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FDA Committee Recommends Approval of Pfizer/BioNTech Vaccine

Full FDA now to consider emergency use authorization for first U.S. vaccine candidate against Covid-19.
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Pfizer  (PFE) - Get Pfizer Inc. Report and BioNTech  (BNTX) - Get BioNTech SE Report won approval Thursday from a Food and Drug Administration advisory committee for their vaccine candidate to combat Covid-19 after a day-long hearing online.

The committee’s recommendation to approve an emergency use authorization for the vaccine passed 17 to 4, with one abstention. It now goes to the full FDA for final consideration. The FDA typically follows the guidance of its advisory committees but doesn’t have to. Nevertheless, with the pandemic exploding out of control in most of the U.S., the agency is expected to act quickly to roll out the vaccine.

Some members of the committee objected to approving the vaccine for use in 16- and 17-year-olds because of relatively thin data on the age group. In the end, however, the committee approved a statement saying that the benefits of the vaccine outweigh its risks.

The vaccine was approved in the UK earlier this month and went into use this week. Initial responses have shown the vaccine does carry some side effects, including pain at the injection point, fatigue, and aches. In at least two cases, people with allergies had severe responses, according to published reports.

The FDA has already planned to recommend against using the vaccine on people at risk of a severe reaction, according to comments from an agency doctor during the hearing. 

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The FDA is expected to consider another vaccine candidate from Moderna  (MRNA) - Get Moderna, Inc. Report as early as next week. The Moderna candidate is similar to the Pfizer/BioNTech one as both use messenger RNA in the cell to stimulate an immune response to the coronavirus that causes Covid-19.

Johnson & Johnson  (JNJ) - Get Johnson & Johnson Report also has a vaccine candidate in late trials, as do several other pharmaceutical and biotech companies.

Initial supplies of the Pfizer/BioNTech vaccine may be limited to 50 million doses in the U.S. because most of its production was put under contract to other countries after the Trump administration declined to lock down a larger portion of the production last summer, according to a New York Times report. Production is expected to ramp quickly in 2021 with a billion or more doses likely to become available.

Other vaccine candidates in late stage trials include efforts from AstraZeneca  (AZN) - Get Astrazeneca PLC Sponsored ADR Report, Johnson & Johnson, and Novavax  (NVAX) - Get Novavax, Inc. Report.

Shares of Pfizer fell 5 cents, or 0.1%, to $41.80 in regular trade, but added 2.32% after hours. Shares of BioNTech  rose $6.73, or 5.5%, to $129.54 in during the regular session and jumped another 2% after hours.

Shares of Moderna fell 90 cents, or 0.6%, to end $155.69, and tacked on more than 1% in late trade.