FDA approves first mRNA vaccine against respiratory syncytial virus
最近審查：14.06.2024
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The FDA has approved the world's first mRNA-1345 vaccine (mRESVIA) against respiratory syncytial virus (RSV) for people 60 years of age and older to protect against lower respiratory tract disease, Moderna said in a press release.
“The FDA approval... Is based on the strength and versatility of our mRNA platform,” said Stéphane Bancel, CEO of Moderna, in a press release, noting that this is the first time an mRNA vaccine has been approved for a disease different from COVID-19.
The vaccine will be Moderna's second commercial product, along with the SARS-CoV-2 mRNA vaccine (Spikevax).
FDA approval of the mRNA-1345 vaccine is based on results from the phase 3 ConquerRSV study. The study included approximately 37,000 adults aged 60 years and older and found the mRNA-1345 vaccine to be 83.7% (95.88% CI 66%-92.2%) effective in preventing lower respiratory tract disease associated with RSV when at least two signs or symptoms are present. The vaccine was equally effective (82.4%) against lower respiratory tract disease with at least three signs or symptoms (96.36% CI 34.8%-95.3%).
Systemic adverse reactions were more common in those who received the vaccine compared with the placebo group (47.7% vs. 32.9%), with the most common being fatigue, headache, myalgia and arthralgia. Serious adverse events occurred in 2.8% of participants in both groups. Most reactions were mild or moderate in severity and were temporary. Less than 0.1% of reactions were determined to be related to the vaccine.
Results from a follow-up analysis of the study's primary endpoint, conducted during the FDA review, were consistent with the primary analysis, according to the press release. Additional long-term analysis also showed continued protection against RSV-associated lower respiratory tract disease over a mean follow-up period of 8.6 months.
The mRNA-1345 vaccine is expected to be available in the United States for the 2024-2025 respiratory virus season, according to the manufacturer, and will be available in a prefilled syringe to improve ease of administration and reduce the risk of administration errors.
The vaccine consists of an mRNA sequence encoding a stabilized preconfluent F glycoprotein, since preconfluent F glycoprotein is the primary target for neutralizing antibodies and is highly conserved between both RSV-A and RSV-B subtypes. The vaccine also uses the same lipid nanoparticles as the Moderna-1273 mRNA vaccine.
In 2023, the FDA approved two non-mRNA vaccines—one from Pfizer (Abrysvo) and one from GSK (Arexvy)—that can also be used in older adults. The Pfizer vaccine is also approved for pregnant women to protect newborns from the virus.