Human trials of Covaxin started about two week ago and it may be available by the end of the year, Union minister of health and family welfare Harsh Vardhan has said.
Covaxin, one of the three vaccine candidates against the coronavirus disease (Covid-19) being developed in India, has been approved for skin trials by the Central Drugs Standard Control Organisation (CDSCO).
The vaccine made by Hyderabad-based Bharat Biotech International Limited is currently being tested through an intramuscular route, where it is injected directly into the muscle. A separate clinical trial of the potential Covid-19 vaccine will now be conducted alongside through the intradermal route, that is just under the skin, the pharmaceutical regulatory body said on Saturday.
Covaxin, developed in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV), has received Drugs Controller General of India (DCGI) approval for Phase I and II human clinical trials and the trials commenced across India from July.
The Phase I trials are conducted on a small group of volunteers to determine safety, dosage and learn about the immune response it generates while the next stage, Phase II trials, involves a larger number of healthy volunteers typically in the 100s or less to learn more about safety and effectiveness of the vaccine, said Dr Priya Sampathkumar, an infectious diseases specialist with US’ Mayo Clinic.
Human trials of Covaxin started about two weeks ago and it may be available by the end of the year, Union minister of health and family welfare Harsh Vardhan has said. The trial is being conducted on 1,125 patients at 12 hospitals across the country including All India Institute of Medical Sciences.
Meanwhile, Serum Institute of India which is producing the Oxford vaccine said it is ready to begin human trials in India this month and is hoping to have the AstraZeneca shot available by the year-end. The third vaccine candidate, ZyCoV-D from Zydus Cadila, has begun clinical trials with the first human dosing and is likely to complete clinical trials in a few months, the health minister said.