Respiratory Syncytial Virus Vaccine (GSK)

iStock, EyeEm Mobile GmbH Health Secretary Robert F. Kennedy Jr. endorsed the expanded use of RSV vaccines for people 50 through 59 years old who are at risk of severe disease. Health and Human Services Secretary Robert F. Kennedy Jr. has signed off on the broader use of respiratory syncytial virus vaccines—in line with the recommendations of the CDC vaccine advisors whom he ousted last month. In April, the CDC’s Advisory Committee on Immunization Practices recommended expanding the use of RSV vaccines to adults aged 50 through 59 years who are at a higher risk of severe infection. Previous guidelines only endorsed the shot for high-risk older adults aged 60 to 74 and for all seniors 75 and up. “With no current CDC Director and pending confirmation of a new CDC Director, this recommendation was adopted by the HHS Secretary on June 25, 2025,” according to an update to the CDC’s website . The broader use of RSV vaccines in older adults “is now an official recommendation of the CDC.” Kennedy has also signed off on the ACIP’s endorsement of GSK’s meningococcal vaccine Penmenvy, which the FDA approved in February. There are currently three commercial RSV vaccines. First to market in May 2023 was GSK’s Arexvy , which is indicated for older adults 60 and up and at-risk people 50 through 59 years. Following a month later was Pfizer’s Abrysvo, available for use in patients 60 and above, as well as at-risk adults 18 through 59 years. Abrysvo can also be used in pregnant women 32 through 36 weeks of gestation. Moderna also has an RSV vaccine. The mRNA-based mRESVIA is also approved for older adults 60 and up, as well as at-risk younger adults 18 through 59 years. The RSV recommendations were made by the CDC’s previous vaccine advisory panel, which Kennedy completely purged last month in a move that he claimed would help “reestablish public confidence in vaccine science.” Experts have told BioSpace that despite Kennedy’s misgivings about supposed industry interference in the ACIP, conflicts of interest have largely been well-managed by the CDC, which directs its panelists to recuse themselves from voting on matters relevant to their conflicts. Kennedy soon reconstituted the ACIP, but this time with fewer members, several of whom are documented vaccine critics. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, has also spoken of restoring the public’s confidence in vaccines. One such initiative is the FDA’s new risk-based approach to COVID-19 vaccine approval. It recently came to light that this has caused some friction within the agency’s ranks. On May 30, the FDA’s product review committee recommended the approval of Moderna’s COVID-19 shot MNEXSPIKE for patients 12 years and up who have previously been inoculated with a coronavirus vaccine. That same day, however, Prasad put out his own memo disagreeing with the committee’s conclusions, instead endorsing a more limited use for the shot that included blanket use only for those 65 and up. For people 12 through 64 years, Prasad wanted MNEXSPIKE indicated only in the presence of an underlying condition that could heighten the risk of severe COVID-19 outcomes. “I am unable to conclude that the product has improved safety or reduced reactogenicity for younger individuals at low risk of severe disease,” he wrote in his memo. “Furthermore, uncommon risks, including those that might be novel to MNEXSPIKE, cannot be ruled out.” In a statement to Endpoints News , a spokesperson for HHS defended Prasad’s action, contending that he is “correcting course with data, with transparency, and with the courage to say what others won’t. That’s how trust in science is rebuilt.” The FDA approved MNEXSPIKE on May 31—a day after the back-and-forth at CBER—with a label that reflects Prasad’s more restricted recommendations.

The US Centers for Disease Control and Prevention (CDC) has endorsed broader use of respiratory syncytial virus (RSV) vaccines for adults ages 50 to 59 who face a higher risk of severe illness. The move aligns with guidance issued by the CDC's former vaccine advisory panel, made just weeks before Health Secretary Robert F. Kennedy Jr. abruptly dismissed all 17 members of the group.The recommendations, first proposed by the CDC's Advisory Committee on Immunization Practices (ACIP) in April, were approved by Kennedy even as the CDC awaits a permanent director. The newly appointed ACIP members – all hand-picked by Kennedy – convened for the first time last week over a meeting that spanned two days.Pfizer's Abrysvo and GSK's Arexvy, both of which already have FDA approval in the 50-59 age group, are poised to gain from the broader RSV guidance.ACIP took a more restrictive approach last year, recommending RSV shots only for adults 75 and older or those 60 to 74 at high risk. That was a narrower focus than its 2023 policy, which had opened the door for RSV vaccines to be given to all people over 60 after talking with their healthcare provider.The broader age range could provide a welcome boost to Arexvy and Abrysvo, both of which saw sales slide in 2024. Arexvy sales plummeted 52% to £590 million ($805 million), while Abrysvo fell 15% to $755 million – declines both GSK and Pfizer attributed to last year's tighter ACIP recommendations. Moderna's RSV shot mRESVIA has struggled with uptake, hampered by both the restrictive guidance and its later arrival compared to Arexvy and Abrysvo.Meanwhile, the CDC continues to implement vaccine policy in the absence of permanent leadership, as President Donald Trump's nominee for CDC director, Susan Monarez, awaits Senate confirmation.