Pfizer Inc., one of the many pharmaceutical companies racing to develop a coronavirus vaccine, said it hopes to have a treatment authorized for emergency use by the end of the year.
CEO Albert Bourla in an open letter published Friday revealed that while scientists are working quickly to develop a vaccine, that it would not be ready by Election Day – a claim that has been repeatedly made by President Donald Trump. He added that the earliest the company would seek authorization from the Food and Drug Administration would be the third week of November.
Pfizer expects to have preliminary numbers by the end of October regarding whether the vaccine works, but it would still need to collect safety and manufacturing data. The CEO also emphasized all three aspects – safety, efficacy and manufacturing quality data – would prove key in ensuring the treatment’s success.
“To ensure public trust and clear up a great deal of confusion, I believe it is essential for the public to understand our estimated timelines for each of these three areas,” Bourla said.
“A key point that I’d like to make clear is that effectiveness would satisfy only one of the three requirements and, alone, would not be enough for us to apply for approval for public use.”
Still, the company is “operating at the speed of science,” with safety remaining its No. 1 priority, Bourla noted.
The FDA has said it takes several weeks to process an emergency use authorization, which means a vaccine could be approved for such use by the end of 2020. Still, it would only allow for distribution to high-priority and at-risk individuals, which will be defined at an advisory committee meeting on Oct. 22.
Another leading U.S. contender, Moderna Inc., previously announced the earliest it could seek authorization of its own vaccine would be Nov. 25.