The Covid-19 vaccine from Pfizer and BioNTech is safe and produces a “robust” immune response in a clinical study with children aged 5 to 11 years, the drug manufacturers announced in a press release on Monday.
The companies tested a two-dose regimen of 10 micrograms – about a third of the dose for teenagers and adults – given three weeks apart. The shots were well tolerated and produced an immune response and side effects comparable to those seen in a study of people ages 16-25, they said.
Common side effects in teenagers and adults include fatigue, headache, muscle pain, chills, fever, and nausea, according to the Centers for Disease Control and Prevention.
The data, which included more than 2,200 children, will be presented to the Food and Drug Administration and other health authorities “as soon as possible,” the companies said.
“We are committed to extending the protection offered by the vaccine to this younger population, subject to regulatory approval, particularly as we are tracking the spread of the Delta variant and the significant threat it poses to children,” said Albert Bourla, CEO of Pfizer in a press release.
The new data comes as many parents say they are careful to get their children vaccinated, especially as schools reopen and the highly contagious Delta variant continues to spread. The exposure has led to an increase in hospital admissions in the United States, including young children who are currently unsuitable for the syringes.
So far, the Pfizer BioNTech coronavirus vaccine has been approved by the FDA for people ages 12 and older, while Moderna and Johnson & Johnson’s vaccines have been approved for adults.
The FDA is expected to make a decision sometime this week on which groups are eligible to receive a third dose or booster dose of the Pfizer vaccine. An FDA advisory committee unanimously recommended Pfizer booster vaccinations for people 65 years and older and other at-risk Americans on Friday.
Bourla said last week that Pfizer could submit data on children ages 5-11 by the end of this month.
In addition, Pfizer expects to release clinical trial data by the end of October on how well its Covid vaccine is working in children aged 6 months to 5 years, he said.
The publication shared on Monday made no mention of whether any of the children in the study had myocarditis, a rare heart disease that occurs in a small number of adolescents and young adults.