SARS-CoV-2 Spike Protein Vaccine (Recombinant) (Novavax)

iStock, Alexandros Michailidis In November, Pfizer was reportedly looking to divest its stake in BioNTech, though the German biotech at the time denied these rumors. In a vaccines-focused deal, Pfizer is fronting $30 million to partner with Novavax, just a few months after the pharma was rumored to be distancing itself from its other big vaccine collaborator, BioNTech. Aside from its upfront commitment, Pfizer will put up to $500 million on the line in development and sales milestones, according to a Tuesday news release . Novavax will also be entitled to high-mid-single digit percentage royalties on net sales that might result from the partnership. In exchange for its investments, Pfizer will receive a non-exclusive license to Novavax’ Matrix-M adjuvant technology, which makes use of naturally occurring compounds from soapbark trees, allowing for a “targeted and efficient way” of boosting the body’s immune response, according to the company’s website . Pfizer will be able to apply the adjuvant to up to two disease areas, according to the press announcement, though it remains unclear what these indications are or if the company has a set number of programs in mind. Tuesday’s vaccines pact with Novavax follows reports in November 2025 that Pfizer was considering divesting its stake in vaccine partner BioNTech, with which it owns the COVID-19 shot Comirnaty. Pfizer at the time remained tight-lipped about the rumors, and BioNTech denied the news: “We continue to have a close and strong collaboration,” a spokesperson for the company told Reuters , otherwise refusing to comment on Pfizer’s business dealings. The Novavax deal also comes amid growing skepticism toward vaccines, driven in no small part by controversial policies and antagonistic rhetoric from the Trump administration. Last month, for instance, Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, claimed, without providing evidence , that “at least” 10 children had died “because of” COVID-19 vaccines. An internal FDA memo released two weeks later stated that the claim was an overestimate. Vaccines JPM26: Sanofi’s CEO Keen To Buy the Dip as Vaccine Rhetoric Impacts Short-Term Sales Buying vaccine biotech Dynavax was an easy choice for Sanofi despite antivaccine moves by the Trump administration. January 14, 2026 · 3 min read · Annalee Armstrong But at the J.P. Morgan Healthcare Conference last week, Sanofi CEO Paul Hudson said these high-level headwinds present a business-making opportunity . “If you’re a short-term thinker, you don’t move,” he said, referring to the high level of uncertainty in the vaccine space right now. “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.”

iStock, wildpixel The FDA intends to place a black box label—its most serious warning—on COVID-19 vaccines, according to reporting by CNN . It is unclear if the warning would apply to Moderna’s, Pfizer/BioNTech’s and Novavax’s shots, or to all age groups. The FDA may be gearing up to slap a black box warning on COVID-19 vaccines, according to two individuals who spoke with CNN on Friday. A boxed warning, which alerts the public to the serious risks associated with a drug or medical device has been attached by the FDA to products including opioids for addiction, for example, and the acne medicine Accutane for birth defects. These risks should be weighed against the treatment’s benefits. The plans for a black box warning, first reported by CNN on Friday morning, are expected to be rolled out by the end of this year. It is unclear, however, whether they will apply to all COVID-19 vaccines or only mRNA vaccines—which have faced considerable scrutiny since Health Secretary Robert F. Kennedy Jr. took office in February, and since being politicized by the pandemic . Moderna and Pfizer/BioNTech make the two mRNA-based vaccines approved for use in the U.S., Comirnaty and Spikevax. The only other FDA-approved COVID vaccine is Novavax’s protein-based shot Nuvaxovid. It also isn’t clear whether the warnings will apply to all age groups, CNN reported. In a statement to the publication on Thursday, Department of Health and Human Services spokesperson Andrew Nixon said, “Unless the FDA announces it, any claim about what it will do is pure speculation.” BioSpace has not heard back from HHS for further details as of publication. The black box initiative is being led by Center for Biologics Evaluation and Research head Vinay Prasad, according to one of the people who spoke with CNN . This follows Prasad’s claim in an internal FDA memo late last month that the deaths of 10 children could be linked to COVID-19 vaccinations. The alleged deaths were first flagged by acting Center for Drug Evaluation and Research director Tracy Beth Høeg, then a senior advisor to the agency. The memo set off an eruption of protest from healthcare and ex-regulatory leaders. More than a dozen former FDA and CDC officials in an editorial published in The New England Journal of Medicine earlier this month decried the proposed vaccine policy changes laid out in Prasad’s memo. The FDA is also expanding its investigation of deaths potentially related to COVID-19 across multiple age groups, an agency spokesperson told Bloomberg earlier this month. Notably, the CDC on Thursday released a report showing that the 2024–2025 formulations of the COVID-19 vaccine were 76% effective at preventing emergency or urgent care visits in children aged 9 months through 4 years.