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  • Alex Lipovtsev

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.

  • 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

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


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