- For Immediate Release:
Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.
“The country is in the middle of a wave of the highly contagious omicron variant, which spreads more rapidly than the original SARS-CoV-2 virus and other variants that have emerged,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Vaccination is our best defense against COVID-19, including the circulating variants, and shortening the length of time between completion of a primary series and a booster dose may help reduce waning immunity. Today’s action also brings consistency in the timing for administration of a booster dose among the available mRNA vaccines. We encourage everyone to get vaccinated—it’s never too late to get your COVID-19 vaccine or booster.”
The most commonly reported side effects by individuals who received a booster dose of the Moderna COVID-19 Vaccine after completion of a two-dose primary series were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain and chills. The fact sheets for recipients and caregivers and for healthcare providers include information about the potential side effects, as well as the risks of myocarditis and pericarditis.
The amendment to the EUA was granted to ModernaTx Inc.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- FDA Office of Media Affairs