The FDA’s Vaccines and Related Biological Products Advisory Committee met on Tuesday October 26, 2021 for an all day session on Pfizer and BioNTech’s Covid-19 vaccine for kids aged 5-11.
The specific question that the 18 FDA panelists were tasked with answering was this:
“Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine when administered as a 2-dose series outweigh its risks for use in children 5-11 years of age?”
By now you may have seen the viral 7-second clip of Dr. Eric Rubin, a Harvard professor of immunology, one of the FDA advisors, who stated that “we’re never gonna learn about how safe this vaccine is until we start giving it, that’s just the way it goes!”. Here is that clip:
Here’s the larger context of that clip. Starting at hour 6:33 in the full video below, Dr. Eric Rubin states:
“This is a much tougher one, I think, than we had expected coming into it. The data show that the vaccine works, and it’s pretty safe … and yet we’re worried about all of these, um, we’re worried about a side effect that we can’t measure yet; and um, and but it’s probably real, and we are, we see a benefit that isn’t the same as it is in older age groups. So for me I think it’s going to revolve around two questions.
First off, how – whether there is going to be a use for this vaccine in this age group. And then, how the decision gets made to use it within this age group. And I think what choice we hear is that, it is a very sort of personal choice. If I had a child who was a transplant recipient, I would really want to be able to use a vaccine like this. And there are certainly kids who probably should be vaccinated. The question of how broadly though I think is a substantial one. And I know it’s not our question. And I know we’re kind of punting that, to the ACIP. But I do think that it’s a relatively close call…
“But we’re never gonna learn about how safe this vaccine is until we start giving it, that’s just the way it goes. That’s how we found out about – complications of other vaccines… And I do think that we should vote to approve it.”
In the full embedded video below, which is nearly 8 hours, I set it to begin playing at hour 7:11. This is after the vote had taken place, with 17 doctors voting yes and 1 abstaining. Below I have transcribed some of their most interesting and shocking comments. Most of them seem very unsupportive of a mandate and they say that parents should have a choice in whether their kids get this vaccine. I urge you to watch this portion of the video and read the transcript of their comments, the key points of which I have emphasized in bold text.
Because the way this seems to have worked so far is that the FDA advisors discussed the issues, including the potential dangers of the vaccine, for nearly 20+ hours publicly, and then gave it their tacit and guarded approval, (‘with a heavy conscience’ as one doctor even admits below) yet the governments, corporations, and schools, dishonestly interpret that approval as justification of an immediate and widespread mandate. But that is clearly not their intention or recommendation here.[Highlight excerpt transcripts:]
After hour 7:11 Dr. Misner discusses the increased risk of myocarditisin children: “I’d like to point out the rate of hospitalization in this age group is 0.1 per 100,000. Or less than 10 per million. And the rates of myocarditis… were as high as 150 cases per million. So I think we have to very carefully monitor the safety profile of this vaccine going forward if the ACIP does recommended it, and hopefully it will be for those children who have other risk factors. Over.
Dr. Levy: “I voted yes after some deliberation… The surveillance systems are going to be critical here and I’m hoping that this starts out as a campaign if it moves forward that starts with choice and parents and their care providers partnering in those decisions. Thank you.”
Dr Rubin: Discusses ACIP, & says: “…if they — a recommendation that says that there’ll be discretion in how it’s used as opposed to a mandate, which I think we are, would all be concerned about, at this point, we are going to get plenty of experience with this … and we will know how safe this is… We wanna save the kids we can save, I do think that we, it will be useful to have a lot more information though to determine how best to deploy the vaccine. So I- I’m still, I- I- I- I- I think that we’re… we we ended up sort of in-between, We decided to vote for it with, uh, a, with a lot of, heavy conscience, um, and um, but I’m hoping this is the start of learning more about it.”
Dr. Pergen: “So um I really hope that um as we think about this that we focus similarly the way we did in adults that mandates were not immediate after the vaccine was approved, and we see sort of a delay in that sort of approach because I think there is the safety concerns or things that have been brought up by committee members, and some, there is some issues that folks have, but we wanna make sure that we’re doing right by children, by giving them the opportunity to get vaccinated as well. So I think that’s going to be an important piece as we move forward. And I think you’ve heard that from committee members that there is some concern about school mandates and such at the moment. So I think that’s important to keep in mind, at least in the short-term.
“I also think this sort of begs another question that I think we haven’t talked about enough, is that we don’t do enough in early phases of vaccine trials to include children. And I think, um, obviously when they’re pediatric vaccines that’s different, but I think we need to rethink our strategies in how we do this. Because having this data a few months back would have been very valuable, if you think about this? I’d love to see the FDA rethink how they want to advise vaccine companies about doing this kind of research. Because having this at an earlier phase, and I think my pediatric colleagues would agree with this, would be very advantageous.
Dr. Hildress: “But to be honest, the best way to protect the health of some kids would be to do nothing at all, because they’re gonna be just fine… My vote was primarily to make sure that those who really need it can get it.”