Pfizer, BioNTech say COVID-19 vaccine safe for children aged 5 to 11

Pfizer said it would share the results with regulators in the US and other countries and would seek emergency use authorization in the US by the end of the month.

The companies said the two-dose shot was safe and well tolerated among the children in the study. According to the companies, the vaccine produced levels of antibodies that were similar to those of young adults, which met the study’s measure of success.

Pfizer and BioNTech said they have yet to determine the vaccine’s efficacy — how well it protects against Covid-19 — for children in the age group. The companies provided the results in a press release. They have not been reviewed by independent experts or published in any medical journal.

Albert Bourla, chief executive of Pfizer, said: “We are eager to expand the protection offered by the vaccine to this young population, subject to regulatory authority, especially as we track the spread of the delta variant and it There is substantial danger to children.” Statement.

Many parents are waiting to give vaccines to young children, hoping to protect them as the school year begins.

According to health experts, young children have a lower risk of serious illness and hospitalization than adults, and when they are infected, they experience mild symptoms. Yet young children are going to hospital in greater numbers than ever before in the pandemic as the delta spread mainly among unvaccinated people.

Doctors and health officials say it will be important to vaccinate children not only to protect them from the virus, but also to protect the children around them and their family members.

The Pfizer-BioEntech vaccine is approved for use in the United States for children under the age of 12. Some parents with young children have them enrolled in clinical trials to get the shot as soon as possible. Others pushed for youth to receive the vaccination after the Food and Drug Administration issued full approval for the shot, even though the label specifies use only for people 16 and older.

After studying the shot in a small number of children to settle on the dosage, Pfizer expanded the size of the study in June to enroll about 4,500 subjects. Two-thirds of subjects received two doses of the vaccine — in a smaller dose than adults — three weeks apart, the rest received a placebo.

Pfizer said a review of data from 2,268 children in the trial showed that those who received two 10 microgram doses a month after the second dose had lower antibody levels than those found in those aged 16 to 25. who received a 30 microgram dose in a separate Pfizer. Study.

Neutralizing antibodies, which prevent the virus from entering cells and replicating, play a key role in the body’s immune response against COVID-19.

According to Pfizer, younger children who received the vaccine showed fewer side effects, such as fever and chills, than children aged 16-25. There were also no cases of myocarditis, an inflammatory heart condition that has so far been found to be a rare side effect mainly in young men.

Pfizer said the results of the study for young children aged 6 months to 5 years could be out by the fourth quarter of this year.

This story has been published without modification to the text from a wire agency feed