GSK, Moderna and Pfizer are all looking at potential respiratory syncytial virus vaccine sales slumps thanks to recently updated CDC guidelines regarding the use of RSV shots in seniors.
This was a decidedly bad week for vaccine makers, not just for those in the COVID-19 business but for respiratory syncytial virus (RSV) and other vaccines as well. GSK, Moderna and Pfizer all reported disappointing second-quarter earnings this week. Moderna was by far the hardest hit, cutting its full-year 2024 revenue guidance from $4 billion to a range of $3 billion to $3.5 billion, citing lower Q2 sales in Europe for both its COVID-19 and RSV vaccines. Investors were not happy, and Moderna’s stock price dropped 20%.
The dynamic at work for Moderna’s COVID-19 vaccine is plain to see as the market continues to transition to an endemic environment with lower than expected vaccination rates. However, the RSV vaccine market is an entirely different animal. Moderna’s mResvia, approved by the FDA in late May, is the company’s second-ever product and the third RSV vaccine to enter the market behind shots developed by GSK and Pfizer.
Jefferies analysts in a Thursday note to investors said Moderna’s management “walked back confidence” for RSV and now anticipate a “slower ramp due to competition and fewer contracts,” adding that the company expects “modest” revenues this year.
Moderna desperately needs another revenue source as COVID-19 demand continues to wane. At the same time, Pfizer’s RSV vaccine Abrysvo is moving in the wrong direction as it generated sales of $56 million in Q2, compared to $145 million in the previous quarter. GSK is the clear RSV market leader with its Arexvy shot but the company’s shingles vaccine Shingrix disappointed in Q2, posting a surprise year-over-year 5.5% decline.
Still among the big news this week: GSK was forced to lower its 2024 outlook for its vaccines business after revenue from Arexvy missed expectations, due in part to updated CDC guidelines regarding the use of RSV shots in seniors. The company now expects its vaccines revenue to grow by a low- to mid-single-digit percentage this year, down from its previous guidance of a high-single-digit to low-double-digit percentage.
The problem for all three companies when it comes to RSV is that in late June, the CDC’s Advisory Committee on Immunization Practices (ACIP) reviewed data on the RSV vaccines from GSK, Moderna and Pfizer, passing a unanimous motion recommending a single dose of RSV vaccine for adults aged 75 and older as well as for those who are 60 to 74 years old with an increased risk of severe RSV.
Last week, data and analytics company Airfinity slashed its sales projections by 64% for RSV vaccines for older adults in the U.S., from $4.7 billion annually to $1.7 billion by 2030. The firm blamed the drastic reduction on the ACIP’s recommendation that the vaccines be offered only as a single lifetime dose for older adults.
According to Airfinity, prior to the new ACIP recommendations, everyone aged 60 and older was offered the RSV vaccine in the U.S. However, with the guidelines narrowed to all those over 75 years of age and individuals deemed to be at high risk over 60, the firm contends the estimated eligible population has been reduced by 44%.
“The ACIP recommendations will likely stunt revenue growth in the U.S. market unless new data can support the benefit of booster shots,” Airfinity’s RSV lead Isabella Huettner said in a statement. While the global RSV rollout will offer additional revenue opportunities for GSK, Moderna and Pfizer, she noted that “the trend appears to be for a single lifetime vaccine recommendation for those over 75 year olds, as was recently confirmed by the UK.”
GSK, Moderna and Pfizer are all looking at a potential RSV vaccine sales slump, thanks to the CDC. Making matters worse, the ACIP delayed its anticipated recommendation for high risk 50- to 59-year-olds. For GSK, Airfinity estimates that the delay in the ACIP recommendation amounts to approximately $300 million in lost revenue this year.
Speaking with media on Wednesday, GSK CEO Emma Walmsley called the decision “surprising” and said the company would share additional data with U.S. agencies by the end of this year. For now, market share estimates remain up in the air.
