Research & Development
US FDA Authorizes Up To 15-Doses Per Vial of Moderna COVID-19 Vaccine
5 April 2021 - - The US Food and Drug Administration has authorized US-based biotechnology company Moderna, Inc's (NASDAQ: MRNA) COVID-19 Vaccine to be kept at room temperature conditions once removed from the refrigerator for administration for 24 hours, an increase from the previous 12 hours, the company said.

Additionally, a punctured vial is now useable for up to 12 hours, an increase from the previous six hours.

These new guidelines are reflected in an updated Emergency Use Authorization label. The Moderna COVID-19 Vaccine is ready for use and does not need to be diluted.

Moderna said FDA made its decision based on submitted stability data.

The FDA also authorized inclusion of a new vial presentation with a maximum of 15 doses of its COVID-19 vaccine. In parallel, the FDA also authorized a maximum of 11 doses of its COVID-19 vaccine in the current format, from the previously authorized 10 doses per vial.

The Moderna COVID-19 Vaccine now can be supplied in two vial presentations (a multiple-dose vial containing a maximum of 11 doses or a multiple-dose vial containing a maximum of 15 doses). The company expects that the 15-dose vials will begin shipping in the coming weeks.

Moderna is continually learning, adapting and working closely with its partners and the US government to identify ways to facilitate accelerated vaccine administration, address bottlenecks and accelerate production.

One identified constraint on the production process has been the capacity of the fill-and-finish process. Moderna studied the possibility of adding more doses to each vial of vaccine to address bottlenecks, accelerate production and reduce the need for consumable materials that are in high demand.

Moderna will continue to collaborate with its manufacturing partners and the federal government to increase the efficiency of its production process without compromising quality or safety.

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 authorization for its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore and Qatar. Additional authorizations are currently under review in other countries and by the World Health Organization.

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.