The Food and Drug Administration commissioned the research, received the answer, and is not releasing it
Last week, the New York Times and Washington Post reported yet another troubling case of data suppression at the Food and Drug Administration (FDA). 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and accepted by working pharmacovigilance journals; after political appointees declined to sign off, they were withdrawn.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, received the answer, and 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. The Covid studies were not small. One examined the records of 7.5 million Medicare beneficiaries for 14 pre-specified adverse outcomes after 2023–2024 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-Barré risk that has been on the package insert for years.
Robert B Shpiner is a clinical professor of medicine (pulmonary and critical care) and associate professor of neurosurgery (neurocritical care) at the David Geffen School of Medicine at UCLA, where he has practiced critical care for more than 40 years
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