Home >News >India >Serum Institute asked to modify protocol for Oxford vaccine trial

NEW DELHI: A committee of experts at the apex drug regulator has deferred its decision on Serum Institute of India Pvt Ltd’s covid-19 vaccine trial, and has asked the company to amend its protocol for the phase II and III clinical trial of the University of Oxford’s vaccine candidate.

“After detailed deliberation the committee recommended for amendment to the protocol… Accordingly, the firm should submit revised protocol for evaluation of the committee," as per minutes of Tuesday’s meeting of the subject expert committee (SEC) for covid-19 related proposal in the Central Drugs Standards Control Organization, a copy of which has been seen by Mint.

An email sent to Serum Institute of India on this development remained unanswered at the time of publishing.

As part of the amendment in protocol, the regulatory panel has asked the company to demarcate Phase II and Phase III part of the protocol and also asked for the trials to be distributed pan India.

The panel has also asked the company to specify the role of Indian Council of Medical Research (ICMR) in the trial. Mint could not ascertain a link between ICMR and Serum Institute’s trial of the Oxford vaccine candidate.

Serum Institute of India had applied to the government for approval for the clinical trial of about 1,600 participants over the age of 18, as per a report by the Press Trust of India on Saturday.

The company, which is the world’s largest vaccine manufacturer by number of doses produced and sold, globally, had last month signed an agreement with British-Swedish multinational pharmaceutical company AstraZeneca, the co-developer of the vaccine, to supply an additional 1 billion doses, principally for low- and middle-income countries.

While there are more than 150 vaccine candidates undergoing clinical trials, with human trials of more than two dozen of these underway, the University of Oxford’s vaccine candidate is seen as the front runner.

Interim data from a clinical study published in The Lancet journal last week showed that the vaccine candidate was safe and provided dual immunity against the fatal respiratory disease.

Serum Institute plans to price the vaccine at less than 1,000 per dose, chief executive officer Adar Poonawalla had told Mint in an interview last week. Poonawalla has also said that the company would reserve around half the vaccines it produces for India.

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