FDA advisors recommend Moderna COVID-19 vaccine for emergency use

Dec. 18, 2020

An outside expert panel for the Food and Drug Administration (FDA) recommended emergency use authorization (EUA) for Moderna's COVID-19 vaccine, putting the nation on the cusp of having two COVID-19 vaccines and expanding the reach of immunization campaigns, according to a news report from Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota.

The main question before the group was whether the benefits outweigh the risks in people ages 18 and older. The measure passed with 20 yes votes, 0 no votes, and 1 abstention. The FDA usually follows the recommendations of its Vaccines and Related Biological Products Advisory Committee (VRBPAC), and the FDA has signaled that it would quickly make its approval decision.

Though both the Moderna and the earlier approved Pfizer-BioNTech vaccines are messenger RNA (mRNA) vaccines, they have some differences and are not interchangeable. Both are highly effective in the 95 percent range, but their mRNA molecules are different and their lipid nanoparticle delivery systems have different components. The Moderna vaccine can be stored in normal freezer conditions, unlike the Pfizer-BioNTech vaccine, which requires supercold storage.

Moderna studied its vaccine in people ages 18 and older, whereas Pfizer-BioNTech vaccine trials included 16- and 17-year-olds, which was a sticking point in VRBPAC deliberations last week for the first vaccine. Both vaccines are administered as two doses, but Moderna's vaccine is given as 100-microgram doses 4 weeks apart, and the Pfizer-BioNtech vaccine is given as 30-microgram doses given 3 weeks apart. The vaccines have similar side effect profiles.

The EUA, once finalized by the FDA, will allow Moderna's vaccine to be shipped to states, but the immunization in people can't begin until the Centers for Disease Control and Prevention (CDC) recommends it. The CDC's vaccine advisory group meets on December 19 to make its recommendation, which the CDC typically approves.

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