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Coping with COVID: Moderna prepares to apply for FDA authorization of COVID-19 vaccine today

Upon completion of its Phase 3 trial, Massachusetts-based Moderna has announced plans to ask the Food and Drug Administration on Monday for emergency use authorization of its COVID-19 vaccine candidate, which it claims to be 94.1 percent effective.

Following the lead of Pfizer, Moderna will now be the second company to submit its COVID-19 vaccine for approval from the Food and Drug Administration (FDA).

The Massachusetts-based biotechnology company has since finished its Phase 3 trials and said it will be submitting its vaccine today, asking for emergency use authorization.

Moderna claims its trials found its version of the COVID-19 vaccine to be 94.1 percent effective. It also said the vaccine is 100 percent effective at preventing severe cases of COVID-19 with no serious side effects.

Moderna said it expects the FDA’s Vaccines and Related Biological Products Advisory Committee to convene on Dec. 17 to discuss its submission. That is a week after the FDA is expected to discuss another candidate, developed by the U.S. pharma giant Pfizer and its German partner BioNTech, which has also applied for regulatory approval having observed a similar level of efficacy.

Both the Moderna and Pfizer-BioNTech drugs involve inserting special code called mRNA into the body, tricking it into developing an immune response. No mRNA-based drug has ever won approval before.