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Moderna asks the FDA to approve its vaccine for children under 6 years of age




But external experts said they would be surprised to see the FDA take such a stance. “There is a certain discretion there, but if you have something, you have reviewed it and it meets an unmet medical need, you will want to get it out whenever you can,” said Dr. Jesse L. Goodman, a former chief researcher. for the agency, said.

Dr. Paul Burton, Moderna’s chief physician, said in an interview Wednesday that “the data we have now, which will go into today, should be sufficient for the FDA to begin the review.” He said he hoped the agency would “carefully and appropriately assess the data and not keep it up,”[ads1]; adding: “They want to do the right thing. They always have.”

The modern clinical trial data showed that the antibody response of the youngest children compared favorably with that of adults aged 18 to 25 years, and met the primary success criterion of the trial. Although the trial was not large enough to measure the vaccine’s effectiveness, Moderna said on Thursday that the vaccine appeared to be 51 percent effective against symptomatic infection among those younger than 2, and 37 percent effective among those 2 to 5.

These results were slightly better than those previously published by Moderna for children under 2 years of age. The company said it was because the second time ruled out infections that had not been confirmed by a PCR test analyzed in a laboratory. Dr. Burton said that the new results came from a more thorough analysis, but that they did not differ significantly from the previous ones. He said that the Omicron variant accounted for about 80 percent of the infections in the study group. The side effects were at the same level as those from previously approved childhood vaccines, with fever in 15 percent to 17 percent of the children, Moderna said.

Omicron has distorted the calculation to evaluate vaccines because it has proven far better than previous versions of the virus to avoid the vaccines’ shield against infection, although their protection is still strong against serious illness and death. Both Moderna and Pfizer found that compared to previous studies, the effectiveness of vaccines against infection plummeted in clinical trials for young children, which were mainly performed during the winter’s Omicron wave. There is no agreed standard for what will constitute a successful Covid vaccine for young children.

Although it limited vaccine protection, Omicron helped build the nation’s immunity. As of February, 60 percent of Americans, including 75 percent of children, had been infected with the coronavirus at some point, according to research released this week by the Centers for Disease Control and Prevention. In December 2021, when the Omicron variant began to spread, only half had as many antibodies indicating a previous infection, the agency said.

Dr. Sean O’Leary, an infectious disease specialist at Children’s Hospital Colorado, said the CDC’s findings did not reduce the need to vaccinate young children. “Many children have been infected,” he said, “but there are certainly additional benefits to getting vaccinated.” He added: “I also acknowledge that it is a complex situation” for the FDA

The fact that the pandemic is on a relative break may give the agency a little respite. For those 17 and under, the number of new hospital admissions is one-eighth of what it was in January, when it reached a high level. Daily admissions now number fewer than 120 children, out of around 73 million nationwide, according to the CDC



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