Fauci: ‘We Don’t Have Time’ to Run Clinical Trials for Updated Boosters
Dr. Anthony Fauci is claiming that there was not enough time to wait for clinical trial data before clearing updated COVID-19 booster shots.
“We don’t have time to do a clinical trial because we need to get the vaccine out now,” Fauci said on CBC this week, pointing to how about 400 Americans are dying per day with COVID-19 and thousands of others are in hospitals with the disease.
The updated boosters, made by Pfizer and Moderna, were authorized by the U.S. Food and Drug Administration on Aug. 31 and subsequently recommended for virtually all Americans 12 and older by the U.S. Centers for Disease Control and Prevention (CDC).
Both shots contain elements of the Wuhan, BA.4, and BA.5 virus variants. No human data was or is available for the formulations. Pfizer and Moderna presented data on preclinical testing, done on mice. They also referenced human data for a different formulation, combinations of the Wuhan and BA.1 strains.
Since BA.5 is the dominant variant in the United States, “you have every reason to believe that [the updated formulation] is going to be better than having a vaccine that isn’t highly specific to the circulating strain,” Fauci said. “That hasn’t been proven in a clinical trial,” he acknowledged.
Fauci, the director of the National Institute of Allergy and Infectious Diseases, isn’t part of the U.S. regulatory or recommendation process on vaccines but his comments are followed closely by millions of Americans. The institute he heads runs clinical trials and does other work.
Fauci was echoing other top U.S. officials, including CDC Director Dr. Rochelle Walensky.
Walensky said on “Conversations on Health Care” during a segment broadcast on Aug. 29 that waiting for human data would leave the boosters outdated.
“If we wait for those data to emerge in human data, not just mice data, we
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