Chief executive Albert Bourla wrote in the letter that while the company’s project may have effectiveness data in October, there will not be enough safety data to satisfy the standards laid down by the Food and Drug Administration until the last part of November.
“A key point I want to clarify is that effectiveness is only satisfying one of the three requirements and, alone, is not enough for us to apply for approval for public use,” said Bourla. “Safety is, and will remain, our top priority.”;
The letter was received by Eric Topol, a physician-scientist at the Scripps Research Translational Institute who joined other experts in sending a letter to Bourla in late September, asking the company not to ask for permission for a vaccine. before late November. Topol recently had a virtual meeting with company executives to express his concerns and said he was disappointed that they would not respond directly when asked if they would ask for more use of a vaccine before November. 3.
Bourla’s emphasis on having data in October “is what worries many of us, whether it is accidentally played by political pressure or simply because incentives are aligned,” Topol said. “I thought [the letter] very good. I hope the potential has done this sooner. ”
The FDA in October issued a guideline explaining the criteria for an emergency use permit, which would hold a vaccine given to healthy people at a higher standard than the standard low threshold. a medical product that “may be effective” for emergency use. The agency released – despite White House opposition – that vaccine candidates should have a minimum of two months of follow-up data on half of study participants.
Pfizer will not have such data until the third week of November. Moderna, a biotechnology company, does not have enough safety data to apply for regulatory permission until two days before Thanksgiving, according to spokesman Ray Jordan. Two other final vaccine trials, from AstraZeneca and Johnson & Johnson, have been suspended due to potential safety concerns.