FDA set to consider EUA for Moderna’s COVID-19 vaccine

Dec. 16, 2020

As U.S. Food and Drug Administration (FDA) vaccine advisors prepare to consider Moderna's COVID-19 vaccine for emergency use authorization (EUA) later this week, an agency review posted ahead of the meeting made a strong case, suggesting that a two-dose regimen was safe and 94 percent effective at preventing disease, according to news report from the Center for Infectious Disease Research and Policy (CIDRAP) at that University of Minnesota.

The FDA's 54-page report is a more detailed analysis of data that weren't in Moderna's initial efficacy findings, which it released on Nov 16. The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) meets on Dec 17. The FDA typically accepts the recommendations of its advisory committee.

According to the new documents, the vaccine was effective against severe disease; of 30 people with severe infections, none were in the group that received the vaccine. Like the Pfizer-BioNTech vaccine, the one from Moderna shows protection across a range of groups, including people of color, different ages, and both sexes. And similarly, temporary side effects were common, including fatigue, headaches, muscle aches, and injection-site tenderness.

However, additional data from Moderna suggest the vaccine may protect against asymptomatic infections, a key consideration in a vaccine's usefulness for preventing the spread of the virus to others. Impact on asymptomatic spread was a key question that came up in VRBPAC's consideration of the Pfizer-BioNTech vaccine, and experts say more research on the topic is needed.

Moderna's EUA application is for people ages 18 and older, which sidesteps issues the Pfizer-BioNTech vaccine faced in its bid for use in 16- and 17-year-olds, which were included in small numbers in its clinical trials. Another difference between the two vaccines is that Moderna's can be stored frozen in temperatures similar to a regular freezer, whereas the Pfizer-BioNTech vaccine requires super-cold freezer storage.

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