Meryl Nass, RESCUE with Michael Capuzzo: The High-Speed, Bivalent Covid Boosters Are Here
On Wednesday, August 31, the FDA issued emergency use authorizations for new Pfizer and Moderna mRNA booster vaccines for covid. The next day, September 1, the CDC’s advisory committee and CDC Director approved the immediate rollout of the new vaccines. They will be administered in the US starting this week.
Fastest vaccine rollout in world history
Surprisingly, more than a month before either agency had given its okay to the entirely new formulation, the federal government ordered 105 million doses from Pfizer and 66 million doses from Moderna.
The desired composition of the vaccine had only been formally determined by FDA after its advisory committee had met on June 24, 2022.
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This is the fastest rollout of a new vaccine in world history. How did it happen? Instead of this being a tale of human grit and ingenuity, it is a tale of human weakness and recklessness. Let me ask again: how did such a rapid vaccine rollout occur?
It occurred the only way it could possibly occur: by bending the rules, creating a new regulatory playbook, and failing to obtain any human data for the new vaccines. The manufacturers did not have to go through months-long trials, and FDA did not have to pore over any human trial data, because there weren’t any. Let that sink in: the new BA.4/5 bivalent vaccines have only been tested in mice, not humans.
Unexpected international coordination
Here is an amazing fact: On the same day that the CDC gave its approval to start the vaccine program, September 1, health agencies in Canada, Switzerland and the European Union’s FDA (the European Medicines Association) also rolled out new, bivalent booster shot programs. Almost simultaneously, the UK authorized two different bivalent boosters on August 15 and September 3.
The UK has told people to expect the largest rollout in history for the new bivalent boosters. And it has started the program by promising large bonuses to doctors if they manage to vaccinate every single resident of a nursing home by October 23.
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