U.S. regulators are urging drugmaker Pfizer to apply for emergency authorization to give it a two-dose regimen of a COVID-19 vaccine for children aged 6 months to 5 years, while awaiting data on a three-dose regimen, aimed at clearing the way for injections . Back in late February, a person familiar with the matter told The Associated Press.

The company’s application is expected to be filed as soon as Tuesday.

Early data from Pfizer suggests the vaccine — administered to young children at one-tenth the strength of an adult vaccine — is safe and produces an immune response. But last year Pfizer announced that two doses of the vaccine proved less effective at preventing COVID-19 in children ages 2-5, and regulators encouraged the company to add a third dose to the study because they believed another dose would boost the vaccine’s effectiveness The effect is very similar to the adult booster dose.

Now, the U.S. Food and Drug Administration is pushing the company to submit an application based on the two-dose data for approval in February, and then return after data from a third-dose study expected in March. Get additional authorization, the people said. Assuming the FDA and the Centers for Disease Control and Prevention approve the vaccine, the two-step authorization process could mean young children can be vaccinated more than a month earlier than previously estimated.

The person spoke on condition of anonymity to discuss sensitive regulatory issues. Given the emergence of highly transmissible omicron variants of COVID-19, the decline in the efficacy of the two-dose vaccine is not surprising, the person said. Getting younger kids to get two doses earlier will eventually speed things up because they get the expected stronger protection from the third dose.

This is good news for parents with young children who are the last age group not to have COVID-19 injections approved.

Not a Modern Healthcare subscriber? Register today.