Pfizer CEO Albert Bourla and his vaccine partner BioNTech have said the companies expect phase 3 data by the end of October—and that an FDA application could soon follow. But more than 60 researchers and bioethicists urged the partners to wait for more safety data before submitting their shot for a green light.
The experts called on Pfizer to wait until late November at least to submit its vaccine to the FDA. That 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, has said it expects to know by the end of October whether its program works.
“To be successful, the public needs to have the utmost trust in the vaccine and the science behind it,” the experts wrote. “Submission of an application for an EUA before this standard is met would severely erode public trust and set back 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 around 44,000 people for the trial.
A Pfizer spokeswoman said the company is “very appreciative” of the experts’ input, and that the company is “committed to providing sufficient efficacy and safety data to help FDA determine the best regulatory mechanism for making the vaccine available to the public.”
“We anticipate providing FDA with safety data, including the median of two months safety data after the second dose, on a rolling basis,” she added. The drugmaker will track safety and outcomes data for two years during the trial.
BioNTech developed the mRNA vaccine platform the partners are advancing, and Pfizer teamed up with the biotech to contribute its expertise in vaccine R&D, manufacturing and distribution.
Pfizer and BioNTech are among a group of COVID-19 vaccine developers that signed a joint safety and efficacy pledge earlier this month, saying they wouldn’t cut any corners during the R&D process. The pledge came as political pressure on the process caused observers to wonder about the FDA’s ability to make a decision based on science, not politics.
Aside from Pfizer and BioNTech, AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, and Sanofi also signed the pledge.