Pfizer, BioNTech announce trial vaccine results show it's safe for kids aged 5-11; seek approval soon

By Team Newsable | First Published Sep 20, 2021, 7:12 PM IST

They intend to submit their data "as soon as possible" to regulatory bodies in the European Union, the United States, and worldwide.

Pfizer and BioNTech announced on Monday that their coronavirus vaccine trial results showed it was safe and produced a robust immune response in children aged five to eleven and that they would seek regulatory approval soon. "In participants aged five to eleven years old, the vaccine was safe, well-tolerated, and demonstrated robust neutralising antibody responses," US pharmaceutical behemoth Pfizer and its German partner said in a joint statement. They intend to submit their data "as soon as possible" to regulatory bodies in the European Union, the United States, and worldwide.

The trial results are the first of their kind for children under 12, with a Moderna trial for children aged six to eleven still ongoing. Both the Pfizer and Moderna vaccines are already being given to adults and adolescents over the age of 12 in countries worldwide. Although children are considered less at risk of severe Covid, there are concerns that the highly contagious Delta variant could lead to more severe cases. Inoculating children is also seen as key to keeping schools open and helping end the pandemic.

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According to Pfizer CEO Albert Bourla, the company is eager to extend the vaccine's protection to a younger population. According to the two pharmaceutical companies, children aged 5 to 11 received a two-dose regimen of 10 microgrammes in the trial, compared to 30 microgrammes for older age groups. The statement said that the 10 microgramme dose was "carefully selected as the preferred dose for safety, tolerability and immunogenicity" for that age group.It further added that the side effects were "generally comparable to those observed in participants 16 to 25 years of age". In the past, the most commonly reported side effects included discomfort and edoema at the injection site and headache, chills, and fever.

Pfizer and BioNTech are also testing their vaccine on infants aged six months to two years, as well as children aged two to five years. According to the firms, the topline results for those trials are due "as soon as" the fourth quarter of this year. Pfizer-BioNTech trials have enrolled up to 4,500 children aged six months to eleven years in the United States, Finland, Poland, and Spain.

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