FDA Authorizes Updated COVID Booster Shots for Children as Young as 5 FDA Authorizes Updated COVID Booster Shots for Children as Young as 5

(Reuters) – The U.S. Food and Drug Administration on Wednesday authorized Omicron-tailored COVID-19 booster shots from Moderna Inc and Pfizer Inc for children, a move that will expand the government’s fall vaccination campaign.

Moderna’s bivalent vaccine is authorized for those aged six and above, while Pfizer’s updated shot can be administered in children of five years of age and above.

Pfizer/BioNTech’s vaccine, a 10 microgram dose version, will be shipped immediately after it receives recommendation from the U.S. Centers for Disease Control and Prevention (CDC), the companies said.

Pfizer said it has the capacity to ship up to 6 million pediatric doses in the first seven calendar days following the receipt of authorization, without any impact to distribution output of the doses for individuals aged 12 years and older.

The redesigned bivalent booster shots from both Moderna and Pfizer target the original version as well as the currently circulating BA.4 and 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 that causes COVID-19,” Peter Marks, head of FDA’s Center for Biologics Evaluation and Research, said in a statement.

The BA.5 subvariant of Omicron currently remains the dominant strain, accounting for nearly 79% of the cases in the country, according to U.S. government data.

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.

Following the latest authorization, Pfizer’s monovalent vaccine will no longer be allowed for administration as a booster dose for children between 5 and 11 years.

(Reporting by Jyoti Narayan, Manas Mishra and Mrinalika Roy in Bengaluru; Editing by Saumyadeb Chakrabarty and Shinjini Ganguli)