approved for ages 18+ in 11 countries Limited data on ages 65+ Two full 0.5 mL doses, 4-12 weeks apart Intramuscular injection Stored refrigerated at 38-46°F for at least 6 months Use within 6 hours Efficacy ~70% What’s on the horizon?
Johnson & Johnson-Janssen Non-replicating adenoviral vector DS-DNA not as fragile as RNA Phase 1/2a trials studied ages 18-55 Phase 3 trial data expected on ages 65+ ONE DOSE ONLY! Intramuscular injection Storage and handling unknown 90% showed neutralizing antibody titers at Day 29, 100% at Day 57 and up to Day 71, irrespective of dose or age What’s on the horizon?
Novavax Protein subunit Harvested spike proteins injected as a nanoparticle Phase 1/2a trials “elicited robust antibody responses” Primary phase 3 findings estimated March 2021 Ages 18+ Two-dose series, 21-days apart Adjuvant added Storage and handling unknown Vaccine side effects
Almost all issues No adjuvant or with vaccine side preservative effects occur (thimerosal for within two example) in months of Pfizer-BioNTech receiving the or Moderna vaccine vaccine What defines adverse effect?
Adverse events = unintended, unexpected pharmacologic effects that occur when a medication is administered correctly VS. Side effect = secondary unwanted effect as a result of drug therapy Side effects in clinical trials
Pfizer-BioNTech Moderna Pain at injection site Pain at injection site 84% 92% Fatigue 63% Fatigue 70% Headache 55% Headache 65% Muscle pain 38% Myalgia 62% Chills 32% Arthralgia 46% Joint pain 24% Chills 45% Fever 14% Nausea 23% Swelling at injection Fever 16% site 10%, redness 10% Swelling 15%, redness 10% Side effects
Most all of these So not really side effects are side effects so secondary to a much as robust immune expected effects response, which is what we want Shot sequence
Pfizer-BioNTech: Adverse One shot expected effects followed by a tend to be worse second shot 3 after second weeks later dose: the Moderna: One immune system shot followed by is “primed” second shot one month later Adverse effects
Required by ISDH to keep patients for 15 minutes at facility to monitor for AEs If history of anaphylaxis or allergic reaction, monitor for 30 minutes. Other Trial AEs Reported
Bell’s palsy Pfizer 4 recipients Moderna 3 recipients, 1 placebo Appendicitis Pfizer 8 recipients, 4 placebo Facial filler AEs Moderna 3 recipients (with history of facial fillers) experienced facial swelling Anaphylaxis
Though rare, anaphylactic reactions have occurred from COVID-19 vaccine Providers should have a plan in place in case of need for emergency medical attention Be able to identify immediate allergic reactions and have meds (such as epi pen, anti-histamines) on site Anaphylaxis – Pfizer-BioNTech VAERS reviewed Pfizer-BioNTech vaccines administered Dec 14–23, 2020 21 cases of confirmed anaphylaxis reported from 1,893,360 first doses (11.1 cases per million doses) 71% of occurred within 15 minutes 17/21 (81%) had a documented hx of allergies or allergic rxns 7 (33%) patients had experienced a prior episode of anaphylaxis
MMWR Morb Mortal Wkly Rep. 2021 Jan 15;70(2):46-51 Anaphylaxis - Moderna VAERS reviewed Moderna vaccines administered Dec 21–Jan 10 10 cases of confirmed anaphylaxis reported from 4,041,396 first doses (2.5 cases per million doses) 9/10 of occurred within 15 minutes 9/10 had a documented hx of allergies or allergic rxns 5/10 had experienced a prior episode of anaphylaxis
MMWR Morb Mortal Wkly Rep. 2021 Jan 22 (early release) Recognizing Anaphylaxis
Anaphylaxis involves ≥2 organ systems
Respiratory: sensation of tightness in throat, stridor, SOB, wheeze, cough GI: nausea, vomiting, diarrhea, abdominal pain CV: dizziness, fainting, tachycardia, hypotension Skin/mucosal: hives, itching, swelling (lips, face and/or throat)
Symptoms come on suddenly and progress quickly. Anaphylaxis
CDC recommends vaccination sites having the following (minimum) equipment on hand: 3 epinephrine prefilled syringes/ autoinjectors H1 antihistamine BP cuff Stethoscope Timing device (check pulse) Management
If anaphylaxis suspected… Quickly assess airway, breathing, circulation and mental status. Call emergency services. Place patient in supine position, feet elevated. Immediately administer epinephrine. EpiPen Epipen
May need special epiPens with extra long needle for obese individuals to reach the muscle (normal epiPen may deliver sub-Q) Standard sizes What AEs are you required to report?
Vaccine administration errors, whether or not associated with an adverse event (AE) Serious AEs regardless of causality. Serious = Death Life threatening AE requiring hospitalization Persistent incapacity Congenital anomaly/birth defect Medical event that may require medical or surgical intervention to prevent one of the above outcomes Post vaccination cases of Multisystem inflammatory Syndrome Post vaccination cases of COVID-19 resulting in hospitalization or death AE Reporting
Encouraged to report to VAERS any clinically significant AEs following vaccination, even if you are not sure if vaccination caused the event Reporting AEs Vaccine Adverse Event Reporting System
https://vaers.hhs.gov/reportevent.html Phone: 1-800-822-7967 VAERS
Online reporting system - required by law Can also fax a PDF of form Submit: Patient information Demographics Medical history Vaccine information Date administered, manufacturer, lot # Route, body site Reporter/Facility Describe AE and outcome *Provide as much detail as possible Reporting to manufacturer (not required) Post-Vaccination
Patient Education: Provide a vaccination card to the recipient or their caregiver Included in shipment Make sure to list manufacturer and lot # Back side
Stress importance of returning for 2nd dose! Post-Vaccination
Patient Education: Required to provide patient with EUA vaccine fact sheet for recipients and caregivers Specific to either Pfizer or Moderna Can also handout CDC fact sheet “what to expect” Includes V-Safe instructions
Available to download/print at: https://www.cdc.gov/coronavirus/2019- ncov/vaccines/expect/after.html V-Safe
Smartphone app for health check-ins post-vaccination. Uses text messaging and web surveys CDC tool to monitor for side effects Helps to remind patients to go in for second dose Any clinically important events reported by a participant would be sent to VAERS for follow-up Documentation
Medical record: Vaccine, date it was administered, manufacturer, lot number, vaccination site and route Patient’s consent Record name and title of the person administering Immunization information system: Report the vaccination to the appropriate state/local agency (CHIRP) Required to keep documentation regarding immunization x 7 years Billing
Manufacturer Product Administration Administration CPT code code – dose 1 code – dose 2
Pfizer-BioNTech 91300 0001A 0002A
Moderna 91301 0011A 0012A
AstraZeneca 91302 0021A 0022A
Janssen/J&J 91303 0031A
At each visit use appropriate product CPT code and either administration code 1 or 2.
Billing for administration only. The product/supplies are obtained at no cost to provider.
Can request reimbursement for uninsured patients via the Provider Relief Fund. Cost
No cost to patients No co-pay, no deductible Can bill insurance for reimbursement to administer shot Per CMS website: 2 dose-series initial dose $16.94 and second dose $28.39 $28.39 for a single-dose COVID-19 vaccine (none currently available in US fit this) Geographically adjusted [email protected]