The pharmaceutical company Moderna has finished its primary evaluation of its COVID-19 vaccine’s effectiveness, based on the Phase 3 clinical trial. The analysis revealed a 94.1% success rate in preventing individuals from becoming infected with COVID-19, considering 196 verified instances among the 30,000 people participating in the study. Moderna also determined the vaccine to be 100% effective in averting severe illness, including cases needing hospitalization, and reported no substantial safety issues throughout the trial process. Based on these findings, the company plans to request emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) on Monday.

Requesting an EUA represents the subsequent phase in making Moderna’s COVID-19 vaccine accessible for distribution and administration. If the authorization is granted, the vaccine can be administered to those at highest risk in environments where it could reduce fatalities, such as frontline healthcare professionals, prior to receiving complete and definitive regulatory clearance from the U.S. health oversight agency. Moderna will also pursue conditional marketing authorization from the European Medicines Agency, allowing for comparable application within the EU.

Moderna’s vaccine utilizes mRNA technology, delivering genetic instructions to the body to stimulate the creation of potent antibodies. These antibodies work to block the areas on cells that COVID-19 uses to cause infection. This is a comparatively recent therapeutic strategy for human application, but it holds the potential to offer even greater protection against COVID-19 than naturally produced antibodies, without the risks linked to introducing any form of the virus – whether live or inactive – to trigger an immune response.

In mid-November, Moderna initially announced a 94.5% efficacy rate for its COVID-19 vaccine based on preliminary data. This conclusive analysis of the same data closely aligns with the initial findings, which is encouraging for those anticipating an effective solution becoming available shortly. This data is currently awaiting peer review, but Moderna intends to submit the Phase 3 study results to a scientific journal for that purpose.

Moderna’s vaccine development is part of the U.S.’s Operation Warp Speed initiative, designed to accelerate the creation, manufacturing, and delivery of a COVID-19 vaccine. This program was launched earlier this year in response to the unprecedented pandemic. Other vaccine candidates, including one developed by Pfizer in collaboration with BioNTech, and another from Oxford University/AstraZeneca, are also progressing through Phase 3 trials and preparing for emergency approval and use. Pfizer has already submitted its EUA application to the FDA, while the Oxford vaccine is expected to delay its U.S. application until it finishes another round of testing following the discovery of a dosage error in its initial trial – which unexpectedly resulted in promising efficacy outcomes.