NIMS begins subject enrollment for corona vaccine's clinical trial

Clay Curtis
July 7, 2020

Ganguly said the strain of the virus was given to BBIL in May end, and in July, human trials have been scheduled.

ICMR has partnered with Bharat Biotech International Limited to develop COVAXIN, whereas Zydus Cadila is working on ZyCov-D Vaccine.

The Indian Council of Medical Research issued a statement after a letter was leaked on Friday showing ICMR Director General Balram Bhargava as saying the agency "envisaged" launch of the vaccine for public health use by August 15, with the aim to begin patient enrolment for human trials by July 7.

One of the disagreements concerned monitoring of trial participants for a serious potential symptom of COVID-19 ― decreased oxygen levels ― in the event that the vaccine caused the disease instead of triggering an immune response to the virus.

The envisioned timeline is markedly shorter than other front-runner vaccine efforts from American and Chinese drug makers, most of which started human clinical trials months ago and are now entering the last of three stages of testing.

Given that the coronavirus is spreading in the country at an exponential rate, people are waiting for the vaccine to be available soon.

The speediness has alarmed some in the medical fraternity.

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"In the past years, India has emerged as one of the significant vaccine manufacturing hubs".

On the direction of the Indian Council of Medical Research (ICMR), authorities at NIMS began the process to register 30-60 subjects for the trial. "If the data of any phases are unacceptable, then the clinical trial is required to be immediately aborted", the statement read.

In phase 1, Bharat Biotech plans to enroll 375 people for the clinical trials scheduled that are scheduled to start next week and 750 people will enroll in the second phase.

Several clinician-researchers said they found the letter surprising because, as a doctor-researcher involved in past clinical trials, Bhargava would be expected to grasp the complexity of assessing a brand-new medicine or vaccine - something that typically takes years.

If the vaccine passes the clinical trials, Brazil will be entitled to produce 70 million additional doses at an estimated cost of $2.30 each. Indian institutions have also engaged in Research and Development for the development of vaccines in India. Developing a vaccine is a complicated procedure that involves proving its effectiveness and safety, he said.

The ICMR has selected 12 institutes to conduct these trials, including AIIMS in Delhi and Patna. "We are all working day and night to meet the deadline but still it will be neck to neck race", he said, adding that he doesn't anticipate any shortage of volunteers "in the current scenario". "It's not about getting there first but to be able to do it well and it is good that India has been able to come up with candidate vaccines, which is not a small achievement".

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