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FDA authorizes bivalent COVID-19 booster vaccines for children under 5 years of age


The US Food and Drug Administration (FDA) announced Thursday that bivalent COVID-19 vaccines targeted at Omicron have been licensed for use in children up to 6 months of age.

“Today, the US Food and Drug Administration amended the Emergency Use Authorizations (EUAs) for Moderna and Pfizer-BioNTech COVID-19 Updated (Bivalent) Vaccines to include use in children up to 6 months of age. age,” the agency said in a statement. statement.

The agency said that children ages 6 months to 5 years who received the original Moderna COVID-19 vaccine are now eligible to receive the updated booster vaccine that specifically targets the Omicron variant of the virus.

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

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

Children ages 6 months to 4 years who have already completed their three-dose Pfizer series are not eligible for the updated booster shot, the FDA said.

The decision comes three days after Pfizer and BioNTech filed an application with the FDA for an emergency use authorization for their Omicron BA.4/BA.5 bivalent adapted COVID-19 vaccine.

“More children now have the opportunity to upgrade their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so, especially as we approach the holidays. and the winter months, where more time will be spent indoors,” FDA Commissioner Robert M. Califf, MD, said in a statement.

“As this virus has changed and immunity from previous COVID-19 vaccination wanes, the more people stay up-to-date with COVID-19 vaccines, the more benefits there will be for individuals, families and health. public by helping prevent serious illness. hospitalizations and deaths,” Califf added.

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The sign is seen outside of the Food and Drug Administration headquarters in White Oak, Maryland on August 29, 2020.

The sign is seen outside of 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.

Only 3% of children under the age of 2 and nearly 5% of those between the ages of 2 and 4 have received their primary doses so far, according to the CDC.

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

Moderna and Pfizer’s updated vaccines are combination shots containing half the original vaccine and half modified to match the BA.4 and BA.5 Omicron strains that until recently were dominant. Now, the descendants of BA.5 are responsible for the majority of COVID-19 cases.

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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-world data showing that an updated booster, using either company’s version, offers adults additional protection. The analysis found that the greatest benefit was in people who had never received a previous booster, just two doses of the original COVID-19 vaccine, but that even those who received a dose during the summer were more protected than if they had received one. skipped the newer vaccine. Shooting.

Executives from Pfizer and Moderna thanked the FDA for expanding the authorization of their vaccines.

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“With the FDA’s decision, children and adolescents of all age groups in the US will now be eligible for our updated COVID-19 bivalent booster, providing families with an important protection tool as we move through winter months,” said St├ęphane Bancel, CEO. of Modern. “We appreciate the FDA’s timely review.”

“This authorization provides an opportunity for parents to help better protect their young children against COVID-19, including diseases caused by Omicron sublineages,” said Pfizer CEO Albert Bourla. “Nearly 40 million Americans have received a booster dose of an updated vaccine. It is critical that we all continue to do our part to help protect ourselves by staying current on COVID-19 vaccines, as recommended by public health authorities. , especially now as we plan to get together for the holidays and head into the winter season.”

Associated Press contributed to this report.



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