Pfizer will need to submit data on its vaccine candidate to the US Food and Drug Administration (FDA) and wait for a review -- two stages that will take several weeks each, US Health and Human Services Secretary Alex Azar told Fox News.
The drugmaker said on Monday that early data shows its vaccine is 90% effective, but Azar said Pfizer needed to pull together the details and provide them to the FDA for an independent review process before authorization.
So, you should be thinking in the several week time period, both for the submission and then review by FDA of the data,” Azar said Monday.
Azar said that thanks to Operation Warp Speed, the government has guaranteed receipt of an FDA-authorized vaccine from Pfizer -- 100 million doses that were purchased for around $2 billion, Azar said. There is also an option for another 500 million. These will start in increments of about 20 million doses, which begin in late November and continue monthly, according to Azar.
The timescale: In a news release on Monday, Pfizer said it plans to seek emergency use authorization from the FDA, soon after volunteers have been monitored for two months following their second dose of vaccine, as requested by the agency. Pfizer said it anticipated reaching that marker by the third week of November.