Washington — Albert Bourla, the head of pharmaceutical giant Pfizer, which is among the companies developing a coronavirus vaccine, said Sunday there is a “good chance” the company will know whether its vaccine works by the end of October.
In an interview with “Face the Nation,” Bourla said it’s not yet known whether Americans will be able to receive a coronavirus vaccine before 2021, as issuance of a license depends on federal regulators. But studies from Pfizer indicate “we have a good chance that we will know if the product works by the end of October.”
Still, Bourla said Pfizer is preparing for approval from the federal government and distribution of a vaccine before the end of the year.
“We started already manufacturing and we have already manufactured hundreds of thousands of doses, so just in case we have a good study readout, conclusive and FDA, plus the advisory committee feels comfortable that we will be ready,” he said.
Pfizer, which has partnered with BioNtech on its coronavirus vaccine, has begun enrolling 30,000 people in its phase three vaccine trial but is looking to expand its enrollment to 44,000. Bourla said the decision to increase the number of participants stems from its desire to expand to more vulnerable populations.
“We go to younger people. Right now, the study recruits from 18 to 85. Now we will go to 16 years old,” he said. “Also, we will go to people with special conditions, chronic conditions like HIV patients, but also we will try to use it to increase the diversity of the population.”
While Pfizer is one of several companies currently enrolling participants in its phase three vaccine trial, it is the only U.S.-based pharmaceutical company that has rejected federal dollars for its vaccine candidate.
Bourla acknowledged that if its coronavirus vaccine fails, Pfizer will absorb the financial hit. But he said he decided not to accept government funding for vaccine development to shield the pharmaceutical giant from politics.
“I wanted to liberate our scientists from any bureaucracy,” he said. “When you get money from someone that always comes with strings. They want to see how we are going to progress, what type of moves you are going to do. They want reports. I didn’t want to have any of that. I wanted them — basically I gave them an open checkbook so that they can worry only about scientific challenges, not anything else. And also, I wanted to keep Pfizer out of politics.”
While Bourla stopped short of predicting when Americans may be able to receive a coronavirus vaccine, Dr. Scott Gottlieb, former commissioner of the Food and Drug Administration and a member of Pfizer’s board of directors, has stressed he does not believe a vaccine will be widely available until 2021.
“This is likely to be a very staged market entry,” he said on “Face the Nation.” “I think that’s what people should expect. But for most people, they will not have access to a vaccine until 2021. I think maybe the first quarter of 2021, probably the first half of 2021. And that’s assuming that these vaccines are demonstrated to be safe and effective in these large trials.”
If any population in the U.S. is to receive a coronavirus vaccine this year, Gottlieb predicted it will be those who are at a high risk of becoming very sick from the virus or frontline workers who are at a high risk of contracting it.
What we’re going to be doing is targeting the vaccine to select groups of people who are at very high risk of a bad outcome from COVID to try to reduce their risk,” he said. “But it’s not going to be used to achieve broad-based immunity, at least in 2020, perhaps in 2021.”
September 14, 2020