OGYÉI issued a temporary authorization for distribution of the product for emergency use
OGYÉI granted a temporary authorization for distribution of the product for emergency use for the Russian vaccine Sputnik V (Gam-COVID-VAC) based on government decree No 488/2020.
National Institute of Pharmacy and Nutrition (OGYÉI) made its decision after more than two months of evaluative work, site visits and active communication with the manufacturer. The conditions of this licence included that the vaccine must comply with the laboratory test of NNK (National Public Health Centre). In addition, NNK will investigate each production batch with the similar laboratory tests and will release them to the Hungarian market only after that.
OGYEI has also approved a temporary authorization for distribution of the product for emergency use of Astra ChAdOx1 S vaccine in Hungary, also based on government decree No 488/2020, whereas this decree states that medicines approved in the United Kingdom may also be used in Hungary. The UK authorities examined the product, which was considered safe and effective, so no further testing was needed. Thanks to this licence, Hungary will be able to start vaccinations with the AstraZeneca vaccine for the first time in the European Union.
Both conditional marketing authorization shall be valid for six months and may be renewed for further six months.