Moderna requires the US Food and Drug Administration to authorize its vaccine for children under 6 years old. 2022-04-28 09:45:22


In an interview on Wednesday, Dr. Paul Burton, Moderna’s chief medical officer, said “there is an unmet medical need” for young children.

“The data we have now, which will come in today, should be enough for the Food and Drug Administration to start a review,” he said. He said he hoped the agency would “carefully and appropriately evaluate the data and not put it on hold.” He added, “They will do the right thing. They have always done it.”

Our director’s clinical trial data showed that the antibody response of younger children was positive compared to that of adults aged 18-25 years, meeting the primary criterion for success in the trial. Although the trial was not large enough to measure the vaccine’s effectiveness, Moderna said on Thursday that the vaccine appears to be 51 percent effective against symptomatic infections among those younger than two years old, and 37 percent effective among those aged Between 2 and 5 years old.

These results were slightly better than those previously released by Moderna for children under two years old. The company said that was because the second time around, the company had ruled out infections that had not been confirmed by a PCR test analyzed in the lab.

Dr. Burton said the new findings came from a more rigorous analysis, but they did not differ significantly from their predecessors. And the Omicron variant, which has proven adept at getting around the body’s first line of defense, accounted for about 80 percent of injuries in the study group, he said.

Omicron scrambled the calculus to evaluate vaccines because they proved much more adept than previous versions of the virus at evading the vaccines’ shield against infection, although its protection against severe disease and death remains strong. Moderna and Pfizer both found that, compared to other previous trials, the efficacy of their vaccines against infection in young children’s clinical trials, which were conducted significantly more during the winter, decreased in effectiveness of their vaccines.

At the same time, Omicron helped build the nation’s immunity. As of February, 60 percent of Americans, including 75 percent of children, have had the coronavirus at some point. by search Released this week by the Centers for Disease Control and Prevention. Sean O’Leary, an infectious disease specialist at Children’s Hospital of Colorado, said the CDC’s findings did not reduce the need for young children to be vaccinated. “A lot of children have been infected,” he said, “but there is definitely an added benefit of vaccination.”