The Food and Drug Administration approved updated COVID-19 boosters from Moderna and Pfizer, marking a major step towards the rollout of new vaccines for the fall.

The approved mRNA vaccines have been updated to include a monovalent component that corresponds to the Omicron variant XBB.1.5, which has been the dominant COVID strain spreading across the nation in recent weeks. 

This has led to an uptick in cases, especially breakthrough infections, though there hasn’t been an increase in hospitalizations or deaths like in previous spikes during the more than three-year pandemic.

The FDA approved individuals over the age of five to receive a single dose of the updated booster at least two months after receiving a previous COVID vaccine. Infants from six months to four years of age are eligible to receive one or two booster doses.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”

As for next steps, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet Tuesday to decide on a recommendation related to who should receive an updated vaccine.

It is expected that the updated boosters will be available for patients nationwide by the end of the week, just as many Americans make plans to get their annual flu shot. 

The CEOs of both companies released statements welcoming the FDA’s decision to greenlight the updates shots.

“COVID-19 remains a leading cause of death in the U.S. and poses a significant threat to vulnerable populations, particularly as we enter peak respiratory virus season. As the primary circulating strain continues to evolve, updated vaccines will be critical to protecting the population this season,” Moderna CEO Stéphane Bancel said in a statement. “We appreciate the FDA’s timely review and encourage individuals who intend to get their flu shot to also get their updated COVID-19 vaccine at the same time.”

Pfizer CEO Albert Bourla noted that the action comes as COVID cases are on the rise once again, albeit spiking at a smaller rate and with less hospitalizations than previous years.

“Now, most people 6 months or older in the U.S. are eligible to receive this season’s COVID-19 vaccine, even if they have never been vaccinated against COVID-19 before,” Bourla stated. “We expect this season’s vaccine to be available in the coming days, pending recommendation from public health authorities, so people can ask their doctor about receiving their COVID-19 vaccine during the same appointment as their annual flu shot, saving time now and helping to prevent severe disease later when respiratory viruses are at their peak.”