Pfizer Left COVID-19 Vaccine Data out of Submissions to FDA, Documents Show

Pfizer says U.S. regulators worked closely with the company on all of its biodistribution studies.

People walk by the Pfizer world headquarters in New York City on Nov. 9, 2020. Kena Betancur/AFP via Getty Images

Data on how parts of a Pfizer-BioNTech COVID-19 vaccine spread in the bodies of mice were withheld from regulatory submissions to the U.S. Food and Drug Administration, according to a new comparison of those submissions and similar documents sent to Japanese regulators.

Byram Bridle, who has a PhD in immunology and is an associate professor of immunology and virology at the University of Guelph in Canada, authored the comparison. It was dated Aug. 13 and released on Oct. 4 by Dr. Robert Malone, a vaccine adviser to the U.S. government.