Request is submitted for Pfizer vaccine for children aged 12 to 15 in Serbia

The application for the authorization for the vaccine Pfizer/BioNTech for children aged 12 to 15 in Serbia was submitted yesterday to the Medicines and Medical Devices Agency.

„On June 7, 2021, the Medicines and Medical Devices Agency of Serbia received a request for a supplement to the drug authorization for the product Pfizer/BioNTech vaccine against COVID-19 disease, which refers to the extension of the area of application of this vaccine for the age of 12-15 years. The request with the accompanying documentation, which is defined by the law and bylaws that are harmonized with the EU directives, was submitted by the holder of the drug authorization, the company Pfizer, a representative office in Serbia,“ confirmed the Agency, the Nedeljnik weekly reports.

Urgent consideration

When asked when ALIMS could approve the Pfizer/BioNTech vaccine against coronavirus for children aged 12 to 15, the Agency said that, the same as in the case of all the requests for medical devices, drugs and vaccines used in the fight against the SARS-CoV-2 virus, the Agency also gave absolute priority to this case and took it under urgent consideration.

„Thanks to the good organization and dedicated work of our highly qualified experts, we expect this assessment process to be completed as soon as possible, but not before all the highest professional criteria are confirmed and all scientific facts are checked proving that this vaccine is safe and effective at that age as well. Although it has received authorizations in the USA and the EU, our assessors must perform all controls to be completely confident in the decision we will make and stand behind, as well as behind every approval, permit and certificate of analysis we issue, both in the time of the pandemic and otherwise,“ says the Agency.

As a reminder, the European Medicines Agency (EMA) gave the green light for vaccination of children and adolescents between 12 and 16 years of age with the Pfizer vaccine in late May, and the British Medicines Agency approved last week the use of the vaccine for children aged 12 to 15.

Izvor: Nedeljnik

Foto: Beta AP