By Michael Erman
(Reuters) -The U.S. Food and Drug Administration approved Novavax (NASDAQ:NVAX)’s COVID-19 vaccine, but limited its use to older adults and people over the age of 12 with conditions that put them at risk due to the illness.
The vaccine’s prospects were thrown into doubt after the FDA missed its April 1 target to approve the shot, which is a more traditional protein-based vaccine unlike its messenger RNA-based rivals. U.S. Health and Human Services Secretary Robert F. Kennedy Jr., a long-time vaccine skeptic, also raised concerns about the efficacy of the shot in a CBS interview.
Novavax Chief Corporate Affairs and Advocacy Officer Silvia Taylor said in an interview that the company had been notified of its approval late on Friday night after substantial back-and-forth with regulators.
She said the company was not concerned about the limited approval, because the population was in line with those who generally seek out the shots.
"I think there’s a growing consensus that you don’t need a universal recommendation anymore, and the U.S. is an outlier in terms of having that," Taylor said.
She noted that the outside expert panel that advises the CDC on vaccines has discussed tightening the recommended population of who should receive annual shots.
"It’s just presaging where this is probably going from a policy standpoint," Taylor said.
The company, along with competitors Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE), will also need to file for an additional approval if it needs to change the strain of the virus its vaccine targets for the upcoming COVID-19 immunization season.
That change will be discussed at a meeting of FDA vaccine advisers later this week.
The approval restricts the use of the vaccine, sold under the brand name Nuvaxovid, to individuals aged 65 and older, and those between 12 and 64 who have at least one underlying condition that increases their risk of developing severe illness from COVID.
According to the U.S. Centers for Disease Control and Prevention, a wide list of conditions constitutes an additional risk, ranging from various illnesses, such as diabetes and heart disease, to behaviors like physical inactivity and substance abuse.
Novavax CEO John Jacobs said in a statement that the approval was a "significant milestone" that solidifies a path for people to access the vaccine. The company missed out on the pandemic vaccine windfall due to manufacturing issues and regulatory hurdles.
Former FDA Chief Scientist Jesse Goodman said the agency appears to have overstepped by limiting its approval for Novavax, depriving some people of an opportunity to make a choice about what vaccine they wish to receive.
"The FDA approval process is intended to assess safety and efficacy, and allow access to approved vaccines. It is not the place to make policy recommendations for how to use approved vaccines," Goodman said.