Pfizer and BioNTech announced Monday that the vaccine Covid-19 was safe and generated a strong immune response during a clinical trial with children aged 5-11 years.
Two-doses of 10 micrograms, about one third of the dose used for teens and adults, were tested by the companies. They were administered three weeks apart. They found that the shots were well tolerated, produced an immune response, and side effects similar to those observed in a study of 16- to 25-year-olds.
According to the Centers for Disease Control and Prevention, common side effects for adults and teens include headaches, muscle pain and fever.
According to companies, the data, which contained more than 2,200 children and was submitted to the Food and Drug Administration and other regulators "as quickly as possible".
Albert Bourla, CEO of Pfizer, stated that the company is eager to expand the protection provided by the vaccine to younger people, subject to regulatory approval. He also noted that the Delta variant spread rapidly and poses a substantial threat to children.
These new data come as parents are anxious to get their kids vaccinated as schools reopen and the deadly delta strain continues to spread. There has been an increase in hospitalizations in the United States due to the strain, even among children who are not eligible for the shots.
The FDA has approved the Pfizer BioNTech coronavirus vaccine for children as young as 12 years old. Moderna's and Johnson & Johnson's vaccines are now available for adults.
The FDA will make a decision on who is eligible for a third dose or booster shot of the Pfizer vaccine sometime this week. A Friday advisory committee of the FDA recommended Pfizer booster shots for people 65 years and older, as well as other vulnerable Americans.
Bourla stated last week that Pfizer could submit data about children ages 5-11 by the end 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 years, as soon as October ends.
Monday's release didn't mention that any children in the trial had myocarditis. This rare condition affects a small percentage of young adults and adolescents.