OGYÉI issued a Temporary Pharmacovigilance License to CoviShield vaccine, It is, like the AstraZeneca coronavirus vaccine, a vector-based product developed by the University of Oxford and AstraZeneca.
The CoviShield vaccine is manufactured in India using technology provided by AstraZeneca to the Serum Institute in India, based on documents provided under a licensing agreement.
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According to the relevant government decree, Hungary has the possibility to use products that have been approved in a country where production of medicines and clinical trials can be considered equivalent to Hungarian regulations (Canada, Australia, the United States, Israel, Japan, Switzerland and New Zealand).
The CoviShield vaccine was licensed by Health Canada in February.
The licensing was based on a comparison with the AstraZeneca vaccine, which concluded that: The two products are similar to the extent necessaryThe efficacy and safety of CoviShield can be determined from the AstraZeneca vaccine.
Another option for Hungary in the Canadian-Chinese collaboration is the Convidecia vaccine, developed by CanSino Biologics Inc. And the Beijing Institute of Biotechnology, which is also a vector-based vaccine.
The advantage of preparation is that One vaccine is enough to provide protection. OGYÉI permitted the vaccine to be received for testing of samples contained in the Laboratory of the National Center for Public Health (NNK). Last December, OGYÉI reviewed the preparation’s documentation, and the manufacturer sent its answers to the questions to the Medicines Authority.
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It is important to emphasize that the use of vaccines can only take place after the completion of the two processes, the licensing process and laboratory tests, during which specialists, such as the European Medicines Licensing process and others, need to ensure that the vaccines are safe, effective and of appropriate quality.
If negotiations are successful and vaccine shipments arrive in Hungary from new sources, then – as before – all production batches can be used after approval by the National Center for Public Health (NNK), informing OGYÉI in a statement.