A committee of advisers to the Food and Drug Administration voted unanimously to recommend that the agency authorize COVID-19 vaccines from Moderna and Pfizer-BioNTech for children as young as 6 months.
The committee's recommendations, in a pair of 21-0 votes, pave the way for the FDA to make COVID-19 vaccines available to immunize the last group of people to become eligible for them. The agency is expected to authorize the vaccines soon.
On Friday and Saturday, a committee of expert advisers to the Centers for Disease Control and Prevention is scheduled to meet and make recommendations about the use of the vaccines. Then, Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, will weigh in with a statement on their use.
If, as expected, she endorses them, the way would then be clear for vaccination of the youngest children to begin as soon as Tuesday.
While the risk of death and serious COVID-19 illness is lower for young children than people in older age groups, several committee members and a top FDA official said that authorization of vaccines that could protect young people from the worst outcomes would be worthwhile.
In remarks at the beginning of the day’s deliberations, Dr. Peter Marks, the FDA’s top vaccine official said that as of May 28 there had been 442 deaths from COVID-19 reported for children under 4 years old. “We are dealing with an issue where I think we have to be careful we don’t become numb to pediatric deaths because of the overwhelming number of older deaths here,” he said. “Every life is important. And a vaccine-preventable death [is one] we would like to do something about.”
The expert committee found that the benefits of the Moderna COVID-19 vaccine given as two shots four weeks apart outweigh its risks for use in infants and children 6 months through 5 years of age.
The advisers also voted in favor of the Pfizer-BioNTech COVID-19 vaccine for infants and children 6 months through 4 years of age. That vaccine is given in three shots. The first two are given three weeks apart. The third dose is given eight weeks after the second shot.
Pfizer revised its vaccination protocol during its clinical trial to include a third dose after two doses didn’t prompt a strong immune response in children ages 2 to under 5 years old.
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