After the delayed approval of its next-generation COVID-19 vaccine, Novavax now awaits the first meeting of the recently overhauled CDC vaccine advisory committee next week. Throughout a tumultuous season, the Maryland-based company is relying on agility and a diverse pipeline to stay ahead of rapidly changing regulations.
Novavax has been a symbol of biopharma’s struggle to adjust to the onslaught of regulatory changes that have hit the vaccine space over the past four months.
Company executives said they are unsure whether their newly approved next-generation COVID-19 shot Nuvaxovid will be on the agenda when the CDC’s recently revamped Advisory Committee on Immunization Practices (ACIP) meets next week. However, “ACIP is so important in vaccines . . . so we’re watching that space,” Silvia Taylor, chief corporate affairs and advocacy officer, told BioSpace on the sidelines of BIO2025 in Boston.
According to a federal notice released June 12, recommendation votes are scheduled for COVID-19, human papillomavirus (HPV), influenza, meningococcal and respiratory syncytial virus (RSV) vaccines. On June 18, however, CDC published a draft agenda that does not list a vote on COVID-19 vaccines, for which Health Secretary Robert F. Kennedy Jr. himself already announced changes to the CDC’s recommendations.
As for the eight new ACIP members appointed by Kennedy to replace the 17 he summarily turfed on June 9, Taylor said “some of them are maybe questionable choices to us,” while others might have a “mixed history of being supportive of vaccines.”
Novavax won FDA approval on May 16 for an updated version of Nuvaxovid—for seniors aged 65 years and older and those 64 years and under with an underlying condition that puts them at greater risk of severe outcomes from the disease. These restrictions—in line with new risk-based guidance issued days later by the agency—separate Novavax from the original mRNA-based vaccines from larger peers Pfizer/BioNTech and Moderna that are not encumbered by these limitations. The May 31 approval of Moderna’s next-gen COVID vaccine mNEXSPIKE, however, did come with the same set of restrictions.
When asked for their reaction to the approval, Taylor and Novavax colleague Ruxandra Draghia-Akli, head of R&D, said it is in line with vaccine uptake across age groups. As of Nov. 4, 2023, only 14% of people 18 to 50 years of age received a COVID-19 vaccine, according to CDC data. “So probably those individuals that are getting vaccinated are exactly the population that has a risk factor,” Draghia-Akli said.
Taylor agreed, saying that the population was “already behaving even more restrictive, when you think about it, than some of the references.”
The executives again expressed optimism about Nuvaxovid’s chances for growth in the COVID market, particularly as commercialization efforts switch hands to Big Pharma partner Sanofi this year. “They’re a huge player in vaccines. They can do a better job, not only in the U.S., but around the world,” Taylor said.
This strategy is representative of the agility that is enabling Novavax to weather the rapidly changing regulations in the vaccines space. In May 2024, Novavax and Sanofi inked a co-exclusive licensing agreement to co-commercialize Nuvaxovid and develop novel COVID-19–influenza combination vaccines based on Novavax’s Matrix-M adjuvant. “We give them our technology, they take the lead,” Taylor said. This enables the company to branch out into other areas—both through licensing and alone—including in RSV, shingles and avian influenza (bird flu).
Moderna recently took a hit in the latter space when HHS on May 29 terminated a contract previously awarded for the development of an mRNA-based bird flu vaccine. Despite this, Novavax is hoping for support from the Biomedical Advanced Research and Development Authority (BARDA) for an experimental bird flu vaccine, which is ready to enter the clinic. “We know that BARDA is still committed to funding something for pandemic influenza,” which could include bird flu, Taylor said.
She pointed to the fact that Moderna’s vaccine is based on mRNA technology, which the current administration appears to be targeting. While Taylor wouldn’t conjecture as to this being a factor in HHS’ decision regarding Moderna, National Institutes of Health officials have reportedly advised scientists to remove mentions of mRNA vaccine technology from grant applications. “Given that we’re protein-based, our conversations with them continue,” Taylor said.
She and Draghia-Akli also offered their thoughts on an ambitious goal floated by FDA Commissioner Marty Makary at the Drug Information Association’s annual meeting in Washington this week: that a universal flu vaccine could be available in the next five years.
“There have been a lot of failures in this field,” Draghia-Akli said. “Maybe now, with all the AI, with machine learning, with the numerous platforms that have been tried and tested, can we get to something better? I think that five years is very optimistic, but who knows?”
