FDA Authorizes Covid Booster Shots That Target Omicron BA.5 Variant

[unspeakablehorror]

FDA Authorizes Covid Booster Shots That Target Omicron BA.5 Variant

Pfizer and Moderna were originally developing boosters to target omicron BA.1, the variant that caused the massive wave of infection last winter. But the FDA told the vaccine makers in late June to switch gears and target BA.4 and BA.5 instead as those variants quickly gained ground. The sudden change in plans left little time for clinical trials in humans before a fall rollout.

As a consequence, the authorization is based on human clinical trials from the BA.1 shots, which produced a better immune response than the original doses, according to the FDA. But it’s unclear how the BA.5 boosters will perform in humans since the data is based on BA.1.

While I have no hesitation about getting this vaccine myself, I do think the lack of data for additional benefits over the original vaccine means we shouldn't assume that the BA.5 vaccine will have some specific additional benefit over the original or the BA.1 vaccines, which both have human data.  I entirely understand the reasoning behind this, but if they're going to compare this to the flu vaccine (which we still have more data for making variants for), they should be upfront about how the effectiveness for that vaccine can vary widely from year to year.  To be clear, this vaccine will not be less effective than the prior one, but because there is no human data yet, we cannot say it will be more effective than the original vaccine or the BA.1 vaccine either.  That is just a guess.  It's a reasonable guess, but very much a guess nonetheless.

The vaccines greatly reduce the chance of dying, hospitalization, and other bad outcomes.  But none of the vaccines, even the omicron BA.1 booster being used in other countries for which we do have human data, guarantee protection, and especially they do not guarantee protection against any particular outcome from covid.  Masking is still vital to reducing transmission for everyone, but especially to vulnerable populations, and for reducing long covid, as is avoiding public spaces as much as possible (and avoiding or masking up when around anyone who lives with you as much as is practical for your situation).