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Pfizer CEO Albert Bourla and his vaccine partner BioNTech have said that the companies expect phase 3 data by the end of October, and a request from the FDA could soon follow. But more than 60 researchers and bioethicists urged partners to wait for more safety data before submitting their vaccine for the green light, Bloomberg reports.
Experts asked Pfizer to wait until at least the end of November to submit its vaccine to the FDA. That would give the trial researchers enough time to collect at least 2 months of safety data after the participants receive their second doses. Pfizer, for its part, has said it hopes to know by the end of October if its program works.
“To be successful, the public must have the utmost confidence in the vaccine and the science behind it,” the experts wrote, as quoted by Bloomberg Law. “Filing an application for an EUA before this standard is met would seriously erode public confidence and delay efforts to achieve widespread vaccination.”
As of Monday, Pfizer’s phase 3 trial had enrolled more than 35,000 participants and more than 24,000 had received their second doses. The company aims to enroll about 44,000 people for the trial.
A Pfizer spokeswoman said the company is “very grateful” for the expert comments and that the company is “committed to providing sufficient efficacy and safety data to help the FDA determine the best regulatory mechanism to make the vaccine. is available to the public. ”
“We anticipate providing the FDA with safety data, including the two-month median safety data after the second dose, on an ongoing basis,” he added. The drug manufacturer will monitor the safety data and results for two years during the trial.
BioNTech developed the mRNA vaccine platform that the partners are promoting, and Pfizer partnered with biotechnology to contribute its expertise in vaccine R&D, manufacturing and distribution.
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Pfizer and BioNTech are part of a group of COVID-19 vaccine developers who signed a joint safety and efficacy pledge earlier this month, saying they would not take shortcuts during the R&D process. The promise came as pressure Politics of the process had observers wondering about the FDA’s ability to make a decision based on science, not politics.
In addition to Pfizer and BioNTech, AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax and Sanofi also signed the pledge.
