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Moderna (MRNA) Initiates Rolling BLA Filing for RSV Vaccine

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Moderna (MRNA - Free Report) announced that it has started regulatory submissions in the United States, Europe and Australia, seeking approval for its respiratory syncytial virus (“RSV”) vaccine mRNA-1345 to prevent RSV-associated lower respiratory tract disease (“RSV-LRTD”) and acute respiratory disease (“ARD”) in older adults aged 60 years and above.

While management has initiated a rolling biologics license application (“BLA”) filing with the FDA for mRNA-1345, it has submitted a marketing authorization application for the same in the European Union, Australia and Switzerland.

If approved, this will be Moderna’s second marketed product. Currently, the only marketed product in the company’s portfolio is its COVID-19 vaccine, whose sales have started to plunge as the majority of the population across the globe has been immunized and governments across the world encourage their citizens to resume pre-pandemic behavior.

The regulatory filings are based on positive data from an interim analysis of the pivotal phase III ConquerRSV study. Data from the study showed that participants who received mRNA-1345 achieved vaccine efficacy of 83.7% against RSV-LRTD, defined by two or more symptoms of the disease in older adults. The vaccine also achieved 82.4% efficacy against RSV-LRTD, defined by three or more symptoms of the disease. mRNA-1345 was well tolerated and no safety concerns were identified.

Shares of Moderna have lost 31.2% year to date compared with the industry’s 10.2% decline.

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If approved, Moderna’s RSV vaccine will face stiff competition from GSK (GSK - Free Report) and Pfizer (PFE - Free Report) , which have recently received approvals from the FDA for their respective RSV vaccines, Arexvy and Abrysvo, to prevent RSV-LRTD in older adults. Last week, the U.S. Centers for Disease Control and Prevention (“CDC”) recommended both GSK and Pfizer RSV vaccines for older adults. The vaccines are expected to be launched during the upcoming fall season.

The FDA approval of GSK’s Arexvy and Pfizer’s Abrysvo was based on data from pivotal studies that evaluated these vaccines. The data supporting GSK’s vaccine showed overall vaccine efficacy of 82.6% against RSV-LRTD and the Pfizer vaccine achieved a vaccine efficacy of 85.7% against RSV-LRTD, as defined by three or more symptoms of the disease.

Pfizer and Moderna are also evaluating their vaccines for use in other patient populations. While Moderna is also evaluating mRNA-1345 in an ongoing phase I study in pediatric populations, a regulatory filing for Pfizer’s Abrysvo is already under review, seeking label expansion for use in pregnant individuals to prevent RSV-LRTD in infants from birth up to six months of age. A final decision is expected later this year, in August.

In separate news, Moderna reportedly signed a memorandum of understanding and a land collaboration agreement to research, develop and manufacture mRNA medicines in China. While a local Chinese media outlet reported that Moderna could make an investment worth $1 billion, a Reuters article also reported that any medicine developed under this agreement will be exclusive to China and “will not be exported.”

This investment is likely being made by Moderna with the intent to exploit market opportunities in China amidst the rising geopolitical tensions between the United States and China. Moderna has been keen on selling its COVID vaccine in China, but the country has been insisting on using Chinese-made vaccines for its population.

Being one of the most populous countries in the world, China is an attractive market for pharmaceuticals. The country houses an aging population that suffers from several harmful diseases.

Last month, a Financial Times article reported that AstraZeneca (AZN - Free Report) had similar concerns about the rising geopolitical risk between the two countries and has been engaged in drafting plans to spin off its China business and list it separately in Hong Kong. This will likely allow AstraZeneca to insulate itself politically from the Chinese government’s crackdown on foreign companies by making it a more plausibly domestic Chinese business. A domestic listing will also bolster the country’s support for AstraZeneca’s drug innovations and secure faster marketing approvals for therapies.

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Moderna currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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