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Pfizer and BioNTech's Coronavirus Vaccine Ready for Regulatory Submission in December, Maybe Earlier

By Brian Orelli, PhD – Jul 10, 2020 at 2:34PM

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The companies' CEOs give different timelines on a potential submission.

BioNTech (BNTX -0.28%) and Pfizer (PFE -0.77%) are right on the heels of Moderna (MRNA -0.04%) in the race to potentially develop a messenger RNA (mRNA) vaccine against SARS-CoV-2, the novel coronavirus that causes COVID-19.

In an interview with The Wall Street Journal, BioNTech CEO Ugur Sahin predicted the companies will have enough data for a vaccine to be ready for approval by December. The companies are still trying to figure out which of multiple vaccine candidates should be taken into a 30,000-patient phase 2/3 clinical trial that is scheduled to start this month. The timeline is pretty close to Moderna's, which has indicated it expects data by Thanksgiving from a yet-to-be-started, 30,000-patient phase 3 clinical trial.

Pfizer's CEO, Albert Bourla, has an even more bullish timeline for the duo's vaccine candidate. In an interview with Time, Bourla said, "We should be able in the September time frame to have enough data to say if the vaccine works or not. And to submit that to the FDA. So for a potential approval in October, if we are lucky."

A syringe and a shoulder

Image source: Getty Images.

Both articles described a potential approval, but it's likely the men were actually referring to an emergency use authorization (EUA) by the U.S. Food and Drug Administration, which is easier to obtain than a full approval but only lasts as long as the pandemic rages on.

Companies can likely obtain an EUA simply by showing their vaccines create antibodies toward the virus, but the FDA has indicated that a full approval will require data showing vaccines actually protect patients from developing COVID-19. That kind of data seems like a tall order to produce in two to four months, although if U.S. infection rates ratchet up higher, perhaps enough of the placebo-treated patients will get COVID-19 to show that the companies can demonstrate differences in infection rates.

Brian Orelli, PhD and The Motley Fool have no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

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Stocks Mentioned

Pfizer Stock Quote
Pfizer
PFE
$44.12 (-0.77%) $0.34
BioNTech SE Stock Quote
BioNTech SE
BNTX
$137.19 (-0.28%) $0.38
Moderna Inc. Stock Quote
Moderna Inc.
MRNA
$125.62 (-0.04%) $0.05

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