FDA Set to Release Analyses of the Pfizer-BioNTech Covid-19 Vaccine

The Food and Drug Administration concluded in a detailed analysis that the first Covid-19 vaccine being considered for U.S. distribution “met the prescribed success criteria” in a clinical study, paving the way for the agency to green-light distribution as early as this weekend.

An outside panel of scientific advisers will review the FDA report Thursday, along with a companion analysis from the vaccine’s manufacturers, Pfizer Inc. and German partner BioNTech SE. A favorable recommendation from the panel is expected to be followed within a few days by the FDA granting emergency authorization for the vaccine.

The FDA analysis released Tuesday highlighted various “known benefits” from the vaccine. These included “reduction in the risk of confirmed Covid-19 occurring at least seven days after Dose 2.” The Pfizer vaccine requires two doses for full protection.

In addition, the FDA said another benefit was reduction in the risk of confirmed Covid-19 after the first dose and before the second dose. Another clear benefit, the agency said, was “reduction in the risk of confirmed severe Covid-19 any time after dose 1.”

The reference to reduction in confirmed severe disease was important, as early critics of some of the vaccine trials were concerned that only mild to moderate disease was prevented.