New Delhi: The Drug Controller General of India (DCGI) on Monday said that Oxford Covid19 vaccine candidate 'Covishield' is the front runner of all other vaccine candidates in India.
Top officials in India's apex drug regulator told ETV Bharat that Phase II and III trial of Oxford vaccine is going on simultaneously.
"The Phase II and III clinical trials of Oxford vaccine candidate is going on in different sites across the country," said a top DCGI official on condition of anonymity.
Developed by Oxford University and manufactured by the Serum Institute of India (SII), the last stage of the clinical trial is going on smoothly, officials said.
The SII has partnered with British-Swedish Pharma company AstraZeneca for manufacturing covid19 vaccine candidate.
Earlier, in September SII had paused the clinical trial of the vaccine after DCGI asked for some more safety documents. However, later in September it again resumed the trial after submitting necessary safety documents to DCGI.
On the issue of indigenous Covid19 vaccine, officials from DCGI said that vaccine candidates from Bharat Biotech are also doing well.
"The phase II trial of Bharat Biotech vaccine candidate is found satisfactory. However, we have asked Bharat Biotech for some more documents before it starts the Phase III trial," officials said.
It may be mentioned here that representatives from Bharat Biotech had recently presented the Phase III clinical trial protocol along with the interim data of phase I and II clinical trials of its vaccine candidate before the Subject Expert Committee (SEC) of DCGI.
After detailed deliberations, the committee opined that the design of the Phase III study is in principle satisfactory except for clarification on definitions of asymptomatic etc.
The committee had suggested the firm to submit safety and immunogenicity data from the phase II trial. Amid all the ongoing clinical trials, India is expecting to have the Covid19 vaccine by the first half of next year.
However, Union Health Minister Dr Harsh Vardhan on Sunday said that supplies of Covid19 vaccine would be available in limited quantities in the beginning.
"In a huge country like India, it is critical to prioritise vaccine delivery based on various factors such as per risk of exposure, comorbidity among various population groups, the mortality rate among Covid19 cases and several others," said Dr Vardhan.
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