FDA approves new Covid-19 boosters from Pfizer and Moderna

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The U.S. federal drug regulator has approved new Covid-19 booster doses made by Moderna and Pfizer to curb the faster spread of the infection in the United States.

The U.S. Food and Drug Administration said on Monday that anyone 5 years and older will be eligible to receive an updated shot from Moderna or BioNTech/Pfizer as long as at least two months have passed since their last dose of a Covid-19 vaccine.

“The FDA anticipates that updated vaccines will become available in the near future,” the regulator said, without giving a specific date. An advisory group from the Centers for Disease Control and Prevention is scheduled to meet Tuesday to discuss recommendations about who should get the vaccine, with a decision made and distribution could begin as early as this week.

The updated vaccine “is expected to provide good protection against currently circulating Covid-19 variants,” the FDA said.

The move comes as Covid-19 hospitalizations have been on the rise in the U.S. since July, CDC data shows. There were 17,418 hospital admissions in the week ending August 26, almost three times the number in the week ending July 8. The death toll has increased over the same period, with 658 deaths in the week ending August 26.

“Vaccination remains critical to public health and continued prevention of severe 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 reassured that these updated vaccines meet the agency’s rigorous scientific standards for safety, effectiveness and manufacturing quality.”

According to the CDC, more than 69% of Americans have received at least two doses of a Covid-19 vaccine. Only 17% have received the newer bivalent booster vaccine, which was authorized in September 2022.

The FDA said on Monday that Covid-19 vaccines “may need to be updated annually, just like seasonal flu vaccines” unless “significantly more virulent variants” emerge, which may require faster action.

A new wave of infections could reignite a polarized debate in the United States over how to manage public safety measures, which often cut across party lines between Republicans and Democrats. State leaders have had to enact guidelines on mask-wearing, school attendance and vaccine passports during the pandemic, angering those who believe the guidelines are too loose or too strict.

First lady Jill Biden tested positive for the virus last week, while US President Joe Biden, who is currently attending the G20 summit in India, has tested negative multiple times, according to the White House.