WASHINGTON — A U.S. company, which is in Phase 3 of testing, has gotten the green light from the FDA to start testing on children.
A pediatrician at Children’s National Hospital said it is important to include children in the studies so the right dosage can be determined for them.
The pharmaceutical company Pfizer announced on its website this week that the U.S. Food and Drug Administration approved an expansion of its Phase 3 clinical trial to include kids as young as 12 years old. The drugmaker and its Germany-based partner, BioNtech, requested permission in September. It is the first coronavirus vaccine trial to include children in the U.S.
Dr. Linda Fu is a pediatrician at Children’s National Hospital who tells WUSA9 clinical trials are just as important for kids.
“It’s really important for testing to begin in children as soon as safety has been established in adults because the longer we delay, the longer it’ll be until children are able to receive a vaccine,” Dr. Fu said.
Like other officials, Dr. Fu said data is needed to help researchers develop a safe and effective vaccine for children who may require a smaller dose. Other vaccines like Hepatitis A and B come in pediatric doses.
“Their immune systems work differently,” said Dr. Fu, who says you can’t group kids and adults in the same category when it comes to the COVID-19 vaccine. “There may be a different reaction to children than what we see in adults.”
According to the Centers For Disease Control and Prevention, more than 270,000 children have been diagnosed with the coronavirus since March in the U.S., which has nearly 8 million total cases. Most of the cases in kids have been reported among adolescents between the ages of 12 to 17.
“Children are often an afterthought in trials,” Dr. Fu said. “But for something like this, it makes sense that adults are tested first because they seem to get a little more sick with the disease.”
“However, it’s really important for children to be vaccinated in order for them to go back to school and parents to get back to work,” Dr. Fu said.
Moderna and Johnson & Johnson are two other companies that have been in the advanced stages of their COVID-19 vaccine clinical trials. Johnson & Johnson just paused its clinical trial because of an unexplained illness in one of the volunteers this week.
In a statement on when the company will consider enrolling children, Moderna said:
“Moderna shares the urgency associated with assessing COVID-19 vaccine candidates in children. Now that Moderna has sufficient safety data in adults, we intend to start pediatric trials by the end of this year, subject to regulatory approval. Because these regulatory discussions are still underway, we don’t at this point have further public commentary about timing, protocols or funding,” according to a Moderna Spokesperson.
A spokesperson for Johnson & Johnson said this in a statement:
“We can confirm that our compound development plan will also include studies evaluating the global population, including children,” said a Johnson & Johnson spokesperson. “ We will only move forward with that after data from adults is analyzed.”