US FDA authorizes updated COVID booster shots for children 5 years and above

On Wednesday, the U.S. Food and Drug Administration 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 to children five years of age and above. Pfizer/BioNTech’s vaccine, a ten microgram dose version, will be shipped immediately after it receives a 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 on the distribution output of the doses for individuals aged 12 years and older.

FILE PHOTO: Vials labelled “VACCINE Coronavirus COVID-19” and a syringe are seen in front of a displayed Pfizer logo in this illustration taken December 11, 2021. REUTERS/Dado Ruvic/Illustration/File Photo

The redesigned bivalent booster shots from Moderna and Pfizer target the original version and 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.

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

Around 11.5 million people received the updated shots over the first five weeks of the rollout last month, representing 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.