FDA poised to approve Moderna’s COVID-19 Vaccine

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The first COVID-19 vaccine from Pfizer (NYSE: PFE) was approved last week by the U.S. Food and Drug Administration (FDA). Quick on its heels is a second vaccine, this one from Moderna (NASDAQ: MRNA), which is potentially just hours away from receiving likely approval from the agency. As it turns out, the advisory committee in charge of reviewing the vaccine and providing a final recommendation voted in favor of Moderna’s new coronavirus treatment.

The FDA advisory committee, an independent of medical experts called by the FDA occasionally called to review controversial drug candidates, ruled unanimously in a 20-0 vote in favor of approving the vaccine. That’s better than the Pfizer vaccine, where an earlier advisory committee still had some experts vote against approving the treatment.

The evidence for the vaccine highly outweighs any issues that we have seen,” said panel member Hayley Gans, a Stanford University professor. “We’re talking about a pandemic where we really need to move this forward, and there’s really an effort to get this done quickly. There’s no doubt in my mind that it looks like the benefits outweigh the risks,” added another member, Dr. Steven Pergam.

While it’s not that surprising, especially since the past clinical results have been overwhelmingly positive, it’s still a reassuring sign for investors. Moderna and Pfizer are the two leading companies when it comes to the COVID-19 vaccine race, but there are some key differences between the two. Among others, Moderna’s vaccine doesn’t need to be stored in cold temperatures, something that Pfizer’s treatment does need.

Shares of Moderna were up around 5.1% in response to the news, with the biotech’s stock likely to jump even more once the FDA approves this vaccine. Since the start of the year, Moderna has shot up by over 700% due to the excitement surrounding its long-awaited vaccine. Unlike most other vaccine developers, which use RNA-based technologies, Moderna is the only biotech that uses new mRNA-technology. This new type of mechanism is expected to be even more effective, at least according to what current studies have shown so far.

The U.S. government, which worked closely alongside Moderna in developing this vaccine, said that they would be distributing around six million doses to around 3,200 federal locations in the first batch. Production is expected to begin within 24 hours after approval.

Taking into consideration just how quickly the FDA approved Pfizer’s vaccine following the advisory committee’s recommendation, most investors are expecting the FDA to do the same tomorrow. If not on Friday, then a weekend announcement is the next most likely possibility. Although most traders are already expecting this to happen, it wouldn’t be surprising if shares jump even more once the news is officially announced.

 

Moderna Company Profile

Moderna Inc is engaged in creating transformative medicines based on messenger RNA, or mRNA. It transfers the information stored in the genes to the cellular machinery that makes all the proteins required for life. The firm is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, autoimmune and cardiovascular diseases. Its clinical trials include mRNA-1647, mRNA-1893, mRNA-4157, and mRNA-2416 among others. – Warrior Trading News

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