FDA Says Pfizer-BioNTech Vaccine Is Safe, Effective
Thomas M. Burton and Jared S. Hopkins
The Food and Drug Administration said 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.
In its report Tuesday, the FDA noted that the two-dose vaccine provided benefits even after just the first injection—cutting the risk of getting Covid-19 by about half. The vaccine was found to be 95% effective after the second dose, three weeks later.
FDA scientists also found that the vaccine was effective in reducing the risk of confirmed severe disease after the first dose, an important finding as some health experts were concerned Covid-19 vaccines would protect against only mild to moderate disease.
Side effects were common, however, especially in younger people, the analysis found. The most common complaint was fatigue, followed by muscle pain and joint pain.