Moderna Inc. requests authorization for COVID-19 vaccine

Moderna Inc. requests authorization of emergency use for the coronavirus (COVID-19) vaccine with regulators in the U.S. and Europe. This request follows the exciting and promising results of the COVID-19 vaccine trials proving 94% effective in the final analysis of the Phase 3 trial.

Moderna’s Phase 3 trial included nearly 30,000 volunteers with 196 patients developing COVID-19 but a majority of these cases were observed in the placebo group. These promising results were the final step Moderna needed before applying for emergency use of the COVID-19 vaccine with U.S. and European regulators.

BREAKING NEWS: Moderna to file for emergency FDA approval in the race for a vaccine. https://t.co/iplMX9Br3V pic.twitter.com/0kGIy0APxR

— Good Morning America (@GMA) November 30, 2020

The Moderna vaccine will be available in shot form and the study results prove that this vaccine offers strong protection against COVID-19. Moderna is the third pharmaceutical company to apply for emergency vaccine use with Pfizer and BioNTech applying for emergency use on Nov. 20 in the U.S. as well as the UK who is also assessing the AstraZeneca vaccine.

The next step of the FDA approval process is to hold a public debate with scientific advisors on the evidence of each participating candidate for the study. Once approved, Moderna expects to have 20 million doses ready for the U.S. by the end of 2020 with recipients will need two doses and will ultimately provide enough for 10 million patients.

The manufacturing process has already begun and Moderna is ready to start sending out shipments of the vaccine within 24 hours of FDA clearance. A separate panel of U.S. experts designated by the Center for Disease Control and Prevention (CDC) will create a strategy for the distribution of who will receive the initial supplies first.

The initial distribution plan will reserve some doses for health care workers, then the elderly and long-term care facility residents. If everything goes according to plan and the vaccine is approved, Moderna Inc. will be able to provide enough of the vaccine for the general public by Spring 2021.