Pfizer, BioNTech to delay seeking authorization of their COVID-19 shot in young children

Pfizer Inc. and BioNTech SE said Friday they are continuing to test their COVID-19 vaccine in children between the ages of 6 months old and 4 years old and will now wait until April when they believe they will have clinical data evaluating three doses to seek emergency authorization in the U.S. This announcement comes less than two weeks after the companies submitted an application for emergency authorization to the Food and Drug Administration for this age group based on data using the first two out of three doses. At that time, Pfizer CEO Albert Bourla said in a news release: “If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose.” An FDA advisory committee was then scheduled to meet on Tuesday to discuss whether the benefits of the vaccine outweigh the risks among young children. (The FDA said Friday that the meeting has been postponed.) Over the past year, Pfizer’s stock has gained 46.3%, while BioNTech’s shares are up 44.0%. The S&P 500 is up 15.2%.

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