India begins human trials of two COVID-19 vaccines: ICMR

Human trials of two vaccines that may provide immunity against COVID-19 have begun in India, the Indian Council of Medical Research (ICMR) said on Tuesday. According to the ICMR, about 1,000 volunteers will be vaccinated under these clinical trials.

In a press briefing, Director-General of ICMR Dr Balram Bhargava said that as India is one of the largest manufacturers of vaccines in the world, it is our “moral responsibility” to develop a vaccine that can break the chain of transmission of this coronavirus infection as quickly as possible.

The two vaccines in human trials have been prepared by Hyderabad-based Bharat Biotech International Limited (BBIL) and Ahmedabad-based pharmaceutical company Zydus Cadila Healthcare Limited, respectively. The Drug Controller General of India (DCGI) had last month permitted these two drug companies to conduct human trials of their vaccines. This approval was granted for first and second stage trials.

Speaking at the press briefing on Tuesday, Dr Bhargava said that the two made-in-India vaccines had been successfully used on mice and rabbits, and data from those trials had been submitted to DCGI. Subsequently, both vaccine makers were allowed to enter initial stages of human trials this month.

Referring to India’s role in the fight against COVID-19, the ICMR Director-General explained that India is known to be the world’s largest makers of generic drugs: 60% of the medicines used in the US are of Indian origin. He added that what isn’t as well-known is the fact that 60% of vaccines worldwide are also supplied by Indian pharma. This includes vaccines that are used in countries across Africa, Europe and South-East Asia, among other regions.

Dr Bhargava said that even if the vaccine is developed in another part of the world, it would have to be produced by India or China in the end, as these two countries are the largest manufacturers of vaccines. All the countries that are trying to make vaccines know this. That is why they are in touch with India, Dr Bhargava said.

India's top vaccine candidates for COVID-19

India's top vaccine candidates for COVID-19

Bharat Biotech’s Covaxin contains inactivated forms of SARS-CoV-2 that will be injected into the muscle (intramuscular injection) in two doses, 14 days apart. Trial participants aged 18-55 will receive the vaccine in the first phase, which will test for any side-effects of Covaxin. In phase 2, the age band will be increased to 12-65 years and the researchers will look for signs that the vaccine can actually help participants make antibodies (immunogenicity) against SARS-CoV-2, the coronavirus that causes COVID-19.

Zydus Cadila's ZyCoV-D vaccine is given through intradermal injection—injected just below the skin. It is based on DNA plasmid—it will produce a protein that is also found on the outer shell of the SARS-CoV-2 virus. If everything works out, the body should recognise this protein as a foreign substance and develop antibodies to attack it. This vaccine is to be administered in three doses, on day 0, 28 and 56. The company hadn't started recruiting participants at the time of writing, but it is looking to do phase 1 trials with healthy individuals aged 18-55 years. In phase 2 trials, the company will recruit volunteers over 12 years of age.