An FDA expert panel is meeting today to discuss Moderna’s coronavirus vaccine, likely paving the way for the 2nd authorized COVID-19 shot in the US


moderna covid vaccine record time 2x1
Moderna; Samantha Lee/Business Insider
  • An influential expert panel is meeting Thursday to vote on authorizing Moderna’s coronavirus vaccine. 

  • By the end of the day, the committee will vote on whether or not to recommend emergency use authorization.

  • The US Food and Drug Administration isn’t required to follow the group’s advice, but often does so. The agency could OK Moderna’s shot as soon as Thursday night or Friday, according to media reports.

  • Healthcare and science reporters Andrew Dunn and Hilary Brueck are providing live updates from the day-long meeting.

  • For more stories like this, sign up here for Business Insider’s daily healthcare newsletter.

FDA and CDC are investigating allergic reactions to Pfizer’s vaccine, but have no answers or recommendations yet

EpiPen allergic reaction treatment
An EpiPen can be used in an emergency to treat anaphylactic shock by injecting epinephrine through clothing. Getty

Dr. Stanley Perlman, a University of Iowa immunologist, asked about possible explanations for allergic reactions to COVID-19 vaccines, after two healthcare workers in the UK, and then two more in Alaska, had anaphylactic reactions after receiving Pfizer’s vaccine. 

Pfizer’s vaccine ingredients don’t seem to be anything highly allergenic, and at least one of the healthcare workers had no history of allergies, leaving experts (like Perlman) puzzled as to what’s going on. 

“At this point we and CDC are continuing to investigate cases and consider data,” said Doran Fink, an FDA vaccine expert. “At this point, we don’t have enough information to make definitive recommendations one way or another, and as we continue to investigate and evaluate the data we will consider whether additional recommendations need to be made.”

9:00 AM: Panel kicks off, releasing key voting question

FDA advisory committee voting question Moderna coronavirus vaccine
The key voting question facing the FDA’s expert panel on Moderna’s coronavirus vaccine FDA

We are off and running for a marathon meeting expected to wrap up at 5:15 p.m. 

On Tuesday, the FDA released the most detailed results yet from Moderna’s late-stage study in preparation for this meeting. The agency’s summary showed the two-dose vaccine to be overwhelmingly protective at preventing symptomatic COVID-19 with no major safety concerns.

All in all, it’s a very similar profile to Pfizer’s vaccine, which was authorized last Friday, and we compared what we know about each shot here.

It’s poised to be a long but important day. The panel’s recommendation on whether or not to OK Moderna’s vaccine is seen as the last remaining barrier to an FDA authorization decision.

Here’s the agenda for the day: 

9:00 a.m. — Introductions

9:30 a.m. — FDA deputy director Doran Fink outlines emergency use authorization

10:05 a.m. — Stanford researcher Steven Goodman discusses the possible options for ongoing placebo-controlled vaccine trials, given COVID-19 shots are now being rolled out

10:45 a.m. — Moderna chief medical officer Tal Zaks and senior vice president Jacqueline Miller present the biotech’s vaccine data

12:00 p.m. — Public comment

1:00 p.m. — Zaks and Miller answer questions from committee members

2:00 p.m. — FDA medical officer Rachel Zhang presents the agency’s perspective on the vaccine data

3:10 p.m. — Committee discusses, ultimately votes, and adjourns

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