This Week’s Biopharma News: RFK Jr Selects New Members for US Vaccine Committee
Our latest news roundup reports on a new RSV FDA approval for Moderna, payment hikes in the UK, and calls in the US for a ban on direct-to-consumer advertising.
| 4 min read | News
RFK Jr selects new members for vaccine committee
After recently firing all 17 members of the US Advisory Committee on Immunization Practices (ACIP), RFK Jr has selected eight new experts, some of whom have previously expressed skepticism against vaccines, including COVID-19 vaccines. The new members are: Joseph Hibbeln, Martin Kulldorf, Retsef Levi, Robert Malone, Cody Meissner, Michael A. Ross, James Pagano, and Vicky Pebsworth.
In a statement, President of the American Medical Association, Bobby Mukkamala, expressed concern that members were selected “without transparency and proper vetting to ensure they have the expertise necessary to make vaccine recommendations to protect the health of Americans.”
New approval for Moderna RSV vaccine
The FDA has expanded the indication of Moderna’s RSV vaccine mRESVIA to adults aged 18 to 59 years. Previously, the vaccine was only approved for adults over the age of 60.
Adults aged 18 to 59 years with chronic conditions, including cardiovascular and pulmonary diseases, are increasingly recognized as a high-risk population for respiratory syncytial virus (RSV)-related complications, including respiratory tract disease. Recent estimates suggest that more than one-third of adults in this age group have comorbidities that are associated with heightened risk of severe RSV outcomes. Disease burden and hospitalization rates in this group are comparable to those seen in older adults.
Moderna says it intends to have the vaccine available for the 2025-2026 respiratory virus season.
GSK also seeking RSV vaccine indication expansion
In Europe, GSK is also seeking to expand use of its own RSV vaccine (Arexvy) in a wider range of adults. The EMA has accepted the company’s regulatory application to expand use of the vaccine to include adults from 18 years of age. A regulatory decision on the submission is expected in the first half of 2026. GSK says it is also seeking expanded indications for the vaccine in the US and Japan.
UK government doubles payment rate for pharma companies
The UK government has announced that, from July 1, 2025, pharmaceutical companies selling newer branded medicines to the UK’s National Health Service (NHS) under the statutory pricing scheme will be required to pay back 31.3 percent of their sales revenue. This means that for every £100 in eligible sales to the NHS, £31.30 must be returned to the government. The new rate, up from the current 15.5 percent, applies to companies not participating in the UK’s voluntary pricing agreement.
The statutory scheme operates alongside the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG), both of which were designed to cap NHS spending on branded medicines. Companies not participating in the voluntary agreement are automatically enrolled in the statutory alternative.
The government acknowledged in its consultation response that rising payment percentages may influence company decisions around UK investment and product launches. An expedited review of VPAG is underway, with the aim of finding a mutually acceptable path forward.
Industry groups, including the Association of the British Pharmaceutical Industry (ABPI), have raised concerns about the implications of the rate hike. A statement from the ABPI says: “The new annual average rate is now well over three times what is required in Germany, which has a 7 per cent payment rate, and four times the average payment rate in France, which has an average payment rate of 5.7%.”
US senators push for ban on direct-to-consumer advertising
Senators Bernie Sanders and Angus King have introduced the End Prescription Drug Ads Now Act legislation. As the name suggests, the bill proposes banning prescription drug advertising on television, radio, print, digital platforms and social media.
In a statement, Sanders said: “With the exception of New Zealand, the United States is the only country in the world where it is legal for pharmaceutical companies to advertise their drugs on television. It is time for us to end that international embarrassment.”
RFK Jr previously voiced support during the 2024 presidential campaign for ending direct-to-consumer advertising of prescription drugs.
Tirzepatide versus semaglutide
According to a study published in The New England Journal of Medicine, a clinical trial funded by Eli Lilly has shown that tirzepatide led to higher weight loss in obese adults compared with semaglutide. Tirzepatide achieved a 20.2 percent mean reduction in body weight compared with 13.7 percent with semaglutide at 72 weeks. Additionally, 19.7 percent of the participants receiving tirzepatide achieved a weight reduction of 30 percent or more compared with 6.9 percent among those in the semaglutide group.
“Tirzepatide pharmacologically activates two metabolic receptors, GIP and GLP-1, which have both overlapping and nonoverlapping expression and function,” the study authors explained. “This dual-agonism activity of tirzepatide may contribute to the greater weight reduction observed with tirzepatide than with semaglutide, a monoagonist used in the current trial.”
