Human trials of Covaxin on 375 people starting soon

Covaxin, India’s first possible vaccine against COVID-19, will be tested on over 1,100 people in two phases, according to a report in Bloomberg. Bharat Biotech, an unlisted Indian vaccine maker, received regulatory approval to start human clinical trials for its experimental shot. The phase 1 trial of Covaxine is scheduled to start next week. The company has planned to enroll 375 people in the first phase of clinical trials, an Indian Council for Medical Research (ICMR) spokesperson told Bloomberg. The company has set July 13 as the last date of enrollment for first trial.

The ICMR has selected 12 institutes to conduct these trials, including AIIMS in Delhi and Patna. Depending on the results of the first trial, the company has a plan to enroll 750 people in the second phase of trial.

Hyderabad’s Nizam’s Institute of Medical Sciences was one of the trial sites that received ICMR’s letter. “We are all working day and night to meet the deadline but still it will be neck to neck race,” said C. Prabhakar Reddy, a professor in Nizam’s Institute of Medical Sciences, adding that he doesn’t anticipate any shortage of volunteers “in the current scenario.”

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

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

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

Bharat Biotech “is working expeditiously to meet the target, however, final outcome will depend on the cooperation of all the clinical trial sites involved in the project,” the ICMR letter said.

The ICMR on Sunday said it has not 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 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.

Zydus to conduct COVID-19 vaccine trial on 1,000 volunteers

Zydus, another pharmaceutical firm, also receiveapproval from authorities to start human trials for its COVID-19 vaccine contender.

Zydus Cadila group chairman Pankaj Patel told PTI that human trials for the coronavirus vaccine will be started soon and it will take three months to finish the trials. The trials will be conducted on 1,000 volunteers, he added.

The vaccine, ZyCoV-D, showed a “strong immune response” in animal studies, and the antibodies produced were able to completely neutralise the wild type virus, Zydus, part of Cadila Healthcare Ltd, said in a statement.

Globally, over 100 candidates are being tested on humans but no vaccine has yet been approved. – Livemint