Hepatitis B vaccine(GlaxoSmithKline Plc)

iStock, nito100 Buying vaccine biotech Dynavax was an easy choice for Sanofi despite antivaccine moves by the Trump administration. “It’s a good time to do vaccine BD and M&A,” according to Sanofi CEO Paul Hudson. While vaccine sentiment is suffering amid the Trump administration’s rhetoric, Hudson says he’s playing the long game with Sanofi’s acquisition of Dynavax . “With the uncertainty, if you’re a short-term thinker, you don’t move. If you’re a long-term thinker—which is what we have to be—then there are less people to compete against to make acquisitions,” Hudson told reporters at a media breakfast in San Francisco on day three of the J.P. Morgan Healthcare Conference. To end 2025, Sanofi offered $2.2 billion to buy Dynavax. The center of that deal is the hepatitis B vaccine Heplisav-B. That the vaccine is for adults could help Sanofi overcome some of the vaccine hesitancy that is rising, particularly in America, Hudson said. “We know that the sensitivities are less in the adult context.” And it was those sensitivities that set the stage for the French drugmaker to pay what Hudson called an “appropriate price” for Dynavax. Elsewhere on the company’s business development (BD) bingo card, he also pointed to Sanofi’s July 2025 acquisition of Vicebio for $1.6 billion, scooping up a combination vaccine for respiratory syncytial virus (RSV) and human metapneumovirus (hMPV). “Those things will launch 5, 6, 7, 8 years from now. And so we have to assume that there’ll be a new administration or two between now and then,” Hudson said. “We don’t know what their sensitivities will be, but it’s okay, as long as there’s some objectivity in the regulator.” Hudson hinted that there could be more deals to come in the vaccine space. Sanofi’s legacy vaccine sales fell 8% in the third quarter and Hudson is predicting similar “softness” in the quarters to come. Hudson reiterated that the sales decline can be pinned on the “misinformation that is going around.” He noted the rise in measles cases as people opt out of vaccines. “We think it will settle down and we’ll move through it,” Hudson said. Sanofi has not provided guidance for 2026 yet. Hudson also spoke to recent vaccine schedule updates and other antivaccine actions at the Department of Health and Human Services (HHS). The CEO suggested that people are capable of educating themselves when it comes to vaccines in partnership with their care providers. “The vast majority of people understand the benefit of vaccines and their lives and generations of their family have been protected that way,” Hudson said. “Not everybody looks to the top of the HHS to get people with their guidance on how to live their lives.” He continued: “So I think people should be respectful of all guidance given, but I think talking to their own healthcare professional is still probably the best thing to do.” Vaccines Pesky ‘Macro Factors’—aka RFK Jr.—Come for Vaccine Pharmas’ Wallets Following restricted vaccine approvals and changes to CDC immunization schedules, Merck, Pfizer, GSK and Sanofi are all suffering revenue hits to their vaccine programs. November 7, 2025 · 4 min read · Annalee Armstrong Read more The Next Moment Vicebio and Dynavax’s programs may be years out from FDA review, but Sanofi’s flu-COVID combo, licensed from Novavax, is not. Hudson expects regulatory review to happen in 2027 or 2028. That shot is “going to be the next moment, I think, for an acceleration on vaccine utilization,” Hudson said. The product will offer convenience with a one-and-done approach for both infectious diseases. And it will be the only non-mRNA COVID shot available in the U.S. for those who do not want to receive a shot featuring that technology. “We think people are still very vaccine literate. We think they understand the reactogenicity or the tolerability challenges of mRNA,” Hudson said. Those post-vaccine reactions may have been tolerated during the global pandemic, but that’s not the case anymore, the CEO explained. He expects Sanofi will garner the over-55 and over-65 markets, particularly as the combo can offer a high dose needed for older people, who are at higher risk of death from the flu. “While there may be debates on Facebook and other places, the over-65s, I think, are highly motivated to get protected,” Hudson said, “because they know they are the ones that are most vulnerable.”

Sanofi’s executive vice president of vaccines Thomas Triomphe said the deal “brings new option to our portfolio”. Image credit: Below the Sky via Shutterstock.com. Sanofi has agreed to acquire hepatitis B vaccine manufacturer Dynavax for an equity value of around $2.2bn, bolstering the former’s pipeline amid significant vaccine policy changes in the US. The transaction, for a price of $15.50 per share in cash, is expected to close in the first quarter of 2026. Through the deal, Sanofi will acquire Dynavax’s hepatitis B vaccine HEPLISAV-B. The product won approval in the US and Europe in 2017 and 2021, respectively. Sanofi does not currently have a hepatitis B vaccine in its portfolio. The French drugmaker previously won approval for a hepatitis B vaccine in a joint venture with MSD, though the latter company now commercialises the jab, which is known under the HBVaxPro and Recombivax HB brand names in Europe and the US, respectively. Heplisav-B is administered via a two-dose regimen delivered within one month, unlike GSK’s Engerix-B and MSD’s Recombivax HB. These rival products are given in three doses over six months. With the Dynavax acquisition, Sanofi is adding a strong revenue avenue for the virus that causes serious liver infection. HEPLISAV-B generated sales of $268.4m in 2024, with Dynavax forecasting net product revenue of between $305m and $325m for 2025. GlobalData forecasts HEPLISAV-B will reach $677m in annual sales in 2031. GlobalData is the parent company of Pharmaceutical Technology . GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence William Blair analyst Matt Phipps said: “While the deal value does come slightly below our net present value for Heplisav of $2.6bn, we believe the acquisition makes sense given growing regulatory concerns around vaccines and investor questions on management’s strategy for value creation.” Earlier in December, the US Centers for Disease and Prevention (CDC) changed its guidance to no longer recommend that all US newborns receive the hepatitis B vaccine. The significant policy changes have created volatility in the infectious disease vaccine sector, along with catalysing backlash from several medical bodies . The jewel in Dynavax’s pipeline is its shingles vaccine candidate, currently in a Phase I/II trial. In results announced in August 2025, the jab, dubbed Z-1018, demonstrated comparable efficacy to GSK’s blockbuster Shingrix – a product that dominates the shingles market. However, Z-1018 had fewer local and systemic post-injection reactions, which might give it a market advantage on tolerability. About one in three people in the US develop shingles at least once in their lives, according to the CDC. Shingrix generated £3.4bn globally for GSK in 2024, representing the size of the shingles market. Sanofi’s executive vice president of vaccines Thomas Triomphe said: “Dynavax’s marketed adult hepatitis B vaccine and shingles candidate bring new options to our portfolio and underscore our commitment to providing vaccine protection across the lifespan.” Phipps commented that: “Sanofi is a logical acquisition partner for Dynavax given the company has extensive vaccine capabilities but the portfolio does not have an adult hepatitis B or shingles programme.” Pharmaceutical Technology Excellence Awards - Nominations Closed Nominations are now closed for the Pharmaceutical Technology Excellence Awards . A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact. Excellence in Action Awarded the 2025 Pharmaceutical Technology Excellence Award for Business Expansion in Integrated Manufacturing , Upperton Pharma Solutions is rapidly expanding its UK GMP and sterile manufacturing footprint. Find out how Upperton’s integrated CDMO model helps pharma companies move from early development to clinical and niche commercial supply with fewer handovers and faster timelines. Discover the Impact