The Food and Drug Administration on Thursday authorized updated COVID-19 shots aimed at protecting against the original strain of coronavirus and two subvariants that have circulated widely this year.
The FDA amended emergency use authorizations for the bivalent vaccines developed by Moderna and Pfizer-BioNTech for children as young as 6 months old. The updated shots target the original virus and the BA.4 and BA.5 subvariants of the omicron variant.
“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,” FDA Commissioner Robert Califf said in a statement.
“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.”
Today, we amended the emergency use authorizations (EUAs) of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age. https://t.co/dHHwGFJ7fW pic.twitter.com/z4zZNwZZZ0— U.S. FDA (@US_FDA) December 8, 2022
Officials said that as of Thursday, children between the ages of 6 months and 5 years who were vaccinated with the original Moderna shots are eligible to get a booster of the updated Moderna shot two months after completing a primary series of the original formulation.
Children from 6 months to 4 years old who have not yet begun getting original vaccines developed by Pfizer-BioNTech or who have gotten only their first two of three doses will be eligible to get the newly authorized shots. Officials said that children in that age group who have already gotten their three-dose primary series of Pfizer-BioNTech shots will not be eligible for the updated vaccines.
“Children in this age group who have already completed their primary series would still be expected to have protection against the most serious outcomes from the currently circulating omicron variant,” FDA officials said. “The data to support giving an updated bivalent booster dose for these children are expected in January. The agency is committed to evaluating those data as quickly as possible.”
As of last week, nearly 1.8 million Americans under the age of 5 have gotten at least one dose of any of the available COVID-19 vaccines, according to the Centers for Disease Control and Prevention. About 856,000 young children have been fully vaccinated, CDC data shows.
In October, officials recommended the bivalent vaccines for children as young as 5.
More than 80% of the total U.S. population has gotten at least one COVID-19 vaccine shot, according to the CDC. As of last week, nearly 69% of Americans have been fully vaccinated, and almost 13% of those who have been fully vaccinated have gotten the reformulated booster shots, CDC data shows.
Since the start of the pandemic, officials have confirmed more than 99.3 million COVID-19 infections and reported over 1 million deaths nationwide, according to numbers compiled by Johns Hopkins University. More than 647.4 million COVID-19 cases have been reported worldwide, resulting in 6.6 million deaths, according to the university.
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