LOOK WHO’S “RUSHING” COVID VACCINES NOW:
Democrats and the public-health clerisy denounced President Trump for rushing Covid vaccines. They’ve been curiously quiet about the Food and Drug Administration’s gunshot approval last week of revamped booster shots with no trials showing they are safe or effective.
The FDA granted emergency-use authorization to mRNA shots by Pfizer and Moderna that are bivalent, targeting the initial Wuhan variant as well as the currently predominant BA.4 and BA.5 strains. The Biden administration ordered 171 million doses earlier this summer, so FDA authorization seems to have been a fait accompli. The FDA probably should have made the reconfigured vaccines available to high-risk and elderly patients. But the case is weak for young people, given the limited benefit and uncertain risks.
The FDA is in a tough spot. The original vaccines, which targeted the Wuhan variant, are much less effective against Omicron and even less so against subvariants that evolved in rapid fire—BA.2, BA.2.12.1, BA.4 and BA.5. Vaccine makers spent this winter and spring testing vaccine configurations for Omicron and future variants. Some variants—including those that never became widespread in the U.S., such as Beta—share many of the same mutations. The trouble is nobody knows how the virus will evolve.
In late June, Pfizer and Moderna presented data to an FDA advisory committee on their experimental boosters, which targeted Omicron both alone and in combination with the Wuhan variant. The BA.4 and BA.5 variants had surged relatively recently, so the vaccine makers hadn’t had time to devise and test shots targeting them.
The FDA advisers found themselves in conflict, and so were the data. Pfizer’s data showed that its Omicron-specific booster generated a stronger antibody response to Omicron than its combination vaccine. Yet Moderna’s combo booster produced a more durable immune response—i.e., antibody levels stayed high longer.
Some advisory members worried that the FDA was moving too fast with too little data. “I think we need a higher standard than what we’ve been given. I think it’s uncomfortably scant,” said Paul Offit of the Children’s Hospital of Philadelphia. Members also were wary of recommending new boosters that target the BA.4 and BA.5 variants given the lack of evidence. With the advisory committee at loggerheads, the FDA made the executive decision—as is its prerogative—to direct Moderna and Pfizer to reconfigure their vaccines for the BA.4 and BA.5 variants in combination with the Wuhan variant.
The White House wanted the boosters available in the fall, which didn’t leave the FDA time to wait for more studies.