Despite the fact that the Covid-19Pfizer/BioNTech vaccine has been completely approved for individuals 16 and more aged and that it is still allowed for kids as young as 12, the USFDA is advising against administering the vaccine “off-label” in children younger than 12. It states that it would be inappropriate to do so in this case.
The Food And Drug Administration Warns Against The Off-label Use Of The Pfizer Biontech Covid-19 Vaccine In Children Under The Age Of Five
Off-label usage refers to the use of a product in a manner or on a patient that it was not originally intended for; it occurs often with certain medicines, such as when a chemotherapy regimen authorized for one form of cancer is used to treat another type of cancer.
It is still unknown whether or if the Pfizer/BioNTech Covid-19 vaccine will be licensed or permitted for use in children less than 12 years old, and the optimal dose for this age range has not been established. That would be a significant source of worry if parents were to vaccinate their children because we don’t have the appropriate dosage, we don’t have the necessary safety data, and we don’t have all of the necessary effectiveness evidence, either. Woodcock said that they do not suggest that children less than 12 years old be vaccinated with this particular vaccine. It will not be acceptable in this situation.
As a result, the FDA and the AAP both strongly recommend that all eligible adolescents, ages 12 to 17, receive the Delta coronavirus vaccine as soon as possible, particularly as a highly communicable Delta coronavirus variant goes being circulated throughout the country. According to the Academy, in the most recent reporting period, the AAP reported 180,000 new instances of Covid-19 among children and adolescents. So far, about 8.5 million teenagers between the ages of 12 and 17 have received a complete Covid-19 vaccination. This is a 34 percent coverage rate. The fact that so many parents are eager to get their younger children vaccinated is undeniable, but Woodcock of the FDA points out that children are “not simply tiny people.”
The American Academy of Pediatrics likewise “highly opposes” the use of the vaccine off-label in children less than 12 years old, citing the fact that the dosage of the adult vaccination is much greater than the doses being studied in children under 12. Clinical trials for the COVID-19 vaccine in children ages 11 and younger are currently underway, and we must wait for the results of those studies before administering the vaccine to younger children, according to American Academy of Pediatrics President Dr. Lee Savio Beers in a statement released on Monday following the FDA’s approval.
AAP Committee on Infectious Diseases Chair Dr. Yvonne Maldonado also advised doctors to wait until clinical studies in young children have been completed before administering the vaccine to children under the age of 12 to prevent influenza. In a letter addressed to Woodcock earlier this month, the American Academy of Pediatrics (AAP) urged the FDA to move quickly to approve a vaccination for children under the age of 12. By the end of September, Pfizer hopes to receive vaccination trial results on children aged 5 to 11. The firm may then seek to have its vaccine approved for use in children younger than that by the end of the year. The firm has also said that data for even younger children, ages 2 to 5, may become accessible in the near future as well.
Moderna and Johnson & Johnson are also collaborating on pediatric research projects. The FDA requested last month that Pfizer and Moderna increase the number of youngsters aged 5 to 11 participating in research studies. In addition, the FDA requested six 6 months of following-up safety data with children rather than the 2 months it had requested with the adults.