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Pfizer bivalent COVID-19 shots in kids received expanded approval by U.S. FDA

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Reuters    15 March 2023

In a statement released on Tuesday, Pfizer Inc. said that the U.S. Food and Drug Administration had expanded the emergency use authorization (EUA) for the bivalent COVID-19 vaccine developed by the company and its partner BioNTech SE as a single booster dose in certain children.

 

The updated authorization applies to children aged six months to four years who have finished their initial three doses of the Pfizer original vaccine.

 

For children aged six months to four years who have not finished their primary immunization series or received the third dose, the U.S. health regulator approved Pfizer/revised BioNTech′s injection as a third dose in December.

 

The revised authorization from the health regulator is based on information from 60 children from the expanded age group who underwent primary vaccination with three doses and a booster shot from Pfizer/BioNTech and demonstrated an immune response to both the original SARS-CoV-2 virus strain and Omicron BA.4/BA.5.

 

The youngest children in the United States are the final group to become eligible for immunization, the first round of which was initiated in June of last year.

 

Government data showed that as of November 30, only 2.7% of eligible children under the age of two and less than 5% of those between the ages of two and four had finished their primary immunization series. This shows that young children are receiving their first doses of the vaccination with much delay.

 

 (Source: https://health.economictimes.indiatimes.com/news/pharma/u-s-fda-expands-authorization-of-pfizer-bivalent-covid-19-shots-in-kids/98648740)

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