Pfizer said Friday it will not be able to apply for emergency use of its COVID-19 vaccine until the third week of November, making it all but impossible for President Trump to trumpet a breakthrough before Election Day.
CEO Albert Bourla said Pfizer may know by the end of October whether its shots are effective, depending on how many coronavirus cases appear during late-stage trials. But it must also satisfy regulators’ vigorous safety requirements.
The Food and Drug Administration is demanding two months of safety data on half of trial enrollees following their final dose, so the pace of Pfizer trial pushes any approval closer to Thanksgiving.
“So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November,” Mr. Bourla wrote in an open letter. “All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency.”
The upshot is the U.S. could roll out a vaccine before the end of the year, inoculating health care workers and first responders first.
But Mr. Trump hasn’t been shy about pushing for emergency approval of a vaccine before voters have their say on Nov. 3, as he emphasizes drug therapies and a vaccine over mitigation methods such as mask-wearing or societal lockdowns.
Pfizer was considered the most bullish of drugmakers pursuing a vaccine. Its CEO repeatedly pointed to late October as a critical point for knowing more about its progress.
Other companies, including AstraZeneca, Moderna and Johnson & Johnson, had suggested they would seek approval later in the year, a timeline that aligns with what federal officials besides Mr. Trump had been saying for some time.
AstraZeneca and J&J each have been forced to hit pause on their trials to investigate an unexplained illness in their respective trials.