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A committee of Food and Drug Administration advisers has unanimously recommended that the agency approve the COVID-19 vaccine from Moderna and Pfizer-BioNTech for children under 6 months of age.
The committee’s recommendation, in a 21-0 vote, paves the way for the FDA to make the COVID-19 vaccine available so that people in the last group can be vaccinated to become eligible for it. The company is expected to approve the vaccine soon.
On Friday and Saturday, a committee of expert advisers from the Centers for Disease Control and Prevention will meet and make recommendations about vaccine use. Then, Dr. Rochelle Walenski, director of the Centers for Disease Control and Prevention, will weigh in with a statement on their use.
If, as expected, he supports them, the way to vaccinate the youngest children will be clear by Tuesday.
Although the risk of death and the risk of serious COVID-19 disease is lower in older children, many committee members and a top FDA official said that approval of the vaccine, which could protect young people from the worst outcomes, would work.
In a comment at the beginning of the day’s discussion, Dr. Peter Marks, the FDA’s top vaccine official, said that as of May 28, 442 people had died from Covid-19 for children under 4 years of age. “We are dealing with a problem where I think we need to be careful that we do not become paralyzed by pediatric deaths due to the high number of adult deaths here,” he said. “Every life is important. And a vaccine-preventable death [is one] We want to do something. “
The expert committee found that the benefits of the Moderna COVID-19 vaccine, given as two shots at four-week intervals, outweighed the risk of use in infants and children 6 months to 5 years of age.
Advisers also voted in favor of the Pfizer-BioNTech COVID-19 vaccine for infants and children aged 6 months to 4 years. That vaccine is given as three shots. The first two are given at three-week intervals. The third dose is given eight weeks after the second shot.
Pfizer revised its vaccination protocol to include a third dose during its clinical trials while two doses did not induce a strong immunity in children under 2 to 5 years of age.