- Novavax (NVAX) is taking part in a meeting with the U.S. Food and Drug Administration (FDA) today.
- This concerns an Emergency Use Authorization (EUA) for its Covid-19 vaccine.
- The company is hoping that the FDA will approve its vaccine.
Novavax (NASDAQ:NVAX) stock is in the news today as investors prepare for results from the company’s meeting with the FDA.
Let’s go over everything investors in NVAX stock need to know about today’s meeting.
- This meeting will see the FDA reviewing Novavax’s EUA application for its Covid-19 vaccine.
- Novavax is seeking the EUA for the use of its vaccine in adults.
- Investors will want to keep an eye out for a few things during the meeting.
- Among these is the FDA’s response to a potential myocarditis issue with the vaccine.
- The vaccine’s trial results include a 0.007% incident of heart inflammation.
- This was pointed out by the FDA last week, sending shares of NVAX stock falling.
- Another sticking point to keep in mind is the vaccine’s chemistry, manufacturing and controls (CMC) preparation.
- This is another concern the FDA has highlighted about the NVX-CoV2373 vaccine.
- CMC is one of the main reasons the EUA meeting has been delayed for so long.
- Another detail to note is that Novavax’s vaccine is different from other Covid-19 shots.
- While the major focus has been on new mRNA vaccines, Novavax developed a more traditional vaccine.
- This means it uses the same technology used for Hepatitis B and influenza vaccines.
- Novavax could see interest in its vaccine from people that have been skeptical of mRNA alternatives.
- Either way, investors are hoping the FDA will approve the EUA, which could be a catalyst for NVAX stock.
NVAX stock is currently halted as of this writing.
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On the date of publication, William White did not hold (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.