An FDA committee will meet in mid June to review the trial data of covid-19 vaccine for children aged 6 months to 5 years, the agency announced on Monday. If all goes as expected, it may sign the vaccine for that age group within a few days after the meeting Earlier, Pfizer / biontech said in a press release on Monday morning that the company's three doses of covid-19 vaccine had a strong immune response in children aged 6 months to 5 years. They plan to submit the data to the food and Drug Administration this week.
According to the press release, a preliminary analysis of clinical trial data from 1678 children also showed that these vaccines were about 80% effective in preventing symptomatic covid-19 infection, but this was only based on data from a small number of cases.
The vaccine dose in this age group is one tenth that of Pfizer / biontech adult vaccine. The companies initially tested two low-intensity vaccines in children in this age group, but data released at the end of 2021 showed that the two vaccines did not produce a strong immune response in this group. The companies then added a third needle to their experiment. The U.S. Food and Drug Administration initially said it would review vaccines for children under the age of five before obtaining complete data, but withdrew the decision in early February - a setback for parents eager to vaccinate their young children and return to kindergarten.
Moderna applied to the US Food and Drug Administration for approval of its vaccine for children aged 6 months to 6 years in March. It uses a quarter of the dose of adult vaccine, and the company says two doses are enough to produce an immune response comparable to adults. The FDA will review Moderna data and Pfizer / biontech data at its June meeting.
This is a long wait for parents of children in this age group, because children in this age group are the last to be eligible for vaccination. The surge in covid-19 cases in the United States due to the continued impact of the virus variant has led to a record number of hospitalizations for children under the age of five, making the waiting more anxious.
"We know parents are eager to let us determine whether these vaccines are safe and effective," the food and Drug Administration said on twitter on Monday. "We are working as soon as possible to carefully review all the data.".