Modernas RSV shot wins FDA approval for use in older adults | Company Business News – Mint

Moderna Inc. 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.

Also Read: The Covid Vaccine Windfall Turns on Pfizer and Moderna

The US Food and Drug Administration approved Cambridge, Massachusetts-based Modernas vaccine against respiratory syncytial virus, a flu-like illness that affects elderly adults and babies most severely, according to a statement Friday. The decision had earlier been expected by May 12, and was delayed because of administrative constraints" at the agency, Moderna said earlier this month.

Modernas shot, called mRESVIA, was cleared for use in adults 60 and older and will compete with products that arrived last year from GSK Plc and Pfizer Inc. Those two generated about $2.4 billion in sales combined, with GSK emerging as the clear leader.

Also Read: Covishield vaccine side effects: Ex-ICMR scientist says only 7 in 10 lakh may face risk

The vaccines effectiveness declined 5% during a follow-up analysis performed for the FDA, which could put Modernas shot at a disadvantage, according to Bloomberg Intelligence analysts. Moderna shares fell as much as 7.1% as of 2:41 p.m. in New York. They had rallied in recent weeks on speculation the company might develop a vaccine against a form of bird flu thats been spreading in cattle and has infected three US farmworkers.

Moderna said it expects to have mRESVIA available in the US for this falls respiratory virus season.

The approval is a big moment for Moderna, which previously only had just one product, its Covid shot. Like rival Pfizer, Modernas 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.

Also Read: AstraZeneca to withdraw sales of Covid-19 vaccine globally

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 thats easier for pharmacists to administer than others that require multiple steps. Bloomberg Intelligence expects the RSV market for seniors to be worth $11 billion by 2032, with GSK holding a 45% share, Pfizer having 35% and Moderna with 20%.

Advisers to theUS Centers for Disease Control and Prevention are expected to meet in late June to make recommendations about this years RSV shots, such as which ones to take and how often.

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Modernas RSV shot wins FDA approval for use in older adults | Company Business News - Mint