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Pfizer Apply for Permission to Use COVID-19 Vaccine for Toddlers

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Pfizer and its partner BioNTech have completed a permit application with the US drug regulator to allow the COVID-19 vaccine they are developing to be given to children under the age of five.

A filing with the US Food and Drug Administration (FDA) was completed Wednesday (1/6/2022) with complete data showing that three injections of a low-dose vaccine produce a strong immune response in children as young as 6 months old.

There is no COVID-19 vaccine for children in this age group in most countries around the world.

It remains unclear how many parents will vaccinate their children as demand for vaccines for children aged 5-11 is still low.

Pfizer and BioNTech on May 23 said their trial showed that the vaccine at a dose of 3 micrograms produced the same immune response in children under 5 years as two doses of 30 micrograms in children aged 16-25 years in previous trials.

Their competitor, Moderna, in March released trial data showing its two-dose formulation of the vaccine was safe and produced the same immune response in young children as it does in adults.

The FDA’s independent counsel will discuss the filings from the two manufacturers at a meeting on June 15.

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