The FDA has blocked publication of multiple studies examining the safety of COVID-19 and shingles vaccines, despite findings that serious side effects were rare, according to a May 5 report from The New York Times.
The studies analyzed millions of patient records, including 7.5 million Medicare beneficiaries and 4.2 million vaccine recipients, and found no significant safety concerns beyond rare events such as anaphylaxis occurring in about 1 in 1million cases.
Agency officials directed researchers to withdraw COVID-19 vaccine studies accepted for publication and did not approve submission of shingles vaccine research to a safety conference.
A spokesperson for HHS told the Times the studies were withdrawn because conclusions were not supported by the underlying data and to maintain scientific standards.
The move follows a separate decision to block a CDC report on COVID-19 vaccine effectiveness that found the shots reduced emergency department visits and hospitalizations by about half.
External experts who reviewed the FDA studies said the findings were generally consistent with existing evidence, raising concerns about transparency and access to vaccine safety data.
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