FDA Approves New COVID Vaccine Amid Surge in Summer Cases

WASHINGTON — The U.S. Food and Drug Administration (FDA) has approved an updated COVID-19 vaccine aimed at mitigating severe symptoms of the virus just in time for the cold and flu season. This decision, made public on Thursday, aligns with rising COVID-19 cases observed over the summer.

New booster shots from Moderna and Pfizer have been formulated to target currently circulating variants. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, emphasized that vaccination remains vital in preventing COVID-19. “These updated vaccines meet the agency’s rigorous standards for safety, effectiveness, and manufacturing quality,” Marks stated. He further urged eligible individuals to consider getting vaccinated due to waning immunity from prior infections and vaccinations.

As schools reopen across the U.S., wastewater surveillance, which has shown an upward trend since early May, may see further increases. Additionally, emergency department visits related to COVID-19 began escalating in May. Although the mortality rate declined through the first half of the year, data from the Centers for Disease Control and Prevention indicates a slight uptick in June.

Regarding pediatric vaccinations, the FDA has approved the updated Pfizer-BioNTech vaccine for unvaccinated children aged six months to four years, with three doses required. Those who have previously received a COVID-19 vaccine can receive one or two doses of the updated vaccine, depending on their prior vaccination schedule. Children aged five to eleven can obtain a single dose of the updated vaccine, while those previously vaccinated must wait a minimum of two months since their last shot.

For individuals over the age of 12, one dose of the updated vaccine is available if they have been previously vaccinated, also requiring a two-month waiting period since their last dose. Pfizer announced that its vaccine will begin shipping immediately, making it available in pharmacies, hospitals, and clinics across the United States in the coming days. Moderna similarly anticipates that its updated vaccine will be accessible in various healthcare settings shortly.