FDA advisory committee recommends Novavax vaccine for use in adults

 The FDA's vaccine advisory committee voted in favor of Novavax's (NVAX) COVID-19 vaccine for use in adults, paving the way for the company to get its first product authorized in the U.S.

But the day-long meeting raised a number of concerns presented by Novavax's late entry to the vaccine field.

Before any data was even presented, questions were raised by committee members about the need to authorize yet another COVID-19 vaccine, as demand has waned in the U.S., and about the manufacturing struggles Novavax — which relied on contract manufacturers— faced from the start.

FDA's Dr. Peter Marks noted that even with three other vaccines available, and with 89% of adults receiving at least one dose, there remained some unmet need. In particular, Marks noted, there are those who are not comfortable with mRNA vaccines, and the Johnson & Johnson (JNJ) vaccine has faced some concerns over associated risks of blood clots.

"Anything we can do to make people more comfortable ... is something we feel we are compelled to do," Marks said in support of weighing Novavax's application.

But some panelists questioned whether or not a primary course application was useful rather than using the vaccine as a booster.

Novavax chief medical officer Dr. Filip Dubovsky noted, "One in 10 Americans has yet to be vaccinated, and we haven't given up on them."

Novavax also faced concerns over reports of heart inflammation, or myocarditis, that had also been linked to mRNA vaccines like Pfizer (PFE)/ BioNTech (BNTX) and Moderna (MRNA).

Experts noted that the link to myocarditis only occurred after the real-world data for the mRNA vaccines came in, so there was no indication of the risk at the time. In addition, the Novavax vaccine is being reviewed after a year of such data, which means there was already reason to look for it and find it when it does occur.

But Dr. Paul Offit, a vaccine expert and director of the Vaccine Education Center at the Children's Hospital of Pennsylvania, said the reason behind the heart inflammations is necessary to understand.

https://finance.yahoo.com/news/fda-advisory-committee-recommends-novavax-vaccine-for-use-in-adults-194314939.html