A few days ago, I noticed a headline over at The Hill that seemed rather disturbing. It dealt with the FDA seeing “growing pressure to authorize vaccines for children under twelve.” There were similar urgings making the rounds in terms of when booster shots should be given. I immediately wondered where this “pressure” was coming from and who was applying it if it wasn’t originating with the scientists conducting the clinical trials on younger patients. Was it political pressure?
So now we're sciencing based on polling data? https://t.co/KkYraok0Ii
— Jazz Shaw (@JazzShaw) August 29, 2021
Sure enough, reading further into the article, the report said that the pressure was being applied by “experts and elected officials.” The elected officials were 100 members of Congress who wrote a letter to the FDA, urging them to speed things up. The only members quoted were Democrats. The only “expert” quoted was the president of a pediatric association, not a virologist. Are those the people who should be “pressuring” the FDA to move up the schedule? The Biden administration quickly chimed in, urging more speed. We’ve now seen the same thing with the question of boosters.
Apparently, I wasn’t the only one who noticed the unscientific and inappropriate nature of what was going on. Politico is now reporting that two top FDA vaccine regulators resigned last night, citing frustration with the conflicting messages being issued and the lack of appropriate scientific caution before rushing into such declarations.
On Tuesday, two top FDA vaccine regulators resigned — a decision that one former official said was rooted in anger over the agency’s lack of autonomy in the booster planning so far. A current health official said the pair, Marion Gruber and Philip Krause, left over differences with FDA’s top vaccine official Peter Marks. Now the agency is facing a potential mutiny among its staff and outside vaccine advisers, several of whom feel cut out of key decisions and who view the plan to offer boosters to all adults as premature and unnecessary.
POLITICO spoke to 11 current and former health officials and people familiar with the matter who described growing exasperation with the administration’s disjointed process for implementing its booster plan. Those sources said there is little coordination between federal health agencies, even as two top FDA officials try to guide the rollout.
They are describing what’s going on inside the FDA as a “mutiny” at this point. When Peter Marks announced the plan to start offering boosters by September 20 in accordance with what the White House wanted, that was a bridge too far for some of the researchers and experts working under him. Still, Biden’s “Covid czar” Jeff Zients, responded to the news of the resignations by saying that the decision “was made by and announced by the nation’s leading public health officials… and as our medical experts laid out having reviewed all the available data.”
Obviously, not all of those “medical experts” were on the same page since two of the highest-ranking ones decided to walk away from their posts in the middle of a health crisis. And others who are still at their posts are being described as “angry and frustrated” with the way this is playing out. A significant number of them see the rush to administer boosters at this point as being “premature and unnecessary.”
What happened to following the science? Hasn’t that been the mantra of the Biden administration and every other politician trying to rush the vaccination campaign as much as possible? Some of these expert virologists believe that we need more time to study the admittedly small number of cases of heart inflammation among children receiving the shots. One member of the FDA vaccine advisory committee was a bit more blunt in his assessment of where the booster decision came from.
It was “the administration’s booster plan; it wasn’t the FDA’s booster plan,” said Paul Offit, a University of Pennsylvania infectious disease expert who sits on FDA’s vaccine advisory committee. “The administration has kind of backed themselves up against the wall a little bit here.”
Neither fear nor political pressure should be guiding these decisions. If there are infectious disease experts working on this problem who sincerely believe that they need more time to do this safely and conclusively, that should be the only factor being taken into consideration. Do you remember how much the press was freaking out when Donald Trump started promoting medical treatments for COVID before the FDA had fully approved them? (A drug that was later determined to be quite effective for some patients, by the way.) This seems like a much larger breach of medical protocol, but so far all we’re hearing are crickets.