FDA Panel Backs Pfizer, Moderna Shots for Children 5 Years and Younger

THURSDAY, June 16, 2022 (HealthDay News) — An advisory panel to the U.S. Food and Drug Administration voted unanimously on Wednesday to recommend the emergency use of both the Pfizer and Moderna COVID-19 vaccines for the country’s youngest children.

The approvals come not a moment too soon: More than two years into the pandemic, children younger than 5 years still have no vaccine available to them.

The panel’s recommendations will now go to the FDA, which is expected to approve the use of the vaccines this week. On Friday and Saturday, an advisory panel to the U.S. Centers for Disease Control and Prevention plans to vote on whether to endorse the shots. The final step in the approval process will come when CDC Director Rochelle Walensky, M.D., greenlights the shots.

On Wednesday, regulators and company officials spent much of the morning discussing side effects caused by the vaccines, the vast majority of which were mild and tolerated by children in the clinical trials: irritability and crying, sleepiness, fatigue, and loss of appetite. Smaller numbers of these children had fevers, most of which did not become severe, The New York Times reported.

In younger age groups, fevers of any kind can be more dangerous, a fact that pressured vaccine makers to calculate dosing correctly. Pfizer chose a dose at just a 10th of the strength of the adult dosing, given in three shots; the first two are administered three weeks apart, with the third coming at least eight weeks after the second. Moderna used a quarter of the strength of its adult dosing, administered in two shots, four weeks apart.

“I know that the death rate from COVID and young children may not be extremely high,” Jay Portnoy, M.D., of the Children’s Mercy Hospital in Kansas City, Missouri, said during the meeting, The Times reported. But, “it’s absolutely terrifying to parents to have their child be sick” or hospitalized, he noted.

The New York Times Article