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FDA authorises Pfizer and its partner BioNTech SE’s omicron single-dose booster shot for children under five

The omicron single-dose booster shot for kids under five years old was approved by the US Food and Drug Administration (FDA) on Tuesday. According to the government, children who have already received three doses of the initial vaccine are eligible to obtain the booster.

The FDA reported that after obtaining the clinical trial results of 60 children in the relevant cohort, the emergency use authorization (EUA) was granted. The new booster dosage was given to the children who had already received the three doses.

Children’s immune systems showed good defence against the original Covid strain as well as omicron BA.5 and BA.5 a month after receiving the injection.

‘Today’s authorisation provides parents and caregivers of children 6 months through 4 years of age who received the three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 Vaccine an opportunity to update their children’s protection by receiving a booster dose with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent,’ said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

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