The CEO of Pfizer He said the company is prepared to have the coronavirus vaccine before the end of the year, which differs from other less enthusiastic expectations shared by health authorities.
Albert Bourla noted Sunday on CBS’s “Face the Nation” show that he is “fairly certain” that the vaccine the company is developing in partnership with BioNTech SE is safe and could be available to Americans before 2021, depending on the approval from US Food and Drug Administration (FDA) regulators.
“I can’t say what the FDA will do,” Bourla said. “But I think that’s a likely scenario and we are preparing for it.”
For Bourla there is a 60% chance that Pfizer and BionTech will know the efficacy of the vaccine by the end of October
Pfizer, based in New York, and the German BioNTech are seen as leaders in the race to develop a coronavirus vaccine, along with Moderna Inc. and AstraZeneca Plc. Bourla said there is a 60% chance that Pfizer and its partner will know the efficacy of their still experimental vaccine by the end of October.
“Of course that doesn’t mean it works; It means we will know if it works, ”Bourla said. The date the clinical trial results are ready will depend on enough people taking part in the study to contract COVID-19 to do the calculations. But positive results could clear the way for approval, he said.
Bourla talks about his certainties right after Pfizer and BioNTech increased the number of participants they are seeking for their clinical trials with the goal of including more people from diverse backgrounds.
Increased enrollment of volunteers is expected to test the Covid 19 vaccine
The companies said in a statement Saturday that they hope to enroll 30,000 patients this week they originally searched for their final phase clinical trial. They are also expanding that target to 44,000 participants to include people aged 16 and over, and to include people with HIV, hepatitis B, and hepatitis C.
Bourla told CBS that they will also focus on recruiting more people of color, including African Americans and Latinos, for the final stage of the trial in the coming weeks. She noted that the proportion of study participants is currently 60% white and 40% black and, in terms of age range,. older volunteers make up 44% of the group.
The companies joined other vaccine developers who last week signed an unusual pledge to submit their applications to the FDA for approval of their vaccines only when the drugs have been shown to be safe and effective in large clinical trials. That followed concerns that the president Donald Trump is pushing the regulator to speed up the process to launch a vaccine to the market before the elections on November 3.
Bourla said part of the reason Pfizer did not accept taxpayer money to fund research and development for the COVID-19 vaccine was to avoid red tape and government influence. “I wanted to keep Pfizer out of politics,” he said.
Trump has spoken publicly about the possibility of a vaccine being licensed before the November election, even though other US health authorities, including National Institutes of Health Director Francis Collins, have said that they think it is more realistic to think that this will happen closer to the end of the year. However, there will not be enough vaccines available to cover the majority of Americans until well into 2021.
Former FDA Commissioner Scott Gottlieb, also speaking on CBS, said it is “unusual” for the approval process of any drug or vaccine to be discussed in a political context. “I don’t think there will be an authorization before the election,” said Gottlieb, who sits on the Pfizer board of directors. He added that Americans’ mistrust of a COVID-19 vaccine will likely dissipate after the elections.
Pfizer’s board of directors said it does not believe there will be a vaccine authorization before the election
The former FDA chief said he doesn’t think most Americans will get vaccinated until 2021 or after.
“This is likely to be a very staggered market entry”Gottlieb stated. He outlined a process where regulators will first issue an emergency use approval that will provide a limited supply of vaccines for people at high risk of infection, like frontline workers. Then the FDA will “slowly reduce that approval” to make it more widely available, Gottlieb said.