Pfizer and BioNTech claim that the Covid-19 vaccine is safe for children aged 5 to 11

Pfizer Inc. and partner BioNTech SE announced that their Covid-19 vaccine was proven to be safe in children aged 5 to 11 years old in late-stage research. 

The two-dose injection was shown to be safe and well-tolerated by the youngsters in the trial, according to the businesses. The vaccination produced antibody levels comparable to those of younger adults, meeting the study's success criteria.

The data, which covered almost 2,200 children, will be submitted to the Food and Drug Administration and other health officials and it would seek emergency use authorization in the U.S. "as soon as possible," according to the firms.

Pfizer CEO Albert Bourla stated last week that the firm expects to submit data on children aged 5 to 11 by the end of this month. If the FDA reviews the data for that age range as thoroughly as it did for 12- to 15-year-olds, the doses may be available in time for Halloween, CNBC reported. 

“Depending on how long the FDA takes to review the application, whether it’s a four-week review or a six-week review, you could have a vaccine available to children as early as probably by the end of October” or early November, Scott Gottlieb, a Pfizer board member and the former head of the FDA, told CNBC on Monday.

The businesses tried a two-dose regimen of 10 micrograms delivered three weeks apart — roughly one-third the amount used for teenagers and adults. The jabs caused an immunological response and side effects equivalent to those found in a study of persons aged 16 to 25.

According to the Centers for Disease Control and Prevention, common side effects for teenagers and adults include tiredness, headache, muscular discomfort, chills, fever, and nausea.

So far, the FDA has approved the Pfizer-BioNTech coronavirus vaccine for children as young as 12, while the vaccines from Moderna and Johnson & Johnson have been approved for adults.

The FDA is scheduled to make a decision this week on which groups are qualified for a third dosage of the Pfizer vaccine, known as a booster injection. An FDA advisory group unanimously recommended Pfizer booster injections to adults 65 and older, as well as other vulnerable Americans, on Friday.

Inputs from CNBC