COVID-19 Vaccines

1/28/2021

COVID-19 Vaccines

& Nurse-to-Nurse Chat

Take Note

RECORDING THIS SESSION

1 1/28/2021

Interactivity

• Chat box • Question & answers • Polls

Connecticut Nurses Association COVID-19 Web Page

ASSOCIATION PHILOSOPHY

Americans have rated nurses as the #1 most ethical and honest profession, according to the most recent Gallup poll (2020). https://nurse.org/articles/nursing-ranked-most-honest-profession/ 4

2 1/28/2021

A little Bit About Yourself

• Hospital (inpatient) • Hospital (outpatient) • Home Care • Medical Office • Long-Term Care • School System • University/Faculty • Student In what setting do • Not Currently Working you currently work? • Retired • Other (submit in text box)

A little Bit About Yourself

• Yes, currently work • Not now, plan to work in the future • Still undecided • Have no plan to work in future • Other

Do you have a plan to work in a COVID-19 Vaccination Clinic?

3 1/28/2021

Welcome

Dr. Jennifer Girotto, PharmD, BCPPS, BCIDP

Associate Clinical Professor of Pharmacy Practice and Pediatrics University of Connecticut

Member Governor Lamont’s COVID-19 Vaccine Advisory Group

COVID-19 Vaccines Jennifer Girotto, PharmD, BCPPS, BCIDP Clinical Associate Professor University of Connecticut

4 1/28/2021

OBJECTIVES

• Identify COVID-19 vaccines currently or likely soon to be authorized in the US as part of Emergency Use Authorization • Explain current mechanisms of action for COVID-19 vaccines • Answer common questions regarding COVID-19 vaccines

Phases of Vaccine Development and Approval

Emergency use authorization

Phase I Phase II Phase III • Dose finding/escalation • Evaluation of dose • Comparison to placebo (tens of people) clinically (hundreds of or current standard of FDA approval people) care (thousands to tens of thousands of people)

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Year Total patients in Vaccine Approved Phase II & III Prevnar 2000 42,723 Boostrix 2005 6,192 Adacel 2005 11,758 Vaccine Trials Menactra 2005 10,942 & Participants RotaTeq 2006 67,469 Gardasil 2006 26,985 Zostavax 2006 41,943 Rotarix 2008 86,801 Prevnar 13 2010 50,774

Moderna COVID 2020 14,673 Pfizer-BioNTechCOVID 2020 18,198

Weinberg SH, et al. Human Vaccines & Immunotherapeutics 2012; Polack FP, et al. NEJM 2020; Baden LR, et al NEJM 2020; Modernatx.com

14 Vaccines in at least Phase III Development

Current Vaccine Dosing Technology Phase Pfizer-BioNTech 2 doses 21 days apart mRNA EUA

Moderna 2 doses 28 days apart mRNA EUA

Ad26.COV2.S Johnson & Initial trial 1 dose now Adenovirus Phase III Johnson evaluating 2 doses vector AZD1222(Covishield) 2 doses 28 days apart Chimp Phase III Astrazeneca/UofOxford adenovirus vector

6 1/28/2021

How does the COVID-19 Vaccine Work & How were they made so fast?

Traditional Approaches: • Requires growing the virus • Weakened - live attenuated • Killed - inactivated

Newer Approaches • Does not require full virus at any point • Viral vector vaccines • Genetic vaccines (including Classification of Vaccines mRNA) • Virus-like particle

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Vaccine Process Unique Characteristics

• History of prior SARs infections SARs CoV1 & MERS • Spike Protein • RNA sequence known • Combining experts from government and pharmaceutical industry with sufficient funds

Mechanism of Action of COVID-19 Vaccines: mRNA

Moderna slides to ACIP Dec 2020

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Mechanism of Action of COVID-19 Vaccines: Adenovirus Vectors

• Adenovirus usually causes mild cold disease • Virus infects host cell • The DNA will then have the host cell make spike protein • Non-replicating virus vectors so no additional virus created/produced • Currently in development with this mechanism https://edhub.ama-assn.org/jn-learning/video-player/18547208 • Johnson & Johnson is human adenovirus vector • AZ – Univ of Oxford is chimp adenovirus vector

9 1/28/2021

Do the COVID-19 Vaccines with the Emergency Use Authorization Work? Do patient’s need both doses? Do they prevent infection or just symptomatic disease?

Example: Efficacy • Currently uncertain with likely large range of possibility After Dose 1 Pfizer- • Explains why CDC recommends 2 doses for full BioNTech protection

FDA Briefing Document: https://www.fda.gov/media/144245/download

10 1/28/2021

Moderna Vaccine Efficacy After 2 Doses

Baden LR, et al NEJM 2020

PfizerNBiotech Vaccine Efficacy after 2 Doses

Polack FP, et al. NEJM 2020

11 1/28/2021

Do they prevent infection or symptomatic disease?

https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-12/slides-12-19/02- COVID-Miller.pdf

Scheduling Doses

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Characteristic Pfizer – BIoNTech Moderna Minimum age 16 years 18 years authorized CDC Current Number of Doses 2 2 Clinical

Dose 30 mcg 100 mcg Overview of 2 0.3 ml/dose 0.5 ml/dose EUA Available Interval between 21 days 28 days doses Vaccines: Number of doses ~ 6 doses per vial ~ 11 doses per vial per vial Moderna and How comes Powder requires Comes as solution Pfizer- reconstitution with 1.8 ml preservative BioNTech free normal saline

• Interchangeability of mRNA vaccines. • Vaccines are NOT interchangeable no safety or efficacy data. • In rare situations when the first-dose vaccine product cannot be determined or is no longer available, any available mRNA COVID-19 vaccine may be Should patients administered at a minimum interval of 28 days between doses to complete the mRNA COVID-19 receive the vaccination series. • If two doses of different mRNA COVID-19 vaccine same vaccine products are administered in these situations (or inadvertently), no additional doses of either product for both doses? are recommended at this time. • CDC provides ways to help ensure patients receive same vaccine For Vaxtext – pt will be asked question regarding if they want just • Having pts sign up for second appointment at same vaccine reminder or symptoms, site before they leave. when they received the vaccine and • Remind pts to bring vaccine cards to second visit which they received. (Let them (picture on phone), know it does not sign them up for • Record vaccine administration in MAR appointments • Sign up for VaxText (1-800-vaxtext) if tech savvy

13 1/28/2021

• Pfizer-BioNTech COVID-19 vaccine 21 days apart COVID-19 • Moderna COVID-19 vaccine 28 days apart Vaccine Scheduling per • New information (1/21/2021) – can be st CDC, Updated scheduled as late as 6 weeks after 1 dose • Although not recommended to be scheduled Jan 21,2021 earlier, doses can be given up to 4 days before schedule • If inadvertently given earlier – okay to count dose • If patient does not receive vaccine within 6- week period, not need to restart series

https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html

• Spacing between OTHER vaccines – minimum interval of 14 days before Ask about or after administration with ANY other vaccine due to lack of data. other • If there is a situation where 2 vaccines are being considered vaccinations closer, risk vs benefit must be too… assessed. If administered closer no need to redose, vaccine is counted.

https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html

14 1/28/2021

What if a Patient Had COVID-19 Illness?

• Vaccination should be delayed until the patient has recovered from the acute illness and no longer requires quarantine/isolation. • First and/or second dose • No testing or assessing for prior COVID-19 is recommended • Due to limited vaccine supply patients with recent infection may temporarily delay vaccination with the understanding as time goes on their risk for reinfection will increase. • Importantly, those who have been vaccinated should be treated(e.g. antiviral therapy, monoclonal antibodies, convalescent plasma, and/or corticosteroids) similarly to those who have no prior history of vaccine if they do become ill with COVID-19. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html

Are These Vaccines Safe?

15 1/28/2021

• Most adverse effects occur soon after vaccines are administered • The mRNA vaccines had a median of ~ 2 months when they applied for authorization. CDC and pharmaceutical companies following adverse Vaccines and effects continually. • Highlights the importance of reporting any Side-Effects severe adverse effects to VAERS • Over 23 million doses COVID-19 vaccine doses administered in US • Long-term adverse effects not apparent by 1-2 months is extremely unlikely but still unknown.

mRNA Vaccine Safety – Summary of what is known

• Moderna • Injection site reactions D1 84%; D2 89% vs ~ 20% placebo • Systemic reactions D1 55%; D2 79% vs ~ 40% placebo • Pfizer BioNTech • Systemic reactions ~ 75%; more common D2 than D1 and more common in younger patients (18 – 55 y vs > 55y) • Most in both groups grade 1 or 2 in severity; severe adverse reactions rare. • Anaphylaxis rate • Data for Pfizer-BioNTech from VAERS 12/14 – 12/23 from VAERS • 21 cases of anaphylaxis after 1,893,360 first doses (rate of 11.1 cases per million doses or 0.001%) • 71% and 86% occurred within 15 and 30 minutes of vaccination

Polack FP, et al. NEJM 2020; Baden LR, et al NEJM 2020; MMWR Jan 2021

16 1/28/2021

How long to monitor patients for adverse effects?

Additional information on risk assessment: https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html

17 1/28/2021

Type of reaction and Immediate allergic reaction Vasovagal Reaction Vaccine Adverse Reaction timing after vaccination Most occur within 15-30 minutes of Most occur within 15 minutes Median of 1 to 3 days after vaccination vaccination (with most occurring day after vaccination) Signs and symptoms Constitutional Feeling of impending doom Feeling warm or cold Fever, chills, fatigue Cutaneous Skin symptoms present in ~90% of Pallor, diaphoresis, clammy skin, sensation of Pain, erythema or swelling at people with anaphylaxis, including facial warmth injection site; pruritus, urticaria, flushing, angioedema lymphadenopathy in same arm as vaccination Neurologic Confusion, disorientation, dizziness, Dizziness, lightheadedness, syncope (often Headache lightheadedness, weakness, loss of after prodromal symptoms for a few seconds consciousness or minutes), weakness, changes in vision (such as spots of flickering lights, tunnel vision), changes in hearing Respiratory Shortness of breath, wheezing, Variable; if accompanied by anxiety, may N/A bronchospasm, stridor, hypoxia have an elevated respiratory rate Cardiovascular Hypotension, tachycardia Variable; may have hypotension or N/A bradycardia during syncopal event Gastrointestinal Nausea, vomiting, abdominal cramps, Nausea, vomiting Vomiting or diarrhea may diarrhea occur Musculoskeletal N/A N/A Myalgia, arthralgia nd Vaccine recommendations: Those with immediate allergic reactions should not receive a 2nd dose. Other reactions can receive 2 dose

Being Prepared to Manage Potential Anaphylaxis

• AAAI 2020 Practice Parameter: https://www.aaaai.org/Aaaai/media/MediaLibrary/PDF% 20Documents/Practice%20and%20Parameters/Anaphyla xis-2020-grade-document.pdf

CDC suggests for COVID-19 Vaccinations: “Symptoms are considered generalized if there are generalized hives and/or more than one body system is involved. If a patient develops itching and swelling confined to the injection site, the patient should be observed closely for the development of generalized symptoms (beyond the recommended observation periods noted above, if necessary). If symptoms are generalized, epinephrine should be administered as soon as possible and emergency medical services should be sought.”

18 1/28/2021

What is known and/or recommended about COVID-19 vaccination in special populations?

19 1/28/2021

Immunocompromised

• Patients maybe at increased risk for severe COVID-19 illness • Only a few patients with stable HIV infection included in trials, no specific data on safety/efficacy of either vaccine in any other immunocompromised population • May receive vaccine, but should be counseled on lack of safety and efficacy data, possible decreased immune response, and need to continue all current guidelines to protect themselves • Note: Not currently recommended to be tested for antibody response to vaccine and not recommended to receive re-vaccination or additional doses (guidance being looked into and could change in the future)

Other Conditions

• Autoimmune Disease: No data specifically on these populations but were NOT excluded from trials. No increased markers of autoimmune or inflammatory conditions vs placebo seen in clinical trials. Patients may receive vaccine • Bell’s Palsy: Cases have been reported with both vaccines but at rates expected to be seen in general population and not thought to be specific to vaccines. Any cases of this or other adverse effects should be reported to VAERS. Additionally, patients with hx of Bell’s palsy can receive the vaccine if they do not have any contraindication to vaccination.

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• Pregnancy: • Limited data, following patients who receive vaccine and are pregnant. • Animal studies with Moderna do not expect issues. • CDC Recommendation “If pregnant people are part of a group that is recommended to receive a COVID-19 vaccine (e.g., healthcare personnel), they may choose to be vaccinated. A conversation between the patient and their clinical team may assist with decisions regarding the use of a mRNA COVID-19 vaccine, though a conversation with a healthcare provider is not required prior to vaccination. When making a decision, pregnant people and their healthcare providers should consider the level of COVID-19 community transmission, the patient’s personal risk of contracting COVID-19, the risks of COVID-19 to the patient and potential risks to the fetus, the efficacy of the vaccine, the side effects of the vaccine, and the lack of data about the vaccine during pregnancy.” • ACOG has similar recommendations https://www.acog.org/clinical/clinical-guidance/practice- advisory/articles/2020/12/vaccinating-pregnant-and-lactating-patients-against-covid-19 but also reinforces that patients should be supported in whatever decision they make and that they should be reminded of the importance of hand washing, social distancing and wearing a mask. • Lactation • No data on effect of these vaccines on breastfed infant or production/excretion of milk. • CDC suggest unlikely to impact breastfeeding infant. ACOG groups lactating women similar to pregnant patients and suggests consider discussing the use of the vaccine with a healthcare personnel to make the decision.

• Currently ONLY authorized in those 16 years old and older for Pfizer-BioNTech vaccine (18 years+ Moderna) Children and • Clinical placebo-controlled trials for Adolescents both listed down to 12 years in US. • No trials currently listed for patients < 12 years old 

21 1/28/2021

More Information on Emergency Authorization of These Vaccines

• Healthcare Provider Fact Sheets • Pfizer/BioNTech: https://www.fda.gov/media/144413/download • Moderna: https://www.fda.gov/media/144637/download More • Patient Fact Sheets (Similar to VIS, but for since not-FDA Information approved they are Fact Sheets) • Pfizer/BioNTech: https://www.fda.gov/media/144414/download • Moderna: https://www.modernatx.com/covid19vaccine- eua/eua-fact-sheet-recipients.pdf

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