FDA authorizes Moderna COVID-19 vaccine for emergency use in the US

By Jane Byrne contact

- Last updated on GMT

© GettyImages/mirsad sarajlic
© GettyImages/mirsad sarajlic

Related tags: EUA, Vaccine, European union, COVID-19

The US Food and Drug Administration (FDA) has authorized emergency use of Moderna’s vaccine against COVID-19, mRNA-1273, in individuals who are 18 years of age or older.

Following the announcement on Friday [December 18], Moderna said delivery to the US government would begin immediately.

Approximately 20 million doses will be delivered to the authorities by the end of December 2020. Moderna said it expects to have between 100 million and 125 million doses available globally in the first quarter of 2021, with 85-100 million of those available in the US.

Under the US vaccine development and distribution project, Operation Warp Speed, the US Department of Defense (DoD), in partnership with the US Department of Health and Human Services (HHS) and the US Centers for Disease Control and Prevention (CDC), will manage allocation and distribution of the vaccine in the US. 

It is up to the CDC’s Advisory Committee on Immunization Practices (ACIP) to identify priority population groups for inoculation with the vaccine. 

The authorization for the US manufactured mRNA-1273 comes one week after the FDA granted EUA for the Pfizer/BioNTech vaccine, which is now being distributed in the US.

BLA filing 

Moderna said it would continue to gather additional data and plans to file a Biologics License Application (BLA) with the FDA requesting full licensure for mRNA-1273 in 2021.

Stéphane Bancel, CEO, Moderna, commenting on EUA for the vaccine, said: “We were able to create and manufacture the Moderna COVID-19 Vaccine in 11 months from sequence to authorization, while advancing clinical development with a Phase 1, Phase 2 and pivotal Phase 3 study of 30,000 participants. It has been a 10-year scientific, entrepreneurial and medical journey and I am thankful to all those who have helped us get here today. We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease.”

Evaluation

The FDA based its recommendation for EUA for mRNA-1273 on the totality of scientific evidence shared by Moderna, including a data analysis from the pivotal Phase 3 clinical study announced on November 30. The primary efficacy analysis conducted on 196 cases indicated a vaccine efficacy rate of 94.1%.

The most common solicited adverse reactions (ARs) after the two-dose series included injection site pain (88.2%), erythema (8.6%), swelling (12.2%), and ipsilateral lymphadenopathy (14.2%).

While the majority of these ARs were grade 1 (mild) or grade 2 (moderate), there was a higher occurrence of grade 3 (severe) reactions after the second injection, reported the company. The majority of local solicited ARs occurred within the first one to two days after injection and generally persisted for one to two days. 

Related topics: Markets & Regulations, COVID-19

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