First COVID-19 vaccine candidate COVAXIN from India, gets DCGI approval for human trials

India’s first vaccine candidate against the novel coronavirus, COVAXIN, has received a nod from the Drug  Controller General of India (DCGI) for further clinical trials Phase I and 2 in infected people. The vaccine is under development by Hyderbad-based biotechnology firm Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). The clinical trials of the experimental COVID-19 vaccine in humans are scheduled to begin in July 2020, Bharat Biotech  said in a note. COVAXIN has been expedited through national regulatory protocols, and subjected to “comprehensive pre-clinical studies” according to the company, which reports that the results are “promising” and “show extensive safety and effective immune responses”. Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech, said, “The collaboration with ICMR and NIV was instrumental in the development of this vaccine. The proactive support and guidance from CDSCO has enabled approvals to this project. We worked tirelessly to deploy our proprietary technologies towards this platform.” [caption id=“attachment_8541611” align=“alignnone” width=“1280”] An illustration of COVAXIN, the vaccine candidate for COVID-19 developed by Bharat Biotech. Image: Bharat Biotech[/caption] “The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad,” the company added.

COVAXIN™, India's 1st indigenous Covid-19 vaccine, developed by Bharat Biotech successfully enters human trials.

@ICMRDELHI @DBTIndia @icmr_niv #BharatBiotech #COVAXIN #covid19 #Collaboration #Indiafightscorona #makeinindia #ICMR #coronavirusvaccine pic.twitter.com/MSehntuE8d

— Bharat Biotech (@BharatBiotech) June 29, 2020

The company hasn’t yet released details on how long the next steps are likely to take, when the vaccine might be launched in the market or its price. In May 2020, Bharat Biotech went into a partnership with Thomas Jefferson University, Philadelphia, for an exclusive deal to develop a new vaccine candidate for COVID-19 that was invented at Jefferson. The vaccine was developed using an existing deactivated rabies vaccine as a vehicle for coronavirus proteins, according to a Business Line report. Dr Matthias Schnell, an infectious diseases expert, and his lab at Thomas Jefferson reportedly developed the vaccine in January, after which they completed preliminary tests in animal models that showed a “strong antibody response in mice receiving it,” the report adds. [caption id=“attachment_8488691” align=“alignnone” width=“1280”] A vaccine candidate against COVID-19 (the SARS-CoV-2 virus), provided by Imperial College London. About a dozen vaccine candidates are in early stages of testing in thousands of people. Image: Imperial College London via AP[/caption] In the past, vaccine maker Bharat Biotech has manufactured the H1N1 vaccine during the swine flu outbreak, and has over 140 global patents and 16 vaccines in its portfolio. The most significant of their developments is arguably the rotavirus vaccine Rotavac, a next-gen vaccine against a viral gastroenteritis that got pre-approval from the WHO after an Oxford laboratory found it safe and efficacious. Among the first companies in India to announce a vaccine candidate was Ahmedabad-based Cadila Healthcare. Their candidate is currently in pre-clinical studies. Pune biotech firm Serum Institute and Panacea Biotec in Delhi, are also among the leading candidates from India to develop a COVID-19 vaccine. The Gilead Sciences treatment candidate remdesivir was found to be effective in reducing the amount of time an infected COVID-19 patient spent in the hospital. Yet, a cure for COVID-19 has not been found. Meanwhile, India reported over 18,000 cases on 29 June alone. The number of COVID-19 cases in India now stands at 5,66,840 and counting. The Ministry of Home Affairs has released guidelines for Unlock 2.0, which is expected to come into force till 31 July.