Big pharma giants Pfizer and BioNTech have officially halted recruitment for a large-scale US clinical trial of their updated COVID-19 vaccine….after failing to recruit enough participants.
It would seem that people are waking up now and refusing to volunteer to be Pfizer Guinea Pigs.
Enrollment in their trial of an updated COVID-19 vaccine for 50 to 64 year olds, had been too low to generate the needed data.
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According to Reuters, In a letter to trial investigators dated March 30, seen by Reuters and previously unreported, Pfizer said it would stop surveillance for signs of COVID illness for all participants in the study after April 3.
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Enrollment was closed on March 6, following a review of current epidemiological trends, it said.
The move comes as COVID vaccine makers grapple with pushback from the U.S. administration and weak U.S. demand for the shots.
The U.S. Food and Drug Administration toughened requirements for COVID vaccine use last year, including asking for large, placebo-controlled trials in the 50-64 age group for it to be included in recommendations.
Pfizer and BioNTech told Reuters they had informed the FDA about their intent to halt the COVID-19 vaccine study, citing challenges getting enough participants. The target enrollment was roughly 25,000 to 30,000 participants.
“This study is not ending as a result of any safety or benefit-risk concerns. We intend to stop the study due to slow enrollment and therefore the inability to generate relevant post-marketing data,” the companies said.
Shares of Pfizer and rival COVID-vaccine maker Moderna were up nearly 1%, while U.S.-listed shares of BioNTech rose about 2%.
FDA vaccine chief Vinay Prasad, who had pushed for the placebo-controlled trials in healthy adults and children, is leaving the agency this month. Experts warned that requiring large new trials could delay or limit the availability of updated shots for lower-risk groups.
It was unclear what the path to approval could be for this group. The FDA was not immediately available for comment. The companies did not comment on plans for marketing the shot for this age group.
The Pfizer-BioNTech study halt comes ahead of an expected May meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, which would use study data to guide decisions on strain selection for COVID vaccines this autumn.
“Without the data, there probably just won’t be a presentation,” said Dr. Jesse Goodman, a former FDA chief scientist. “And without the presentation, there may not be a specific approval for this age group.”
