Child Covid-19 Vaccine Data Will Be Submitted To FDA Within ‘Days,’ Pfizer CEO Says
Once it’s submitted, the FDA is expected to take approximately four to six weeks before it decides whether to approve the shots.
This Weekthat 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.
Pfizer releasedinitial trial dataearlier this week, which has not yet been peer reviewed, that found the child Covid-19 vaccine—which is one-third the dose that’s given to adults—is “safe” and “well tolerated” among five- to 11-year-olds.The data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.
Former FDA head Dr. Scott Gottleib, who serves on Pfizer’s board,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. headtopics.com
U.S. Surgeon General Dr. Vivek Murthyearlier in September the government is ready to “process that [data] quickly” as soon as Pfizer submits it.Big Number5.5 million. That’s the approximate number of Covid-19 cases that have been reported in children as of September 16,
accordingto the American Academy of Pediatrics, the most recent date for which data is available. Children make up 15.7% of all U.S. Covid-19 cases, but cases have been particularly on the rise among kids in recent months amid the highly infectious delta variant’s spread. The AAP reports child cases made up 25.7% of the cases reported the week of September 9-16, and the total number of Covid-19 cases in children since the start of the pandemic increased by 9% just in the span of two weeks, between September 2 and September 16.
What To Watch FortestingCovid-19 vaccines in children but has not yet released any of its findings, and Pfizer is also undergoing trials of its shot in children under five years old. That trial data is expected to come by the end of the year, Pfizer said earlier this week.
Key Background Read more: Forbes »
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