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, suggesting the agency will soon green-light the historic product.
The agency Tuesday released two separate analyses, one from its own staff scientists and one from the vaccine’s manufacturers, Pfizer Inc. and German partner BioNTech SE .
The FDA analysis 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.