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Moderna To Not Seek FDA COVID-19 Vaccine Approval Until After US Election

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Moderna To Not Seek FDA COVID-19 Vaccine Approval Until After US Election

Moderna Inc (NASDAQ: MRNA) CEO Stéphane Bancel scuttled hopes that a COVID-19 vaccine from the drugmaker would be available before the presidential election takes place in the United States in an interview with the Financial Times published Wednesday.

What Happened: Bancel told FT that the Massachusetts-based company would not be in a position to seek emergency use authorization for the jab from the Food and Drug Administration before the end of November.

“November 25 is the time we will have enough safety data to be able to put into a EUA file that we would send to the FDA — assuming that the safety data is good, [i.e.,] a vaccine is deemed to be safe.

The Moderna CEO also revealed that full approval would be sought at the earliest in January, and is unlikely to be granted before March.

“I think a late [first quarter], early [second quarter] approval, is a reasonable timeline, based on what we know from our vaccine,” Bancel told the FT.

Moderna is midway through its late-stage trial and has injected 15,000 volunteers with the vaccine as of Friday, out of the total 30,000 participants, according to Bancel.

Why It Matters: Bancel said that rival Pfizer Inc (NYSE: PFE) was on a faster track because of a shorter interval between its two doses and due to the design of its trial, as per FT.

President Donald Trump indicated during the debate Tuesday that he had spoken to Pfizer and other companies, including Moderna, about the progress of the vaccine.

Trump suggested it could be possible to have a COVID-19 vaccine approved before Nov. 1. 

The Centers for Disease Control and Prevention instructed states last month to prepare to distribute two vaccines to high-risk groups and health care workers — these vaccines were thought to be the candidates of Moderna and Pfizer, as per the New York Times.

Price Action: Moderna shares closed nearly 0.3% higher at $70.75 on Wednesday and gained another 0.35% in the after-hours session. 

 

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Posted-In: 2020 Presidential ElectionsBiotech News Health Care Politics FDA Media General Best of Benzinga

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