India becomes testing ground for global vaccine candidates

Nearly 30 COVID-19 vaccine candidates are under development by both industry and academia in India, according to the Indian government. These vaccines are at different stages of pre-clinical and clinical development, of which three candidates are at an advanced stage of Phase I, II or III trials and four are at an advanced pre-clinical development stage.

Health Minister Harsh Vardhan said last week that there are chances of the COVID-19 vaccine becoming available in India in early 2021. He said four vaccine candidates are currently in advanced stages of pre-clinical tests. However, he conceded that, even if a vaccine were developed, it would take time to become available in bulk quantities.

“The government is providing all essential assistance for the development of a vaccine and three vaccine candidates are in various human trial phases – Phase I, Phase II and Phase III,” he added.

India has emerged as a testing ground for several global vaccine candidates. While Pune-based drug maker Serum Institute of India is overseeing work on the British-Swedish company Oxford-AstraZeneca novel vaccine, recent reports also revealed that a crucial deal has also been signed with American pharma company Novavax to test and produce vaccine doses in the upcoming months.

The Serum Institute of India has begun testing the vaccine candidate developed by AstraZeneca and Oxford University in Phase-III trials.

“The Phase-III trials of the Covishield vaccine will begin next week at Sassoon Hospital and volunteers will be administered the vaccine candidate dose,” said Dr Muralidhar Tambe, dean of state-run Sassoon Hospital in Pune.

He said that he will be able to comment further only after trials began.

However, seven volunteers selected for Phase-III trials failed in the initial test and a hospital official said they were declared ineligible to continue for various reasons, including testing positive for antibodies.

Serum Institute will undertake the trial of another COVID-19 vaccine candidate developed by American company Novavax. Global Phase-III tests of Novavax vaccine are likely to begin in October. The India trials of this vaccine are expected to start in late October, according to Vardhan. In India, Novavax has signed a deal with the Serum Institute of India for the manufacture of 100 million doses of the vaccine and it is assumed that at least half of this would be intended for supplies within India.

Two indigenous vaccines in stage of human trials

The Indian Council of Medical Research (ICMR), apex national body responsible for the formulation, coordination and promotion of biomedical research in India, has said two indigenous vaccines are also in the stage of human trials.

The vaccine candidate developed by Hyderabad-based Bharat Biotech International in collaboration with ICMR is in Phase-II trials as is the vaccine developed by Ahmedabad-based Zydus Cadila. The ZyCoV-D, developed by Zydus Cadila, is in the course of mid-scale testing and has shown good results so far. COVAXINTM, India’s other indigenous vaccine, is being developed by Bharat Biotech in association with the ICMR – National Institute of Virology (NIV).

Also, Bharat Biotech said on 23 September that it would manufacture up to a billion doses of a single-dose intranasal COVID-19 vaccine in association with the Washington University School of Medicine, St Louis, Missouri. The Phase-I trials will take place in the US university’s vaccine and treatment evaluation unit in St Louis. Bharat Biotech will undertake clinical trials in India after receiving the required regulatory approvals.

Meanwhile, the Russian Direct Investment Fund (RDIF) and India’s leading Hyderabad-based pharmaceutical company Dr Reddy’s Laboratories have consented to collaborate on clinical trials and the supply of 100 million doses of the COVID-19 vaccine candidate Sputnik V to India.

Vaccine ‘likely next year’

Dr Sanjay Rai, head of the community medicine department, AIIMS, recently said that clinical tests were taking place satisfactorily at selected centres across the country, and a vaccine was likely by next year.

Dr T Mariappan, former scientist with the Indian Council of Medical Research, said: “The minimum duration required for a successful vaccine is 15-18 months, provided the clinical trial should have completed all procedures laid down by the Indian Council of Medical Research, India.”

Earlier this week, the Drugs Controller General of India (DCGI) issued a new set of guidelines for COVID-19 vaccine candidates, focusing on safety, immunogenicity and efficacy parameters.

“A COVID-19 vaccine candidate should have at least 50% efficacy in the Phase-III clinical trial for it to be widely deployed,” said Dr Balram Bhargava, director general, Indian Council of Medical Research, in a news conference.

He warned: “All vaccines for respiratory viruses are not 100% effective.”

Immunising entire population

But, while a vaccine will be key to bringing India’s huge outbreak under control, medical experts have cautioned that manufacturing hundreds of millions of doses speedily to make them available to people across the country is an uphill task.

Besides, a very large number of competent and trained health workers will have to be stationed in different parts of the country for distribution of the doses to people in rural and far-flung regions and very advanced logistics and huge manpower will be needed.

There is also the ethical issue of testing a vaccine on the general population. This issue is the same as with any other vaccine or any other drug and, in India, the concerns are the same as in any other part of the world.

Capacity in neighbouring nations

While India’s COVID-19 tally continues to mount, the government has launched a training programme to bolster clinical trial research capacity for neighbouring countries, including Nepal, Maldives, Bangladesh, Mauritius, Sri Lanka, Bhutan and Afghanistan.

India’s Department of Biotechnology launched the programme in association with the Ministry of External Affairs and the first online orientation to this training was conducted on 22 September.

India’s COVID-19 tally stood at 5,646,011 as on 23 September, while the fatality count has now mounted to 90,020 after 1,085 more lives were claimed by the deadly virus on the previous day. India recorded 89,746 recovered and discharged cases during those 24 hours, according to the Union Home Ministry data update on 23 September.