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Moderna Coronavirus Vaccine Wins FDA Advisory Panel OK

The move paves the way for final FDA approval for emergency use as the second vaccine available to combat Covid-19 in the U.S.
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Moderna’s  (MRNA) - Get Moderna, Inc. Report coronavirus vaccine candidate won approval from an FDA advisory committee late Thursday, paving the way for the second vaccine candidate to combat the Covid-19 pandemic to win full FDA approval.

The committee voted 20-0 with one abstention to recommend that the FDA grant Moderna’s emergency use authorization.

Last week, Pfizer  (PFE) - Get Pfizer Inc. Report and BioNTech  (BNTX) - Get BioNTech SE Report won emergency use authorization from the FDA for their vaccine candidate. Vaccinations using the Pfizer/BioNTech product began this week for health workers and older people in senior facilities.

Moderna, which has seen its stock rise close to 700% this year, used its novel approach to vaccine development to rapidly develop and test a candidate in mere months, compared with a more standard multi-year process.

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The Cambridge, Mass.-based company develops vaccines and other treatments through the use of messenger RNA. In the case of the vaccines, the substance is used to induce an anti-body response in healthy people that will fight off infection by disease.

The approach has a couple of key benefits since it in effect spurs the body to manufacture its own defenses against a disease, allowing for much faster development of vaccine candidates.

The coronavirus vaccine is the first Moderna product to advance through late-stage trials for consideration by the FDA, albeit as an emergency use approval.

Pfizer and BioNTech's vaccine candidate also uses mRNA technology, and was approved for emergency use by the FDA last week.  

Shares of Moderna fell $4.30, or 3.1%, to $139.70 in after-hours trading Thursday. In the regular session the stock rose 5%.