The European Medicines Regulatory Authority said it expects to rule on the approval of Moderna's coronavirus vaccine for use in children aged 12 to 17 next month, after submitting an application from the drugmaker, Reuters reported.
The regulator said the European Medicines Agency (EMA) committee would speed up the evaluation of the data submitted with the application, adding that delays would occur if the EMA requested any additional information.
The two-dose vaccine is already being used in the European Union (EU) for people over 18, and in the United States and Canada, the company has also sought approval in Canada for use in teens, the agency said.
The agency indicated that if Moderna's vaccine is approved, it will become the second vaccine suitable for use in adolescents in the European Union after the Pfizer and BioNTech vaccines last month, as vaccination of children is important to reach herd immunity against the Corona virus, and Moderna said last month that its vaccine has proven to be safe. and its efficacy in adolescence.
On the other hand, Pfizer is starting to test its Corona vaccine on children between the ages of 5 and 11 years, as it announced that it has started clinical trials in its last stages of its Corona virus vaccine.
Lower doses for children, 10 mcg, will be used, compared to the 30 mcg for those 12 years and older.
The company said it hopes to have data in the latter half of 2021, which is still in the early stages of trials on children aged six months to four years.
Parents and doctors debate whether or not children should be vaccinated because they make up only 0.1% of all coronavirus deaths.
A few weeks after the injection was approved for 12- to 15-year-olds in the United States, companies are now testing safety and efficacy in younger children.
According to a press release, about 4,500 participants will be enrolled at nearly 100 clinical trial sites in 26 states, Finland, Poland and Spain.
Trials in children aged 6 months to 4 years are still in their early stages and will expand once researchers can determine safety.
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