FDA Grants EUA to Moderna COVID-19 Vaccine

The FDA has granted emergency use authorization (EUA) to Moderna’s vaccine candidate for coronavirus disease 2019 (COVID-19) for use in individuals 18 years of age and older.¹

The Moderna messenger RNA (mRNA) vaccine is the second vaccine to be authorized by the FDA for tackling the COVID-19 pandemic that began to surge in early March.

On Thursday, in a vote 20-0 with 1 abstention, a panel of advisors to the FDA recommended the mRNA COVID-19 vaccine. The decision closely trails the authorization of the Pfizer-BioNTech vaccine, which was authorized last Friday.² Both the Pfizer-BioNTech and the Moderna vaccines for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) must be administered in 2 injections.

Related: FDA Grants EUA to Pfizer/BioNTech COVID-19 Vaccine

The EUA was based on Moderna’s phase 3 COVE study showing an efficacy rate of 94.1% and an efficacy rate of 100% against severe COVID-19 cases. The study, which included approximately 30,000 individuals receiving either 2 vaccine doses or 2 placebo doses, showed the most frequent adverse reactions to be injection site pain, fatigue, myalgia, arthralgia, headache, and redness at the injection site, according to researchers.¹

Following authorization for the Pfizer-BioNTech vaccine in the United Kingdom and subsequently in the US, there have been reports of severe allergic reactions to its vaccine: at least 2 incidents in the UK last week and 1 in Alaska on Tuesday.³ The FDA has affirmed that it is closely monitoring these reactions and confirmed that there are no new restrictions on administering the vaccine at this time.

The FDA authorization comes in tandem with all-time high COVID-19 case and hospitalization counts in the US, with cases and hospitalizations reaching upwards of 17,004,147 and 114,237 at press time, respectively. This week, Vice President Mike Pence received a dose of the Pfizer-BioNTech vaccine at a televised event in order to boost public confidence and uptake of the vaccine once widely available, most likely in spring 2021. Coronavirus-related deaths in the US have surpassed 300,000 as of this week.^3,4

References

1. FDA Takes Additional Action to Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine. News release. FDA; December 18, 2020. Accessed December 18, 2020. https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid

2. Hensley S. FDA Panel Recommends Moderna’s COVID-19 For Emergency Use. NPR; December 17, 2020. Accessed December 18, 2020. https://www.npr.org/sections/health-shots/2020/12/17/947264730/fda-panel-weighs-modernas-covid-19-vaccine.

3. Johnson CY, Achenback J. FDA investigating rare allergic reactions to Pfizer coronavirus vaccine, but says rollout will continue. The Washington Post; December 17, 2020. Accessed December 18, 2020. https://www.washingtonpost.com/health/covid-vaccine-allergic-reactions/2020/12/17/a8490340-409d-11eb-8bc0-ae155bee4aff_story.html.

4. The COVID Tracking Project. The Atlantic; December 17, 2020. Accessed December 18, 2020. https://covidtracking.com/data.