from The Epoch Times:
FDA and CDC left out clinical data on bivalent booster
Moderna and regulatory agencies did not present clinical data on bivalent shots at the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) committee meetings in June and September 2022, respectively.
Presentations to the FDA and CDC advisory committee excluded data from Moderna’s own clinical study that showed bivalent boosters may be no better at preventing infections than previous booster shots.
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The data showed that among people who were never infected, 3.2 percent who took the bivalent booster got infected afterward, while 1.9 percent who took the monovalent booster were later infected.
Advisors to the FDA and CDC expressed concerns of lack of transparency.
Dr. William Schaffner from Vanderbilt University, a nonvoting member of the CDC advisory committee, said that he was disappointed that the data were not presented.
“I think in the interests of transparency, those data should have been presented,” Schaffner said, “though they were very limited, and early data.”
FDA advisor and a professor of clinical pediatrics at the University of California San Diego, Dr. Mark Sawyer, said that he understands people’s concern with the data being excluded, but not all information can be presented.
The committee has limited time, so the information presented must be relevant to the big picture.
“Seeing that data would not have changed my opinion about the outcome,” said Sawyer, “and it would certainly have distracted from the discussion.”
The four advisors for the FDA and CDC who were contacted by The Epoch Times agreed that if the data were presented, it may have prolonged the discussion, but would not have changed the voting outcomes.
Both the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting and the CDC’s Advisory Committee on Immunization Practices (ACIP) meeting approved Moderna bivalent boosters.
The excluded data come out of a Moderna study with 772 participants. The study compared bivalent boosters containing mRNA components of the original and the BA.1 Omicron strain against the original Wuhan-strain booster.
