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FDA Withdraws COVID-19 and Shingles Vaccine Studies, HHS Confirms

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A Health and Human Services Department spokesperson confirmed on Tuesday that the FDA blocked publication of several studies supporting the safety of COVID-19 and shingles vaccines.

Background

The studies, conducted by FDA scientists in collaboration with data firms, analyzed millions of patient records and found rare side effects from the vaccines.

According to the New York Times, in October scientists were directed to withdraw two COVID-19 vaccine studies that had been accepted for publication in medical journals.

In February, top FDA officials did not approve submission of study abstracts on the shingles vaccine Shingrix to a drug safety conference.

Statements

An HHS spokesperson stated that the studies were "withdrawn because the authors drew broad conclusions that were not supported by the underlying data."

The spokesperson added that "the FDA acted to protect the integrity of its scientific process and ensure that any work associated with the agency meets its high standards."

Regarding the shingles vaccine research, the spokesperson said the study design "fell outside the agency's purview."