Pfizer’s Covid-19 vaccine receives FDA authorisation for children aged 5 to 11

The Pfizer BioNTech Covid-19 vaccine has received FDA authorisation for children aged 5 to 11.

An expert committee that advises the US Food and Drug Administration has recommended that regulators authorise Pfizer-BioNTech’s coronavirus vaccine for 5- to 11-year-olds, bringing about 28 million children a major step closer to becoming eligible for shots.

The vote was 17-0 in favour, with one abstention. Federal regulators and scientists made a strong push, arguing that 8,300 children between 5 and 11 had been hospitalised with Covid-19 and nearly 100 had died over the course of the pandemic.

The vaccine is administered as a two-dose primary series, 3 weeks apart, but in a lower dose, 10 micrograms, than that used for individuals 12 years of age and older, 30 micrograms.

Scientists at the U.S. Food and Drug Administration (FDA) said on Friday, October 22, that the likely benefits of giving the Pfizer/BioNTech COVID-19 vaccine to 5 to 11-year-olds clearly outweigh the risks of reported rare cases of heart inflammation.

Dr Jay Portnoy, a medical director at Children’s Mercy Hospital in Kansas City, Mo., said he had seen critically ill children in the intensive care unit and “terrified” parents. “I’m looking forward to being able to actually do something to prevent that,” he said.

Read more:

FDA Warns Pfizer And Moderna Vaccines May Cause Heart Inflammation

Pfizer announced on June 9 that it will test its vaccine in children under 12 years of age in a larger group of children after having chosen which doses to give them during the early stages of the trial.

The pharmaceutical giant confirmed that 4,500 children between the ages of six months and 11 years participated in its study which was spread across 90 clinical centres in Spain, Finland, Poland and the United States.

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