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The Studies have shown that children’s doses of Pfizer’s COVID-19 vaccine are safe and more than 90% effective in children between the ages of 5 and 11the drug company said Friday as federal regulators consider authorizing the injections for younger children.
The Food and Drug Administration (FDA) released the data on Friday, noting that the smallest doses of the vaccine were shown to be nearly 91% effective in preventing symptomatic COVID-19 in children ages 5 to 11..
The study involved nearly 2,300 children in that age range, many of whom received two doses of the vaccine three weeks apart. The others received doses of placebo.
The dose given to the youngest children, 10 micrograms, is one third of the amount given to adults and children 12 to 16 years of age.
Pfizer said the smaller dose would minimize side effects, but still trigger a strong immune response.
The Pfizer vaccine is already being given to children ages 12 to 16. If its lowest dose is approved, the vaccine would be the first to be licensed for children up to 5 years of age.
“Two primary doses of the vaccine administered three weeks apart between 5 and 11 years of age have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern, and high (effectiveness) against COVID-19 symptomatic in a period when the Delta variant was predominant, ”notes the 82-page Pfizer report.
“Given all the (data), the benefits of the Pfizer-BioNTech COVID-19 vaccine in children 5 to 11 years of age outweigh the known or potential risks.”
The FDA is expected to release an independent review of the Pfizer data soon.
The panel will need to approve lower doses for younger children, the FDA and Centers for Disease Control and Prevention should also approve them.
If that happens, children in the lowest age range could start getting the vaccine next month.
The data showed that the antibody response in the children at the lowest dose was comparable to the immune response seen in the adults who had received the vaccine.