FDA urged to publish follow-up studies on covid-19 vaccine safety signals

In July 2021 the US Food and Drug Administration (FDA) quietly disclosed findings of a potential increase in four types of serious adverse events in elderly people who had had Pfizer’s covid-19 vaccine: acute myocardial infarction, disseminated intravascular coagulation, immune thrombocytopenia, and pulmonary embolism. Little detail was provided, such as the magnitude of the increased potential risk, and no press release or other alert was sent to doctors or the public. Eighteen days later, the FDA published a study planning document (or protocol) outlining a follow-up epidemiological study intended to investigate the matter more thoroughly. This recondite technical document disclosed the unadjusted relative risk ratio estimates originally found for the four serious adverse events, which ranged from 42% to 91% increased risk. More than a year later, however, the status and results of the follow-up study are unknown. The agency has not published a press release, or notified doctors, or published the findings … or updated the vaccine’s product label.The Cody Meissner, a paediatrician and member of the FDA’s Vaccines and Related Biological Products Advisory Committee, said … “One of the great problems was the suppression of opposing voices to various recommendations and that’s going to cause extraordinary harm … everyone is aware that there are going to be side effects from any vaccine and as time goes by, we’re going to find out more and more about those side effects.”

Note: For more along these lines, see concise summaries of deeply revealing news articles on coronavirus vaccines from reliable major media sources.

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Author: {Want To Know}

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