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. 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."
Latest
Latest News
Each news summary is created according to strict standards. Here's how we do it.
Each summary is created using a consistent editorial procedure. The target length is approximately 16 lines of 11-point Arial text in a 650-pixel-wide column. Up to 25% of a summary may be set in bold to emphasize the most important ideas. Summaries are composed of verbatim excerpts presented in the same sequence as they appear in the original news source, with very minor editorial additions. Where material has been omitted between excerpts, the omission is indicated with ellipses (...). Any words added by an editor for clarity or context appear in [brackets]. Our original news editor was Fred Burks. Tod Fletcher edited most summaries from 2007 through 2014, and Mark Bailey has served as news editor since 2014.