COVID-19 Vaccine: India Enrols 375 Volunteers For Human Trials


Posted on: Wed 08-07-2020

India says it has engaged 375 people for the initial phase of Covaxin, the country’s first possible vaccine against the COVID-19 global pandemic.

The Times of India reported that the human trial would be carried out on over 1,100 people in two phases, adding that Bharat Biotech, an unlisted Indian vaccine maker, have received regulatory approval to start human clinical trials for the experimental shot.

The phase 1 trial of Covaxine is scheduled to start next week. Spokesperson of the Indian Council for Medical Research, Dr. Rajnikant Srivastava, announced that the company has set July 13 as the last date of enrolment for the first trial.

He noted that the ICMR has selected 12 institutes to conduct the trials, including All India Institute of Medical Sciences in Delhi and Patna. “Depending on the results of the first trial, the company has a plan to enrol 750 people in the second phase of the trial,” he said.

Whether the vaccine will be approved for general use depends on the outcomes of those trials, ICMR spokesperson said.

One of the trial sites that received ICMR’s letter was Hyderabad’s Nizam’s Institute of Medical Sciences, which remarked that it has been working all working hard to meet up with the deadline in it envisaged would be a be neck-to-neck race.

A professor in Nizam’s Institute of Medical Science, C. Prabhakar Reddy, added that he does not anticipate any shortage of volunteers “in the current scenario.”

Citing the firm’s “track record in developing the Vero cell culture platform technologies,” Bharat Biotech said in a June 29 statement that Covaxin, described as the “inactivated vaccine” candidate, has demonstrated safety and immune response in preclinical studies.

The company has earlier developed vaccines against polio, rotavirus, Japanese encephalitis and Zika, according to the statement.

The Indian vaccine maker revealed that it is working expeditiously to meet the target, knowing that the final outcome would depend on the cooperation of all the clinical trial sites involved in the project.

The ICMR on Sunday said it has now set a 15 August deadline for a Made-in-India vaccine for COVID-19, after a controversy over setting a hurried target for the drug.

“Just as the red tape was not allowed to become a hindrance in the fast-track approval of new indigenous testing kits or for introducing in the Indian market potential COVID-19 related drugs, the indigenous vaccine development process has also been sought to be insulated from slow file movement,” an ICMR statement said.

Source: punch healthwise