Researchers reported on Wednesday that Moderna's coronaviruses vaccine elicits a strong immune response in children aged 6 to 11.
Moderna requested permission from the FDA for the vaccine to be used in this age group. Authorization is unlikely to increase the low immunization rates among young children.
The Pfizer-BioNTech vaccine has been available for children aged 5 to 11 since November, but as of Wednesday, just 28.7 percent had received two doses. There is no vaccine for children younger than 5 years old.
Moderna asked the F.D.A. to approve its vaccine for use in young children. The Moderna vaccine is expected to be used in children of all ages in June, after the agency reviews the company's data on adolescents.
Pfizer and BioNTech withdrew their application for authorization to use their vaccine in the youngest children after data suggested that two doses did not provide adequate protection against the Omicron variant.
The F.D.A. is expected to review the data from the third dose in June.
We can do it this way in the future, but we can't leave children to the last.
She said that the process has been confusing and unfair for parents of the youngest children, who have not been able to get a vaccine more than two years into the Pandemic.
Moderna requested F.D.A. authorization for use of its vaccine in adolescents. The agency gave the go-ahead to Pfizer-BioNTech's vaccine for use in that age group in just three weeks, but the review of Moderna's vaccine had stopped.
The United States has the longest delay in authorization. Europe's drug regulators approved Moderna's vaccine for adolescents aged 12 to 17 last summer, and recommended approval for children aged 6 to 11.
The Moderna vaccine has been authorized in Canada and Australia.
One in four of the 28 million children in the United States have been protected against the coronaviruses. The fact that the infection is less risky for children may be the reason for parental reluctance.
The risk of a kid getting severe Covid is much, much, much lower, said Dr. Ofer Levy, director of the precision vaccines program at Boston Children.
He said he had just treated a child with leukemia who had been hospitalized for Covid.
I'm not into mandates, but I think that families should have the option of protecting their youngest.
The New England Journal of Medicine published a trial in which Moderna chose to give half the adult dose of its vaccine to children aged 6 to 11. More than 4,000 children were randomly assigned to receive two shots.
The vaccine was given to three-fourths of the children. Half of the children are from communities of color. The vaccine's power was measured by the researchers. The vaccine trials relied on this approach.
The children who received the vaccine produced higher levels of their immune system than young adults. The trials were small enough to assess the vaccine's ability to save lives.
The researchers estimated that the vaccine had an efficacy of 88 percent against infections with the Delta variant.
The same level of immunity is going to be just as protective in a younger age group as it was in an older age group, according to Dr. Permar.
The shots produced only a few minor side effects, including pain at the injection site, headaches and fatigue, and less often than adults. About half of the children had some sort of illness.
The side effect may become an issue in children younger than 5 because they need to be tested for infections in order to rule them out.
The trial was small enough to not detect the heart problems that have been seen in other age groups. The Pfizer-BioNTech vaccine appears to cause less myocarditis in young children than in adolescents or young adults.
The vaccine's power against the Delta variant was measured in Moderna's trial. The Omicron variant of the vaccines has proven to be less effective in all age groups.
The Moderna vaccine has been shown to cause a strong immune response in children and adolescents against the Omicron variant and other coronaviruses.
The vaccine's performance in real-world data won't be as high as it is in the lab.
Dr. Permar said she hoped the Pandemic would change the way vaccines are evaluated.
We need to think of a different way to approach the next Pandemic, because kids and pregnant women need to be included in trials earlier.
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