FDA’s Vaccines and Related Biological Products Advisory Committee met last Thursday to discuss the request for emergency use authorization for a COVID-19 vaccine from Moderna. They recommended Emergency Use Authorization of the Vaccine and the FDA commissioner promptly approved their recommendation.
See: FDA Authorizes Pfizer Vaccine for Emergency Use & ACIP Recommends Administration Schedules. Meeting information on the Moderna meeting this week can be found here.
The CDC’s Advisory Committee on Immunization Practices met yesterday and are meeting today to make their administration recommendations to the CDC director.
Today’s ACIP meeting is from 9am to 2:30pm. Here’s the ACIP Final Agenda for today and yesterday & here is the Webcast Link. Here are the Presentation slides from this weekend’s ACIP meetings.
Data released by Moderna in their application for EUA stated the following:
“The EUA request includes safety and efficacy data from an ongoing Phase 3 randomized, double-blinded and placebo-controlled trial of mRNA-1273 in approximately 30,400 participants. Efficacy in preventing confirmed COVID-19 occurring at least 14 days after the second dose of vaccine was 94.5% (95% CI 86.5%, 97.8%) with 5 COVID-19 cases in the vaccine group and 90 COVID-19 cases in the placebo group. Subgroup analyses of the primary efficacy endpoint showed similar efficacy point estimates across age groups, genders, racial and ethnic groups, and participants with medical comorbidities associated with high risk of severe COVID-19.”
Analysis of approximately 30,350 participants ≥18 years of age randomized 1:1 to vaccine or placebo with a median of 7 weeks of follow-up after the second dose supported a favorable safety profile, with no specific safety concerns. The most common solicited adverse reactions associated with mRNA-1273 were injection site pain (91%), fatigue (68%), headache (63%), muscle pain (59%), joint pain (44%), and chills (43%). Severe adverse reactions occurred in 0.2% to 9.7% of participants, were more frequent after dose 2 than after dose 1, and were generally less frequent in participants ≥65 years of age as compared to younger participants.
See these documents for the particulars: Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Briefing Document – FDA and Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Briefing Document Addendum- Sponsor
