With new CDC recommendations, RSV market’s long-term value falls sharply in US: Airfinity – FiercePharma

A month after a CDC panel narrowed its recommendations for who should receive vaccines to protect against respiratory syncytial virus (RSV), Airfinity has put numbers to the impact, reducing the projected market value in the United States by 64% by the end of the decade.

The London-based healthcare analytics company has sliced the RSV market value for seniors in the US from $4.7 billion to $1.7 billion in 2030.

Last year, when RSV vaccines debuted, the CDC recommended that people age 60 and older should receive a shot. But in a surprise move four weeks ago, the CDCs Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend a single lifetime dose for those age 75 and older.

As for people ages 60-74, RSV vaccines were recommended only for those who have underlying conditions that leave them vulnerable to severe disease. Additionally, the experts delayed an expected recommendation for RSV shots for people ages 50-59 with underlying conditions.

Last year, the market size for RSV shots for older adults in the US was $2.4 billion. With the new recommendations, Airfinity projects the market size to slide this year to $2.2 billion.

The analysts say the new recommendations reduce the eligible population in the US by 44% to 46 million. Under the previous recommendation, Airfinity saw sales from older adults reaching $3.7 billion in 2024.

The ACIPs skittishness on RSV vaccines came following reports of theirpotential linkto the rare neurological disorder Guillain-Barr syndrome (GBS). Earlier this year, health officials flagged a preliminary statistical analysis that discovered 23 of the 9.5 million older adults who received an RSV vaccine developed GBS.

The ACIP recommendations will likely stunt revenue growth in the US market unless new data can support the benefit of booster shots, Isabella Huettner, Airfinitys RSV analyst, said in a statement.

Airfinity projected that the new CDC recommendations amount to $300 million in lost revenue for GSK. In early June, the FDA expanded the label for GSKs vaccine Arexvy to people ages 50-59 with underlying conditions. The company used a valuable priority review voucher to speed the agencys decision. But the approval carries little weight until the CDC expands its recommendation to the age group.

GSK, which has projected peak sales of its RSV vaccine to reach 3 billion pounds ($3.8 billion), saw a 7% tumble in its share price when the new ACIP recommendations were released. Last year, Arexvy racked up $1.6 billion in sales, compared to $890 million for Pfizers RSV vaccine Abrysvo.

Meanwhile, with a May approval for its RSV vaccine, Moderna has entered the market. In June, the companys shares dropped 11% when it reported 50% efficacy for mRESVIA after 18 months. That compares to 79% and 78% efficacy for Arexvy and Abrysvo, respectively, after two years.

Moderna has two advantages with its shot however as it has not been linked to GBS and it comes in a pre-filled syringewhich is more attractive to physicians.

Much still has to be decided related to RSV vaccines. Airfinity pointed out that future dosing recommendations could change as long-term efficacy and safety data emerge. With recommendations for a booster every two to three years, the U.S. market could increase in annual value to between $5.2 billion and $6.6 billion, Airfinity projects.

Based on current data, GSK appears to be most likely to capture the majority of the market in the long term, due to promising efficacy and durability, Huettner added. And, while the safety concerns remain until more data become available, GSK appears to have lower Guillain-Barr Syndrome rates than Pfizer.

This will be another telling year for RSV uptake as GSK, Pfizer and Moderna launch their shots for the first time in the UK, Canada and the major markets in Europe.

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With new CDC recommendations, RSV market's long-term value falls sharply in US: Airfinity - FiercePharma