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The first three RSV vaccines on the market were supposed to be home runs for Pfizer, GSK and Moderna, but new CDC guidelines may unexpectedly thwart their success. Executives at the big three pharmaceutical companies are trying to look on the bright side.
The CDC’s Advisory Committee on Immunization Practices A surprising vote The committee, announced in June, recommended RSV vaccination only for those 75 and older, or those 60 to 75 years old who are at risk for severe illness. Vaccine developers had originally planned to make the recommendation available to all adults over 60, regardless of risk factors. The committee also postponed a vote on vaccinating adults 50 to 59 years old.
The decision dealt a major blow to the three companies’ potential sales: the RSV vaccine market was projected to be worth $4.7 billion annually by 2030, but the recommendation slashed that estimate by 64%, to just $1.7 billion in projected sales by the end of the decade. According to the data That means only one of them, if any, has the potential to be a blockbuster at that point, according to analytics firm Airfinity.
Still, based on that recommendation, about 40 million people in the U.S. would be eligible for vaccination, Moderna CEO Stephane Bancel noted during the company’s second-quarter earnings call last week.
Here’s what executives from GSK, Pfizer and Moderna said about the new RSV vaccine guidelines and how they plan to move forward in a shrinking market.
“When you look at ACIP’s 60-74 (age group), it’s inevitable that it’s going to be negative for that population. You have to be realistic. But when you break that population down, there are some silver linings.”
Luke Miels
Chief Commercial Officer, GSK
GSK, which brought its first RSV vaccine, Alexi, to market in May last year, is on track to generate revenue of 244 million pounds ($311 million) in 2024, accounting for about two-thirds of the retail share, company figures show. Second Quarter Earnings ReportSince its release, about 8 million of the roughly 85 million people aged 60 or older in the United States have received the Alexi shot.
While the new recommendation may result in lower vaccination rates in the 60-74 age group than initially expected at about 13% last year, GSK’s chief commercial officer Luke Miles said actual vaccination rates may be largely unaffected by the ACIP vote. For example, he noted, doctors are unlikely to withhold their recommendations based on the ACIP decision.
Additionally, Alexi is the first RSV vaccine to receive FDA approval for the 50-59 age group, providing a new opportunity to expand market share, GSK CEO Emma Walmsley said.
Regarding competition from two other RSV vaccines on the market, Miels said Alexi is “the clear leader in the minds of doctors and patients,” and the clinical data is the strongest of the three, adding that it’s “the vaccine you want to give to your mom.”
“The ACIP guidelines themselves recommend one dose for all adults 75 years of age and older and high-risk individuals ages 60 to 74, clarifying and strengthening the instructions for those who are eligible to receive the vaccine.”
Aamir Malik
Pfizer U.S. Chief Commercial Officer
Pfizer’s Avrisbo fell just short of GSK in sales. $201 million worldwide The company has applied for approval in the United States and Europe for use in all adults under the age of 59, making the drug more widely available even though older populations are thought to be at higher risk.
The Pfizer vaccine is also unique in that it has been approved for vaccination of mothers, said U.S. Commercial Chief Executive Aamir Malik. Said This could be seen as an easier way to package the vaccine so that health care providers can vaccinate different groups of people with a single dose.
Malik noted that Abrisvo has only been on the market for six months, and that a clear recommendation from ACIP will help demonstrate medical need and expand the “opportunity set” in the future.
Pfizer executives remain bullish on Avrisbo’s potential after setting peak sales expectations of more than $2 billion in December 2022.
“Since we donated $2 billion, things have only gotten more positive because we’ve all been amazed at how much the medical community and the authorities have focused on this disease,” Pfizer CEO Albert Bourla said.
“As the public health situation evolves, we continue to believe that CDC and ACIP recommendation agencies will consider any waning efficacy, the possibility of revaccinating more people again and providing additional benefit to the public, and ultimately recommend revaccination for those at highest risk for RSV infection.”
Dr. Stephen Hogue
President of Moderna
Of the three RSV vaccine makers, Moderna is most excited about its vaccine, called mResvia, which is the company’s second to market after its COVID-19 vaccine, sales of which have fallen dramatically since the pandemic began.
Moderna’s vaccine was the most recent, approved just a few months ago in May. CEO Stephane Bancel Admitted While the market size this year is likely to be smaller than expected, the clarity provided by the guidelines could actually be a benefit to uptake among the target population, he said.
“With vaccinations, you can have a different response from doctors, pharmacies and consumers if the guidelines are clear, versus if there are fewer guidelines and more people are eligible,” Bancel said. “It’ll be interesting to see how this season goes.”
Overall, with respiratory illness season fast approaching, executives like Moderna’s Hoge believe several factors could influence how the public responds to newly available RSV options, and that the ACIP recommendation may not be as harmful as it seems on paper.
