Serum Institute of India (SII) has been asked to revise its protocol for the COVID-19 vaccine trial by a CDSCO panel after they submitted an application to Drugs Controller General of India (DCGI) requesting permission for conducting phase 2 and 3 human clinical trials of the candidate COVID-19 vaccine by Oxford University.
A meeting of Subject Expert Committee (SEC) on COVID-19 held on Tuesday sought additional information on SII’s application and asked the company to revise its protocol for the phase 2 and 3 human trials of the vaccine.
A revised protocol on conducting trials was then submitted by SII to DCGI on Wednesday evening.
The official source said that SII was asked to resubmit their application for evaluation by the SEC after clearly defining the phase 2 and phase 3 part of the protocol. The panel also recommended SII to distribute the proposed clinical trial sites across India.
SII had proposed the enrollment of 1,600 subjects during the trial, which lacked proper justification.
The company has submitted their revised protocol to DCGI for further action by SEC and DCGI, said Prakash Kumar Singh, Additional Director, Government Affairs, SII.
The SII submitted its first application seeking permission for conducting the phase2 and 3 trials of the potential COVID-19 vaccine ‘Covidshield’ developed by Oxford University to DCGI on Friday. SII is collaborating with AstraZeneca for manufacturing the same.
As per the application, SII will run a randomized controlled, observer-blind study to determine the immunogenicity and safety of ‘Covishield’ in healthy adults of India. They are planning to enroll nearly 1,600 individuals of more than 18 years in the study.
The vaccine had shown an acceptable safety profile in the initial results of the first two-phase trials conducted in five trial sites in the UK. It was observed that the homologous boosting increased antibody responses in those people who received the vaccine.
SII, the world’s largest vaccine maker, signed an agreement to manufacture the potential Oxford vaccine in partnership with British-Swedish pharma company AstraZeneca, to introduce the vaccine.
Serum Institute of India is collaborating with AstraZeneca to manufacture and supply 1 billion doses of the COVID-19 vaccine developed by Oxford University,” said Adar Poonawalla, the CEO of Serum Institute of India.
He added that the Oxford vaccine would be manufactured to meet the requirements of low and middle-income countries across the globe, besides India and the phase 2 and 3 human trials are expected to begin in India by August.
Satisfactory progress of the vaccine trial was reported by Oxford university recently, making it the leading candidate vaccine among the dozens of COVID-19 vaccines being developed and tested around the world.