Pfizer CEO Albert Bourla says company crossed safety milestone for Covid-19 vaccine, EUA submission imminent
Pfizer won’t say when they’ll send their Covid-19 vaccine to the FDA, except that it’s going to be very soon.
Speaking at New York Times and STAT summits Tuesday, CEO Albert Bourla said that, in their Phase III trial with BioNTech, they have already passed the minimum two-month follow-up the agency requires that developers reach to obtain emergency use authorization. With news last week that an interim analysis showed the vaccine was “over 90% effective,” that would appear to give the Big Pharma and their biotech partner most of the data required to achieve the first US OK for a Covid-19 vaccine.
“We are preparing now for submissions,” Bourla said at the Times conference.
Which will come when exactly?
“Let us not create expectations,” he said at STAT. “We will announce it as soon as we are doing it.”
Moderna has trailed directly behind the legacy pharma, announcing on Monday that their vaccine was 94.5% effective in an interim analysis and saying they would submit for an EUA “in the coming weeks.”
The dual efforts, each centered around highly similar mRNA vaccines, have been in a two-headed race to the finish since late July, when both began the country’s first Phase III trials on the same day.
Bourla had repeatedly said Pfizer would have data on the vaccine’s efficacy in October. But after the FDA increased the safety requirements for authorization in their official guidance, amid controversy over whether President Trump could ramrod a vaccine before Election Day and as outside scientists pushed back on the low number of cases they required before a readout, Bourla said the company would likely have data in early November and submit for an EUA in November.
The company is now on track to match that schedule. In conversations Tuesday, Bourla said they listened to scientific pushback on their initial readout protocol, but he rejected the idea that politics had anything to do with the timing of the announcement. Trump has accused the company of delaying it until after the election.
“The election for us was always an artificial line,” he said. “It may have been important for the president, but it wasn’t for us.”
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