American pharmaceutical giant, Pfizer Inc. has disclosed that it could seek emergency-use authorization for its Covid-19 vaccine in the U.S. by late November if the shot is shown to be effective in a large late-stage trial.
This announcement rules out the assertion by US President, Donald Trump, that a Covid-19 vaccine would be ready before the Presidential election.
This disclosure was made by the Chief Executive Officer of Pfizer, Albert Bourla, in an open letter published on the company’s website on Friday, October 16, 2020.
While noting that safety reviews will dictate the timeline, with the Food and Drug Administration (FDA) requiring that at least half the people in the study be watched for side effects for two months, Bourla said that milestone should be achieved in the third week of November.
Bourla wrote, “Let me be clear, assuming positive data, Pfizer will apply for emergency authorization use in the U.S. soon after the safety milestone is achieved. An initial readout on whether the vaccine is effective could come later this month, depending on how quickly subjects in the trial, some of whom got a placebo shot, become infected with the virus.’’
Pfizer said the regulatory filing for the vaccine could come as soon as safety data are available, possibly in the third week of November, lifting the company’s shares by 2.5% in premarket US trading.
The timeline by Pfizer now allows for a possible U.S authorization of a Covid-19 vaccine later this year, a major step in controlling the coronavirus pandemic that has killed over a million people globally and devastated the world’s economy.
Although Bourla’s letter puts to rest any notion that a vaccine could be cleared for emergency use in the U.S. before Election day, a goal President Donald Trump had pushed for, the Pfizer CEO’s timetable could give the president a partial victory. If Pfizer is able to, say in late October from the data, show that its inoculation protects people from the virus, that could let Trump claim his administration successfully pushed for a working vaccine before Nov. 3, regardless of whether the FDA has reviewed it.
Pfizer and its German partner BioNTech SE are on track to potentially be the first to show the efficacy of a Covid-19 vaccine. They and rival vaccine developers are intensely working, with an almost unprecedented public interest in every detail of their clinical trials. Johnson & Johnson and AstraZeneca Plc have had studies of possible vaccines or treatments delayed because of safety concerns.
The letter confirmed a timeline laid out by BioNTech CEO Ugur Sahin this week. Sahin said the partners haven’t had to stop their late-stage study over safety concerns.
A group of leading scientists previously urged Pfizer to wait until at least late November before seeking emergency authorization.