The pharma maker plans to apply for FDA Emergency Use Authorization for the vaccine after the third week of November.
While President Donald Trump was optimistic that a COVID-19 vaccine would be ready prior to the presidential election, Pfizer says its vaccine candidate with partner BioNTech will likely be ready in late November.
“In the instance of Emergency Use Authorization in the U.S. for a potential COVID-19 vaccine, FDA is requiring that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine,” wrote Pfizer Chairman and CEO Albert Bourla in an open letter. “Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November. “
Pfizer will apply for EUA soon after the safety milestone is achieved in the third week of November, Bourla wrote.
“All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency,” he wrote.
Meanwhile, Moderna's COVID-19 vaccine could receive FDA EUA in December, if the company obtains positive interim results in November, MarketWatch reported.
If positive interim results from a large clinical trial take longer to get, the EUA may not occur until early next year, Chief Executive Stéphane Bancel said during The Wall Street Journal's annual Tech Live conference.
In addition, Pfizer received FDA approval to enroll children as young as 12 years old in its COVID-19 vaccine trial, NPR reported.
Until now, children under 16 have not been included in any COVID-19 vaccine trials in the U.S., NPR said.
Meanwhile, Bourla explained that Pfizer and BioNTech may know wether their vaccine is safe and effective by the end of October. “To do so, we must accumulate a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo. Since we must wait for a certain number of cases to occur, this data may come earlier or later based on changes in the infection rates,” he noted.