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US FDA approves Moderna's RSV vaccine, its second marketed product
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US FDA approves Moderna's RSV vaccine, its second marketed product
May 31, 2024 8:36 AM

May 31 (Reuters) - The U.S. Food and Drug Administration

has approved Moderna's ( MRNA ) respiratory syncytial virus

(RSV) vaccine, the company announced on Friday, giving it a shot

at much-needed new revenue from a second product.

Moderna's ( MRNA ) vaccine was approved by the FDA for the prevention

of RSV-associated lower respiratory tract disease in adults aged

60 or older.

RSV, which produces symptoms similar to a cold but can be

fatal for young children and older adults, causes about 14,000

deaths annually in adults aged 65 and older.

The Cambridge, Massachusetts-based company has been banking

on its experimental shots to make up for vastly lower demand for

its Spikevax COVID-19 vaccine, its only marketed product.

Moderna's ( MRNA ) RSV shot is the first messenger RNA-based (mRNA)

vaccine not for COVID-19 to be approved in the United States. It

will be sold under the brand name mRESVIA

The company has said mRNA vaccines, which teach the body to

make specific proteins that the immune system can recognize and

attack, have the potential to treat multiple diseases and be

more effective than conventional shots.

"The FDA approval of our second product, mRESVIA, builds on

the strength and versatility of our mRNA platform," Moderna ( MRNA ) CEO

Stephane Bancel said in a statement.

Analysts on average forecast sales for Moderna's ( MRNA ) RSV vaccine

of $340 million in 2024, growing to $830.5 million next year,

according to LSEG data.

A panel of advisers at the U.S. Center for Disease Control

and Prevention (CDC) will vote next month on recommendations for

the vaccine's use and intended population.

A positive decision from the agency will allow Moderna ( MRNA ) to

compete in the U.S. fall vaccination campaign against market

leader GSK and Pfizer ( PFE ), which has badly lagged

its British rival since both launched their RSV shots last year.

GSK's Arexvy is currently approved in the U.S. for adults

aged 60 and over. British drugmaker has applied to extend the

approved age group to include adults aged 50-59.

Pfizer's ( PFE ) Abrysvo is approved for adults aged 60 and older,

as well as women at 32 through 36 weeks of pregnancy in order to

protect their infants at birth.

Moderna ( MRNA ) filed for FDA approval on data from a late-stage

trial that showed its vaccine was 83.7% effective at preventing

at least two symptoms of RSV, such as cough and fever.

The company's shares fell last February, after new data

showed faster declines in the efficacy of its RSV vaccine when

compared to the GSK and Pfizer ( PFE ) shots.

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