FDA Panel Recommends EUA for Moderna’s COVID-19 Vaccine

The Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee has voted in favor of granting Emergency Use Authorization (EUA) to Moderna’s coronavirus 2019 (COVID-19) vaccine, mRNA-1273.

The EUA recommendation was based on data from the placebo-controlled COVE study that investigated the efficacy and safety of mRNA-1273 in more than 30,000 adults aged 18 years and older. Results as of November 21, 2020 showed that the vaccine was 94.1% effective based on 196 confirmed cases, of which 185 occurred in the placebo group and 11 occurred in the mRNA-1273 group.

When stratified by age, vaccine efficacy was found to be 95.6% for participants 18 to less than 65 years of age and 86.4% for participants 65 years and older. The data also included 30 severe cases, all of which were among participants in the placebo group. The most common solicited adverse reactions reported included injection site pain and erythema/redness, fatigue, myalgia, arthralgia, and headache.

Based on these findings, the panel voted 20 yes and 0 no on whether the totality of the available scientific evidence supports the effectiveness of the vaccine in preventing COVID-19 in individuals 18 years of age and older; 1 member abstained. The committee concluded that the potential benefits of the vaccine outweigh its known and potential risks.

In meeting documents, it was noted that more data will be needed to determine the duration of protection, the effectiveness of the vaccine in certain populations at high risk of severe disease (ie, patients with HIV/AIDS),  as well as in those with prior SARS-CoV-2 infection. Additionally, no data are available on the efficacy of the vaccine in children 17 years of age and younger. Vaccine effectiveness against asymptomatic infection, long-term effects of COVID-19 disease, mortality, and transmission also remain unclear at this time.

The mRNA-1273 (100μg) vaccine is administered intramuscularly as a series of 2 doses (0.5mL each), given 28 days apart. The product is supplied as a preservative-free frozen suspension in multi-dose vials containing 10 doses. Unlike the Pfizer/BioNTech vaccine, which requires storage conditions of -70°C, unopened vials of mRNA-1273 vaccine remain stable at 2° to 8°C (36° to 46°F) for up to 30 days, -20° C (-4°F) for up to 6 months, and at room temperature for up to 12 hours.

Although not bound by the committees’ recommendations, the FDA does take them into consideration when making decisions on approval. Following the meeting, the Agency announced that it “will rapidly work toward finalization and issuance of an Emergency Use Authorization.”

References

1. Moderna receives FDA advisory committee vote supporting emergency use for Moderna’s vaccine against COVID-19 in the United States. [press release]. Cambridge, MA: Moderna; December 17, 2020.
2. FDA statement on vaccines and related biological products advisory committee meeting. [press release]. Silver Spring, MD: US Food and Drug Administration; December 17, 2020.

This article originally appeared on MPR