FDA Advisory Committee Recommends Novavax Vaccine for Adults

Posted on

This week the Food & Drug Administration’s vaccine advisory committee voted in favor of Novavax’s (NVAX) COVID-19 vaccine for use in adults.

This move pushes the company forward to getting its first product authorized in the United States.

Before any data was even presented, the committee members had expressed concerns over the need to authorize yet another COVID-19 vaccine.
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.

According to Marks, 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, supporting Novavax’s application.
The 21-0 vote with one abstention marks a win for the Maryland biotech company who is offering an alternative first-line defense for people who’ve refused mRNA shots.

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.”

An FDA staff review found the company’s shot to be 90% effective at preventing new cases in a clinical trial however it carried the possible risk of causing heart inflammation, particularly in young males.

Disclaimer: We have no position in any of the companies mentioned and have not been compensated for this article.

Daily updates