Pfizer may be within days of filing emergency authorization request for Covid-19 vacc

Pfizer may be within days of filing for an emergency use authorization for its Covid-19 vaccine, having collected the safety data necessary to submit an application to the Food and Drug Administration, CEO Albert Bourla said Tuesday.

“We are very close to submitting for an emergency use authorization,” Bourla said during the STAT Summit, which this year is a virtual event. Bourla sidestepped the question of whether Pfizer’s filing would be made this week.

“Let us not create expectations,” he said in conversation with STAT’s Matthew Herper. “We will announce it as soon as we are doing it.”

The FDA required manufacturers to follow at least half of the people who received vaccine in their Phase 3 clinical trials for two months, to ensure there is at least that amount of safety data before a vaccine is considered for use.

Pfizer, which is producing a messenger RNA, or mRNA, vaccine, was the first to announce preliminary results from its Phase 3 trial. It is expected it will be the first Covid-19 vaccine cleared for use in the United States. If all goes according to plan, vaccinations could begin sometime in December. It’s expected the company will be able to supply the U.S. with enough vaccine in 2020 to vaccinate 20 million people.

The Pfizer vaccine was shown to be strongly protective in a preliminary analysis of Phase 3 data, with efficacy of over 90%. The trial was designed to show if the vaccine protected against symptomatic Covid infection. Pfizer’s announcement was followed this week by word from Moderna that its vaccine — also an mRNA vaccine — had been shown to be highly protective.

Bourla said he was relieved to see that another vaccine was also successful and hoped there are many more, because the global need for Covid vaccines exceeds the production capacity of any single company.

Asked how the company was able to move so swiftly — no vaccine has ever been produced this fast — Bourla said Pfizer had to make “zillions” of decisions in the process, and was blessed in making the right calls. “To get this done the stars needed to be aligned and stay aligned,” he said.

He denied allegations that the company played politics in the timing of the announcement that the vaccine worked. President Trump has alleged the news was held until after the Nov. 3 election to deny him a vaccine “win.”

“It happened just at the speed of science,” Bourla said, recalling that he told Pfizer scientists in March that there would likely be a fall surge in cases and a vaccine would be needed to save lives.

“I did not have any political or any artificial timelines in my mind when I said I’m expecting it by the end of October. I said it because we had a very high probability that we would have results by the end of October,” he said.

Pfizer intends to offer vaccine to people who were randomly assigned to get a placebo injection in their Phase 3 trial; Bourla said the company has a “moral obligation” to the people who stepped forward to volunteer for the trial.

The FDA has been discouraging vaccine manufacturers from doing that preemptively, arguing that the trials should stay blinded — neither the participants nor the scientists who monitor them know who got vaccine and who got placebo — for as long as is practical to generate as much data out of the trials as possible. Bourla said Pfizer is in discussions with the FDA over when the vaccination of placebo arm participants can take place.

The Pfizer CEO was also asked about the mRNA technology, long thought to be highly promising but only now being put to the test. While companies have been working on mRNA vaccines for a number of pathogens for several years, these will be the first licensed vaccines made this way, if they are approved.

Bourla predicted the technology will be used for multiple viral vaccines and other uses as well, such as cancer therapies.

“I think we have a very glorious demonstration that the technology works,” he said. “I think this technology is cutting edge and we’re just seeing the beginning of what it can offer humanity.”