The U.S. Food and Drug Administration (FDA) on Jan. 31 approved the Moderna COVID-19 vaccine, which will be marketed as Spikevax, for prevention of COVID-19 in individuals age 18 years and older. This is the second COVID-19 vaccine to receive FDA approval, following approval of the Pfizer-BioNTech vaccine in August 2021.

The approval is based on FDA's evaluation and analysis of follow-up safety and effectiveness data from the ongoing clinical trial that supported the December 2020 emergency use authorization (EUA) for the vaccine, as well as information from post-EUA experiences to inform safety and effectiveness. The analyses included 14,287 vaccine recipients and 14,164 placebo recipients age 18 years and older who had no evidence of SARS-CoV-2 infection before receiving the first dose. The results show the vaccine was 93% effective in preventing COVID-19, with 55 cases occurring in the vaccine group vs. 744 cases in the placebo group, and 98% effective in preventing severe disease. Data used in the analyses was gathered before the omicron variant emerged.

FDA's separate safety analysis included 15,184 vaccine recipients and 15,162 placebo recipients age 18 years and older, more than half of whom were followed for safety outcomes for a minimum of four months after receiving the second vaccine dose.

In addition, the FDA evaluated post-authorization surveillance data on myocarditis and pericarditis following vaccination and determined that data show increased risks particularly within seven days following the second dose. The observed risk was highest in males ages 18 to 24 years. Short-term follow-up suggest that symptoms resolved in most individuals, although some required intensive care support. The prescribing information for the vaccine will include a warning about these risks.

The FDA will require Moderna to conduct post-marketing studies to further assess the risks of myocarditis and pericarditis. These studies will include an evaluation of long-term outcomes of individuals who develop myocarditis following vaccination. Moderna also will conduct additional post-marking safety studies to look at pregnancy and infant outcomes among women who receive the vaccine while pregnant, although this is not an FDA requirement.

For more details, see the full FDA press release. Access additional guidance, as well as vaccination resources for patients and clinicians, on ACC's COVID-19 Hub.

Clinical Topics: Cardiovascular Care Team, Congenital Heart Disease and Pediatric Cardiology, COVID-19 Hub, Heart Failure and Cardiomyopathies, Pericardial Disease, Prevention, CHD and Pediatrics and Arrhythmias, CHD and Pediatrics and Prevention

Keywords: COVID-19, COVID-19 Vaccines, SARS-CoV-2, Pregnancy, Adolescent, Young Adult, Adult, United States Food and Drug Administration, Myocarditis, Vaccination, Critical Care, Pericarditis, ACC Advocacy

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