Moderna submits BLA with FDA for COVID vaccine
pharmafile | June 2, 2021 | News story | Research and Development | COVID-19, EU, FDA, Lonza, Moderna, production
Moderna has initiated the rolling submission process with the FDA for a Biologics License Application (BLA) for the licensure of its mRNA COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.
The vaccine is currently available in the US under an Emergency Use Authorisation, which was granted in December 2020. As of today, according to the US Centres for Disease Control and Prevention (CDC), more than 124 million doses of the Moderna COVID-19 jab have been administered in the US.
Moderna will continue to submit data to support the BLA to the FDA on a rolling basis over the coming weeks with a request for a Priority Review.
Stéphane Bancel, Chief Executive Officer of Moderna, said: “We are pleased to announce this important step in the US regulatory process for a Biologics License Application of our COVID-19 vaccine. We look forward to working with the FDA and will continue to submit data from our Phase III study and complete the rolling submission.”
Moderna have also announced an additional agreement with Lonza to support drug substance manufacturing for its global supply chain.
The agreement will establish a new production line at Lonza’s Geleen site in the Netherlands, contributing to the supply of an additional 300 million doses of Moderna’s updated booster variant vaccine candidate per year, at a 50μg dose.
In a statement, Moderna said that they expect to be able to supply the equivalent of 600 million 50μg doses per year from production within the EU.
Juan Andres, Moderna’s Chief Technical Operations and Quality Officer, said: “We thank our manufacturing partners for their work and their commitment and are proud to be building on the strong foundations we have established with Lonza to further increase our manufacturing capabilities in Europe.
“This additional production will help us continue to scale up our production as we continue to develop best-in-class variant boosters so we can help end this pandemic as fast as possible.”
Kat Jenkins
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