Lower Respiratory Tract Infections

A CDC advisory group has expanded its recommendation for who should receive RSV vaccines. The broadened population is a potential boost for sales of RSV shots from GSK and Pfizer. The ACIP also voted to endorse a new meningococcal vaccine from GSK and a new shot from Bavarian Nordic which defends against the emerging chikungunya virus. A year after narrowing its recommendation for who should use vaccines to defend against respiratory syncytial virus (RSV), a panel of experts advising the Centers for Disease Control and Prevention (CDC) has expanded its endorsement.The reversal from the Advisory Committee on Immunization Practices (ACIP) is a potential boost for GSK and Pfizer. Both companies saw sales of their RSV vaccines for adults tumble last year after the CDC ruled that the shots should be limited to people age 75 and older and those ages 60-74 who are at risk of developing severe RSV-linked lower respiratory tract disease (LRTD).The ACIP’s new recommendation expands the eligible at-risk group to people ages 50 and older. The new guidance is pending final approval from the director of the CDC and the Department of Health and Human Services (HHS).After the FDA approved GSK’s Arexvy and Pfizer’s Abrysvo in 2023, the CDC recommended the shots for all people 60 and older, pending a doctor’s endorsement.From 2023 to last year, sales of Arexvy tumbled (PDF) 51%, from 1.2 billion pounds ($1.6 billion) to 590 million pounds ($754 million). Meanwhile, revenue from Abrysvo fell (PDF) 15% from $890 million to $755 million during the same stretch. The new direction from the ACIP comes after a review of positive results of a phase 3 trial evaluating the immune response and safety of Arexvy in adults ages 50-59, including those at increased risk for severe RSV-LRTD due to certain underlying medical conditions, compared to adults aged 60 and above.According to the CDC, between 15,000 and 20,000 RSV-associated hospitalizations occur annually (PDF) in the U.S. among adults ages 50 to 59. Those with chronic obstructive pulmonary disease (COPD), asthma, heart failure and diabetes are at increased risk from an RSV infection.GSK’s Chief Scientific Officer Tony Wood said in a release that the new guidance would increase the RSV vaccine-eligible patient population by 13 million.Other ACIP vaccine guidanceThe CDC experts also endorsed GSK’s 5-in-1 shot Penmenvy, advising that it should be part of the adolescent meningococcal vaccination schedule for people ages 16 to 23. The recommendation also applies to kids ages 10 to 15 who are at increased risk.The ACIP also unanimously endorsed Penmenvy for the Vaccines for Children (VFC) program, which provides free doses for eligible children.The vaccine, which was approved by the FDA in February, is an alternative to separate administration of two shots that cover five meningococcal serogroups. Penmenvy will challenge Pfizer’s pentavalent option Penbraya, which hit the market in 2023. Because of their convenience, these vaccines are expected to increase immunization rates in the U.S.   The ACIP also signed off on Bavarian Nordic’s chikungunya vaccine Vimkunya for people age 12 and older who are traveling to a country where there is an outbreak of the mosquito-borne virus. The shot, which also was approved by the FDA in February, may also be considered for those traveling or moving to a country without an outbreak but with elevated risk for U.S. travelers. ACIP also recommends Vimkunya for laboratory workers with potential for exposure to the virus.According to CDC, there has been evidence of chikungunya virus transmission to humans in more than 50 countries within the last five years.The ACIP meeting was the first under new HHS Secretary Robert F. Kennedy Jr. On Tuesday, the panel discussed potentially narrowing the recommendations for COVID-19 and HPV vaccines. The ACIP will vote on its guidance for those shots at its next meeting, set for June 25-26.

The recommendation builds on the committee’s June 2024 vote for the use of RSV vaccines for people aged 60 to 74 at high risk. Credit: MargJohnsonVA/Shutterstock. The US Advisory Committee on Immunization Practices (ACIP) has voted to recommend the use of respiratory syncytial virus (RSV) vaccines, including GSK’s adjuvanted Arexvy, for use in the adult population between the ages of 50 and 59 who are at higher risk for severe disease. This group includes individuals with asthma, heart disease, diabetes and chronic obstructive pulmonary disease (COPD) and those in residential care. People with these conditions are more susceptible to severe outcomes from RSV, which can lead to hospitalisation, pneumonia and even mortality. The recommendation builds on the committee’s June 2024 vote for the use of RSV vaccines for people aged 60 to 74 at high risk and all those aged 75 and above. ACIP’s decision was influenced by the outcomes from a Phase III trial that assessed the safety and immune response of the RSV vaccine in the 50 to 59 age group, particularly in those with high risk for RSV lower respiratory tract disease (RSV-LRTD) due to certain medical conditions. The vaccine has shown efficacy from a single dose in those aged 60 and above. Once approved, the committee’s recommendations will guide healthcare providers on the vaccine’s appropriate usage and notify insurance coverage decisions. GSK chief scientific officer Tony Wood stated: “We are pleased with ACIP’s recommendation to expand the benefits of RSV immunisation to more than 13 million adults aged 50 to 59 who are at increased risk for the severe consequences of this virus. “RSV can have a significant impact on those with underlying medical conditions. We look forward to helping protect more people with RSV vaccination.” The adjuvanted RSV vaccine combines recombinant RSV glycoprotein F stabilised in the prefusion conformation (RSVPreF3) with the company’s AS01 E adjuvant. It is already approved to prevent RSV-LRTD in individuals aged 60 and older in 61 countries and regions, including the US, Japan and Europe. ABL Bio previously entered into a global licensing agreement with GSK to develop treatments for neurodegenerative diseases.

A CDC advisory panel voted to recommend RSV vaccines for at-risk adults aged 50 to 59, a sought-after expansion by vaccine makers who are trying to grow the market. The vote from the Advisory Committee on Immunization Practices on Wednesday was nearly unanimous with one abstention, and expands the CDC’s current guidance for RSV vaccination. The vaccine is currently recommended for adults 60 to 74 with an existing condition that puts them at higher risk for severe disease and all adults 75 and older. Pfizer and GSK’s RSV vaccines already have FDA approval for at-risk adults in their 50s, and Moderna is expecting an FDA decision on these and other at-risk younger adults by mid-June. The recommendations still need the CDC’s stamp of approval. Because there’s no permanent or acting director, the decision is expected to fall to HHS Secretary Robert F. Kennedy Jr. “ACIP has taken an important step” at protecting at-risk adults in their 50s, Alejandro Cane, Pfizer’s vice president of vaccines and antivirals and US medical lead, said in a statement. GSK added that the recommendations open the door for more than 13 million Americans to get vaccinated. Moderna did not immediately have a statement following the decision. The recommendations would apply to almost a third of adults 50 to 59, according to CDC data. Pooled estimates based on existing clinical studies expect the vaccines would have a 69.3% efficacy against medically-attended lower respiratory disease and 76.7% efficacy against RSV-related hospitalization. The CDC work group that proposed the new recommendations acknowledged that uncertainties limited some members from having full-throated confidence in the expansion. Work group presenters highlighted a lack of data on the risk of Guillain-Barré Syndrome, which was added as a warning to the labels of both Pfizer and GSK’s vaccines earlier this year. Committee members also considered the lack of revaccination data available so far, given that people vaccinated in their 50s may have reduced protection by the time they’re older and at higher risk. The committee did not vote on a revaccination recommendation at this meeting, and appeared largely underwhelmed by data presented by Moderna and GSK. RSV rates are still below half for the two age groups for which RSV vaccination is already recommended. Through mid-February, 47% of adults 75 and older received an RSV vaccine and 12% said they would definitely get a shot. That vaccination rate was 37% for at-risk adults 60 to 74, with another 12% reporting that they’ll definitely get the shot. If the older population is any indication, there’ll be work ahead to convince Americans they should get the shot. December 2024 survey data among adults 60 to 74 with high-risk conditions found that 22% didn’t know enough about the vaccine, and 21% were concerned about serious side effects. Pfizer and GSK, manufacturers of the RSV vaccines Abrysvo and Arexvy, respectively, faced a sharp slowdown in sales in the most recent season. The trend was attributed to a combination of a lack of revaccination guidance and narrowed ACIP recommendations over the summer to focus on high-risk adults 60 to 74. In the first RSV vaccine season, the committee recommended that all adults 60 and older consult a healthcare provider before getting vaccinated, known as shared clinical decision-making. Though the committee sought to make it more clear who should get the vaccine, they minimized the population of eligible recipients. Moderna got a late start to the season and had $25 million in sales through the fourth quarter. Chikungunya, meningococcal vaccine votes The panel recommended Bavarian Nordic’s recently-approved chikungunya vaccine for people who are traveling to a country with a known virus outbreak or where there’s an elevated risk for travelers. The vaccine was also recommended for lab workers with potential exposure. The committee also reviewed data from Valneva’s chikungunya vaccine after six serious adverse events were reported last year in adults over 65. Five of those patients were hospitalized and one reported to an internist. For each case, at least one immunization expert that the CDC consulted believed that an association with the vaccine was “plausible.” But those experts from the Clinical Immunization Safety Assessment (CISA) Project also noted that it can be difficult to differentiate between vaccine-induced reactogenicity that impacts existing comorbidities versus an adverse event caused directly from the vaccine. Tracy Beth Høeg, special assistant to FDA commissioner Marty Makary, said that the agency is “going to get together a relevant group of experts so we can develop a plan” on Valneva’s vaccine. The product was still recommended for travelers. GSK received unanimous support for its pentavalent vaccine against meningococcal infection. The committee recommended that it “may be used” when quadrivalent and serotype B vaccines are indicated for the same visit. Editor’s note: This story was updated after additional committee votes and also to include a statement from GSK.