Moderna announces global regulatory submissions for its respiratory syncytial virus (rsv) vaccine, mrna-1345
Moderna has submitted marketing authorization applications for the investigational rsv vaccine, mrna-1345, with the european medicines agency, swissmedic, and the therapeutic goods administration in australia the company has also initiated a rolling submission of a biologics license application to the u.s. food and drug administration for mrna-1345 mrna-1345 met primary efficacy endpoints, demonstrating vaccine efficacy of 83.7% against rsv lower respiratory tract disease in older adults in the phase 3 pivotal efficacy trial, conquerrsv the company plans further regulatory submissions for mrna-1345 worldwide cambridge, ma / accesswire / july 5, 2023 / moderna, inc. (nasdaq:mrna), a biotechnology company pioneering messenger rna (mrna) therapeutics and vaccines, today provided an update on regulatory submissions for mrna-1345, a vaccine for the prevention of rsv-associated lower respiratory tract disease (rsv-lrtd) and acute respiratory disease (ard) in adults aged 60 years or older. the company has submitted marketing authorization applications for mrna-1345 with the european medicines agency (ema), swissmedic in switzerland, and the therapeutic goods administration (tga) in australia and has initiated the rolling submission process for a biologics license application (bla) to the u.s. food and drug administration (fda) for the licensure of the mrna-based rsv vaccine.
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