Human trials of indigenously developed Covid vaccines move to Phase 2: ICMR

Bhargava said once a safe and effective vaccine is developed, the focus should be on prioritisation and its fair distribution, roll-out and cold chain logistics

The Phase 1 human clinical trials of two Covid-19 vaccine candidates developed indigenously by Bharat Biotech in collaboration with ICMR and Zydus Cadila Ltd have been completed and the trials have moved to Phase 2, ICMR Director General Balram Bhargava said on Tuesday.

Addressing a press briefing, he said once a safe and effective vaccine is developed, the focus should be on prioritisation and its fair distribution, roll-out and cold chain logistics, stockpiling and training of people who would be administering the vaccine.

There are about 141 candidates that are being studied world over and 26 are in different phases of clinical trials, he said.

"At the present moment, there are three vaccines that are in different phases of clinical testing in India. The first one is the inactivated virus vaccine developed by Bharat Biotech which has completed its Phase 1 study in 11 sites and has started its Phase 2 study. Phase 1 and 2 are safety and very early efficacy studies.

"Similarly Zydus Cadila's DNA vaccine has also completed Phase 1 studies in 11 sites and started its Phase 2 trials which is also progressing. Recombinant Oxford vaccine to be manufactured by Serum Institute of India, Pune was given approval yesterday for Phase 2 and 3 clinical trials which would start within a week at 17 sites," Bhargava said at the briefing.

Underlining the urgency for the need of a vaccine, the ICMR official said though the pandemic is progressing rapidly, developing a vaccine takes time "not only from the science aspect, but also from the social, cultural and regulatory aspects".

He, however, emphasised that till a safe and effective vaccine becomes available, sustained behavioural change, physical distancing, wearing masks and proper hand hygiene, is probably the best vaccine available at the moment, and even these measures have to be continued absolutely.