FDA approves Novavax COVID vaccine with new conditions
The US Food and Drug Administration (FDA) approved Novavax’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.
US Health and Human Services Secretary Robert F. Kennedy Jr., who calls for safe and effective vaccines, 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.
She noted that the outside expert panel that advises the Centers for Disease Control and Prevention (CDC) on vaccines has discussed tightening the recommended population of who should receive annual shots.
The company, along with competitors Moderna and Pfizer, 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.
Target population
The approval restricts the use of the vaccine, sold under the brand name Nuvaxovid, to individuals age 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 US CDC, a wide list of conditions constitutes an additional risk.
