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 guidance
The 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.