Today, the U.S. Food and Drug Administration approved a second COVID-19 vaccine. Moderna’s vaccine has met the FDA’s rigorous standards for safety, effectiveness and manufacturing quality required for approval. Moderna’s COVID-19 Vaccine has been available under emergency use authorization (EUA) for individuals 18 years of age and older since Dec. 18, 2020.
The FDA’s safety analysis of the Moderna vaccine included approximately 15,184 vaccine recipients and 15,162 placebo recipients 18 years of age and older. More than half of these participants were followed for safety outcomes for at least four months after the second dose. Approximately 7,500 participants originally assigned to receive the Moderna vaccine in the blinded phase of the clinical trial completed safety follow-up for at least 6 months after the second dose.
The most commonly reported side effects by clinical trial participants were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, nausea/vomiting, swollen lymph nodes under the arm and fever.
The FDA conducted its own benefit-risk assessment using modeling to predict how many symptomatic COVID-19 cases, hospitalizations, intensive care unit admissions and deaths from COVID-19 the vaccine in individuals 18 years of age and older would prevent versus the number of potential myocarditis/pericarditis cases, hospitalizations, ICU admissions and deaths that might be associated with the vaccine. FDA has determined that the benefits of the vaccine outweigh the risk of myocarditis and pericarditis in individuals 18 years of age and older.
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