The Committee for Medicinal Products for Human Use (CHMP) will quickly evaluate the data submitted by the company, which has registered the vaccine ‘Comiranati’. The committee will evaluate the results of a large-scale clinical study in adolescents from the age of 12 to decide whether to recommend an extension of the indication.
The committee’s opinion will be forwarded to the European Commission for a legally binding final decision, which will apply to all EU member states.
Pfizer / Biontech Vaccination Comirnati It was registered in the European Union in December 2020.
German Vaccine Manufacturer BioNTech And is its US partner Pfizer In late April submitted an application to the ESA for approval for the use of the jointly developed Kovid-19 vaccine in immunization for children between 12 and 15 years of age. While notifying the application, the companies indicated that existing approvals could be adapted under this step and could be extended to younger age groups.
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.
It has already been reported that EZA announced on Tuesday that it has also started an investigation into the Chinese company Synovac Developed the Kovid-19 vaccine to evaluate its effectiveness and safety as a first step towards its possible approval in the European Union (EU).
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