- 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.
- 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 plan to submit the data to the FDA and other health regulators “as soon as possible.”
A smaller dose of Pfizer and BioNTech’s Covid-19 vaccine is safe and generates a “robust” immune response in a clinical trial of kids ages 5 to 11, the drugmakers announced Monday.
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.
“Depending on how long the FDA takes to review the application, whether it’s a four-week review or a six-week review, you could have a vaccine available to children as early as probably by the end of October” or early November, Scott Gottlieb, a Pfizer board member and the former head of the FDA, told CNBC on Monday.
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