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American Pharma giant Pfizer said on Tuesday that it is going to start a large study to test its coronavirus vaccine in children below 12. It had selected a dosing regime for the trials. This study will enroll around 4,500 children at 90 clinical sites all over the US, Poland, Spain and Finland.
European Medicines Agency, EU’s drug watchdog, had approved the Pfizer/BioNTech COVID-19 jab for 12-year-olds to 15-year-olds. It is the first vaccine to get a green light for children within the age group. On Tuesday, it had also started the assessment of the application for the usage of the Moderna COVID-19 vaccine for people between 12 and 17 years. It will communicate the final decision on this matter by the end of July 2021.
Pfizer COVID-19 vaccine was well-tolerated among children with no major concerns, the EMA had informed. It has been authorised for use in children below 12 in the United States and Canada. Pfizer/BoiNTech has also been approved in the UK for use in children aged between 12 and 15.
On the other hand, EMA is evaluating the use of Moderna in young adults between 12 to 17. In a statement, it had said that Committee for Medicinal Products for Human Use (CHMP) will carry out an assessment of the data submitted by the vaccine maker. This process would usually involve 150 evaluation days other than 210 days which is the norm.