Moderna submits global regulatory submission for respiratory vaccine

(Alliance News) - Moderna Inc on Wednesday said it submitted a marketing authorisation ...

Alliance News 5 July, 2023 | 12:27PM
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(Alliance News) - Moderna Inc on Wednesday said it submitted a marketing authorisation application for the investigational respiratory syncytial virus vaccine mRNA-1345, with the European Medicines Agency, Swissmedic, and the Therapeutic Goods Administration in Australia.

Moderna, the Cambridge, Massachusetts-based pharmaceutical and biotechnology company focused on ribonucleic acid therapeutics, said that mRNA-1345 is an investigational respiratory syncytial virus vaccine that consists of a single mRNA sequence encoded to stabilise prefusion F glycoprotein.

The vaccine uses the same lipid nanoparticles as in the Moderna Covid-19 vaccines.

The company said that the regulatory applications were based on positive data from a prespecified interim analysis of the vaccine.

Moderna also announced that it had initiated a rolling submission of a biologics licence application to the US Food & Drug Administration for MRNA-1345.

"We are proud to announce these filings for the use of our RSV vaccine candidate, mRNA-1345, in the EU, Switzerland, Australia, and the US. RSV is a major cause of lower respiratory tract infections in older adults and can cause a significant burden to health systems through hospitalisations and emergence care admissions," said Chief Executive Officer Stephan Bancel.

"mRNA-1345 represents the second product coming from our mRNA platform to seek global approval, and with recent positive data in rare disease and cancer, we expect more in future - further demonstrating the tremendous potential of mRNA to combat disease."

The announcement of regulatory submission followed the news on Monday that the company had submitted regulatory filing to the European Medicines Agency for an updated Covid-19 vaccine.

Shares in Moderna were up 1.3% in pre-market trading at USD123.30 in New York on Wednesday morning.

By Will Neill, Alliance News reporter

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Security Name Price Change (%) Morningstar
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Moderna Inc 131.65 USD 2.01

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