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Pfizer asks FDA to authorize COVID-19 vaccine for children younger than 5 years old

·1 min read

Pfizer and BioNTech asked the FDA on Wednesday to authorize three doses of their COVID-19 vaccine for children between the ages of 6 months and 5 years old.

The companies originally studied a two-shot regimen of its vaccine, similar to what adults and older children take, but paused their request for authorization in February while they studied the effectiveness of three doses.

Children younger than five take a 3 microgram dose, which is just a tenth of the 30 microgram shot that adults take.

Pfizer released results of the latest study last month that found three doses of their vaccine is 80.3% effective in children younger than 5 years old.

SECOND BOOSTER DOSE OF PFIZER, MODERNA COVID-19 VACCINES AUTHORIZED BY FDA

The FDA's Vaccines and Related Biological Products Advisory Committee will review Pfizer's results when they meet on June 15.

"Our COVID-19 vaccine has been studied in thousands of children and adolescents, and we are pleased that our formulation for the youngest children, which we carefully selected to be one-tenth of the dose strength for adults, was well tolerated and produced a strong immune response," Pfizer CEO Albert Bourla said last month when the result of their three-dose study were published.

Pfizer also said they will submit their findings to the European Medicines Agency and other regulatory authorities around the world.

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Moderna said their vaccine for children younger than 6 years old will be ready for review by the FDA this month.

A Kaiser Family Foundation poll released last month found that just 18% of parents with children younger than 5 said they would immediately get their child vaccinated once it is approved, and 38% said they would wait to see how it works for others.