Serum Institute asked to revise protocol for Covid-19 vaccine clinical trial

A  Central Drugs Standard Control Organisation (CDSCO) expert panel has sought clarifications from Serum Institute of India (SII) over its application to the Drugs Controller General of India (DCGI) seeking permission for conducting phase 2 and 3 human clinical trials of the Oxford vaccine candidate for COVID-19, official sources said on Wednesday. The CDSCO has advised the Serum Institute of India (SII) to submit a revised protocol to perform the clinical trials in India for potential Covid-19 vaccine.

The move comes when the Subject Expert Committee evaluated the submitted protocol by SII. The Subject Expert Committee (SEC) on COVID-19 which held its meeting on Tuesday deliberated on the application by SII and asked the Pune-based firm to revise its protocol for the phase 2 and 3 clinical trials, besides seeking some additional information. On Wednesday evening, SII submitted a revised protocol for conducting the trials to the DCGI. The firm plans to start phase 2 and 3 human trials in India in August. The domestic pharma giant has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for highly infectious disease Covid-19.

“The company on Tuesday was asked to clearly define phase 2 and phase 3 part of the protocol and resubmit their application for evaluation by the SEC,” an official source said. The panel also recommended that the proposed clinical trial sites be distributed across India, the source said. “They also have not given justification for the proposed enrolment of 1,600 subjects during the trial,” the source added. Additional Director, Government Affairs, SII, Prakash Kumar Singh said, “We have submitted our revised protocol to DCGI office today evening for further action by SEC and DCGI.” 

The SII which has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19 had submitted its application to the DCGI on Friday, seeking permission for conducting the phase 2 and 3 trials of the potential vaccine ‘Covidshield’.”According to the application, it would conduct an observer-blind, randomized controlled study to determine the safety and immunogenicity of ‘Covishield’ in healthy Indian adults. The firm said that around 1,600 participants of more than 18 years would be enrolled in the study,” a source had said.  A Lancet medical journal report has stated that a vaccine candidate developed at the University of Oxford has shown encouraging results and it appears to be “safe, well-tolerated, and immunogenic. Initial results of the first two-phase trials of the vaccine conducted in five trial sites in the UK showed it has an acceptable safety profile and homologous boosting increased antibody responses, the source said.

To introduce the vaccine, SII, the world’s largest vaccine maker by the number of doses produced and sold, has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute (Oxford University) in collaboration with British-Swedish pharma company AstraZeneca. On the partnership with AstraZeneca, Serum Institute of India CEO Adar Poonawalla had said, “Serum Institute of India has entered a manufacturing partnership with AstraZeneca to produce and supply 1 billion doses of the COVID-19 vaccine being developed by Oxford University.”

These vaccines will be for India and middle and low-income countries across the world (GAVI countries), he had said. Last week, Oxford University announced the satisfactory progress with the vaccine, making it one of the leading ones among the dozens of vaccine candidates being developed around the world. The clinical trials of a potential Covid-19 vaccine on humans began in April. There was no immediate response from SII when ANI contacted them to make their version.