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Two indigenous COVID-19 vaccines almost complete Phase 2 trials: Will India go for emergency authorization?

Two indigenous COVID-19 vaccines almost complete Phase 2 trials: Will India go for emergency authorization?
Bharat Biotech's Covaxin uses an inactivated strain of the novel coronavirus.

The COVID-19 vaccine candidates developed by domestic pharma firms Bharat Biotech and Zydus Cadila are nearing completion of phase 2 trials.

Written by Longjam Dineshwori |Updated : August 20, 2020 11:37 AM IST

India is making bigger strides in the race to create a potential coronavirus vaccine. Several Indian pharmaceutical companies are working on developing a vaccine for deadly coronavirus that has already infected nearly 22 million people globally. Domestic pharma firms working on the coronavirus vaccines in India include Bharat Biotech, Serum Institute, Zydus Cadila, Panacea Biotec, Indian Immunologicals, Mynvax and Biological E.

On Wednesday, the Indian Council of Medical Research (ICMR) Director-General Dr. Balram Bhargava informed members of the parliamentary standing committee on home affairs that the vaccine candidates developed by Bharat Biotech, Cadila and the Serum Institute of India are at different stages of the trial.

According to the official, phase 2 clinical trials of two indigenous vaccine candidates have almost completed in India. Normally it takes six to nine months for a vaccine to come out, but it could be released early if the centre decides to go for emergency authorization he suggested.

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Prime Minister Narendra Modi had, in his August 15 speech from the Red Fort, said the Centre will start mass-producing the vaccine as soon as researchers give the green signal. So, it is likely that the vaccine that successfully completes phase 2 clinical trials may be given emergency authorization for public use.

Covaxin and ZyCoV-D are two promising indigenous vaccines, both of which have shown satisfactory results in preclinical studies. Read on to know more about these vaccine candidates.

Covaxin

This is a coronavirus vaccine candidate developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).

The company received Drug Controller General of India (DCGI)'s approval to conduct phase I and 2 clinical trials for the vaccine candidate in June and the trials commenced across India from July 15. Phase 1 and 2 trials are meant to determine a candidate vaccine's safety and immunogenicity, which is the ability to provoke an immune response in the body.

Dr Bhargava, said at a press conference earlier this month, that Bharat Biotech's inactivated virus vaccine has completed its phase I study in 11 sites and has started its phase II study.

ZyCoV-D

Ahmedabad-based Zydus Cadila launched Phase II clinical trials of its Covid-19 vaccine candidate, ZyCoV-D, in the first week of August. The company has already completed the Phase I trial, where the DNA vaccine was found to be safe and well-tolerated in healthy participants. The Phase II trial will recruit more than 1,000 healthy adults to test the effectiveness of the vaccine candidate.

The company plans to wrap up late-stage trials by February or March next year and manufacture and deliver millions of doses of its vaccine in 2020-21.

ZyCoV-D was found to be safe, immunogenic and well-tolerated in the pre-clinical toxicity studies. The drugmaker had said that the vaccine was able to elicit a high level of neutralizing antibodies in animal studies.

According to Dr Bhargava, about 141 vaccine candidates are being tested all over the world, with 26 of them in different phases of clinical testing. As per the World Health Organization (WHO), six coronavirus vaccine candidates have reached phase 3 clinical trials.