Pfizer, BioNTech’s COVID-19 Vaccine Candidate Must Be Independently Reviewed
WASHINGTON, D.C. – Pfizer and BioNTech announced today that the initial interim analysis of data from the phase 3 study of the companies’ experimental COVID-19 vaccine shows that it is more than 90% effective. Michael Carome, director of Public Citizen’s Health Research Group, released the following statement:
“The release of preliminary and incomplete clinical trial data by press release to the public is bad science.
“Until the trial results are independently reviewed and scrutinized by staff at the U.S. Food and Drug Administration and the independent experts on the agency’s Vaccines and Related Biological Products Advisory Committee, enthusiasm for the apparently promising interim results announced by Pfizer and BioNTech must be tempered. Crucial information absent from the companies’ announcement is any evidence that the vaccine prevents serious COVID-19 cases or reduces hospitalizations and deaths due to the disease.
“More importantly, critical safety data from the phase 3 trial of the Pfizer and BioNTech vaccine is not yet available. In order to ensure public confidence in this vaccine or any other COVID-19 vaccine being tested, the FDA must wait for sufficient long-term safety monitoring of subjects to be completed before approving such vaccines.”