Novavax Covid Vaccine Approved After Trial Agreement
FDA has given a Novavax BLA traditional approval of Nuvaxovid for active immunization to prevent Covid-19 after the company agreed to an agency-requested postmarketing commitment (PMC) to conduct a Phase 4 placebo-controlled trial in individuals aged 50 through 64 without high-risk conditions for severe Covid-19. The PMC “supplements previously agreed upon postmarketing requirements and commitments which have been commonly required for Covid-19 vaccine manufacturers,” the company says.
The approval, which supersedes a previous emergency use authorization under which the vaccine was previously marketed, is now more limited for its intended patient population. Previously, the vaccine was authorized for those 12 years and older. Now, it is indicated in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from Covid-19 (e.g. asthma, cancer, diabetes, obesity, smoking), the company says. The vaccine will be available in the fall.
The agency missed a user fee target date last month, which the company said was related to a post-approval commitment for clinical trial data (see earlier story). Some FDA watchers were concerned that the data may be required before the vaccine could be approved, which would have likely delayed its availability this fall, and such a requirement could extend to the mRNA vaccines, too.
Asked about the approval delay earlier this month, FDA commissioner Marty Makary said: “We’d like to see some clinical trial data, either before or after, and so we are in discussions, and we’re going to see a mutually satisfactory middle ground.” He said “Americans want to know if they should take a Covid booster. They want to know when they have a comorbid condition, if they should take it. They want to know if their 12-year-old healthy girl should be getting a sixth Covid jab this fall… We have a void of science. It’s been about four years since we’ve had a randomized control trial. So the companies have been creating new vaccines each year and getting a rubber stamp from the FDA.”
Asked whether FDA and the Trump administration still believe in the efficacy of the Covid-19 vaccines, Makary responded: “Show me the data where a young, healthy teenager should be taking a Covid shot right now.” Without the data, opinions have filled that void, Makary said, adding that the administration is committed to gold standard science and common sense.