Pfizer is adding a third dose for children and babies aged 6 months to 5 years. This comes after its COVID-19 vaccine trials failed to provide the expected immunity in the younger children. The trials showed that child-sized doses of the Pfizer/BioNTech vaccine were not producing the expected immunity.
As such, the company said their study will now include evaluating a third dose of three micrograms at least two months after the second dose of the two-dose series. Pfizer, through its vaccine, wants to provide high levels of protection in this young age group.
It should be noted that early tests had indicated that the small dose would produce a strong immune response in the children. But the interim data shows that this small dose regime did not produce the expected immune response in the 2 to 5 year-olds.
Pfizer, in a statement, said no safety concerns were identified and the 3 mg dose demonstrated a favorable safety profile in children 6-months to under 5-years of age. “The decision to evaluate a third dose of 3 mg for children 6-months to under 5-years of age reflects the companies’ commitment to carefully select the right dose to maximize the risk-benefit profile,” it said. “If the three-dose study is successful, Pfizer and BioNTech expect to submit data to regulators to support an Emergency Use Authorization (EUA) for children 6-months to under 5-years of age in the first half of 2022.” The company will also be testing third doses in older children aged 5 to 11 and 12 to 15 in the trials.
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Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said this means a delay in authorization for vaccines for younger children. “I think out of necessity, its going to make the time frame for when we get an emergency use authorization for children that young, it won’t be likely until the second quarter of 2022, and we were hoping it would be in the first quarter.”
Fauci said it is important to get the right dose and the right regimen for children.
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