New COVID vaccines get FDA approval

The Food and Drug Administration has approved a new round of vaccines against COVID-19. The vaccines from Moderna and Pfizer and its partner BioNTech were approved Sept. 10 for people 12 and older and under an emergency use authorization for children ages six months to 11 years old.

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Dr. Peter Marks, 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.”

The vaccines target the omicron subvariant called XBB.1.5, which is no longer the most common strain in circulation. The vaccine makers and FDA say that the vaccine should still provide good protection against COVID. Recent studies support that.

“The data so far suggest that the new COVID vaccines should be really quite effective against even the new emerging variants that we have seen come up in the last weeks,” said Dr. Ashish Jha, the dean of the Brown School of Public Health who served as the White House COVID-19 Response Coordinator. “So I’m actually quite optimistic this new vaccine is going to be protective.”

The shots would be given as a single dose for most people five years of age and older, regardless of prior COVID-19 vaccination history.

Children younger than five may be eligible for multiple doses of this season’s vaccine if they had not previously finished a three-dose series with earlier COVID-19 vaccines.

Moderna and Pfizer say they have produced ample supplies of their vaccines.

A panel of advisers to the Centers for Disease Control and Prevention is likely to recommend the shots for anyone who’s at high risk for serious complications from COVID, such as older people and those with weaker immune systems or other health problems.

Dr. Peter Hotez of the Baylor College, of Medicine and Texas Children’s Hospital, said in an interview, “It’s really important that Americans get this booster. It’s the single most important thing you can do to protect yourself and your family.”

The FDA says people should wait at least two months since their last shot to get boosted. Some experts say people should wait at least three months since the last vaccination or infection, while others recommend waiting four to six months.