China's COVID-19 vaccine safe & immunogenic after Phase 1 trials: Study

The Chinese coronavirus vaccine being developed by the Institute of Medical Biology has been pronounced safe by the researchers after the completion of Phase 1 of clinical trials. Researchers have said that the inactivated SARS-COV-2 vaccine was safe and produced an immune response in test subjects and there were no adverse effects rather than mild pain, redness at the injection site, or slight fatigue. 

Read: China In Talks With WHO To Get Its Locally Produced Vaccine Assessed For Global Use

The study was published in the medical journal medRxiv on October 6 so it can be evaluated and be reviewed by the scientific community. In Phase 1 of the clinical trials, randomised, double-blinded, and the placebo-controlled method was used to test the vaccine on 192 healthy adults aged between 18-59. Two injections of three different doses (50 EU, 100 EU, and 150 EU) of an inactivated SARS-COV-2 vaccine or the placebo were administered intramuscularly with a 2- or 4-week interval between the injections. The safety and immunogenicity of the vaccine were evaluated within 28 days. 

Read: COVID-19 Vaccine 'may Be' Available By The End Of 2020: WHO Chief

Chinese vaccine safe: Study

According to the study, 191 subjects completed the 28-day trial and 44 adverse effects were reported between the period. However, the effects were not so severe and no abnormal variations were observed in the serum samples of immunised subjects. 

A total of 294 adults aged 18 to 59 years were evaluated for inclusion in this Phase 1 trial. Among them, 102 persons were excluded, of whom 84 were ineligible, and 18 withdrew their informed consent. The remaining 192 participants were randomly assigned at a ratio of 1:1 to receive two inoculations with an intervening interval of 14 days or 28 days, and subjects for each schedule were assigned at a ratio of 1:1:1:1 to receive one of the three doses of the vaccine or the placebo.

Read: COVID Vaccine Trials For Kids Should Begin, Says Oxford Study Citing Role In Transmission

The SARS-CoV-2 inactivated vaccine was developed by the Institute of Medical Biology (IMB), Chinese Academy of Medical Sciences (CAM S). Briefly, the virus strain, named KM S-1, was inoculated into Vero cells for production in an environment that met the BSL requirements. The harvested viruses were inactivated by formaldehyde for 48 hours to lyse the viral membrane, purified via chromatography and concentrated, the study said. 

Read: COVID-19 Vaccine: Chinese Company Seeks Co-financing For Phase-3 Trial In Bangladesh