Off-label refers to an approved product used in a manner or on a patient for which it is not necessarily approved; it is common with some drugs, such as when a chemotherapy approved for one type of cancer is used to treat another type.
The Pfizer/BioNTech Covid-19 vaccine is not currently approved or approved for children under the age of 12 and the appropriate dosage for this age group has yet to be determined.
“We don’t have data on the appropriate dose, nor do we have complete data on its safety in children younger than what is in the EUA,” said acting FDA Commissioner Dr. Janet Woodcock during a briefing call on Monday.
“So that would be a big concern that people would vaccinate children because we don’t have the right dose and we don’t have the safety data, nor all the efficacy data,” Woodcock said. “We do not recommend that children under the age of 12 be vaccinated with this vaccine. It would not be appropriate.”
Meanwhile, the FDA and the American Academy of Pediatrics (AAP) both strongly recommend that all eligible adolescents ages 12 to 17 be vaccinated as soon as possible, especially as the highly transmissible strain of Delta coronavirus remains nationwide. circulate.
According to the Academy, the AAP reported 180,000 new cases of Covid-19 among children and adolescents last week.
To date, approximately 8.5 million or 34% of all adolescents aged 12 to 17 have been fully vaccinated against Covid-19.
‘Not just little adults’
Obviously, many parents would like to have younger children vaccinated, but the FDA’s Woodcock said children “are not just little adults.”
“We really should have the data and the right dose before we recommend that children be vaccinated,” Woodcock added on Monday.
The AAP “strongly advises against” using the vaccine off-label in children under the age of 12, noting that the adult vaccine dose is much higher than the doses tested in young children.
“Clinical trials for the COVID-19 vaccine in children 11 years and younger are ongoing, and we need to see the data from those studies before giving this vaccine to younger children,” said AAP President Dr. Lee Savio Beers in a statement Monday, following FDA approval.
“The dose may be different for younger ages,” Beers said. “The AAP recommends not giving the vaccine to children under the age of 12 until it is approved by the FDA.”
dr. Yvonne Maldonado, chair of the AAP Committee on Infectious Diseases, also urged doctors to wait until the clinical trials in young children are completed before giving the vaccine to children under 12.
“We don’t want individual physicians to calculate doses and dosing schedules one at a time for younger children based on experience with the vaccine in older patients,” Maldonado said in a statement Monday.
“We would have to do this based on all the evidence for each age group, and for that the trials need to be completed. I know parents are eager to protect their children, but we want to ensure that children can take full advantage of the ongoing clinical trials .”
Covid-19 vaccine trials underway in younger children
In a letter sent to Woodcock earlier this month, the AAP called on the FDA to work aggressively to approve a vaccine for children under 12.
Pfizer has said it expects vaccine trial data in children ages 5 to 11 by the end of September, and the company could apply shortly after to have the vaccine approved for those younger ages. The company has also said data for even younger children, ages 2 to 5, could be available shortly after.
Moderna and Johnson & Johnson are also working on studies in children.
Last month, the FDA asked Pfizer and Moderna to double the number of children ages 5 to 11 in clinical trials. The FDA also asked for six months of follow-up safety data, rather than the two months it asked for in adults.
“We know that parents are eager to give their children the protection of this vaccine, and the American Academy of Pediatrics shares that sense of urgency,” Beers said Monday. “The Delta variant has led to a significant increase in the number of children and adults infected with the virus. While we wait for a vaccine to be approved for younger children, it’s important that everyone who qualifies gets the vaccine now. the spread of the virus and the protection of those who are too young to be vaccinated.”