The FDA is asking Novavax for a non-mandatory postmarketing commitment to produce additional clinical data for its investigational COVID-19 vaccine.
Novavax believes the application for its COVID-19 vaccine is “approvable,” the company announced on Wednesday, citing “conversations” it’s had with the FDA over the last few weeks.
In its press announcement, Novavax revealed that the FDA has issued a formal request, asking the company for a so-called postmarketing commitment to generate “additional clinical data” for the COVID-19 shot. BioSpace has reached out to Novavax and will update this story accordingly.
Novavax’s shares surged nearly 20% on Wednesday following the news.
Unlike postmarketing requirements, which companies must comply with after a product approval, postmarketing commitments are not required by any statute or regulation. Companies instead have to agree to run these post-approval studies and trials to collect further information on their product and provide better clarity on its safety and efficacy.
Novavax will work to address the FDA’s request “expeditiously” and push the vaccine candidate to approval “as soon as possible,” according to its press release.
Wednesday’s announcement comes after Novavax earlier this month confirmed that the FDA had missed its deadline for releasing a verdict on the investigational COVID-19 shot. At the time, Politico reported that the agency’s principal deputy commissioner Sara Brenner directly intervened in the review, though the regulator did not provide a justification for her actions.
“We had responded to all of the FDA’s information requests,” Novavax said at the time. “We continue to wait on action from the agency and have not yet received an official decision from the U.S. FDA.”
Though the U.S. has declared that the pandemic’s public health emergency over, COVID-19 has been making headlines again, driven in large part by recent policy changes under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr. On Tuesday, for instance, Politico reported that Kennedy was thinking about removing COVID-19 from the government’s immunization guidelines for kids. This move would align with recommendations from the CDC’s Advisory Committee on Immunization Practices, which met last week.
The HHS, under Kennedy, has also pulled funding for at least two COVID-19 vaccines in development. In February, the Department issued a stop order for a multibillion-dollar contract with Vaxart for an oral COVID-19 vaccine. The suspension, which will last for 90 days, will give government reviewers time to assess Vaxart’s data. Earlier this month, the government similarly froze funding for GeoVax’s work on a COVID-19 vaccine.
On a broader scale, Kennedy is also considering sweeping changes to how the U.S. monitors side effects associated with vaccines. In an event earlier this month, he blasted the current practice, saying that “it’s outrageous that we don’t have a surveillance system that functions,” referring to the Vaccine Adverse Events Reporting System, which has been running since 1990. Kennedy’s planned changes could include “automated adverse event reporting.”
