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Pfizer/BioNTech submit data to EMA for COVID-19 vaccine in young children By Reuters

by Mike Robinson

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© Reuters. FILE PHOTO – Susanne Wohlgemuth is a pharmacist who prepares Pfizer/BioNTech vaccines for the Haus an der Linde in Lichtentanne. It’s the day that Germany will start its immunization programme. Hendrik Schmidt/P

(Reuters] -Pfizer Inc. (NASDAQ) and German partner BioNTechSE (NASDAQ) announced on Friday they submitted data supporting use of COVID-19 in children under 12 years.

Although it is not currently allowed in this age group, the vaccine has been approved for use by the United States as well as the European Union for children aged 12 and over.

Companies asked U.S. regulators earlier in the month for emergency authorization to give the shot to young children. An advisory panel of the U.S. Food and Drug Administration will meet next month to discuss the data.

Children are not as susceptible to severe COVID-19 but they have the potential to spread it to other people, especially to vulnerable groups that could be at greater risk for severe disease.

According to the companies, the Pfizer/BioNTech vaccine induced a strong immune reaction in 5- to 11-year olds during a 2-68 participant clinical trial.

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