In an unusual move, the U.S. Food and Drug Administration (FDA) urged Pfizer and BioNTech to apply for authorization of the first COVID-19 vaccine for children under the age of five.
The drug companies said this week that they began sending data for an emergency use authorization before it is settled whether the children will need two or three shots.
The companies said they are providing the information at the request of the FDA in order to address an urgent public health need in the age group. The young children, about 19 million in the U.S., are the only age group not yet able to get the shots.
"Having a safe and effective vaccine available for children in this age group is a priority," acting FDA Commissioner Janet Woodcock said. She said the agency asked for the application because of the recent increase in cases caused by the Omicron variant of the coronavirus. And a decision is expected as soon as this month.
One-tenth of adults’ shot
Pfizer said it plans to give children as young as 6 months shots that contain one-tenth of the dose, or amount, given to adults. The open question is how many shots those children will need.
In early testing, two of the extra-low doses appear to be strong enough for babies but not for somewhat older children. Pfizer now is testing a third shot. The results from those tests are expected in late March.
The FDA said an outside committee of independent experts will meet in mid-February to review the information from Pfizer. The agency did not say how long it will wait for complete information. If the agency approves the vaccine, the U.S. Centers for Disease Control and Prevention (CDC) also needs to approve how the vaccinations will be given.
John Grabenstein used to work on vaccines at Merck. He told Reuters, "I just can't believe that they would authorize getting started without knowing what the third dose would do." But John Moore, a professor at Weill Cornell Medical College, called the plan "a creative solution to a real problem.” He noted that the Pfizer COVID-19 vaccine is known to be safe.
Parents want to return to work
The administration of President Joe Biden has been trying to speed up the approval of COVID-19 shots for children. Officials see vaccinations as important for opening schools and daycare centers and permitting parents to return to work.
The arrival of a vaccine for younger children could help hard-pressed parents as Omicron is sending record numbers of children to the hospital. Many have been pushing for an expansion of the shots to younger children.
Dr. Dyan Hes is a pediatrician, a medical doctor for children, in New York City. He said for many parents, "that's the first thing they ask when they walk through the door: 'When do you think the shot is going to come out?'"
Dr. Sean O'Leary of the University of Colorado is on the American Academy of Pediatrics’ infectious disease committee. He said, "What we're seeing right now is still a lot of hospitalizations and unfortunately some deaths in this age group."
He added that if the FDA approves vaccinations for the younger children, "that's going to be really important because all of those hospitalizations and deaths essentially are preventable."
I’m Jill Robbins.
Lauran Neergaard and Matthew Perrone reported on this story for the Associated Press and Michael Erman reported on it for Reuters. Jill Robbins adapted it for Learning English.
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Words in This Story
apply – v. to ask formally for something (such as a job, admission to a school, a loan, etc.) usually in writing
authorize – v. to give legal or official approval to or for (something)
priority – n. something that is more important than other things and that needs to be done or dealt with first
dose – n. the amount of a medicine, drug, or vitamin that is taken at one time
essential – adj. extremely important and necessary
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