FDA approves bivalent COVID-19 booster shots for children under 5 years of age

The US Food and Drug Administration (FDA) announced on Thursday that the bivalent COVID-19 vaccine targeting Omicron has been approved for use in children as young as 6 months of age.

“Today, the US Food and Drug Administration amended the emergency use authorizations (EUAs) of the renewed (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children up to 6 months of age,” the agency said. statement.

Children ages 6 months to 5 years who received the original Moderna COVID-19 vaccine can now receive an updated booster shot targeting the Omicron variant of the virus, the agency said.

Children who have not yet started the three-dose series of the Pfizer-BioNTech vaccine or have not received the third dose will receive a bivalent booster as a third attempt after two doses of the original Pfizer COVID-19 vaccine.


Deborah Sampson, left, a nurse at the University of Washington Medical Center clinic in Seattle, administers the Pfizer COVID-19 vaccine to a 20-month-old boy, June 21, 2022, in Seattle.
(AP Photo/Ted S. Warren, file)

According to the FDA, children 6 months to 4 years of age who have completed Pfizer’s three-dose series are not eligible for the updated booster gifts.

The decision comes three days after Pfizer and BioNTech filed with the FDA for emergency use approval for their Omicron BA.4/BA.5-Adapted Bivalent COVID-19 vaccine.

“More children now have the opportunity to renew their protection with the bivalent vaccine against COVID-19, and we encourage parents and guardians to consider it, especially when we have more time during the holidays and winter months. conducted indoors,” FDA Commissioner Robert M. Califf, MD, said in a statement.

“As this virus has mutated and immunity from the previous COVID-19 vaccine has waned, the more people who are aware of the COVID-19 vaccine, the more it will benefit individuals, families and public health by helping to prevent severe disease. there will be many benefits. hospitalizations and deaths,” Califf added.

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A sign outside the Food and Drug Administration headquarters in White Oak, Maryland, on August 29, 2020.

A sign outside the Food and Drug Administration headquarters in White Oak, Maryland, on August 29, 2020.
(Reuters/Andrew Kelly/File Photo)

The US Centers for Disease Control and Prevention is expected to follow suit and recommend bivalent boosters for young children.

According to the CDC, only 3 percent of children under the age of 2 and nearly 5 percent of those between the ages of 2 and 4 received their basic doses.

“Vaccines currently remain the best defense against the worst consequences of the disease caused by the circulating omicron variant,” FDA vaccine chief Dr. Peter Marks said in a statement.

Moderna and Pfizer’s updated vaccines are combination vaccines that contain half of the original vaccine and have been modified to match the recently dominant BA.4 and BA.5 Omicron strains. BA.5 lineages are now responsible for the majority of COVID-19 cases.


This August 2022 photo provided by Pfizer shows vials of the company's updated COVID-19 vaccine during production in Kalamazoo, Michigan.

This August 2022 photo provided by Pfizer shows vials of the company’s updated COVID-19 vaccine during production in Kalamazoo, Michigan.
(Pfizer via AP)

Last month, the CDC released the first real data showing that an updated booster using any of the company’s versions offers additional protection for adults. The analysis showed that people who never received a booster had only two doses of the original COVID-19 vaccine, but even those who received the summer dose were more protected than those who missed the new one. shoot

Executives from Pfizer and Moderna thanked the FDA for extending approval for their vaccines.

“With the FDA’s decision, children and adolescents of all ages in the U.S. will now have access to our updated bivalent COVID-19 booster, providing families with important protection during the winter months,” said Stefan Bansel, CEO. The city of Moderna. “We appreciate the FDA’s timely review.”

“This approval allows parents to better protect their children from the disease caused by COVID-19, including Omicron sublineages,” said Albert Burla, CEO of Pfizer. “Nearly 40 million Americans have received a booster dose of the updated vaccine. As recommended by public health authorities, it’s important that we all continue to be aware of the COVID-19 vaccine and do our part to protect ourselves, especially now. because we plan to pack up for the holidays and go into the winter season.”

The Associated Press contributed to this report.

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