NVAX by Novavax,
+0,91%
The COVID-19 vaccine candidate played a leading role in this week’s debate regarding how best to update COVID-19 boosters to better protect once morest omicron.
The problem? The company’s major shooting series are still under review by US regulators.
Novavax’s COVID-19 recombinant protein vaccine candidate was considered a possible alternative for people who are hesitant to be immunized with the new mRNA technology used in Moderna MRNA and BioNTech BNTX/Pfizer PFE vaccines.
It’s been three weeks since the Food and Drug Administration’s advisory committee recommended clearance, which is the final step before the FDA makes its decision. Although JPMorgan analysts predict that the FDA’s decision on Novavax’s vaccine will arrive in mid-July, the lag between the committee’s recommendation and the FDA’s final decision is a departure from how quickly the regulator has previously granted authorizations to other COVID-19 vaccines.
“We haven’t given emergency clearance yet,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said Tuesday, “but I think it’s up to us to figure out when the [Novavax] the vaccine might be available if the company is willing to discuss it — should an emergency use authorization be granted.
Marks is part of a group of federal health officials and independent vaccine experts who met on Tuesday to discuss whether and how to update COVID-19 boosters for the fall in order to better fight omicron or other potential variants.
Moderna and Pfizer executives presented, in addition to Dr. Gregory Glenn, president of R&D for Novavax, who told the committee that the company’s primary injections still under investigation appear to retain their protective durability following six months and resist the troublesome and more transmissible sub-variants of omicron.
“Boosting with the prototype Novavax vaccine may be an option, as it provides both high levels of variant-recognizing antibodies and long-lasting immune responses,” he said.
In response to Marks’ question, Glenn added that the company plans to prepare doses for its first round of vaccines to distribute in July, and Novavax might update its vaccine by the last three months of the year to focus on BA.4, which was responsible for 15% of new cases in the United States last week. (That’s in comparison to just 6% of cases in the first week of June.)
With Novavax’s authorization still pending, two temporary voting members of the Vaccines and Related Biologicals Advisory Committee raised questions regarding the status of Novavax’s application for the first round of vaccines in a discussion intended to focus on a new generation of COVID-19 reminders.
“The most compelling thing I’ve seen today is data from Novavax, showing that their protein vaccine can elicit neutralizing antibodies once morest the prototype strain, once morest BA.1, BA.2 and BA.5” , said Dr. James. Hildreth, President and CEO of Meharry Medical College. “Their data seems more impressive to me than the data presented by Pfizer or Moderna. I’m just wondering whether or not it would be appropriate for the agency to quickly review the data and make the decision to approve the Novavax vaccine.
Dr. Wayne Marasco, professor of cancer immunology and virology at the Dana-Farber Cancer Institute, posed a similar question to regulators.
“We heard Novavax regarding the possibility of their vaccine getting coverage, but they didn’t get an EUA,” he said. “Is that going to be in the formula for the fall too? That this vaccine will be available? Or is it beyond what the committee should be discussing? »
Novavax’s stock has fallen since its all-time high of $319.93 on Feb. 8. It has fallen 63.7% so far this year, while the broader S&P 500 SPX,
-0,22%
is down 19.8%.
