Pfizer-BioNTech COVID-19 Vaccine Overview and Resources

December 13, 2020

On December 11, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer and BioNTech’s vaccine, BNT162b2, for the prevention of COVID-19 in patients. The vaccine has been authorized for use in individuals 16 years of age and older.

More information can be found in the Fact Sheet for Healthcare Providers (vaccination providers) and Fact Sheet for Recipients and Caregivers.

Vaccine Summary

• BNT162b2 is an mRNA-based vaccine, intended to be administrated in two doses.

• Initial data on the vaccine suggests an efficacy rate of over 90% 7 days after the second dose, in participants without prior evidence of having had COVID-19.

• Over 43,000 participants were enrolled in the clinical trial.

• No serious safety concerns were observed during the trials.

• On December 10, the FDA’s Vaccines and Related Biological Products Advisory Committee convened and voted in favor of the following statement: “Based on the totality of scientific evidence available, the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older”.

Allocation and Distribution

• Due to initial scarcity of the vaccine, initial allocation and distribution of the vaccine will be handled by the federal government.

• Operation Warp Speed (OWS), the federal government’s program focusing on vaccine development and distribution, has released its strategy for distributing COVID-19 vaccines, as well as an interim playbook for jurisdiction operations for state and local governments to plan and operationalize a response.

• The OWS strategy includes the creation of ancillary supply kits to accompany the vaccine distribution. The kits will include needles, syringes, alcohol pads, vaccination cards, and limited PPE for vaccine administrators.

• As part of OWS, the federal government announced agreements with CVS and Walgreens. These pharmacies will provide vaccinations to residents and staff of long-term care facilities when vaccines are available for these populations.

• Several advisory committees have released distribution and allocation recommendations for a vaccine:

• The Advisory Committee on Immunization Practices (ACIP) offered an interim recommendation that both 1) health care personnel and 2) residents of long-term care facilities be offered COVID-19 vaccine in the initial phase of the vaccination program.

• The National Academies of Sciences, Engineering, and Medicine (NASEM) published A Framework for Equitable Allocation of Vaccine for the Novel Coronavirus.

• Each state was required to file a COVID-19 vaccination plan with the US Centers for Disease Control and Prevention (CDC). You can view New York State's plan HERE.

Additional Resources

• Pfizer released a US distribution fact sheet for the Pfizer-BioNTech COVID-19 vaccine. This includes information on how the vaccine will be transported and delivered to localities.

• Documents from the VRBPAC December 10 meeting on the Pfizer-BioNTech COVID-19 vaccine are available online and include the FDA review of efficacy and safety data for the vaccine.

• Johns Hopkins University has published a list of FAQs on EUAs and how they relate to COVID-19 vaccines.

• A new website, COVID Vaccine Facts, has been stood up by the Biotechnology Innovation Organization (BIO), to answer questions relating to the development, safety, and efficacy of COVID-19 vaccines.

• The National Governor’s Association (NGA) released a report containing their recommendations on how to equitably distribute a COVID-19 vaccine.

• The Pharmaceutical Research and Manufacturers of America (PhRMA) has several resources on vaccine development and safety. These include:

• An illustrated timeline of how safety is prioritized in vaccine development

• A fact sheet of the ongoing clinical trials for COVID-19 related vaccines and medications

• A step-by-step guide to COVID-19 vaccine development

• A fact sheet on what Emergency Use Authorization means for a COVID-19 vaccine

• Suggested guiding principles for how to safely and effectively develop, distribute, allocate, and use vaccines for COVID-19, from the Pharmaceutical Supply and Payment Chain Coalition

• The American Medical Association (AMA) has offered guidance on how to ethically conduct vaccine trials with healthy volunteers.

• The AMA has hosted several webinars with officials from the FDA and CDC to offer guidance on COVID-19 vaccines to physicians.

• The most recent issue of the Journal of the National Medical Association includes a message from the president of the association discussing the importance of ensuring that COVID-19 vaccines from OWS are safe.

• The National Medical Association has also stood up a COVID-19 Task Force to help address questions and concerns about efficacy, safety, and allocation of COVID-19 vaccines and therapeutics.

CHANYS EM Team would like to thank our partners at Healthcare Ready for the information included in this post.

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