India starts dosing desi vaccineAugust 12, 2020 0 By FM
India has started administering the indigenously developed vaccine candidate for COVID-19 among volunteers at All India Institute of Medical Sciences (AIIMS), New Delhi.
The inactivated vaccine has been developed by Hyderabad-based Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).
More than 3,500 volunteers have already registered for the trial at AIIMS, reports quoting hospital sources said.
The phase I and II randomised, double-blind, placebo-controlled clinical trials of Covaxin are taking place at 12 sites, ICMR said.
At least 375 volunteers will be administered the vaccine in phase I. The second phase will have around 750 volunteers from all 12 sites. These will be recruited from among those between the ages of 12-65 years.
The vaccine has been formulated in three strengths. Each subject will be given any one of the formulations in two doses, two weeks apart. The first 50 will get the lowest strength dose of the vaccine. If it is found to be safe in them, then it will be given to another 50 patients in higher doses.
More vaccines on the way
Indian pharmaceutical firm Zydus Cadila initiated clinical studies on its plasmid DNA vaccine in mid-July. The adaptive phase I/II dose-escalation, multi-centre study will assess the safety, tolerability and immunogenicity of the vaccine on over 1,000 subjects across multiple clinical study sites in India, the company said in a regulatory filing.
The Ahmedabad-based firm is looking to complete clinical trials of ZyCoV-D in seven months, the company’s chairman said.
Meanwhile, Serum Institute of India, which is partnering with AstraZeneca for manufacturing the Oxford vaccine, has has been granted permission by the Drugs Controller General of India (DCGI) for conducting phase 2/3 human clinical trials. Data from phase 3 trials on the Indian population is a mandatory requirement for drugs and vaccines to be marketed in the country.
Panacea Biotec, Indian Immunologicals, Mynvax and Biological E are reportedly among other domestic pharma firms working on the coronavirus vaccines.
Panacea Biotec is setting up a joint-venture firm in Ireland with US-based Refana Inc to develop a vaccine for COVID-19.
Indian Immunologicals has joined hands with Australia’s Griffith University for a new coronavirus vaccine.