The vaccine was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune. The Government of India has approved the use of the COVID shield as well as the COVID vaccine on an emergency basis.
undefined
Covaxin, which is now undergoing phase-3 trials, had raised concerns among experts over its emergency approval earlier this month by India's drug regulator.
undefined
The vaccine, codenamed BBV152, was well tolerated in all dose groups with no vaccine-related serious adverse events, noted the authors of the study funded by Bharat Biotech.
undefined
An article published in the Lancet Infectious Diseases Journal states that all adverse effects of the vaccine are mild to moderate, not serious. Adverse reactions were more common after the first dose of the vaccine adding that one adverse event was reported but was unrelated to the vaccine.
undefined
The randomised phase 1 trial to assess the safety and immunogenicity of BBV152 was carried at 11 hospitals across India. Adults aged 18-55 years who were deemed healthy by the investigator were eligible.
undefined