At long last, Novavax has secured a full FDA approval for its protein-based COVID-19 vaccine, though not in the broad population the company had originally sought.
The FDA has approved Novavax’s shot, known commercially as Nuvaxovid, in adults ages 65 years and older and in people between the ages of 12 and 64 who have at least one underlying health condition that puts them at high risk for severe COVID outcomes.
The vaccine has been available under emergency use authorization in the U.S. since July 2022.
Novavax has long pitched its shot as an alternative to the mRNA COVID vaccines on offer from Moderna and partners Pfizer and BioNTech. While those mRNA vaccines don’t carry the same population restrictions as Novavax’s prophylactic, the company remains confident Nuvaxovid still has a role to fill in the endemic market.
"Market research and U.S. CDC statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally,” John Jacobs, Novavax’s CEO, said in a statement. “This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option."
It’s been a long, strange journey to approval for Novavax, which expected its shot to receive the all-clear from the FDA in early April. After the regulator’s approval decision target date came and went, Novavax confirmed that it was still waiting on word from the agency but felt its application was ready to be greenlit.
Reports at the time suggested political appointees at the FDA intervened in the decision, despite institutional staff feeling that Nuvaxovid was ready for approval.
The FDA ultimately asked Novavax to make a post-marketing commitment to generate additional data on the vaccine in the event of a thumbs up, the company said in late April.
Novavax shed more light on those post-marketing requirements in a Monday press release, noting that the FDA wants it to conduct a phase 4, placebo-controlled efficacy and safety study in people between the ages of 50 to 64 without high-risk conditions for severe COVID-19. Novavax says it is already working with its commercial partner Sanofi to assess funding and execution of the trial.
Novavax is also on the hook to perform additional trials assessing Nuvaxovid’s effect on occurrences of myocarditis and pericarditis—or inflammation of the heart muscle and the thin tissue surrounding the heart, respectively—following vaccination, according to an approval letter from the FDA.
Though perhaps not with the label it had hoped for, the Nuvaxovid approval is no doubt a win for Novavax. Meanwhile, the U.S. nod has triggered a $175 million milestone payout from Sanofi, which made a $1.2 billion bet—including $500 million upfront—on Novavax’s vaccine platform last May.
Under the deal, Sanofi will kick off marketing duties for the shot later this year, with Novavax to receive ongoing royalties from sales of the vaccine.
Novavax figures it will be ready to deliver commercial Nuvaxovid doses this fall, though the company is still waiting on an FDA advisory meeting later this week, during which outside experts will pinpoint the SARS-COV-2 strain to target for the upcoming season.
The green light also comes just in time for Nuvaxovid to be considered for recommendation at a meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP) next month. That said, a delayed gathering of the advisory committee in April suggested changes could be coming to the immunization framework for both COVID and human papillomavirus (HPV) shots in the U.S.
With regards to COVID vaccines, ACIP looks poised to recommend a risk-based approach over previous universal booster recommendations, analysts from Leerink Partners and Citi wrote in notes to clients last month.