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

Children younger than 5 years old take a 3 microgram dose of Pfizer's COVID-19 vaccine, just a tenth of what adults take

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. 

A 13-year-old boy receives a dose of the Pfizer vaccine

Brendan Lo (13) receives a dose of the Pfizer-BioNTech vaccine for the coronavirus disease (COVID-19) at Northwell Health's Cohen Children's Medical Center in New Hyde Park, New York, U.S., May 13, 2021. (REUTERS/Shannon Stapleton / Reuters)

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. 


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 vaccine for COVID-19

A Jackson, Miss., resident receives a Pfizer booster shot from Linda Glenn, Jackson-Hinds Comprehensive Health Center nurse, at a vaccination station next to Jackson State University in Jackson, Mississippi.  (AP Photo/Rogelio V. Solis / AP Newsroom)

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


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.