Well, if Pfizer says so.
Pfizer and BioNTech’s Covid jab is safe for kids ages 5 to 11, says the pharmaceutical giant.
Scott Gottlieb, the FDA Commissioner-turned-Pfizer-board-of-directors – AND CNBC contributor (who also happens to be selling a book about Covid) said he hopes to have the jab approved for children as early as the end of October.
“Subject to the FDA’s careful review, a vaccine for children ages 5-11 could be available as soon as the end of October,” Gottlieb said Monday.
— Morning Joe (@Morning_Joe) September 20, 2021
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 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.
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.