Opinion: How the confusing booster shot debacle aligns Biden with Trump's pandemic response
When President Joe Biden took office, many public health advocates heaved a sigh of relief, assuming the US was back to following the science during this once-in-a-lifetime pandemic, and gone were the days of an American president touting ineffective treatments to the world.
But this latest debacle around the Pfizer/BioNTech booster shot has now not only led to the retirements of two top FDA vaccine officials, both of whom would’ve been key resources as the US soon reviews Covid vaccines for children, but also to question marks around conflicting FDA and CDC opinions and lingering debates on who exactly should receive a boost first and who should be the one that makes that decision.
This ultimate decision to give a third Pfizer dose to virtually anyone who asks for one casts a spotlight on those early Biden assumptions from last winter.
“What President Biden did essentially was sideline the FDA and CDC and say, ‘I’m going to declare this truth'” on boosters, Paul Offit, a member of the FDA’s vaccine adcomm and a vaccine expert at Children’s Hospital of Philadelphia, told me this morning. “It’s reminiscent to the last administration, which declared a series of truths on hydroxychloroquine and convalescent plasma.”
But Saad Omer, director of the Yale Institute for Global Health, told Endpoints that this confusing booster process was “of a different nature” when compared to what transpired with the Trump administration’s response to the pandemic because Trump’s technical experts tried to intervene and undermine the process, as well as pressure the FDA commissioner to align the vaccine authorization schedule with the election.
“That is qualitatively different” from the boosters, Omer said.
Getting ahead of the science
Even still, just as Trump’s administration pushed for EUAs for convalescent plasma and hydroxychloroquine prematurely, and on national television no less in the case of plasma, President Biden in August got way ahead of federal scientists and advisors by setting a timeline for when the boosters would be ready, before the data had even been submitted.
That expedited timeline meant that outside advisors to the FDA didn’t even have adequate time to review the data ahead of their meeting.
“It was rushed. We were rushed. Usually we get the documents from the FDA and company two weeks before [the adcomm meeting], or no less than one week. Here we got it the day before. And one of the papers on which the contention was based that immunity was fading” came out the day before too, Offit said.
After the adcomm unanimously voted that the boosters should not be provided to just anyone, the FDA had to scramble to ask the adcomm another question on whether to give boosters to seniors and others who might be at risk of a serious case of Covid-19.
“Nobody had any problem giving this to people who are older. You get older, your immune system isn’t as robust, so that was easy,” Offit said. “Then it became harder. It was not a leap to give it to people over 50 with high-risk medical conditions, because they might benefit. But then ACIP struggled” with younger populations.
The struggling and scrambling within the CDC and FDA occurred as the FDA’s own career officials were disputing the need for boosters in the Lancet.
Make no mistake, if Marion Gruber and Phil Krause had retired during the Trump administration, much more hysteria would’ve ensued on what exactly was playing out behind the scenes.
Offit said he thought the two FDA vaccine officials, Gruber and Krause, are retiring now because they “didn’t like the way this played out. They see their job as protecting the public from pharmaceutical companies’ products that may not have not been adequately tested and I think that’s what worries them about this.”
“The morale is low in both of these agencies,” Omer added. “I think, unfortunately, a lot of people with a lot of experience have been benched within these organizations. And that includes external advisers and internal staff. A lot of specialized expertise has been underutilized and that’s a problem.”
It’s really the unvaccinated
Just as HCQ and convalescent plasma did not end the pandemic or speed its demise, Offit wondered whether a third dose would have any major impact on the pandemic.
“Pharmacists aren’t going to ask where you work. If you want a third dose, you’ll get a third dose. But the problem with this pandemic is not boosting, it’s getting people who are not vaccinated to get vaccinated,” Offit said. “Children and adults aren’t admitted to the ICU because they haven’t got a third dose, but because they haven’t got any dose.”
Other vaccine experts like Yale’s Jason Schwartz agreed.
“This has to be far from what the White House wanted, as the events of the past month have created so much confusion surrounding the necessity and urgency of boosters for the fully vaccinated, while taking attention away from the much more pressing need to reach the tens of millions of Americans who are eligible for vaccination but have yet to receive their initial doses,” Schwartz told the Washington Post.
So if the first and second doses are the key to wrangling this pandemic, should the US just ship its stockpile of boosters abroad?
Yes, Offit says, as first and second doses provide far more of an impact than giving a third dose.
Omer also stressed the need for global vaccine equity, but he said he thought the US could administer booster shots while increasing vaccine donations to needy countries.
“We can walk and chew gum at the same time,” he said.
‘What’s the problem’
Whereas the data or lack thereof have been of such paramount importance throughout this pandemic in determining which treatments to use and which to stop using, the data behind the booster shots were much more limited than what the FDA and CDC relied on for the initial approval. It still remains unclear if an additional booster will be necessary in another six months or year.
“The frustration for me in all this is: What’s the problem? Dr. [Rochelle] Walensky and others have said they’re trying to prevent serious illness. All of the data presented by the CDC or published by the CDC have shown these vaccines do exactly that,” Offit said. “The administration ultimately got what it wanted, which is the doors were opened.”
Another possible reason the Biden administration wanted to set a booster timeline is because of the massive number of doses that may end up wasted without this third shot campaign.
“Why give Sept. 20 as a date? One possibility is they have enough vaccines to vaccinate everyone in this country. They paid for doses that are sitting around, and we’d be better off with this vaccine in arms than in trash cans,” Offit added.