INDIANAPOLIS, Ind. (WISH) — The U.S. Food and Drug Administration will meet Thursday morning to discuss whether Pfizer’s COVID-19 shot is safe and effective enough. It’s the final step before deciding whether to approve the shot.
Dr. Steven Hahn says it’s possible vaccines will start next week and he will be first in line to get it. He also plans to encourage his family to do the same. But there’s no telling how long the approval process could take.
The FDA understands the urgency and says there’s a good chance the meeting will take all day. It will start with a series of questions from the FDA, Pfizer and the manufacturers. Then, there will be a vote on the answers to those questions.
Dr. Hahn says he can’t prejudge what the committee is going to say, but experts could ask for additional data or analysis. That’s why the FDA is doing paperwork ahead of time to incorporate the committees comments and recommendations regardless of the decision the FDA makes. They’re expecting the decision to come fairly quickly after the committee meeting, but there’s no guarantee it could come Thursday.
The authorization is up to the agency, not the committee, but they take their recommendations very seriously.
“America is very ready to put this pandemic behind us and probably the most important way we’re going to do that is with a vaccine and to develop what’s called herd immunity so we’re all anxious for this to proceed,” Dr. Hahn said. “Our scientists will make that decision. If we do, I think we can all really feel that this is a way and a path forward and that we see light at the end of the tunnel. If it happens, it will be a very hopeful time for us and a particularly important at this point.”
The meeting is public and you can stream it on YouTube, Facebook and Twitter. You can also watch is on the FDA website.
The Moderna committee meeting is Dec. 17 and will follow the same process and procedures. However, there will be a separate review team.
The FDA has issued more than 300 Emergency Use Authorizations for 600 medical products since the start of the pandemic. That’s more than 10 times the number that they have issued in all prior health emergencies.