FDA Approves Updated Covid-19 Booster Shots From Pfizer and Moderna



Courtesy of bu.edu/Janice Checchio
The U.S. Food and Drug Administration on Monday announced the approval of updated Covid-19 boosters from Pfizer and Moderna for emergency use.
The updated vaccines should be available later this week, pending guidance from the Centers for Disease Control and Prevention on who will be eligible to receive them. They are scheduled to meet Tuesday.
“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “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.”
According to the FDA, anyone age 5 or older regardless of vaccination history can receive a booster shot at least two months after a previous vaccination.
Those 6 months to 4 years old who were previously vaccinated are eligible to receive one or two doses of the updated booster, depending on which vaccine they received. Unvaccinated individuals ages 6 months to 4 years are eligible to receive three doses of the updated booster.
The updated monovalent vaccine targets the XBB.1.5 omicron subvariant and related lineages, but vaccine manufacturers say it will offer protection against all variants currently in circulation.
Moderna said its updated vaccine protects against newer variants including the latest omicron subvariant, BA.2.86, nicknamed “Pirola.”
Pfizer, meanwhile, said in a recent statement that pre-clinical data show its updated Omicron XBB.1.5-adapted vaccine “generates an improved response against multiple XBB-related sublineages, including XBB.1.5, XBB.1.16, XBB.2.3, and EG.5.1 (Eris).”
An updated booster produced by Novavax is still awaiting FDA approval. The novavax shot does not use mRNA technology, unlike those from Moderna and Pfizer.
According to the CDC, Covid hospitalizations have been climbing in recent weeks, and are likely to continue increasing in the coming weeks.
The agency reported 17,418 hospital admissions for Covid-19 infections in the week ending Aug. 26, the last week for which data were available, up 15.7% from the week before. The agency reported that deaths due to Covid-19 for the week ending Sept. 2 were up 10.5% from the week before.
In the latest forecast published Sept. 4, the agency predicted that hospital admissions will increase, with potentially up to 10,000 daily admissions reported on Oct. 2.
The CDC in a recent assessment said it expects the updated booster shots “will be effective at reducing severe disease and hospitalization.”
TMX contributed to this article.