Moderna today will officially file for emergency use authorization from the U.S. Food and Drug Administration for its COVID-19 vaccine. The company made the announcement alongside updating its vaccine efficacy rating from its phase 3 trial.
An emergency use authorization (EUA) is a mechanism that allows drugs, vaccines, and other medical interventions to come to market much quicker than they normally would. As the FDA explains, “Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.”
Moderna’s EUA request comes just a week after Pfizer requested an EUA for its own COVID-19 vaccine. Pfizer’s EUA still has to be ruled on, though both its vaccine and Moderna’s could be given approval in as little as a few weeks. Once Moderna’s or Pfizer’s EUA has been granted, the respective company can begin distributing vaccines to the public.
In addition to announcing that it will file for an EUA today, Moderna also noted that the efficacy rating of its vaccine has been slightly adjusted. Previously the company said the vaccine had an efficacy rating of 94.5%. That rating now stands at 94.1% after further testing.
Announcing Moderna’s EUA request, Moderna CEO Stéphane Bancel said, “This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations, and death.”
However, even if Moderna’s EUA is approved, it could be a while before the average American receives the vaccine. If the EUA is approved, up to 20 million doses could be given by the end of December. Those doses will likely be reserved for the front-line medical workers who risk their lives every day treating COVID-19 patients. Moderna says it expects to manufacture 500 million to 1 billion doses of its vaccine globally in 2021.
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