GlaxoSmithKline and Pfizer are also developing RSV vaccines -- and the FDA is expected to decide in a few months whether to approve their shots
Moderna's disclosure this week that its respiratory syncytial virus vaccine prevented most infections in older adults in a clinical trial further sets the stage for a competitive new market ahead of next winter's cold season.
The company's stock (MRNA) gained 3.6% in trading on Wednesday, the day after Moderna said in a news release that its experimental RSV vaccine had an efficacy rate of 83.7% in adults 60 and older. The full data set is expected to be shared at an unnamed medical meeting in the future.
Moderna tested the vaccine candidate in a randomized, double-blind, placebo-controlled Phase 3 clinical trial that enrolled 37,000 older adults in 22 countries, including the U.S. No safety concerns were reported. The most common adverse events were pain at the injection site, fatigue, headache and muscle aches.
The company said it plans to submit the vaccine to the Food and Drug Administration for regulatory approval in the first half of this year. Wall Street expects approval in 2024.
There are currently no RSV vaccines for adults or children, but the attention brought to vaccine development, including messenger RNA technology, as a result of the COVID-19 pandemic revitalized interest in RSV vaccines in what could be a $5 billion market. Though RSV causes regular cold symptoms in most people, it's of particular concern when it comes to infants, who breathe exclusively through their noses, and older adults, who are at a higher risk of developing lung infections or pneumonia. Up to 10,000 adults die every year from RSV infections, according to the Centers for Disease Control and Prevention.
Three shots so far have produced data that indicates they can prevent infection in adults older than 60 years old. The FDA is expected to make a decision whether to approve the investigational RSV vaccines developed by GSK and Pfizer in May. J&J's shot is currently in a Phase 3 clinical trial.
Moderna may use its Priority Review voucher to speed up the review process for its RSV vaccine. That would mean the company gets to participate in the 2024 contracting decision, according to SVB Securities analyst Mani Foroohar, who on Tuesday raised Moderna's price target to $111 from $102 based on the new RSV data.
"This is a milestone for MRNA's pipeline beyond COVID in demonstrating the competitive efficacy of mRNA vaccines," UBS Securities analysts told investors.
Moderna's first and only approved therapy is Spikevax, its COVID-19 vaccine. The company's stock has gained 5.4% over the past year, while the broader S&P 500 is down 14.4%.
(END) Dow Jones Newswires
January 18, 2023 12:30 ET (17:30 GMT)
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