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Pfizer Covid vaccine is safe, generates robust immune response in kids ages 5 to 11


A health care worker administers a dose of the Pfizer-BioNTech Covid-19 vaccine to a teenager at Holtz Children’s Hospital in Miami, Florida, U.S., on May 18, 2021.

Bloomberg via Getty Images. “The Covid-19 vaccine was approved for use in clinical trials in children aged five to eleven years old,” the drugmakers said in Monday’s release.| Bloomberg via Getty Images

Pfizer and BioNTech‘s Covid-19 vaccine is safe and generates a “robust” immune response in a clinical trial of kids ages 5 to 11, the drugmakers announced in a press release Monday.

The companies tested a two-dose regimen of 10 micrograms — about a third the dosage used for teens and adults — administered three weeks apart. They found that the shots produced similar side effects to what was seen in people aged 16-25.

The Centers for Disease Control and Prevention states that common side effects for both teens and adults are fatigue, headaches, muscle pain and chills.

Companies said that the more than 2200 children included in the study will be provided to the Food and Drug Administration and other regulatory agencies “as quickly as possible”.

Albert Bourla, CEO of Pfizer, stated that the company is eager to expand the protection provided by vaccines to younger people, but this must be approved under regulatory approval. He also noted the threat to children from the Delta variant.

The new data comes as many parents say they are anxious to get their children vaccinated, especially as schools reopen and the highly contagious delta variant continues to spread. The strain has led to a surge in hospitalizations across the U.S., including among young kids who are currently ineligible to get the shots.

So far, the Pfizer-BioNTech coronavirus vaccine has been cleared by the FDA for people as young as 12, while Moderna‘s and Johnson & Johnson‘s vaccines have been authorized for adults.

This week, the FDA should make a decision about which individuals are eligible for a third dose or booster shot of Pfizer’s vaccine. An FDA advisory committee on Friday unanimously recommended Pfizer booster shots to people age 65 and older and other vulnerable Americans.

Bourla said last week that Pfizer could submit data on children from ages 5 to 11 by the end of this month.

He also stated that Pfizer will release data from clinical trials on the effectiveness of its Covid vaccine in children aged 6 months to 5.

Monday’s press release did not mention whether the children involved in the trial suffered from myocarditis. Myocarditis is a rare and serious condition that affects only a handful of young adolescents.