Children ages 2-5 did not mount an adequate immune response to COVID-19 after being fully vaccinated with the Pfizer-BioNTech vaccine in a trial, the company said Friday, a setback to its efforts to get the shots cleared by regulators.
The immune response in young children 6 months to 2 years old was comparable to the protection afforded to fully vaccinated people ages 16 to 25. The company also reported there were no adverse reactions in children 6 months to under 5 years of age to the 3 microgram dose, which is one-tenth of the adult-approved dose.
The company said it will also test a third low dose of the vaccine, 3 micrograms, in children 6 months to under 5 years to bolster the body’s immune response at least two months after receiving the second of two doses. Pfizer will also evaluate a booster dose of 10 micrograms in children 5 to 12, as well as doses of 10 micrograms and 30 micrograms in people 12 to 17.
“If the three-dose study is successful, Pfizer and BioNTech expect to submit data to regulators to support an Emergency Use Authorization (EUA) for children 6 months to under 5 years of age in the first half of 2022,” the company said.
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Many parents have been anxiously awaiting regulatory clearance to vaccinate their young children.
The vaccine has been authorized for use in children as young as 5, but only those 16 and older are cleared for a booster dose after the Food and Drug Administration greenlighted boosters for those ages 16 and 17 last week.
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