President Trump has boosted the prospect of a pre-election vaccine as November 3 inches closer, saying that one would be ready by that "special day" and that a preventative COVID-19 shot would be available "within weeks". "This means we may know whether or not our vaccine is effective by the end of October", Bourla said.
Pfizer Chairman and CEO Albert Bourla said in a public statement Friday that it is indeed possible that the company could have enough data to know this month whether the vaccine it is developing actually protects people from coronavirus infection.
On Monday, Johnson & Johnson announced it had paused a large, late-stage clinical trial of its coronavirus vaccine after one of its volunteers became ill with an unexplained sickness. But he added in the letter that the new FDA safety standards would push the company to ask for emergency approval in late November.
The results came from a combined Phase I and Phase II trial involving more than 600 healthy adults conducted between April 29 and July 30.
Two American companies expect to apply for emergency approval for their Covid-19 vaccines by late November, welcome news as the U.S. crossed eight million confirmed cases amid a third surge of its coronavirus epidemic.
The Food and Drug Administration (FDA), which authorises pharmaceuticals for distribution in the United States, asked vaccine developers last week to spend two months monitoring for serious side effects after the second dose is given to trial participants.
As far as Serum Institute is concerned, he said, "We will be ready with 60-70 million dosages of vaccines by December 2020, but that will come in the market in 2021 after the clearance of licencing".
"We estimate that we will reach this milestone in the third week of November", Bourla wrote.
That requires a massive amount of spending both by state and local governments and by federal agencies like the Centers for Disease Control. That dims any lingering expectation that there could be a vaccine by Election Day, as President Trump has asserted.
Dr. William Schaffner, professor of preventative medicine at Vanderbilt University, told TPM in an interview last month that the vaccine would not singlehandedly end the pandemic.
Widespread mask use might also mean that when people do get infected, they have less virus in their body which makes them less sick.
The FDA will require the vaccine to prove effective and safe, while Pfizer will have to demonstrate it is capable of producing large-scale production. The efficacy of any of the vaccine candidates in trials has yet to be determined.