Posted on Apr 27, 2022
Pfizer asks FDA to authorize booster shots for kids ages 5 through 11
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https://www.npr.org/sections/health-shots/2022/04/26/ [login to see] /pfizer-asks-fda-to-authorize-booster-shots-for-kids-ages-5-through-11
Children ages 5 through 11 who've received two shots of the Pfizer COVID-19 vaccine may soon be eligible for a booster. That's if the Food and Drug Administration agrees to a request made Tuesday by pharmaceutical companies Pfizer and BioNTech to authorize their booster shot for kids in this age range.
The companies submitted data to the FDA showing that the low-dose booster shot is safe for children ages 5 through 11 and could help protect them against omicron. Currently, boosters are only authorized for people ages 12 and older.
The companies say a third shot for younger kids could help counter waning immunity that has left other age groups more vulnerable, especially against omicron, which is better at getting around the immune system.
Some independent experts agree. But others remain skeptical that another shot is needed yet for younger kids.
"Over time, immunity to the vaccine wanes. And we know that that happens in children as well. So the data right now really support vaccine and boosters in particular to maintain immunity," says Dr. Yvonne Maldonado, an infectious disease researcher at Stanford who advises the American Academy of Pediatrics and also has been helping test the vaccine for Pfizer.
Children ages 5 through 11 who've received two shots of the Pfizer COVID-19 vaccine may soon be eligible for a booster. That's if the Food and Drug Administration agrees to a request made Tuesday by pharmaceutical companies Pfizer and BioNTech to authorize their booster shot for kids in this age range.
The companies submitted data to the FDA showing that the low-dose booster shot is safe for children ages 5 through 11 and could help protect them against omicron. Currently, boosters are only authorized for people ages 12 and older.
The companies say a third shot for younger kids could help counter waning immunity that has left other age groups more vulnerable, especially against omicron, which is better at getting around the immune system.
Some independent experts agree. But others remain skeptical that another shot is needed yet for younger kids.
"Over time, immunity to the vaccine wanes. And we know that that happens in children as well. So the data right now really support vaccine and boosters in particular to maintain immunity," says Dr. Yvonne Maldonado, an infectious disease researcher at Stanford who advises the American Academy of Pediatrics and also has been helping test the vaccine for Pfizer.
Pfizer asks FDA to authorize booster shots for kids ages 5 through 11
Posted from npr.org
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Medical
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Posted 2 y ago
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PO1 William "Chip" Nagel
..."To move forward, the authorization will need to be reviewed by the FDA and CDC, according to CNBC, which could potentially include reviews by their independent advisory panels. In January, the FDA authorized Pfizer booster doses for children 12-15 without calling a meeting of its outside expert panel.
About 28% of children ages 5-11 have been fully vaccinated with the first two shots, according to the latest CDC data. About 59% of children 12-17 are fully vaccinated, and about 24% have received booster shots.
Pfizer and BioNTech also plan to submit their data to the European Medicines Agency and other regulatory groups worldwide in coming weeks, the companies said."
..."To move forward, the authorization will need to be reviewed by the FDA and CDC, according to CNBC, which could potentially include reviews by their independent advisory panels. In January, the FDA authorized Pfizer booster doses for children 12-15 without calling a meeting of its outside expert panel.
About 28% of children ages 5-11 have been fully vaccinated with the first two shots, according to the latest CDC data. About 59% of children 12-17 are fully vaccinated, and about 24% have received booster shots.
Pfizer and BioNTech also plan to submit their data to the European Medicines Agency and other regulatory groups worldwide in coming weeks, the companies said."
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