US regulators give positive review of Pfizer vaccine data

WASHINGTON — Documents released by US regulators today confirm that Pfizer and BioNTech’s COVID-19 vaccine is strongly protective against COVID-19 — offering the world’s first detailed look at the evidence behind the shots.

The Food and Drug Administration posts its analysis online even as across the Atlantic, Britain begins vaccinating its oldest citizens with the Pfizer-BioNTech shots.

But the US judges experimental vaccines in a unique way: On Thursday, the FDA will convene what’s essentially a science court that will debate — in public and live-streamed — just how strong the data backing the shots really is.

A panel of independent scientists will pick apart the FDA’s first-pass review before recommending whether the vaccine appears safe and effective enough for millions of Americans. The FDA, which typically follows the committee’s advice, is expected to issue a decision in the days following the review. If given the green light, the first recipients would be health care workers and nursing home residents according to plans laid out by each state.

Pfizer and its German partner BioNTech previously reported the shots appear 95% effective at preventing mild to severe COVID-19 disease in a large, ongoing study. That’s based on the first 170 infections detected. Only eight of the infections were among volunteers given the real vaccine while the rest had received a dummy shot.

— AP