Committee Meetings to Be Held December 10 and 17th on Pfizer and Moderna Emergency Use Authorization Requests
The Pfizer and Moderna vaccines (which use a new mRNA vaccine technology) have completed their Phase III clinical trials and are ready for the FDA to review their requests for Emergency Use Authorization of their candidate vaccines. Because this is a public health emergency the FDA can authorize emergency use of the vaccines prior to issuing full approval of the products. You can read more about how that process works in this blog post: How Are New Vaccines and Drugs Approved?
The first step is for the FDA’s Vaccines and Related Biological Products Advisory Committee to review the Phase III trial data and make their recommendation to FDA Commissioner Hahn about whether to authorize emergency use if the vaccines prior to approval.
The VRBPAC meeting for the Pfizer request is Thursday, December 10. The Moderna meeting will be a week later (on December 17). The FDA has promised to make background materials available to the public, including the meeting agenda and committee roster by December 8 for the Pfizer meeting and December 15 for Moderna. The current Commissioner (Hahn) issued this statement committing to data transparency.
The meetings have been set 2 weeks after the EUA applications to allow the committee a couple of weeks to review the data before the meeting. This allows the committee to review the application and data, and it’s possible that they could make a recommendation to the Commissioner shortly after the meetings.
FDA intends to issue a Federal Register notice with details of the meetings, which will include information about a public docket for comments. At that time, public comments can be submitted. These comments will be reviewed by the FDA.
The FDA said that they will be livestreaming the VRBPAC meeting on their YouTube, Facebook and Twitter channels and broadcast from the FDA website. No details are available yet.
If the FDA Commissioner authorizes emergency use of these vaccines, they could potentially become available for distribution in mid to late December. That’s because many months ago the federal government entered into purchasing agreements with Pfizer and Moderna agreeing to pay for vaccine in advance (and even if they turned out to be ineffective). That allowed the manufacturers to make the vaccine during the Phase III trials.