CDC panel backs use of GSK, Pfizer’s RSV shots this year

Adults aged 60 and over in the US will be eligible for vaccinations with respiratory syncytial virus (RSV) vaccines from GSK or Pfizer later this year, if the Centers for Disease Control and Prevention (CDC) follow the advice of expert advisors.

Last night, the CDC’s Advisory Committee on Immunisation Practices (ACIP) voted in favour of making both vaccines available to this age group ahead of the next RSV season, which typically starts in the US in the autumn.

Panellists voted 13 in favour, with one abstention, that individuals aged 60 to 64 can receive a single dose of the vaccine after “shared decision-making” between doctors and patients, given that side effects have been reported with both shots.

A second vote posing the same question for the 65 and over age group was less supported, but still passed with nine in favour and five against.

CDC's director, Rochelle Walensky – who is stepping down at the end of the month – and the Department of Health and Human Services still have to review and approve the recommendation, but typically follow the ACIP’s advice.

There was some dissatisfaction at the meeting that Pfizer would not commit to a price for its Abrysvo vaccine, as the ACIP also considers cost in its deliberations, but GSK has been more forthcoming, saying it will price its Arexvy shot somewhere between $200 and $295. Pfizer said its proposed range of $180 to $270 was subject to revision, depending on negotiations with payers.

So far, the US is the only country in the world that has approved the vaccines, although they have been filed for approval elsewhere.

GSK confirmed in a statement this morning that it intends to launch Arexvy in the US in time for the coming season, estimating that around 55 million people in the US could be eligible for the shots.

The ACIP verdict came shortly after GSK reported updated results from its pivotal AReSVI-006 trial of Arexvy, which it said confirmed that the protective efficacy against lower respiratory tract disease caused by RSV extended into a second season.

That data will also be submitted to the FDA with the aim of adding it to the vaccine’s label claims. Pfizer, meanwhile, expects to have equivalent data for Abrysvo later in 2023.

RSV causes approximately 177,000 hospitalisations and an estimated 14,000 deaths in people over 60 in the US each year.

Later today, the ACIP is turning its attention to maternal use of Pfizer’s vaccine to prevent RSV disease in newborns and infants, as well as Takeda’s dengue fever shot TAK-003, as well as chikungunya vaccines and new pneumococcal vaccines from Pfizer and Merck & Co.