FDA Postpones Meeting , With Expert Advisers , on Pfizer's Vaccine for Young Kids.
FDA Postpones Meeting , With Expert Advisers , on Pfizer's Vaccine for Young Kids.
NPR reports that the FDA has postponed a meeting of expert advisers about the use of the Pfizer-BioNTech COVID-19 vaccine for young children.
NPR reports that the FDA has postponed a meeting of expert advisers about the use of the Pfizer-BioNTech COVID-19 vaccine for young children.
Pfizer reportedly told the Food and Drug Administration (FDA) that new data regarding the vaccine's use in children from 6 months to 4 years of age has emerged.
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Pfizer reportedly told the Food and Drug Administration (FDA) that new data regarding the vaccine's use in children from 6 months to 4 years of age has emerged.
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According to the FDA, the agency postponed the meeting to evaluate the additional data.
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We believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization, Food and Drug Administration statement, via NPR.
Pfizer and BioNTech were applying for authorization of the first two shots, while data was still being collected on a third dose.
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Pfizer and BioNTech were applying for authorization of the first two shots, while data was still being collected on a third dose.
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NPR reports that the companies have now changed course, a decision that will delay access to a COVID vaccine for the youngest children.
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Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group, Pfizer-BioNTech statement, via NPR.
The companies expect to have three-dose protection data available in early April, Pfizer-BioNTech statement, via NPR.
On February 11, Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said that, "it makes sense to wait to evaluate a third dose before taking action." .
On February 11, Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said that, "it makes sense to wait to evaluate a third dose before taking action." .
We realize the need for a vaccine for COVID-19 — even with the drop in cases.
We will do our part to move ahead as fast as we can, Peter Marks, Director of the FDA's Center for Biologics Evaluation and Research, via NPR
