This morning Pfizer and BioNTech announced that smaller doses of the covid-19 vaccine are safe enough to cause a powerful immune response for children ages 5 to 11.
The news comes as the delta variant continues to surge all around America as parents prepare to vaccinate their children for the new school year.
As of Sept. 9, children’s covid cases remain high, with 243,000 new infections reported. According to the American Academy of Pediatrics, this is the second-highest number of children’s coronavirus cases since the start of the pandemic.
The Food and Drug Administration will be provided with data that includes over 2 200 children “as soon as possible.” Last week, Pfizer’s CEO Albert Borla said that by the end of this month, the business would be able to present data on children aged 5 to 11.
Doses may be available in time for Halloween if the FDA spends as much time analyzing the data for the age group as they did for children ages 12 to 15.
Scott Gottlieb, a Pfizer board member and the former head of the FDA, told CNBC, “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.”
According to CNBC, the drugmakers experimented with a two-dose regimen of 10 micrograms taken three weeks apart, about a third of the dosage used for individuals age 16 to 25. According to researchers, the doses were well tolerated and produced an immunological response and side effects equal to those reported in a study of teens and adults.
According to the Centers for Disease Control and Prevention, common side effects in teens and adults include fatigue, headache, muscle discomfort, chills, fever, and nausea.
“We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” Bourla said in a press release that announced the results.
Most data about the research were kept under wraps, including whether any of the children in it developed myocarditis, a rare heart disorder that affects a small number of teenagers and young adults.
The FDA has approved the Pfizer-BioNTech coronavirus vaccination for children as young as 12, while the Moderna and Johnson & Johnson vaccines have been approved for adults.
The FDA is likely to decide this week on which groups are qualified for a third dose of the Pfizer vaccine, known as a booster shot.
On Friday, Pfizer booster doses were unanimously recommended for seniors 65 and older, as well as other vulnerable Americans, by an FDA advisory committee.
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