Emergency Use Authorization Granted to Moderna’s COVID-19 Vaccine

December 21, 2020 – The U.S. FDA has granted Emergency Use Authorization (EUA) to Moderna for a vaccine to prevent COVID-19 caused by the SARS-CoV-2 virus in individuals who are least 18 years old. In clinical studies, Moderna’s vaccine was found to be 94.1% effective. Distribution of the vaccine in the U.S. began on December 21, 2020.

Though not equivalent to full FDA approval, an EUA does allow for the use of unapproved products to diagnose, treat, and/or prevent disease when there is a public health emergency and no available adequate, approved alternative. The FDA believes, based on the current scientific evidence, that the potential benefits of Moderna’s vaccine outweigh the potential risks.

Recommended dosing for Moderna’s COVID-19 vaccine is two doses given one month apart. Failure to administer the second dose according to FDA and manufacturer guidelines can compromise the vaccine’s efficacy. Moderna has submitted a pharmacovigilance plan to the FDA to monitor the safety of the vaccine. The plan includes provisions for longer-term safety follow up for participants in ongoing clinical trials, and other activities aimed at monitoring the safety profile of the vaccine.

The federal government is currently covering the medication costs for the Moderna vaccine, which is considered preventive care under the Affordable Care Act (ACA). As such, the vaccine must be covered at a $0 copayment under the medical and/or prescription benefit for members of ACA plans that are required to provide preventive care vaccine coverage. Plan sponsors are expected to cover the administration costs of the vaccine, which have been set by the U.S. government at $16.94 for the first dose and $28.39 for the second.

Because supplies of the vaccine are limited, distribution and administration are being managed by state and local healthcare agencies according to guidelines from the U.S. Centers for Disease Control and Prevention (CDC). United States residents are being vaccinated in phases, with high-risk populations including frontline healthcare workers receiving the vaccine first. COVID-19 vaccination is not expected to be available to the general population until spring of 2021 at the earliest.