Moderna on Friday secured a long-awaited but expected approval for its RSV vaccine, giving the biotech its first FDA approval for a non-Covid-19 product and kickstarting what’s now a three-way race with GSK and Pfizer in the RSV market.
The shot, which will be branded as mResvia, is approved for use in adults older than 60. It will enter a burgeoning respiratory syncytial virus market that analysts and pharma companies expect to swell to $10 billion over the next few years.
“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” CEO Stéphane Bancel said in a statement. “This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19.”
The approval follows a delay in the FDA’s decision in early May. Moderna said then that the delay was due to “administrative constraints.”
As Moderna’s second approved vaccine and first non-Covid product, the RSV shot marks a milestone for the company as it navigates its post-pandemic path. The road so far has been bumpy, with Covid sales falling faster than expected amid plummeting demand and an endemic virus.
Moderna’s press release also had updated vaccine efficacy numbers from a follow-up analysis of 8.6 months. At an investor day in March, the company had said the efficacy after 8.6 months was 63.3%. Now, the updated efficacy is 78.7%.
The analysis was performed during the FDA review period and included “cases that started before the primary analysis cut-off date but were not confirmed until afterward,” according to the company.
Return to growth
Moderna expects its RSV vaccine to play a significant role in the company’s return-to-growth strategy by 2026 and reverse the $4.7 billion loss it recorded in 2023.
Still on the docket is the CDC’s Advisory Committee on Immunization Practices (ACIP) meeting in June. The CDC is expected to formally make its recommendations for the fall RSV season. It will also be the first time it will evaluate Moderna’s shot for use.
Moderna will need to make up considerable ground after GSK and Pfizer surpassed expectations, bringing in a combined $2.5 billion in RSV vaccine sales last year. But there is still room for the RSV vaccine market to grow, since only about 10% to 15% of people who are eligible to get the shot across the elderly and maternal populations did so during the 2023-24 winter season, Jefferies analyst Roger Song told Endpoints News.
“The interesting thing is some people aren’t necessarily happy about the penetration rate,” he said.
TD Cowen analyst Tyler Van Buren expects the 60-and-older RSV market to grow to about $3 billion this year, meaning Moderna’s shot could generate as much as $1 billion in sales “if they’re really able to compete and at least take an equivalent share of the market” to Pfizer.
The biotech, whose stock $MRNA is up more than 30% since the FDA delay was announced May 10, said earlier this year it’s projecting the RSV vaccine market to peak at $10 billion once shots for children and for use during pregnancy are approved. It has Phase 3 trials underway in a number of other indications, including:
- 12- and 24-month revaccination;
- individuals 50 years and older;
- and co-administration with Covid-19 and flu shots.
Most analysts agree that contracting with big pharmacy players like CVS and Walgreens will be key to Moderna’s efforts to take up market share. Moderna said it can’t comment on contracting until after the ACIP meeting.
There are also questions about whether the CDC committee will recommend once-yearly or twice-yearly dosing. Van Buren noted that Moderna’s vaccine efficacy appeared less durable than GSK and Pfizer’s shots, but he views once-yearly as the likely recommendation as it would follow every other seasonal vaccine schedule.
“There’s never been a vaccine, as far as I’m aware, in history — or there’s not a current vaccine — that is recommended every two years or every other season,” he said.