FDA authorizes updated Covid injections for children as young as 6 months old

WASHINGTON — The Food and Drug Administration on Thursday expanded eligibility for updated coronavirus vaccines to children as young as 6 months old, the latest step to make revamped doses available to more Americans.

The federal government deployed the updated boosters from Pfizer-BioNTech and Moderna in September, although the public showed little interest in new shots. The government has expanded eligibility for children from the age of 5 in October.

The new FDA action further expands access to so-called bivalent vaccines, although there is unlikely to be strong demand for them among parents. Only a small fraction of the country’s youngest children have been vaccinated since the first vaccines were allowed for this age group in June.

The move comes as coronavirus cases in the United States are on the rise. Young children have also been hit hard in recent months by the respiratory syncytial virus, known as RSV. overwhelmed pediatric units across the United States.

“More children now have the opportunity to update their protection against Covid-19 with a bivalent Covid-19 vaccine, and we encourage parents and carers of eligible people to consider doing so – especially as we we are heading into the holidays and the winter months when more time will be spent indoors,” FDA Commissioner Dr. Robert M. Califf said in a statement.

For the country’s youngest children, eligibility for updated coronavirus vaccines will vary depending on the vaccine and the number of doses they received.

Children aged 6 months to 5 years who received Moderna’s two-dose vaccine will be eligible for the company’s updated booster two months after completing their initial vaccination course.

Pfizer’s vaccine is given in a series of three doses for children aged 6 months to 4 years. For these children, the third dose in the series will now be the updated dose instead of the original formulation.

Young children who have already received all three doses of Pfizer’s series will not yet be eligible for an updated booster. But the FDA said it expected new data to become available in January regarding the revamped recall for this population, and the agency said it would evaluate that data “as soon as possible.”

Expanded eligibility for updated vaccines has yet to be approved by the Centers for Disease Control and Prevention.

The Biden administration has struggled to generate interest in the updated booster shots, which target both the original version of the virus and Omicron subvariants. So far, only about 13% of Americans ages 5 and older have received one of the new doses.

The FDA cleared the Pfizer and Moderna vaccines for the nation’s youngest children in June, a decision that came a year and a half after the vaccines were first rolled out for adults.

But few young children have been vaccinated since then. So far, less than 10% of children aged 4 and under have received a dose of the vaccine, and even fewer have completed their full vaccination course.