Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) announced Monday that a smaller dose of their COVID-19 vaccine is safe and generates a "robust" immune response in a clinical trial of kids ages seven to 11.
The news couldn’t come any sooner for parents anxious to get their children vaccinated as kids start the new school year with the delta variant surging across America. Children’s COVID cases remain disturbingly high with 243,000 new infections during the week ended Sept. 9. — the second-highest number of kids’ cases since the beginning of the pandemic, according to the most recent data from the American Academy of Pediatrics.
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.
PFE shares inched up nine cents to $43.98, while those for BNTX faltered $12.68, or 3.5%, to $346.50.
