U.S. health regulators authorized the use of Omicron-tailored COVID-19 booster shots from Moderna and Pfizer in children as young as 5, a move that will expand the government's fall vaccination campaign.
The U.S. Food and Drug Administration on Wednesday green-lighted Moderna's bivalent vaccine for those aged six and above, while Pfizer's updated shot was authorized in children aged five and above.
The U.S. Centers for Disease Control and Prevention also backed the FDA's authorization, clearing the way for the shots to be administered in children.
The redesigned bivalent booster shots from both Moderna and Pfizer target the original version as well as the BA.4 and the currently dominant BA.5 subvariants of Omicron.
"Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus," said Peter Marks, head of FDA's Center for Biologics Evaluation and Research.
Overall, COVID-19 vaccination rates in the United States have stayed low among kids, with nearly 40% of children aged 5-11 vaccinated with one dose of a vaccine so far.
Pfizer/BioNTech's vaccine will be shipped immediately after the CDC's recommendation, the companies said.
Pfizer said it has the capacity to ship up to 6 million pediatric doses in the first seven calendar days, without any impact to distribution output of the doses for individuals aged 12 years and older.
The BA.5 subvariant of Omicron currently remains the dominant strain, accounting for nearly 79% of the cases in the United States.
Around 11.5 million people received the updated shots over the first five weeks of the rollout last month, which represents just 5.4% of the people aged 12 or older who are eligible to receive them.
Reporting by Jyoti Narayan, Manas Mishra and Mrinalika Roy in Bengaluru; Editing by Saumyadeb Chakrabarty and Shinjini Ganguli
Reuters Health Information © 2022