Second COVID-19 Vaccine Granted EUA, Ships for Immediate Use

31 December 2020

BioPharm International

Moderna’s mRNA vaccine to prevent COVID-19 disease is granted FDA Emergency Use Authorization and CDC recommendation.

Initial shipments of the second vaccine to prevent COVID-19 disease rolled out in the United States on Dec. 21, 2020, with frontline healthcare workers and patients and residents in long-term care facilities first in line to receive injections.

On Dec. 18, 2020, FDA issued an Emergency Use Authorization (EUA) for Moderna’s COVID-19 vaccine; on Dec. 19, 2020, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention’s recommended the use of the vaccine for individuals 18 years of age or older, allowing vaccinations to start immediately.

The messenger RNA vaccine received the EUA following review of Phase III clinical trial data that “provides clear evidence that the Moderna COVID-19 Vaccine may be effective in preventing COVID-19,” FDA reported in a statement. The vaccine is administered in two doses, one month apart.

Study results showed the vaccine was 94.1% effective in preventing COVID-19 disease among these clinical trial participants. Adverse reactions after the second dose included injection site pain, erythema, swelling, and ipsilateral lymphadenopathy. The majority of the adverse events were mild or moderate, Moderna reported in a company statement. However, there was a higher occurrence of severe reactions after the second injection.

Data are not available to determine how long the vaccine will provide protection, or if the vaccine prevents transmission of SARS-CoV-2 from person to person.

Moderna reported that the vaccine would be distributed immediately through the US government’s Operation Warp Speed.

Moderna reports that approximately 20 million doses will be delivered by the end of December 2020 and expects to have 100–125 million doses available globally in the first quarter of 2021, with 85–100 million of those available doses in the US.

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