GSK, Pfizer Face Declining Respiratory Syncytial Virus Vaccine Sales Due To Narrow Age Recommendations

In June, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend the routine use of Respiratory Syncytial Virus (RSV) vaccines in all adults aged 75 and above.

The panel also recommended RSV immunization for adults aged 60-74 years who are at increased risk for severe RSV disease, meaning they have certain chronic medical conditions.

The recommendation is for adults who did not get an RSV vaccine last year. The RSV vaccine is not currently an annual vaccine.

ACIP postponed a vote on a recommendation for adults aged 50-59 years at increased risk for RSV-LRTD until additional data became available.

U.S. sales of RSV vaccines from GSK Plc GSK and Pfizer Inc PFE have declined after regulators narrowed the age group eligible for the shots and determined they would be a one-time vaccination for now.

This change excluded millions who were vaccinated last year, impacting demand.

Pharmacists report that the demand for RSV vaccines has dropped by up to two-thirds compared to last year. Reuters highlights that data from healthcare analytics company IQVIA Holdings, Inc IQV supports these claims.

For Pfizer and GSK, RSV vaccines are critical as they seek to build new revenue streams before facing generic competition for their top-selling drugs.

Pfizer is already struggling with weak demand for its COVID-19 products and pressure from activist investor Starboard Value.

Despite a disappointing launch for its RSV vaccine Abrysvo in 2023, Reuters notes that CEO Albert Bourla remains optimistic about its potential in the U.S. market this year.

In 2023, an average of 440,000 people per week received RSV vaccines from GSK and Pfizer in September, with 65% opting for GSK’s Arexvy. However, this September, the weekly average fell to 157,000.

Pharmacists in Nebraska and Iowa have seen bookings drop by 65% compared to last year, while Pharmacy in New York reported an even steeper decline.

On Tuesday, GSK announced new data from the AReSVi-006 phase 3 trial of a single dose of Arexvy in adults aged 60 years and older, including those at increased risk, over three full RSV seasons.

Results indicate that after a single dose of GSK’s RSV vaccine, cumulative efficacy over three full RSV seasons was clinically meaningful at 62.9% against RSV-LRTD and 67.4% against severe RSV-LRTD compared to placebo.

In the third season, the vaccine’s efficacy was 48.0% against RSV-LRTD. These results include efficacy against different RSV subtypes in adults with advancing age (70-79 years) and those with certain underlying medical conditions.

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