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FDA Authorizes Updated Covid Vaccines For Children As Young As 6 Months Old

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The U.S. Food and Drug Administration on Thursday amended the emergency use authorizations of the updated Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children as young as 6 months old.

"More children now have the opportunity to update 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 head into the holidays and winter months where more time will be spent indoors," said FDA Commissioner Robert Califf.

"As this virus has changed, and immunity from previous COVID-19 vaccination wanes, the more people who keep up to date on COVID-19 vaccinations, the more benefit there will be for individuals, families and public health by helping prevent severe illnesses, hospitalizations, and deaths."

The eligibility rules vary depending on whether children received Moderna's or Pfizer's original vaccines as their primary series.

Children 6 months through 5 years old who received Moderna's two-dose primary series are now eligible for an omicron booster two months after completing their second shot.

Kids ages 6 months through 4 years old who have not yet received the third dose of Pfizer's primary series will now receive the omicron shot as their third dose.

Children 6 months through 4 years of age who have already completed their three-dose primary series with the original Pfizer-BioNTech COVID-19 Vaccine will not be eligible for a booster dose of an updated bivalent vaccine at this time.

The FDA said it did not authorize omicron shots for those children who already received three doses of Pfizer's vaccine because the agency is still waiting on supporting data for the booster dose.

"Vaccines remain the best defense against the most devastating consequences of disease caused by the currently circulating omicron variant, such as hospitalization and death. Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research. "Parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing."

The Centers for Disease Control and Prevention needs to sign off on the shots before pharmacies and physicians can start administering them.

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