US revenue for RSV vaccines to be stunted as booster shots are not recommended due to concerns about the risk versus benefit of additional doses.
London, England, July 24, 2024 (GLOBE NEWSWIRE) -- Airfinity has reduced its sales projections for vaccines against Respiratory Syncytial Virus (RSV) for older adults in the US from $4.7bn per year to $1.7bn by 2030.
It follows recommendations from the CDC advisory committee ACIP for the vaccines to be offered only as a single lifetime dose for older adults. Following the rollout of RSV vaccines last year, the committee was hesitant to make any decision on potential booster doses, due to concerns about the risk versus benefit of additional doses.
In 2023, the market revenues in the US totalled ~$2.4bn. Airfinity's estimate framework expects 2024 revenues to decline slightly to $2.2bn. This also considers the new ACIP guidelines narrowing the age eligibility criteria.
Before the new recommendations, everyone aged 60 and above were offered the RSV vaccine in the US; the new recommendations are narrowed to all those over 75 years of age and individuals deemed to be at high risk aged over 60 years. This reduces the estimated eligible population by 44% to 46 million. The US market for RSV vaccines for the elderly could have generated sales of $3.7bn in 2024 under the previously broader age-group recommendation.
Additionally, the anticipated recommendation for high risk 50-59 year-olds to receive a vaccine ahead of the 2024 winter season was delayed by the ACIP, as more safety and 'other' data would be needed. Airfinity estimates that the delay in ACIP recommendation roughly amounts to ~$300mn in lost revenue for GSK. These losses are even more impactful, as GSK used a Priority Review Voucher, commonly valued between ~$20-100mn to accelerate regulatory review of the label expansion, likely in an aim to launch to this additional population ahead of the 2024/2025 season.
In 2023, before the recent ACIP guidelines, Airfinity estimated the market would generate sales of $4.7bn a year by 2030 in the US, assuming boosters were offered annually. Subsequently new GSK efficacy data was released showing that revaccination after 12 months does not increase efficacy compared to single dose, as well as data on the potential risk Guillain-Barré Syndrome associated with additional doses.
However future dosing recommendations could change as long-term efficacy and safety data emerge. Applying scenario frameworks for a booster every two or three years, the US market could increase in value to $6.6bn or $5.2bn respectively.
Airfinity's RSV Lead Isabella Huettner says, "The ACIP recommendations will likely stunt revenue growth in the US market unless new data can support the benefit of booster shots. Global rollout will offer additional revenue opportunities for GSK, Pfizer and Moderna, with the UK, Canada and other EU5 countries expected to launch vaccination programmes for the first time this winter. Nevertheless, the trend appears to be for a single lifetime vaccine recommendation for those over 75 year olds, as was recently confirmed by the UK.
"US market share estimates are difficult to anticipate at this point with different scenarios being possible. 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. And, while the safety concerns remain until more data become available, GSK appears to have lower Guillain-Barré Syndrome rates than Pfizer. It will be interesting to see how Moderna's vaccine will perform; while durability is lower with only ~50% efficacy after 18 months, as of now no vaccine-attributable cases of Guillain-Barré Syndrome have been observed with the shot. Should additional data confirm improved safety signals for Moderna's shot, the vaccine could be favoured by some healthcare providers over other options, despite lower durability."
Airfinity will update and adjust our estimates as new data becomes available.
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Attachments
- Estimated reduction in revenue for the US older adult market, based on updated ACIP recommendations in 2024 (https://ml.globenewswire.com/Resource/Download/2e6a7423-7c42-43da-9e96-a4dc3a729b45)
- Estimated revenue for the US older adult market in 2030, based on different booster scenarios (https://ml.globenewswire.com/Resource/Download/48cedb21-bc45-42be-99b6-6bd5cebe661f)
