Debate Erupts Over Off-Label COVID-19 Vaccine Use For Children Under The Age Of Five

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Parents have been recently pleading for the use of the Pfizer BioNTech COVID-19 vaccine for children below five years old in the United States after the FDA delayed authorizing it. In a statement, Dr. Lee Savio Beers, President of the 2021 AAP, stated that the American Academy of Pediatrics (AAP), advised against off-label usage for children younger than 12 years.

“Dosage may differ for younger children. The AAP advises against giving vaccines to children younger than 12 years of age until they are approved by the FDA.

Moderna is for adults over 18 years old, while Pfizer-BioNTech is for those 16 and older. However, vaccines for younger patients remain under emergency authorization.

The report stated that health care providers agree to not administer vaccines for any non-authorized indications if they sign an agreement.

The 10-microgram vaccine that is approved for children aged 5-11 years has not been tested in children younger than 5. Children who are given a 3-microgram dose of the Pfizer BioNTech pediatric trial may experience more side effects.

The paper also noted that some doctors and parents believe the 3-microgram dose has been proven safe for young children in clinical trials.

Pfizer-BioNTech found that the omicron variant caused a higher rate infection in younger patients than was previously reported in their clinical trials. According to the New York Times, they asked for a delay in authorizing it due to the variant’s inability to overcome the immunity provided by the two dose series of vaccines.

The December data from the clinical trials showed that children aged two to four produced only 60% of an antibody response compared to older teens and young adults. This group is used to benchmark the effectiveness of the vaccine.

Children aged 6 months to 2 years developed an antibody protection that met study goals without safety concerns. However, the Times reported that the dose given to these children was only one-tenth the dose given to children 12 and older.

According to the Guardian, Von Meissner administered 2,500 vaccines in Germany to children aged 6 months to 5 years. The vaccine was not approved in Germany for children younger than five, but there are no restrictions for off-label use.

He said, “I don’t see why I shouldn’t protect little children.” He cautioned that parents should be informed about the potential dangers of using a non-approved vaccine to treat an off-label condition before they are allowed to administer it.

Von Meissner stated that expanding the vaccine’s off-label use in America would provide additional protection for families. Some parents lie about their children’s ages to qualify for the vaccine. However, experts strongly advise against this, according to the report.

Another option for increasing the number of children who get vaccinated is if Pfizer-BioNTech included more children under five years old in its clinical trials. This would provide additional data.

The trial found that the 3-microgram dose was only effective for children aged six months to two years. It did not work in children aged two to five years. According to the report, it was possible to divide the participants below the age of five into different age groups and test different doses within each subset.

Another way to increase access is to make shots available to very high-risk children via the FDA’s expanded accessibility program.

Fatima Khan created a petition to Dr. Janet Woodcock on change.org.