Moderna asks FDA to authorize first COVID-19 vaccine for very young children

The vaccine appears to be effective for children ages 6 months to less than 2 years, and 37 percent effective for children 2 to less than 6 years.

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Moderna has asked the FDA to approve a low-dose version of its vaccine for children younger than 5 years old.

In a study involving 6,700 children, the company said two-doses of the vaccine administered 28 days apart triggered levels of antibodies equivalent to what has protected older children and adults.

The chief executive officer of Moderna said that they have submitted for authorization for their vaccine for young children.

The vaccine appears to be effective for children ages 6 months to less than 2 years, and 37 percent effective for children 2 to less than 6 years, according to the company.

It means that you will reduce your chances of getting disease by half. That is very important for these kids, according to Dr. Paul Burton.

The study was done when omicron was the dominant variant, so it is not surprising that the level of effectiveness is lower. Older children and adults with Omicron immunity are more likely to get infections.

The levels of antibodies that we see clearly show that we should have good protection against severe disease and hospitalization.

A committee of outside advisers is likely to be convened by the FDA to consider the request. The FDA is waiting for data from Pfizer and BioNTech about the effectiveness of a low-dose version of their vaccine in children younger than age 5. Parents of young children were disappointed by the two doses.

An official who is not authorized to speak publicly said that the FDA is expecting to consider the vaccine in June once all the data have been submitted.

The possibility of a delay has angered many parents of young children, who are frustrated and anxious that they haven't been able to vaccine their children even as masks have been dropped and infections are creeping up.

The FDA has been urged to act more quickly.

It is not known how much demand there will be for the vaccine. Only a third of the parents of children ages 5 to 11 have had the vaccine.

We have very reassuring data. There is a need for this for these young children. Right now, they have no other chance for protection. Burton said he was hopeful that the FDA would take the data, do their usual thorough review, and approve this as soon as possible.

The Centers for Disease Control and Prevention and many independent infectious disease specialists have been urging more parents to boost their children's vaccinations. Children are less likely to get seriously ill from the omicron surge, but it can still pose a serious health risk.