Pfizer, BioNTech submit to FDA, say vaccine will be ready ‘within hours’ of authorization
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The first COVID-19 vaccine could be available for use in high-risk populations as early as mid-December after Pfizer and BioNTech announced plans to submit an emergency use authorization request to the FDA on Friday.
The companies said the two-dose vaccine will be ready for distribution “within hours” of an FDA authorization, with up to 50 million doses available globally by the end of the year, enough to vaccinate up to 25 million people. They said 1.3 billion doses could be available by the end of 2021.
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The FDA scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee for Dec. 10 to discuss the request for emergency authorization. Pfizer and BioNTech said they have initiated “rolling submissions” in other places, including Australia, Canada, Europe, Japan and the United Kingdom.
A final analysis of phase 3 results showed that the messenger RNA (mRNA)-based vaccine candidate, called BNT162b2, is 95% efficacious against COVID-19 beginning 28 days after the first of two doses, Pfizer and BioNTech announced this week.
The vaccine, which must be stored at nearly –100°F, will be moved in specially designed, temperature-controlled shippers equipped to maintain extremely cold temperatures, the companies said. Once delivered, they can be stored at normal refrigerated temperatures for up to 5 days.
Another mRNA-based COVID-19 vaccine candidate codeveloped by Moderna Inc. and the NIH was shown to be 94.5% efficacious, according to early data. That vaccine is able to be stored for 30 days at 36°F to 46°F, “the temperature of a standard home or medical refrigerator,” Moderna said.
An FDA authorization of a COVID-19 vaccine by mid- or even late December would be a record-setting feat for vaccine development. The vaccine programs were launched after China shared the genetic sequence of the SARS-CoV-2 virus on Jan. 12. The previous record for developing a vaccine was around 4 years for the mumps vaccine.
National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci, MD, has called the quick pace of COVID-19 vaccine development and the resulting data showing their effectiveness “extraordinary.” In comments during a White House Coronavirus Task Force briefing on Thursday, Fauci noted that 95% efficacy “is almost to the level of what we see with measles, which is 98% effective. So that’s what we’re dealing with.”
Fauci said he wanted to settle any concern that these vaccine programs moved too fast “to put to rest any concept that this was rushed in an inappropriate way.”
“Speed did not compromise at all safety, nor did it compromise scientific integrity,” Fauci said. “It was a reflection of the extraordinary scientific advances in these types of vaccines, which allowed us to do things in months that actually took years before.”
The United States has reported more than 252,000 deaths from the coronavirus and more than 11.7 million cases, including 1 million in just the last week. The latest surge in cases prompted the CDC to urge Americans not to travel for Thanksgiving.
Good news about vaccines is not a reason to relax other efforts against the coronavirus, Fauci said. Instead, he said the country needs to “double down” on public health measures to slow the spread of the virus.
“I’ve used that metaphor that ‘the cavalry is on the way,’” Fauci said during the task force briefing. “If you’re fighting a battle and the cavalry is on the way, you don’t stop shooting. You keep going until the cavalry gets here, and then you might even want to continue fighting.”
Editor’s note: This article was updated after the FDA announced a date for the advisory committee meeting.
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