Yeah, thatâs roughly what Iâm thinking. I think weâll see the CDC ACIP meeting get scheduled and that will give us a better idea if itâs going to be just a couple of days or a week or so.
I tried to piece together some timelines for comparison and I think this is how things went:
Pfizer booster timeline
8/16 Pfizer submits initial data to FDA
8/25 Pfizer submits additional data and initiates supplemental Biologics License Application (sBLA) with application to be complete by âend of weekâ
9/1 FDA VRBPAC meeting scheduled for 9/17
9/15 CDC ACIP meeting scheduled for 9/22-23
9/17 FDA VRBPAC meeting & recommendation vote
9/22 CDC ACIP meeting begins-they close noting they canât move forward without FDA decision
9/22 (evening) FDA authorizes booster (Iâm super curious if they wanted to hear ACIP discussion first?)
9/23 CDC ACIP meeting continues & recommendation vote
9/24 CDC issues guidance and boosters begin immediately (same day)
Pfizer ages 12-15
3/31 Pfizer announces top line results
4/9 Pfizer submits request to expand existing EUA to include ages 12-15
5/4 CNN reports on an email it received from the FDA that VRBPAC will NOT meet to review but likely will for 5-11 (âFor the younger children, we almost certainly will consider more strongly going to an advisory committee meeting.")
5/5 CDC ACIP meeting scheduled for 5/12 with undisclosed agenda
5/10 FDA amends Pfizer EUA to include ages 12-15; CDC ACIP agenda announced
5/12 CDC ACIP meeting & recommendation vote; CDC issues guidance âand providers may begin vaccinating them right awayâ
Pfizer ages 5-11
9/20 Pfizer announces top line results
9/28 Pfizer submits initial data to FDA with formal EUA submission âto follow in the coming weeksâ
10/1 FDA VRBPAC meeting scheduled for 10/26 as it âanticipates receiving a request from Pfizerâ
So I think we need to watch for the CDC ACIP meeting to be scheduled to know how fast this is going to happen. Theyâve been scheduling them about a week in advance, it looks like.
(Note: some of the press releases used different wordings to describe the submissions, so Iâve tried to retain these as Iâm not sure if those wording choices are meaningful or not)
Also, the same day the FDA expanded the Pfizer EUA to ages 12-15, they scheduled a 6/10 VRBPAC meeting to brief them on that and also talk about what would be needed for ages 5-11. The summary of that meeting is really interesting given whatâs happened with Delta and kids since then:
https://www.pfizer.com/news/press-release/press-releases-archive
Pfizer Full Approval (ages 16+)
5/7 Pfizer submits initial Biologics License Application (BLA) with supporting data to be submitted âover the coming weeksâ
8/23 FDA grants full approval
[just came across this in the process and wanted to capture it since it may be relevant for school mandatory vaccine schedules at some point in the future]