Once it’s submitted, the FDA is expected to take approximately four to six weeks before it decides whether to approve the shots.
that the company intends to submit its trial data for five to 11 year olds for approval “pretty soon,” adding it is “a question of days, not weeks.”
Once they submit the data, it will be “up to the [Food and Drug Administration]” to determine whether the vaccine should be approved, Bourla said, but Pfizer “will be ready with our manufacturing to provide this new formulation of the vaccine” if it is.earlier this week, which has not yet been peer reviewed, that found the child Covid-19 vaccine—which is one-third the dose that’s given to adults—is “safe” and “well tolerated” among five- to 11-year-olds.
The data suggested the vaccine provokes an immune response in children similar to that of fully vaccinated 16- to 25-year-olds despite the smaller dose, and also similar mild side effects like pain at the site of the injection, fever, fatigue and chills.on CBS Sunday he expects the agency’s review of the Pfizer data to take approximately four to six weeks, putting the timeline for potential approval somewhere between Halloween and mid-November.
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