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“This is the first Canadian-approved vaccine to prevent Covid-19 in children and a significant success in Canada’s fight against the pandemic,” Supria Sharma, Canada’s chief medical adviser, told a news conference.
Data from clinical trials in the United States, which involved more than 2,000 children who received two doses, confirmed that it was as safe for minors as for adults, she added.
No cases of Covid-19 were reported in vaccinated children. In adults, the vaccine is at least 95% effective in preventing infection.
The European Medicines Agency (EMA) has reportedly started evaluating the use of Comirnaty in children aged 12 to 15 years.
The Committee for Medicinal Products for Human Use (CHMP) will carry out an accelerated evaluation of the data submitted by the company that has registered the vaccine Comirnaty. The Committee will evaluate the results of an ongoing large-scale clinical study in adolescents from 12 years of age to decide whether to recommend an extension of the indication.
The committee’s opinion will then be sent to the European Commission for a legally binding final decision, which will be applicable in all EU Member States.
The Pfizer / Biontech Comirnaty vaccine was registered in the EU in December 2020.
German vaccine manufacturer BioNTech and its US partner Pfizer have already reportedly applied to EZA in late April for approval of the jointly developed Covid-19 vaccine for children aged 12 to 15 years. When notifying the application, the companies indicated that the existing approval under this step could be adapted and extended to the younger age group.
Vaccine manufacturers have previously reported that clinical trials in the United States have shown that the vaccine is 100% effective in the 12- to 15-year-old age group.
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