Pfizer and BioTech To Submit Emergency Use Authorization to FDA for Covid-19 Vaccine

The two biotech giants will look to start injecting high-risk individuals next month.
Anthony RussoNov 20,2020,19:37

The team of Pfizer (NYSE: PFE) and BioTech announced Friday that it will submit a request to U.S. regulators for emergency use authorization for their Covid-19 vaccine candidate.

The biotech giants plan on submitting the request to the U.S. Food and Drug Administration within days. Both also said that they have "initiated rolling submissions" with medical regulators in the U.K and Europe and that they plan on submitting requests to other global agencies by next week.

Officials from the FDA have noted that a review of vaccine submissions against Covid-19 could take weeks. But if all goes well, Pfizer and BioTech could start injecting high-risk individuals in December.

Not too far behind Pfizer and BioTech is fellow mRNA vaccine developer Moderna, (Nasdaq: MRNA) whose vaccine, based on interim data, was showed to be more than 94% effective in its first interim analysis earlier this week. Just days ago, Pfizer and BioNTech said its vaccine was as similar as effective in its final analysis.

Assuming the mRNA vaccine developers are able to pass the FDA hurdle, they could face some challenges with temperature storage. The good news for Moderna is its vaccine just needs to be kept at negative 20 degrees Celsius; while it's still cold most doctors’ offices and pharmacies have freezers that support temperatures that low.

Meanwhile, the Pfizer / BioTech vaccine needs to be kept at minus 75 degrees Celsius, which is not a temperature that freezers of most pharmacies and doctors’ offices currently support.

Intraday, shares of Pfizer, BioTech, and Moderna were trading up 2%, 8%, and 5% respectively from Thursday’s close.

Topics:Pfizer, BioTech, Moderna.