Bharat Biotech gearing up to meet demand as Covaxin gets DCGI nod
Hyderabad: Hyderabad-based vaccine maker Bharat Biotech, which received the Drugs Controller General of India (DCGI) nod for emergency use of its Covid-19 vaccine ‘Covaxin’, is gearing up to meet the vaccine needs of the country. “Following the emergency use permission, the company is in a position to meet any production requirement that the government may have at this time,” company officials said.
On receiving permission from the government, Bharat Biotech CMD Dr Krishna Ella said: “The approval of Covaxin for emergency use is a giant leap for innovation and novel product development in India. While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most. Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist,”
The Subject Expert Committee (SEC) of Central Drugs Standards Control Organization (CDSCO) makes recommendations in respect of Accelerated Approval Process requests. The Subject Expert Committee of CDSCO met on January 1 and 2 and made the recommendation for the consideration and final decision of the DCGI.
Covaxin is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a vero cell manufacturing platform with safety track record of more than 300 million doses. In case of need, the capacity is expandable to 500 million doses.
The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers across India. Bharat Biotech on Saturday crossed 23,000 volunteer mark and expects to recruit all 26,000 volunteers by early this week. The company said the phase III trials could be concluded by mid-February 2021 and by June-July 2021, the vaccine is likely to be ready for marketing.
Covaxin has been evaluated in about 1,000 subjects in phase I and phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific journals. The publication of phase II trial data is undergoing the peer review process, according to the company.
Bharat Biotech is developing Covaxin along with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s Bio-Safety Level-3 bio-containment facility.
The company said that evaluation of Covaxin has resulted in several product characteristics including long-term persistence of immune responses to multiple viral proteins, and has demonstrated broad spectrum neutralising capability with heterologous SARS-CoV2 strains, thus potentially reducing or eliminating escape mutants.
Also read:
India approves 2 Covid vaccines for emergency use
Expert panel recommends Bharat Biotech’s ‘Covaxin’ for emergency use
