WASHINGTON D.C. — Pfizer-BioNTech has asked the FDA for emergency authorization for a two-dose COVID-19 vaccine for children 6-months- to 5-years-old.
The company is still awaiting data on a three-dose course.
Early data from Pfizer has shown that the vaccine is safe and produces an immune response. For the youngest age group, the shots are administered at one-tenth the strength of the adult shot.
While the application was submitted based on the two-dose data for potential approval, data from a third dose study is expected in March.
The two-step authorization process could mean that children 6-months- to 5-years-old could be vaccinated by the end of February, if the FDA and CDC give the approval.
The two doses would be administered three weeks apart and while the third dose is being studied, it would be expected to be administered at least two months after the second dose.
The FDA said it will convene a panel of independent researchers and physicians in mid-February to help review the Pfizer data and while the agency is not required to follow their advice, the input is a key step in publicly vetting vaccine safety and effectiveness.
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