US government studies into vaccine safety are being suppressed | Robert B Shpiner
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- FDA directed scientists in October to withdraw two COVID‑19 vaccine safety studies that had already been accepted by the journals Drug Safety and Vaccine.
- First study examined 7.5 million Medicare beneficiaries for 14 pre‑specified adverse outcomes after 2023–2024 COVID‑19 vaccination and found only anaphylaxis at roughly one per million Pfizer‑BioNTech doses exceeding statistical noise.
- Second study analyzed 4.2 million recipients aged six months to 64 years, confirming rare febrile‑seizure and myocarditis signals already listed on the vaccine label.
- FDA officials in February declined to sign off on submitting Shingrix safety abstracts to a major drug‑safety conference, even though the analysis confirmed a low‑level Guillain‑Barré risk noted on the package insert.
- FDA memo linked the deaths of ten children to COVID‑19 vaccination and was widely reported, while the two safety studies showing rare adverse events were withheld from the public.
Why it matters: Public health officials lose access to large‑scale safety data, while political appointees gain control over the vaccine narrative, potentially eroding trust and influencing vaccine uptake decisions.
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