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Moderna seeks full FDA approval for its COVID-19 vaccine

Moderna's mRNA-based vaccine is currently authorised for emergency use in the US

Moderna is seeking a full US Food and Drug Administration (FDA) approval for its COVID-19 vaccine mRNA-1273, after gaining an emergency use authorisation (EUA) for the jab late last year.

Moderna’s mRNA-1273 vaccine became the second COVID-19 vaccine to be granted an FDA EUA, following Pfizer/BioNTech’s jab.

Pfizer/BioNTech have also already filed their mRNA-based COVID-19 vaccine with the FDA for full approval, announcing they had initiated this process last month.

In a statement, Moderna said it would continue to submit data to support the biologics license application for its vaccine on a rolling basis ‘over the coming weeks’, with the view of requesting a priority review.

“We are pleased to announce this important step in the US regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine,” said Stéphane Bancel, chief executive officer of Moderna.

“We look forward to working with the FDA and will continue to submit data from our phase 3 study and complete the rolling submission,” he added.

Moderna also announced this week that it has signed a new agreement with subcontractor Lonza to increase manufacturing of its COVID-19 vaccine at a new production line at the company’s Geleen site in the Netherlands

The new contract will enable Moderna to produce around 300 million doses each year, beginning at the end of 2021.

Moderna is already working with ROVI in Spain and Recipharm in France on fill/finish capacity for its vaccine in Europe.

In the US, the company is collaborating with Lonza Portsmouth for drug substance production and further partnerships with Catalent, Baxter BioPharma Solutions, Sanofi and Thermo Fisher Scientific for fill/finish services.

“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,” said Juan Andres, chief technical operations and quality officer, Moderna.

“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,” he added.

Article by
Lucy Parsons

2nd June 2021

From: Regulatory



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