DYNAMIC DECEMBER COVID-19 VACCINE MILESTONES

We published COVID-19 Update #58 on 14 December 2020, highlighting the Emergency Use Authorization (EUA) for Pfizer-BioNTech’s COVID‐19 Vaccine for the prevention of COVID-19 for individuals 16 years of age and older. Vaccine Fact Sheets are available for Healthcare Providers and Vaccine Recipients/Caregivers. The CDC's Advisory Committee on Immunization Practices (ACIP) voted 11-0, with three recusals to recommend use of Pfizer-BioNTech’s vaccine on 12/12/2020 for patients 16 and older. ACIP had a unanimous vote to include the vaccine in 2021 immunization schedules. 

Four days later, COVID-19 Update # 59 provided a link to an FDA review of clinical data for Moderna’s COVID-19 vaccine where evidence supported 94.1% efficacy and no major safety concerns. An age specific breakdown of efficacy found the vaccine to be 95.6% efficacious in patients under 65 and 84.6% efficacious in those 65 and older. Efficacy was consistent across race and ethnicity demographics. The most common ADR were mild-to-moderate pain at the injection site, fatigue, headache, muscle pain, joint pain and chills. Three vaccine recipients and one placebo recipient experienced Bell’s palsy, so the FDA has recommended ongoing monitoring for Bell's once widespread vaccination begins. On 12/17/2020, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 20-0, with one abstention to recommend an emergency use authorization for Moderna’s mRNA-1273 as prophylaxis for COVID-19 infections for patients 18 years and older. 

Also on that day we notified subscribers that some vials of the Pfizer-BioNTech COVID-19 vaccine contain overfill of the vaccine. The FDA advised it is acceptable to use each additional full dose in the vials.  But partial doses from different vials, should not be combined for a full dose, since the vials are preservative free.

On Monday, in COVID-19 #60, we noted that on 12/18/2020, the FDA granted an Emergency Use Authorization (EUA) for Moderna’s COVID‐19 Vaccine for the prevention of COVID-19 for individuals 18 years of age and older. Vaccine Fact Sheets are available for Healthcare Providers and Vaccine Recipients/Caregivers. The CDC's Advisory Committee on Immunization Practices (ACIP) voted 11-0, with three recusals to recommend use of Moderna’s vaccine on 12/19/2020. The CDC approved use of any full extra doses contained in the vials.
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The CDC has provided eight point interim clinical considerations for the Pfizer-BioNTech and Moderna COVID-19 vaccines.