Experts have called on Pfizer to wait until at least the end of November to submit its vaccine to the FDA. This would give trial investigators enough time to compile at least 2 months of safety data after participants receive their second doses. Pfizer, for its part, said it expected to know by the end of October whether its program was working.
“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. “Submitting an EUA application before this standard is met would seriously undermine public confidence and slow efforts to achieve widespread immunization.
As of Monday, Pfizer’s Phase 3 trial had enrolled more than 35,000 participants and more than 24,000 had received their second dose. The company aims to enroll approximately 44,000 people in the trial.
A spokesperson for Pfizer said the company was “very grateful” for the experts’ input and “is committed to providing sufficient efficacy and safety data to help the FDA determine the best mechanism. regulations to make the vaccine available to the public ”.
“We plan to provide the FDA with safety data, including the median safety data of two months after the second dose, on an ongoing basis,” she added. The drug manufacturer will track the safety data and results for two years during the trial.
BioNTech has developed the mRNA vaccine platform that partners are advancing, and Pfizer has partnered with biotechnology to provide expertise in vaccine R&D, manufacturing and distribution.
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Pfizer and BioNTech are among a group of COVID-19 vaccine developers who signed a joint pledge to safety and efficacy earlier this month, saying they would not cut corners during the process. R&D. The engagement came as political pressure on the process made observers question the FDA’s ability to make a decision based on science, not politics.
Besides Pfizer and BioNTech, AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax and Sanofi have also signed this commitment.