The FDA has previously approved the Pfizer-BioNTech COVID-19 vaccine (now marketed as Comirnaty) in August of last year for those ages 16 and up. The Moderna vaccine has been available under emergency use authorization (EUA) for individuals 18 or older since December 18, 2020. Latest figures from the Centers for Disease Control and Prevention (CDC) show that more than 74.5 million American have already received two doses of the Moderna inoculation. (More than 120 million have received the full regimen of the Pfizer vaccine, which uses similar mRNA technology as Moderna.) RELATED: Get Up-to-Date COVID-19 News in the Daily Coronavirus Alert The FDA moved ahead with approval after assuring that the Moderna shot met the agency’s rigorous standards for safety, effectiveness, and manufacturing quality required for approval. “The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness, and manufacturing quality required of any vaccine approved for use in the United States,” said acting FDA Commissioner Janet Woodcock, MD, in a statement. “While hundreds of millions of doses of Moderna COVID-19 vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated.” Recent analysis to determine the effectiveness of Spikevax involved 14,287 vaccine recipients and 14,164 placebo recipients 18 years of age and older who did not have evidence of infection prior to receiving the first dose. Although data was collected before the omicron variant emerged, the outcomes showed that Spikevax was 93 percent effective in preventing COVID-19, with just 55 cases of COVID-19 occurring in the vaccine group and 744 COVID-19 cases in the placebo group. Perhaps, most importantly, the investigation found the Moderna vaccine to be 98 percent effective in preventing severe disease. One of the concerns surrounding the Moderna vaccine that may have delayed approval have been reports suggesting the vaccine might cause heart problems in some adolescents — and the FDA is still assessing study related to this issue in those under age 18. In granting this approval, the agency recognized that there was increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following vaccination, particularly within seven days following the second Moderna dose. The highest risk was observed in males 18 through 24 years old, and some individuals required intensive care support. After completing a comprehensive review of the data, federal scientists determined that the benefits of the vaccine outweigh the risks of these heart problems in individuals 18 years of age and older. “Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death. The totality of real-world data and the full BLA [biologics license application] for Spikevax in the United States reaffirms the importance of vaccination against this virus. This is a momentous milestone in Moderna’s history as it is our first product to achieve licensure in the U.S.,” said Stéphane Bancel, chief executive officer of Moderna in a statement. “The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the U.K., Israel, and other countries where the adolescent indication is also approved. We are grateful to the U.S. FDA for their thorough review of our application. We are humbled by the role that Spikevax is playing to help end this pandemic.”
