US government studies into vaccine safety are being suppressed | Robert B Shpiner

"Studies of millions of vaccine recipients were completed by career scientists, peer-reviewed and accepted by working pharmacovigilance journals; after political appointees declined to sign off, they were withdrawn. The agency commissioned the work and received the answer, but is not releasing it. In October, FDA scientists were directed to withdraw two Covid-19 vaccine safety studies that had already been accepted by the journals Drug Safety and Vaccine. In February, top officials declined to sign off on submitting Shingrix safety abstracts to a major drug-safety conference."

"One examined the records of 7.5 million Medicare beneficiaries for 14 pre-specified adverse outcomes after 20232024 Covid-19 vaccination, using a self-controlled case-series design with follow-up of up to 90 days. Only one signal anaphylaxis at roughly one per million Pfizer-BioNTech doses exceeded statistical noise. A second examined 4.2 million recipients aged six months to 64 years for more than a dozen outcomes; it identified the rare febrile-seizure and myocarditis signals already on the label."

"The Shingrix safety analysis confirmed the elevated but low Guillain-Barre risk that has been on the package insert for years. The agency's stated objection that the authors drew broad conclusions that were not supported by the underlying data describes, in any functioning scientific system, the ordinary work of peer review. Reviewers ask for narrower language; editors ask for revised discussion sections; manuscripts appear with more carefully bounded claims."

"What does not happen is for political appointees to instruct staff scientists to withdraw an accepted manuscript. The procedural anomaly is the story. The asymmetry compounds it. In late November, a memo from the same FDA center linked the deaths of 10 child"

Career scientists completed large vaccine safety studies using Medicare and other recipient records and submitted results to peer-reviewed pharmacovigilance journals. After political appointees declined to sign off, the studies were withdrawn despite FDA commissioning the work and receiving the findings. In October, FDA scientists were directed to withdraw two Covid-19 vaccine safety studies already accepted by Drug Safety and Vaccine. One study analyzed 7.5 million Medicare beneficiaries for 14 pre-specified adverse outcomes using a self-controlled case-series design with up to 90 days of follow-up, finding only one anaphylaxis signal above noise. Another study analyzed 4.2 million recipients aged six months to 64 years and identified rare febrile-seizure and myocarditis signals already on the label. A Shingrix safety analysis confirmed the long-standing elevated but low Guillain-Barre risk. The stated objection about broad conclusions resembles normal peer review revisions, not withdrawal of accepted manuscripts.

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