Therapy Areas: Infectious Diseases
Moderna Initiates Rolling Submission of Biologics License Application with US FDA for the Moderna COVID-19 Vaccine
2 June 2021 - - US-based biotechnology company Moderna, Inc. (NASDAQ: MRNA) has initiated the rolling submission process with the US Food and Drug Administration for a Biologics License Application for the licensure of its mRNA COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older, the company said.

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. Once the rolling BLA submission is complete, FDA will notify the company when it is formally accepted for review.

The Moderna COVID-19 Vaccine is currently available in the US under an Emergency Use Authorization, which was granted on December 18, 2020. As of TODAY, according to the US Centers for Disease Control and Prevention, more than 124 m doses of the Moderna COVID-19 Vaccine have been administered in the US

The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases' (NIAID) Vaccine Research Center.

The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the National Institutes of Health on February 24, 2020, 42 days from sequence selection.

The first participant in the NIAID-led Phase 1 study of the Moderna COVID-19 Vaccine was dosed on March 16, 2020, 63 days from sequence selection to Phase 1 study dosing.

On May 12, 2020, the US FDA granted the Moderna COVID-19 Vaccine Fast Track designation. On May 29, 2020, the first participants in each age cohort were dosed in the Phase 2 study of the vaccine. On July 8, 2020, the Phase 2 study completed enrollment.

Results from the second interim analysis of the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were published on September 29, 2020 in The New England Journal of Medicine.

On November 30, 2020, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases.

On November 30, 2020, the company also announced that it filed for Emergency Use Authorization with the US FDA and a Conditional Marketing Authorization application with the European Medicines Agency. On December 18, 2020, the US FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older.

Moderna has also received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore, Qatar, Taiwan, the Philippines, Thailand, Brunei, Paraguay, Japan, South Korea, and an Emergency Use Listing from the World Health Organization.

Preclinical data on the company's variant-specific booster vaccine candidates have been submitted as a preprint to bioRxiv and will be submitted for peer-reviewed publication.

These variant-specific vaccine candidates include mRNA-1273.351, which is more specifically targeted against the SARS-CoV-2 variant known as B.1.351 first identified in the Republic of South Africa, and a multivalent booster candidate, mRNA-1273.211, which combines mRNA-1273 (Moderna's authorized vaccine against ancestral strains) and mRNA-1273.351 in a single vaccine. The company's Phase 2 study to evaluate three approaches to boosting is ongoing.

The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant secretary for Preparedness and Response within the US Department of Health and Human Services is supporting the continued research and development of the company's COVID-19 vaccine development efforts with federal funding under contract no. 75A50120C00034.

BARDA is reimbursing Moderna for 100% of the allowable costs incurred by the company for conducting the program described in the BARDA contract.

The US government has agreed to purchase supply of mRNA-1273 under US Department of Defense contract no. W911QY-20-C-0100.

Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.
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