The discussion this week about how to improve the COVID-19 boosters to better protect against omicron featured the prominent COVID-19 vaccine candidate from Novavax (NASDAQ:NVAX) US regulators are still reviewing the company’s main line of shots.
For those who are wary of receiving vaccinations using the more recent mRNA technology utilized in the Moderna MRNA and BioNTech BNTX/Pfizer PFE shots, Novavax’s recombinant protein COVID-19 vaccine candidate has been suggested as a potential substitute. The FDA advisory committee’s recommendation for permission, the last stage before the FDA makes its choice, was made three weeks ago. Although JPMorgan analysts anticipate the FDA will decide on Novavax’s vaccine by mid-July, the delay between the committee’s recommendation and the FDA’s ultimate decision is unusual given how swiftly the regulator has approved other COVID-19 vaccines.
Dr. Peter Marks, director of the FDA’s Centre for Biologics Evaluation and Research, stated on Tuesday that no emergency use authorization had yet been given. Nevertheless, he added that he thinks it behoves us to understand when the [Novavax] vaccine might be available if the company is willing to discuss that — were an emergency use authorization to be granted. Marks is among a group of government health officials and independent vaccination specialists who met on Tuesday to examine whether and how to upgrade the COVID-19 boosters for the fall to better combat omicron or other potential variations.
In a discussion intended to centre on a new generation of COVID-19 boosters, two temporary voting members of the Vaccines and Related Biological Products Advisory Committee questioned the status of Novavax’s application for the primary series of shots, despite the fact that the Novavax (NASDAQ:NVAX) authorization is still up in the air.
The evidence from Novavax demonstrating that their protein vaccine may elicit neutralizing antibodies to the prototype strain, to BA.1, BA.2, and BA.5, is the most compelling thing he has seen today, according to Dr. James Hildreth, president and CEO of Meharry Medical College. He said he found their data to be more amazing than the information provided by Pfizer or Moderna. He simply questions if it would be appropriate for the organization to swiftly assess the evidence and decide to approve the Novavax vaccination.
Since reaching an all-time high of $319.93 on February 8, 2021, the stock of Novavax has declined. It has lost 63.7 percent so far this year, compared to a 19.8 percent decline for the larger S&P 500 SPX, +0.16 percent.
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