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.
The study is one of nine Pfizer was to complete to examine post-vaccination adverse events.
The study is designed to “prospectively assess the incidence of subclinical myocarditis” after receipt of a third dose, or a booster, in people aged 16 to 30.
Pfizer submitted a timetable to the FDA stating the company would submit a final protocol by Nov. 30, 2021, and complete the study by June 30, 2022, according to the FDA’s approval letter for the company’s vaccine. The final report was due to the FDA by the end of 2022.
The study was one of several examining myocarditis and pericarditis, a related condition. Both are caused by the Pfizer and Moderna vaccines, according to U.S. officials and other experts.
Some of the vaccine-caused myocarditis cases have led to death.
FDA officials expressed concern about the post-vaccination heart inflammation when considering whether to approve Pfizer’s vaccine.
Signal for Myocarditis After New Booster
The bivalent Pfizer vaccine triggered a safety signal for adults aged 18 to 35, Richard Forshee, an FDA official, told the agency’s vaccine advisory committee on Jan. 26.
Regulators cleared that bivalent and one from Moderna in the fall of 2022 despite there being no clinical data for either shot.
The adverse event happened at a concerning rate after a Pfizer bivalent in recent months, according to analyses of data from the FDA’s Biologics Effectiveness and Safety initiative, which pulls from systems such as one managed by CVS Health.
“The only signal we have detected so far is for myocarditis/pericarditis following the Pfizer bivalent vaccine among adults 18 to 35 years old,” Forshee told the panel.
Safety signals indicate a vaccine may cause events but don’t establish causality. But officials have stressed that the bivalents are similar to the original vaccines in defending the authorization without clinical data, and have acknowledged a causal link between the original messenger RNA vaccines and the heart inflammation.
Most of the meeting presentations that went over adverse events focused on ischemic stroke, which triggered the threshold for a safety signal following Pfizer’s bivalent booster in the elderly and following receipt the original Pfizer and Moderna vaccines in all adults.
Officials said that the stroke has happened in many people who received a flu vaccine on the same day as a COVID-19 vaccine. They’re studying whether there’s a connection, though they noted there was no signal for the stroke after a flu shot alone.
Dr. Nicola Klein, a Kaiser Permanente researcher who helps the CDC monitor vaccine safety, said that the signal for stroke wasn’t as strong as that for myocarditis.
“This is a cluster but … it doesn’t stand out as extremely striking, unlike some other signals which we have seen,” Klein said. “For example, myocarditis, it’s an extremely strong signal that you can see without doing statistics.”
Panel Notified of CDC Analyses
During the public comment portion of the meeting, any panel members watching were notified that the CDC’s analyses of reports to a different surveillance system concluded hundreds of adverse events met the safety signal threshold, including approximately 500 with a signal larger than that for myocarditis.
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