FDA halted publication of agency studies on Covid-19 and shingles vaccine safety
The Facts
- FDA officials blocked publication of several studies examining the safety of Covid-19 and shingles vaccines.
- The studies were conducted by agency scientists using millions of patient records and were funded with millions of dollars in public money.
- The studies found that serious side effects linked to the vaccines were very rare.
- In October, scientists were directed to withdraw two Covid-19 vaccine studies that had already been accepted for publication in medical journals.
- In February, top FDA officials did not approve submission of abstracts on studies of Shingrix, a shingles vaccine, to a major drug-safety conference.
- HHS spokesperson Andrew Nixon said the studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data, and said the FDA acted to protect its scientific process.
- The blocked studies involved widely used vaccines, meaning the decision affects whether federal safety findings about products used by large numbers of patients are publicly disseminated.
- It remains unresolved from the available reports whether the studies will be revised and published later or remain unpublished.
Context
What kinds of studies were halted?
The reports describe several FDA-run safety studies on Covid-19 vaccines and Shingrix, a shingles vaccine. Two Covid-19 papers had been accepted by journals before being withdrawn, and abstracts on Shingrix-related studies were not cleared for a February drug-safety conference NYT,Spokesman Review,Anchorage Daily News.
What reason did the government give for stopping publication?
Andrew Nixon, a spokesperson for HHS, said the studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data, and said the FDA was protecting the integrity of its scientific process Guardian,InfoMoney,bdnews24.com.
Why does this matter beyond the internal publication process?
The studies were based on large datasets and addressed the safety of widely used vaccines, so blocking publication limits public access to federal research findings on products used by many patients NYT,Reuters,Honolulu Star Adver….
Where Left and Right agree, and where they split
- Where Left and Right agree
- FDA officials stopped agency scientists from publishing publicly funded vaccine-safety studies based on millions of patient records, including work already accepted by journals, leaving findings that serious side effects were very rare undisclosed for now.
- Where Left and Right split
- Less a disagreement than a question of emphasis: the public’s claim on federal safety findings about widely used vaccines, versus the agency’s obligation to police unsupported conclusions and prove that its gatekeeping is credible.
How left and right read it
When agency scientists use millions of patient records and millions in public money to study widely used vaccines, the public has a strong interest in seeing those safety findings, especially when the studies found serious side effects were very rare. Blocking publication means federal information relevant to large numbers of patients is not being publicly disseminated, and it remains unclear whether that gap will be corrected.
The central issue here is institutional process: HHS says the studies were withdrawn because the authors drew conclusions not supported by the underlying data, and that the FDA acted to protect its scientific process. Even so, when top officials block studies already accepted by journals or prevent abstracts from being submitted, the agency takes on a heavier burden to show that its gatekeeping is consistent and credible.
The receipts — 31 sources
Wire services (2)
Independent coverage (29)
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