1/28/2021 COVID-19 Vaccines & Nurse-to-Nurse Chat 1 Take Note RECORDING THIS SESSION 2 1 1/28/2021 Interactivity • Chat box • Question & answers • Polls 3 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) 5 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? 6 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 7 COVID-19 Vaccines Jennifer Girotto, PharmD, BCPPS, BCIDP Clinical Associate Professor University of Connecticut 8 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 9 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) 10 5 1/28/2021 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 11 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 12 6 1/28/2021 How does the COVID-19 Vaccine Work & How were they made so fast? 13 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 14 7 1/28/2021 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 15 Mechanism of Action of COVID-19 Vaccines: mRNA Moderna slides to ACIP Dec 2020 16 8 1/28/2021 17 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 18 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? 19 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 20 10 1/28/2021 Moderna Vaccine Efficacy After 2 Doses Baden LR, et al NEJM 2020 21 PfizerNBiotech Vaccine Efficacy after 2 Doses Polack FP, et al. NEJM 2020 22 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 23 Scheduling Doses 24 12 1/28/2021 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 25 • 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 26 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 27 • 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 28 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 29 Are These Vaccines Safe? 30 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. 31 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 32 16 1/28/2021 How long to monitor patients for adverse effects? 33 Additional information on risk assessment: https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html 34 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