So many back-room dealings.
The U.S. Food and Drug Administration (FDA) has changed the end date for a key study on post-vaccination heart inflammation without notifying the public.
Pfizer was supposed to complete a study on the occurrence of subclinical myocarditis, or heart inflammation, after receipt of its COVID-19 vaccine. The completion date was listed by the FDA in 2021 as June 20, 2022. Pfizer was also supposed to submit the results of the study to the FDA by the end of 2022 as part of a list of requirements the FDA imposed as a condition of approving Pfizer’s jab.
But after the deadline passed, the FDA quietly changed the date.
Under a list of postmarketing requirements for the Pfizer-BioNTech vaccine, the FDA now says the same study has an “original projected completion date” of June 30, 2023.
The current status of the study is listed as “pending.”
The FDA and Pfizer did not respond to requests for comment.
Jessica Adams, a former regulatory review officer at the FDA, said the wording amounts to misinformation.
“By definition, ‘original’ dates can’t change,” she wrote on Twitter, tagging the agency. “Please correct this ‘misinformation.’”
Dr. Vinay Prasad, who has increasingly criticized the FDA over its decisions during the pandemic, said the new timeline “is so slow it will be entirely moot.”
“Another FDA failure,” he said on Twitter.