Tuesday, August 31, 2021

Day 578: SpikeVax or StrikeVax?

Here at PlagueBlog we intended to report on the extra-metalness of SpikeVax, now shown to make twice as many antibodies as the less-metal-named Comirnaty. But the news overtook us that two vaccine leaders are leaving the FDA, apparently in protest of the Biden administration's recent foray into deciding who should get boosters and when.
A former senior FDA leader told Endpoints that they’re departing because they’re frustrated that CDC and their ACIP committee are involved in decisions that they think should be up to the FDA. The former FDAer also said he’s heard they’re upset with CBER director Peter Marks for not insisting that those decisions should be kept inside FDA. What finally did it for them was the White House getting ahead of FDA on booster shots.

FDA’s former acting chief scientist Luciana Borio added on Twitter, “FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service.”

“These two are the leaders for Biologic (vaccine) review in the US. They have a great team, but these two are the true leaders of CBER. A huge global loss if they both leave,” Former BARDA director Rick Bright wrote, weighing in on the news. “Dr. Gruber is much more than the Director. She is a global leader. Visionary mastermind behind global clinical regulatory science for flu, Ebola, Mers, Zika, Sars-cov-2, many others.”
Here in Massachusetts, cases were up almost a fourth of a percentage point today, after a dip down to a fifth daily since Thursday's high.

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