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Human clinical trials of indigenously developed Covid vaccine candidates move to Phase 2: ICMR

New Delhi: 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 worldover and 26 are in different phases of clinical trials, he said.

"At the present moment, there are three vaccines which 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.

Bhargava also said that rapid antigen tests comprise nearly 25-30 per cent of the total daily tests conducted for the detection of COVID-19 in the country at present.

A record 6,61,892 samples were tested for COVID-19 on Monday, taking the total number of tests conducted so far in the country to 2,08,64,750 and the Tests per Million (TPM) to 15,119.

Of the total 2.08 crore tests conducted so far, around 26.5 lakh are antigen tests, an ICMR official said.

Bhargava said at a press briefing that a rapid antigen detection test has a very high specificity (ability to detect true negatives) of 99.3 per cent to 100 per cent, however, their sensitivity is moderate ranging between 55 to 85 per cent.

"And, that is why, we have reiterated in our advisory that if a person is symptomatic and the rapid antigen test results are negative, it should be followed by RT-PCR tests to confirm the diagnosis.

When started, antigen tests comprised about 5-6 per cent of the total tests being conducted in a day, but this proportion is consistently rising now, he said. Bhargava said of the 11 companies which had approached for validation of their testing kits, three have been approved till now.

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