The secret is there are no secrets
New Food and Drug Administration documents show the agency knew almost nothing about how well mRNA boosters might work when it okayed them. It was mainly using public Israeli data like everyone else.
Anyone paying attention in August 2021 could see the rush to approve mRNA Covid boosters was politically driven and didn’t have much data behind it.
Now we have proof from the inside.
Emails released last week by the Food and Drug Administration show the agency’s vaccine regulators felt heavy pressure from the White House and senior FDA officials to approve boosters.
By itself, that fact is not a huge surprise. The two top vax regulators, Drs. Marion Gruber and Philip Krause, announced their resignations in late August 2021 and within weeks spoke out publicly against widespread booster shots.
No, the most frightening revelation in the emails isn’t the political machinations they reveal. It’s how they explode the myth of FDA omniscience, that the agency somehow had knowledge unavailable to the public to help it understand if boosters might work.
In reality, the emails show the opposite. (The FDA released them in response to a Freedom of Information Act request from the conservative group Judicial Watch, which has done great work using FOIA to unearth government documents on Covid.)
As Gruber and other top FDA officials discussed what to do about boosters, they had almost no data on the safety or efficacy of a third shot. Their most useful estimates of vaccine efficacy came from Israeli studies using the same figures from the Israeli health care system that I had begun highlighting in July on Twitter.
As one physician in the FDA vaccine review office complained to Gruber on Friday, August 20, “And then there is the question of the data that will support these booster doses.”
Without good data, the regulators had no chance to make a reasonable cost-benefit analysis. They simply went with their instincts, like everyone else.
And their instincts were wrong.
The emails make clear the reason Gruber didn’t want to approve boosters for general use in August 2021 was not because she didn’t think they would work. Or that repeated mRNA dosing might raise long-term safety issues.
No, Gruber was sour on boosters because she thought the Covid vaccines worked so well they wouldn’t be necessary!
She and Krause, her deputy, would go on to write that widespread boosters should be delayed because poorer countries should have access to the miracle of mRNA before the United States and other wealthy nations grabbed third shots.
Think of the Africans! And the Indians! And all the other poors!
In the light of everything that’s happened since, this position looks worse than ironic. The poor countries that avoided the mRNA shots have largely put Covid behind them, while wealthy countries navigate their fifth or sixth or seventh waves.
(India: lots of people, no mRNA vaccines, no boosters, no second boosters, no super-special Omicron boosters, not so much Covid!)
Now the world’s wealthy countries cannot give away their miracle jabs, no matter how hard they try.
Yes, that’s right. African nations have resoundingly rejected offers of a free product that Western countries eagerly used on their own citizens. Has anything similar ever happened before? I can’t think of another example.
The mRNAs, groundbreaking in every way.