Health experts and federal officials are advising physicians not to administer the newly approved Pfizer coronavirus vaccine to children under the age of 12, despite pressure from parents clamoring for a way to vaccinate their young children.
While full approval of a drug generally allows for “off-label” use outside the prescribed population, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) said there’s still not enough data about the safety of the vaccines for children in that age group.
“That would be a great concern that people would vaccinate children, because we don’t have the proper dose, and we don’t have the safety data, nor do we have all the efficacy data,” acting FDA Commissioner Janet Woodcock said during a media briefing Monday.
“We need to get the information and data on uses in younger children. They are not just small adults. We’ve learned that time and time again,” Woodcock said.
The dosing amounts for children are likely to be less than the amount used for adults, and clinical trials for children are currently underway.
But there are potentially serious safety concerns if children are given too much, and without full data from completed trials, physicians don’t know the right dosage to administer.
“I’m a fan of vaccines. I would be loath to vaccinate my 9 or 10 year old until I saw the data,” said Paul Offit, a pediatric vaccine expert and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
The American Academy of Pediatrics (AAP) strongly discouraged physicians from using the vaccine off-label in young children.
“We do not want individual physicians to be calculating doses and dosing schedules one-by-one for younger children based on the experience with the vaccine in older patients,” Yvonne Maldonado, chairwoman of the AAP Committee on Infectious Diseases, said in a statement.
“We should do this based on all of the evidence for each age group, and for that we need the trials to be completed. I know parents are anxious to protect their children, but we want to make sure children have the full benefit of ongoing clinical trials,” Maldonado said.
As coronavirus infections spike due to the delta variant, some parents are growing increasingly worried about unvaccinated children. Schools are starting up in areas of the country with low vaccination rates, and some districts are even prohibited from requiring vaccines or masks.
But the AAP said the best way to protect children right now is to make sure everyone around them gets vaccinated.
“While we wait for a vaccine to be authorized for younger children, it’s important that everyone who is eligible now get the vaccine. That will help reduce the spread of the virus and protect those who are too young to be vaccinated,” AAP President Lee Savio Beers said.
Federal health officials have given conflicting estimates on when a coronavirus vaccine could be authorized for children, but it is not likely to occur until later this fall or even into winter of 2022.
“I gotta be honest, I don’t see the approval of kids 5 to 11 coming much before the end of 2021,” Francis Collins, director of the National Institutes of Health, told NPR on Tuesday.
Pfizer has said it plans to submit its clinical data to the FDA about children 5 through 11 years old by the end of September, following the completion of their clinical trial, and then the FDA needs to review it.
But Anthony Fauci, the nation’s top infectious diseases doctor and director of the National Institute of Allergy and Infectious Diseases, said he thinks authorization for younger children could come a bit earlier.
“You could conceivably get an emergency use authorization in the mid- to late fall for individuals 5 to 11,” Fauci said in an NPR interview on Monday, but he also noted timelines are always subject to change.
“It may be that when the FDA looks at the data, they may feel they want a little bit more time for safety. And that may end in a couple of months,” Fauci said.
The Pfizer and BioNTech vaccine is authorized under emergency use for anyone age 12 and older and was given approval for people age 16 and older.
The coronavirus vaccines from Moderna and Johnson & Johnson, respectively, are authorized for people over the age of 18 and have not yet been granted full approval by the FDA.
The CDC updated its guidance for physicians to specify that the Pfizer-BioNTech vaccine is not authorized for any off-label use, including children under 12 or for boosters.
As a result, the CDC said administering the vaccine off-label may not be covered under the COVID-19 public health emergency declaration. Providers may not have immunity from claims, and patients may not be eligible for compensation after a possible adverse event.
The federal government may also decline to reimburse providers for the cost of administering the shot if it’s given off-label. The government owns all the doses and distributes them to states, so it can set the conditions of participation in its vaccination program.
“Ordinarily, a clinician can do this, but this is a circumstance where the vaccine is being distributed under a provider agreement with the CDC, and so providers agree to conform to certain conditions,” Woodcock said.