CORONAVAC

CORONAVAC VACCINE FOR THE PREVENTION OF COVID-19 (PRODUCED USING VERO CELLS), INACTIVATED (hereinafter – CoronaVac vaccine) manufactured by Sinovac Life Sciences Co., Ltd., China, contains inactivated SARS-CoV-2 antigen and is intended for active immunization for the prevention of diseases caused by the SARS-CoV-2 virus in persons aged 18 years and older

The CoronaVac vaccine received emergency use authorization in Indonesia – 11.01.2021, in Turkey – 13.01.2021, in Brazil – 17.01.2021., and was registered in China for general use with obligations on 6 February 2021.

In accordance with Resolution of the Cabinet of Ministers of Ukraine No. 95 of 08.02.2021, which provides for registration of vaccines for the prevention of COVID-19 under obligation for emergency medical use, the CoronaVac vaccine manufactured by Sinovac Life Sciences Co., Ltd., China, is authorized for emergency use in Ukraine (registration certificate No. UA/18630/01/01. MoH of Ukraine order of 09.03.2021 No. 419).

The vaccine is injected intramuscularly into the upper arm in the area of the deltoid muscle. Two doses are required to obtain basic immunity. The second dose should preferably be administered 14-28 days after the first dose.

For the CoronaVac vaccine, preclinical studies and phase I and II clinical trials have been conducted in full. This makes it possible to state that this vaccine is of high quality and safe.

According to the results of the conducted clinical studies (Phase III), which were carried out in Brazil, vaccine efficacy was 51,94%; in Turkey, it was determined by the relative risk indicator, and according to this calculation vaccine efficacy was 91,25%

Discrepancies in the assessment of vaccine efficacy based on interim results of 2 studies – in Brazil and in Turkey) may be explained by different approaches to calculating the efficacy measure.

Systematic safety monitoring was conducted for 7 days after each vaccine dose, and adverse events were collected through voluntary reporting and regular follow-up by investigators for 8-14/28 days. Long-term follow-up of serious adverse events for 12 months after complete vaccination is still ongoing.

Currently, there is limited information on the safety, immunogenicity and efficacy of the CoronaVac vaccine outside the recommended schedule. If more than 28 days have passed, the second dose should be given as soon as possible.

Currently there are no data on the interchangeability of COVID-19 vaccines. Vaccines on different platforms – types (for example, mRNA platform, viral vector, viral vaccines) should be regarded as different vaccines and should not be used interchangeably.

For detailed information on the specifics of using this medicinal product and possible AEFI, please refer to the instructions.