Pfizer and BioNTech’s Covid vaccine is safe and appears to generate a robust immune response in a clinical trial of kids 5 to 11, the drugmakers announced.
Report informs, citing CNBC, that the data, which included more than 2,200 children, will be submitted to the Food and Drug Administration and other health regulators “as soon as possible,” the companies said. Pfizer CEO Albert Bourla said last week the company could submit data on children ages 5 to 11 by the end of this month. If the FDA spends as much time reviewing the data for that age group as it did for 12- to 15-year-olds, the shots could be available in time for Halloween.
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 said the shots were well tolerated and produced an immune response and side effects comparable to those seen in a study of people ages 16 to 25.
Common side effects for teens and adults include fatigue, headache, muscle pain, chills, fever and nausea, according to the Centers for Disease Control and Prevention.