Vaccines: CDC decides to postpone completion of myocarditis study
The US Food and Drug Administration (FDA) has changed the end date of a key study on post-vaccination cardiac inflammation without informing the public.
Pfizer was expected to complete a study on the occurrence of subclinical myocarditis, or inflammation of the heart, after receiving its COVID-19 vaccine. The completion date was listed by the FDA in 2021 as June 20, 2022. Pfizer was also expected to submit study results to the FDA by the end of 2022, as part of a list of requirements mandated by the FDA as a condition of approval of Pfizer's jab. But after the deadline passed, the FDA quietly changed the date.
In a postmarketing requirements list for the Pfizer-BioNTech vaccine, the FDA now says the same study has an "originally scheduled completion date" of June 30, 2023. The current status of the study is listed as "pending." .
Jessica Adams, a former regulatory review officer at the FDA, said it amounts to disinformation. You should not change the close date of a search in order to distort the data.
Dr Vinay Prasad, who has increasingly criticized the FDA for its decisions during the pandemic, said the new timeline "is so slow that it will be completely unnecessary". “Another failure of the FDA,” he commented on Twitter.
Hi everyone, we are the most incompetent organization on earth. For instance, last year, we corrected the number of kids dead from covid bc we can't count to a thousand. But trust us that this very complicated/ debatable adjudication process is correct
https://t.co/dy3fBNsCW1
— Vinay Prasad MD MPH (@VPrasadMDMPH) January 28, 2023
The study was designed to "prospectively evaluate the incidence of subclinical myocarditis" after receiving a third dose, or booster, in people aged 16 to 30 years.
Pfizer submitted a timetable to the FDA that called for a final protocol to be submitted by November 30, 2021, and the study to be completed by June 30, 2022, according to the FDA's vaccine approval letter. The final report was due to be delivered to the FDA by the end of 2022.
The study is one of several looking at myocarditis and pericarditis, a related condition. According to US officials and other experts, both are caused by Pfizer and Moderna vaccines.
On Jan. 26, FDA official Richard Forshee told the agency's Vaccine Advisory Committee that Pfizer's bivalent vaccine has triggered a safety signal for adults ages 18 to 35. Regulators cleared the bivalent vaccine and Moderna's vaccine in the fall of 2022, despite the absence of clinical data for either. The adverse event has occurred at a worrying rate after a Pfizer bivalent in recent months, according to analyzes of data from the FDA's Biologics Effectiveness and Safety initiative, which draws from systems like the one managed by CVS Health.
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The article Vaccines: the CDC decides to postpone the end of the myocarditis study comes from Scenari Economici .
This is a machine translation of a post published on Scenari Economici at the URL https://scenarieconomici.it/vaccini-il-cdc-decide-di-rimandare-la-fine-dello-studio-sulle-miocarditi/ on Mon, 30 Jan 2023 08:00:37 +0000.