Albert Bourla, chief operating officer and chief executive officer of Pfizer Inc., listens during a Senate Finance Committee hearing on drug pricing in 2019.bloomberg file/Zach Gibson
- Sep 13, 2020
Pfizer Inc. Chief Executive Officer Albert Bourla said it’s “likely” the U.S. will deploy a COVID-19 vaccine to the public before year-end and that the company is prepared for that scenario, pushing back against more tepid expectations shared by health authorities.
Bourla said Sunday on CBS’s “Face the Nation” that he’s “quite comfortable” that the vaccine the company is developing in partnership with BioNTech SE is safe and that it could be available to Americans before 2021, contingent on an approval from U.S. regulators at the U.S. Food and Drug Administration.
“I cannot say what the FDA will do,” Bourla said. “But I think it’s a likely scenario, and we are preparing for it.”
New York-based Pfizer and Germany’s BioNTech are seen as frontrunners in the race to develop a coronavirus vaccine, alongside Moderna Inc. and AstraZeneca Plc. Bourla said Pfizer and its partner have a 60% chance of knowing the efficacy of its still experimental vaccine by the end of October.
“Of course that doesn’t mean that it works; that means that we’ll know if it works,” Bourla said. The timing of clinical trial results depends on enough people in the study getting COVIDd-19 to make a calculation. But positive results could clear the way for approval, he said.
Bourla’s assurances come just as Pfizer and BioNTech have expanded the number of clinical trial participants they’re seeking in order to include more people with diverse backgrounds.
The companies said in a statement Saturday that they expect to enroll the 30,000 patients they originally sought for its final-phase clinical trial this week. They are also expanding that target to 44,000 participants to include people as young as 16, and to allow those with HIV and Hepatitis B and Hepatitis C.
Bourla said on CBS that they will also focus on recruiting more people of color, including African Americans and Latinos, to the late-stage trial in coming weeks. He said the study participants are currently 60% White and 40% people of color, and that older volunteers make up 44% of the cohort.
The companies joined other vaccine developers last week in an unusual pledge to only submit applications with the FDA for vaccine clearance when the drugs have shown to be safe and effective in large clinical trials. That followed concerns that President Donald Trump is pushing the agency to cut corners to get a vaccine to market before the Nov. 3 election.
Bourla said part of the reason Pfizer didn’t accept taxpayer dollars to fund its COVID-19 vaccine research and development was to avoid government bureaucracy and influence. “I wanted to keep Pfizer out of politics,” he said.
Trump has said publicly that a vaccine could be authorized by the November election even though other top U.S. health officials, including National Institutes of Health Director Francis Collins, have said they think closer to the end of the year is more realistic. Even then, enough vaccine won’t be available to cover most Americans until well into 2021.
Former FDA Commissioner Scott Gottlieb, also speaking on CBS, said it’s “atypical” that the approval process of any drug or vaccine would be discussed within a political context.
“I don’t think we’re going to see an authorization before the election,” said Gottlieb, who sits on Pfizer’s board of directors. He added that American’s distrust in a COVID-19 vaccine will likely dissipate after the election.
The former FDA chief said he expects most Americans won’t be vaccinated until 2021 or later.
“This is likely to be a very staged market entry,” Gottlieb said. He described a process in which regulators will first issue an emergency use approval providing a limited supply of shots to those at high risk of infection, including frontline workers. Then the FDA will “slowly walk down that approval” to make it more broadly available, Gottlieb said.