Novavax, Inc.

The meeting will now include voting decisions on infant and maternal respiratory syncytial virus prophylactics, plus influenza vaccines, as well as non-voting discussions on COVID, chikungunya, anthrax and measles, mumps, varicella and Rubella vaccines. In the wake of Robert F. Kennedy Jr.’s abrupt revamp of the CDC’s Advisory Committee on Immunization Practices, details from the panel’s planned meeting next week are confirming many industry watcher’s concerns about potential vaccine meddling by the Trump administration.Kennedy appears to be sending the overhauled panel—which now boasts many personal appointees—after a common vaccine ingredient that has been erroneously linked to safety concerns and conditions like autism, several analysts and publications have warned.A new draft agenda (PDF) for the ACIP meeting slated for June 25-26 reveals that the committee is skipping over several highly anticipated vaccine votes and regurgitating discussions on what some experts have referred to as “settled science” around immunization safety, Bloomberg reported late Wednesday.The meeting will now include voting decisions on infant and maternal respiratory syncytial virus (RSV) prophylactics, plus influenza vaccines, as well as non-voting discussions on COVID, chikungunya, anthrax and measles, mumps, varicella and Rubella (MMRV) vaccines.The panel will defer votes planned for COVID vaccine recommendations, adult protection against RSV and vaccination dose schedule reduction for human papillomavirus (HPV) shots, analysts at Leerink Partners highlighted in a Wednesday note to clients.The updated agenda “extends uncertainty on the more controversial vaccine recommendation votes,” analysts at Leerink Partners wrote in a note to clients this week, referring to vaccines that have had their votes delayed from the likes of BioNTech, Merck & Co., Pfizer, Sanofi, Novavax and Moderna. In another unsettling development, the panel’s vote on flu vaccines will zero in on shots containing thimerosal, in a move that would likely take a toll on multidose immunizations from Sanofi and CSL Seqirus, the Leerink team pointed out.Thimerosal—a mercury-containing preservative used in certain adult flu vaccines—has been incorrectly linked to the development of autism in the past. The ingredient was removed from most childhood vaccines in the early 2000s and has never actually been found to be unsafe, Bloomberg explained in its report.Kennedy, who now heads up the Department of Health and Human Services (HHS), is a noted vaccine skeptic who has previously linked childhood immunizations to the development of autism spectrum disorder (ASD).Back in April, Kennedy set the goal to root out the cause of the United State’s “autism epidemic” by September as part of a sweeping research push under the HHS. He also singled out thimerosal in a 2014 book calling for the ingredient’s immediate removal from vaccines, Bloomberg noted.In turn, the talks around thimerosal at next week’s meeting “could give early insight into the new ACIP’s perspective on autism and vaccination,” the Leerink analysts wrote.Though not on the docket for next week’s discussions and votes, Kennedy is reportedly eyeing the use of aluminum ingredients in vaccines, too, Bloomberg reported, citing a person close to the matter.Aluminum is commonly used as an adjuvant—or an ingredient meant to boost the body’s immune response—in vaccines and can be found in at least two dozen shots from drugmakers like GSK, Merck, Pfizer and Sanofi, Bloomberg noted.Analysts at Mizuho Securities agreed with the publication’s skepticism, highlighting that aluminum adjuvants have been a popular vaccine component since roughly 1930 and are included in multiple vaccines recommended by the Centers for Disease Control and Prevention (CDC) for kids and babies.“We see the preponderance of evidence as supporting the use of aluminum adjuvants in vaccines, and believe that review, if done, of licensed vaccines containing aluminum adjuvant will prove this out,” the Mizuho team wrote.Potentially meddling with common ingredients like aluminum and thimerosal not only resurfaces settled debates over vaccine safety but also runs the risk of presenting logistical challenges for flu shot makers who must work fast to get their updated products out in time for each immunization season.“If the committee votes to remove thimerosal from vaccines, manufacturers will have to create and ship single doses, which some manufacturers may not be able to do,” Tina Tan, president of the Infectious Disease Society of America, told Bloomberg.An HHS representative did not provide a formal statement on the agenda changes when reached by Fierce Pharma for comment.Details of the meeting shift come amid a whirlwind two weeks for vaccines makers and the future of immunization policy in the U.S.Last Monday, Kennedy rattled the biopharma industry by abruptly sacking all 17 sitting members of ACIP in a bid to help restore “public trust” in the committee beyond “any specific pro- or anti-vaccine agenda.” In rationalizing the seismic move, Kennedy asserted that public trust in federal health agencies had been greatly eroded. The HHS chief also suggested that ACIP has suffered from chronic conflict-of-interest issues. Earlier this week, the 17 fired ACIP panelists struck back against Kennedy, warning in a JAMA editorial that the HHS’ chief’s “destabilizing decisions” could “roll back the achievements of U.S. immunization policy, impact people’s access to lifesaving vaccines, and ultimately put U.S. families at risk of dangerous and preventable illness.”Since cleaning house at ACIP, Kennedy has appointed several new members to the panel, including individuals with ties to vaccine litigation and the spread of mRNA misinformation.The CDC has been working to catch the new panelists up ahead of next week’s meeting, which has been abbreviated to account for their very recent selection, STAT News reported earlier this week, citing comments made at a CDC all-staff meeting on Tuesday.  

Cade Martin 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?”

June 11, 2025: Novavax’s experimental COVID-19-influenza combination vaccine and standalone flu vaccine demonstrated a strong immune response in adults aged 65 and older, according to a late-stage trial involving 2,000 participants. The Maryland-based biotech confirmed that both vaccines were well-tolerated with no new safety concerns. The combination vaccine was tested against Nuvaxovid, Novavax’s COVID-19 shot, and Fluzone HD, Sanofi’s flu vaccine. Although the study was not designed to yield statistically significant results, the data will support a future late-stage trial aimed at securing regulatory approval. Novavax, which is focusing on commercial partnerships, continues to seek collaborators for advancing its vaccine candidates. Last year, it signed a $1.2 billion licensing deal with Sanofi to further develop Nuvaxovid, which recently received FDA approval for use in older adults and at-risk individuals over 12. The protein-based vaccine offers an alternative to mRNA-based options, such as those from Pfizer and Moderna, strengthening Novavax’s foothold in the vaccine market.