India joins global peers in COVID-19 vaccine clinical trials

Photo: For Representational Purposes Only.

By Deepak Sharma

New Delhi: India’s pharmaceutical industry, with $20 billion annual sales, has joined the global race for the COVID-19 vaccine, as three Indian drug-makers announced their plans to initiate late-stage clinical trials in the country.

Since the beginning of this year, the world is reeling under the impact of Coronavirus pandemic, which has left millions jobless and the whole global economy shattered. Drug-makers across the world are racing to find a vaccine to rescue humanity from its worst crisis since the end of the World War II.

Globally, over 100 vaccine candidates are in various stages of development and over two dozen are in different phases of clinical trials. Of them, three are in the advance stages. Despite having initial encouraging results, experts still warn that there is no guarantee of an effective vaccine soon.

After an initial hiccup, Indian pharmaceutical industry, the world’s largest suppliers of generic medicines, joined their global peers to discover the much-awaited magic bullet to prevent the spread of the pandemic.

India’s health watchdog, Drug Controller General of India (DCGI) headed by V. G. Somani granted permission to two Indian drug makers (Bharat Biotech International and Zydus Cadila) to simultaneously initiate Phase 1 and 2 trials for locally developed vaccine candidate in the country.

DCGI also granted the permission to Pune-based Serum Institute of India (SII) to conduct Phase 2 and 3 clinical trials for a vaccine candidate developed by the United Kingdom’s Oxford Institute.

During the Phase 1 clinical trial, the safety of the newly developed candidate for either drug or the vaccine is tested on a small set of volunteers after completing a similar test on animals.

In the Phase 2, efficacy and immunological response of the candidate is studied on a small group of people. In the Phase 3, the same is studied in a large group of people under different circumstances.

Bharat Biotech International and Zydus Cadila have completed Phase 1 of clinical trials for their respective vaccine candidates against COVID-19, just three weeks after the two companies started human dosing of the immunisation shots against the fatal respiratory disease

The nod allowed the Indian firms to start the Phase 2 without a complete analysis of data of the Phase 1. Enrolment and human dosing of the vaccine candidates began only in mid-July and the completion of trials in such a short time is likely to be unprecedented

Zydus Cadila recently said the Phase I clinical trial of its COVID-19 vaccine candidate, ZyCoV-D, has been completed and it will commence Phase 2 clinical trials from tomorrow.

“ZyCoV-D was found to be safe and well-tolerated in phase 1 clinical trial. The company will now commence Phase 2 clinical trials from Aug.  6,” it said in a release earlier this week.

Similarly, Serum Institute has also announced that it has signed a manufacturing contract with Oxford Institute to produce millions of dosage of its under-development vaccine in India for which it is planning to initiate Phase 2 and 3 clinical trials in India.

According to industry experts, the start of Oxford trials in India will make way for faster delivery of a vaccine in the country, which is the third worst-affected nation by COVID-19.

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