It's official: Pfizer and BioNTech have submitted their Covid-19 vaccine to the FDA — and the agency circled a date for the adcomm
Pfizer and BioNTech’s request for emergency authorization of its Covid-19 vaccine is now in the FDA’s hands. Regulators caught the application Friday afternoon in an open field dash to the goal line.
The agency immediately marked Dec 10 on the calendar for an advisory committee meeting to discuss the request. Pfizer and BioNTech first announced the submission was coming on Friday morning, and Pfizer CEO Albert Bourla confirmed the filing in a video statement later that afternoon. The “historic day,” as Bourla called it, came just 248 days after the pharma first announced plans to develop the candidate with BioNTech — a process which typically takes years.
Now it’s up to regulators, who will examine the mass of data that the companies have generated since winter and solicit recommendations from outside advisors before making a decision. Peter Marks, head of the agency’s vaccine and biologics division, told Business Insider this week that the EUA process will likely take “weeks.”
“The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and stands ready to do so as soon as an EUA request is submitted,” FDA commissioner Stephen Hahn said in a statement, adding that he can’t predict how long the review will take. Hahn, who was accused of bending to President Donald Trump’s political agenda after making misstatements about the benefits of convalescent plasma, promised the FDA would review vaccines in a “thorough and science-based manner.”
In addition to the FDA submission, Bourla said Pfizer and BioNTech have initiated rolling submissions in Australia, Canada, Europe, Japan and the UK, and plan to submit “immediately” to other regulatory authorities around the world.
Moderna isn’t far behind. The Massachusetts-based biotech read out interim results earlier this week, and is expected to announce final Phase III results and head to the FDA soon. Both Moderna CEO Stéphane Bancel and Operation Warp Speed scientific chief Moncef Slaoui have said the FDA may convene advisory hearings to review both Pfizer and Moderna’s vaccine at once. Reviewers were reportedly told to pencil in vaccine hearings from Dec. 8 through Dec. 10., when the agency is scheduled to discuss Pfizer and BioNTech’s candidate.
So how do the candidates stack up? Pfizer and BioNTech say their candidate is 95% effective at preventing symptomatic Covid-19, according to final results. Out of 10 severe cases, 9 were in the placebo group and 1 was in the vaccine group, according to the companies. Meanwhile, Moderna says its candidate appeared to be 94.5% effective, based on an interim look. Of 11 severe cases, all were in the placebo group, they said. Side effects for both were minimal and moderate, the most common ones being muscle ache, headache, and fatigue.
“Today, we were able to submit a very robust data set that we believe meets and, in many cases, exceeds the FDA’s high standards,” Bourla said.
The CEO said Pfizer and BioNTech are prepping to begin shipping the vaccine “immediately” after they get the FDA green light. This week, Pfizer launched a pilot delivery program in Rhode Island, Texas, New Mexico and Tennessee to test the waters, although those states won’t get doses any earlier than other states or have special consideration, the pharma said. Delivery of the vaccine poses a major challenge, as doses must be shipped in -70 degrees Celsius (-94 degrees Fahrenheit) temperatures — colder than Antarctica — to remain stable.
On Friday, Bourla said the companies expect to pump out 50 million doses globally in 2020, and 1.3 billion by the end of 2021.
“I want to thank everyone. Everyone who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world, who have been working day and night to help ensure that science will win,” Bourla said in the video.
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