Published 12:01 IST, January 3rd 2021
As India approves 2 COVID-19 vaccines, here's what DCGI said on Bharat Biotech's Covaxin
In a massive development, the DCGI on Sunday approved Bharat Biotech's Covaxin for emergency use as well as Serum Institute of India's 'Covishield'.
Drug Controller General of India (DCGI) Dr VG Somani on Sunday announced that the vaccines of Serum Institue of India (Covishield) and Bharat Biotech (Covaxin) have been granted permission for restricted use in an emergency situation. Dr VG Somani also informed that permission to conduct phase III trials have been granted to Cadila Healthcare vaccine against Coronavirus.
The massive development comes a day after the Subject Expert Committee (SEC) of the Central Drugs Standards Control Organisation (CDSCO) made recommendations to the Drugs Controller General of India to grant permission for restricted emergency use of the Serum Institute of India (SII) and Bharat Biotech's vaccines. As per an official release, the SEC met on Friday and Saturday and made its recommendations in respect of the accelerated approval process request of the SII, Bharat Biotech International Ltd as well as about phase-III trials of Cadila Healthcare Ltd.
DCGI on Covaxin
About Bharat Biotech's Coviaxin, the official said, "M/s Bharat Biotech has developed a Whole Virion Inactivated Corona Virus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. This vaccine is developed on Vero cell platform, which has a well-established track record of safety and efficacy in the country & globally.
The firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters. All these data have been shared by the firm with CDSCO. Phase I and Phase II clinical trials were conducted in approx.800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response. The Phase III efficacy trial was initiated in India in 25,800 volunteers and till date, ~22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date. The Subject Expert Committee (SEC) has reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in an emergency situation in the public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The clinical trial ongoing within the country by the firm will continue."
This comes amid questions being raised on Covaxin by Congress leaders such as Jairam Ramesh
Bharat Biotech's Covaxin
Bharat Biotech’s Covaxin is an indigenous, inactivated vaccine that is being developed in collaboration with ICMR’s National Institute of Virology (NIV), Pune. According to the company, Covaxin has been developed from an Indian strain of the novel coronavirus, which was isolated by NIV.
Inactivated vaccines are made from microorganisms (these could be viruses, bacteria, etc.) that have been killed through physical or chemical processes. According to a World Health Organization (WHO) module on different types of vaccines and their adverse effects, these killed organisms “cannot cause disease".
Updated 12:01 IST, January 3rd 2021