Moderna Submits Biologics License Application to US FDA for its Covid-19 Vaccine


The company ‘Moderna Inc.’, announced that, it has successfully completed the submission process for the company’s Biologics License Application (BLA) to the US FDA for the purpose of getting full licensure of the novel corona virus vaccine developed by Moderna for the active immunization of the people for preventing the spread of the virus in the people above 18 years of age.

As a part of the submission, the company has also requested for the designation of the Priority Review, and Stephane Bancel, CEO of Moderna said, this Biologics License Application (BLA) submission for their novel corona virus vaccine, which they have started in June 2021, has been an important milestone in their battle against the corona virus and for the company, as this has been the first Biologics License Application submission in their history.

He also said, they are pleased that, their novel corona virus vaccine has been on the very front lines in the fight against the corona virus, and he would again like to thank their partners, who have been responsible for helping the company to advance the clinical development of their mRNA corona virus vaccine.

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He added that, he would also like to thank the US FDA for all their guidance and hard work through the process of the Biologics License Application (BLA) submission along with the whole team of Moderna for the relentlessness of the team for the purpose of pursuing their mission of delivering on the promise of the science of mRNA.