MODERNA gained US approval for its RSV vaccine in older adults, giving the biotech company a second product as it seeks to move beyond its reliance on the fading market for Covid-19 shots.
The US Food and Drug Administration approved Cambridge, Massachusetts-based Moderna’s vaccine against respiratory syncytial virus, a flu-like illness that affects elderly adults and babies most severely, according to a statement Friday (May 31).
The decision had earlier been expected by May 12, and was delayed because of “administrative constraints” at the agency, Moderna said earlier this month.
Moderna’s shot, called mRESVIA, was cleared for use in adults 60 and older and will compete with products that arrived last year from GSK and Pfizer.
Those two generated about US$2.4 billion in sales combined, with GSK emerging as the clear leader.
The vaccine’s effectiveness declined 5 per cent during a follow-up analysis performed for the FDA, which could put Moderna’s shot at a disadvantage, according to Bloomberg Intelligence analysts.
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Moderna shares fell as much as 7.1 per cent as of 241 pm in New York. They had rallied in recent weeks on speculation the company might develop a vaccine against a form of bird flu that’s been spreading in cattle and has infected three US farmworkers.
Fall Season
Moderna said it expects to have mRESVIA available in the US for this fall’s respiratory virus season.
The approval is a big moment for Moderna, which previously only had just one product, its Covid shot. Like rival Pfizer, Moderna’s stock price has plunged as the world moves on from the pandemic.
The RSV shot – the first ever drug using mRNA technology approved for a disease other than Covid – gives it another much-needed revenue stream.
Although later to market, Moderna is betting on a potential advantage over Pfizer and GSK: It has the only RSV shot that comes in a pre-filled syringe that’s easier for pharmacists to administer than others that require multiple steps.
Bloomberg Intelligence expects the RSV market for seniors to be worth US$11 billion by 2032, with GSK holding a 45 per cent share, Pfizer having 35 per cent and Moderna with 20 per cent.
Advisers to the US Centers for Disease Control and Prevention are expected to meet in late June to make recommendations about this year’s RSV shots, such as which ones to take and how often. BLOOMBERG
