Watching Sausages, Laws, and FDA Advisory Committee Decisions Being Made

Sena and I watched the FDA Advisory Committee live streamed meeting yesterday on whether or not Pfizer’s COVID-19 vaccine booster should be given full licensure. You know, there’s a much-discussed question about who actually made the following quote:

“Laws are like sausages; better not to see them being made.”—often attributed to Otto Von Bismarck although it’s been attributed to others.

You can view the arguments about who said it at this link. The point is I think it should also apply to FDA meeting decisions. Our overall impression is that it was a messy process. We watched the entire daylong proceeding. The bottom line was that the committee revised the original question and reframed the approval from full licensure to Emergency Use Authorization (EUA):

The FDA approved the EUA for the booster based on the “totality” of the available evidence instead of just the originally specified Clinical Trial C4591001 (because of the small number of subjects including only a dozen in the older age group; the data from Israel was also fair game) and restricted the population to those age 65 and older (instead of the original 16 years and older). They further specified further that the booster should target those at increased risk for severe disease—which is to be understood to include health care professionals and others at risk for high occupational exposure.

One of the voting members disclosed candidly that his wife had already received a booster shot at a pharmacy well in advance of the meeting (technically off-label) and that he planned to do the same—after they unanimously approved the booster after the question was reframed. Sena and I both thought this was an extraordinary statement coming from an FDA advisory committee member.

The original question was voted down with only 2 of 18 members voting in favor. Dr. Stanley Perlman of The University of Iowa voted no on the original question and voted yes on the revised question. For many days now, the news has been reporting that a large number of people have been getting a booster shot despite the lack of FDA approval.

Dr. Arnold “Arnie” Conto M.D., the Acting Chair of the committee, after being asked to read the original question, slipped by indicating the age as “16 months” instead of “16 years.” He was instrumental in holding the committee members to staying on time for each phase of the meeting.

Dr. Conto: “Do the safety and effectiveness data from clinical trial C4591001 support approval of a Comirnaty booster dose administered at least 6 months after completion of the primary series for use in individuals 16 months of age and older?”

“I see someone has his hand raised. Do you have a question?”

Dr. X: Lips clearly moving but no sound.

Moderator: “Please unmute your mike” (Everyone was guilty of this oversight repeatedly throughout the day. One participant actually started speaking audibly and then leaned over and switched off his mike, possibly not to break the trend).

Dr. X: “Oh my, sorry about that. Arnie, we’re not sure on that part about “16 months and older.”

Dr. Monto: Oh yeah, I meant “at least 16 days and younger.”

Dr. X: Lips moving but no sound.

Moderator: “Unmute, please!”

Dr. X: “Oops, sorry! OK, Arnie. Does anyone know whether we’re supposed to vote on the time machine today, or will that be for the Advisory Committee on Immunization Practices?”

Christopher Lloyd: “I got that covered! Dang, I mislaid the keys to the DeLorean.”

We listened to those making short presentations at the open public hearing. They were each given about 3 minutes to make their statements. Some were in favor of the vaccine booster, others were not. Safety concerns were prominent, especially for giving vaccine boosters to children.

In fact, the committee seemed very ready to change the focus of the booster to place less specific emphasis on children. We imagine that’s part of the reason why the age range was adjusted away from specifying those 16 years and older (although they’ve probably been getting the primary series, even before the August approval of the Pfizer vaccine). One of the committee members asked, after the change of the age from “16 years” to “65 years” (but also specifying those at “high risk for severe disease”) whether that still meant a 16-year-old could get the booster. The answer was “yes.”

That made sense since children can have medical illnesses that increase their risk of serious complications from COVID-19 infection. But some committee members wondered about the 65 years of age cutoff, probably because they were not 65 years old. This and other speculations about how to specify the vulnerable population led to scrambling to get the meeting over because this was a question which the ACIP could clarify—and because it was getting very close to the end of the day.

We still don’t know when the ACIP is going to meet about the booster. They’ve added something for September 22 and 23, but I don’t find an agenda for it yet. Maybe they’ll have sausages for lunch.

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