Covid-19: Phase-2 vaccine trial results by early Nov

The Phase-2 clinical trial results to determine the safety profile of India’s two indigenously developed vaccine candidates against the coronavirus disease (Covid-19) are expected by early November, senior health officials said on Tuesday.

Vaccine candidates by the Indian Council of Medical Research (ICMR) and Bharat Biotech International Ltd — Covaxin — and Cadila Health — ZyCovD — are currently undergoing Phase-2 clinical trials in the country, said Dr VK Paul, chairman of the Covid-19 empowered group looking after vaccines, on Tuesday.

“By early November, we should get to know the Phase-2 trial results for both the vaccine candidates,” said Paul, during the health ministry’s weekly briefing on Covid-19.

Bharat Biotech’s inactivated whole virus candidate vaccine (BBV152) for SARS-CoV-2, the virus that causes Covid-19, is developed using the virus isolate provided by ICMR-National Institute of Virology (NIV), Pune.

The characterisation of the vaccine candidate has been undertaken at ICMR-NIV.

The Phase-3 trial results of Oxford-AstraZeneca vaccine candidate, which Serum Institute of India (SII) will be manufacturing for them in India, will also be known either by November end or early December this year.

“Serum is conducting Phase-3 trials as part of international trials in India, and the progress is on track. Results are expected by November or early December,” said Paul.

The Union government, meanwhile, is making arrangements for procurement, storage and distribution of the vaccine, as and when it is ready for use.

“We have a main expert committee for vaccines, and there are also multiple sub-committees that have been formed to look at various aspects and stages of vaccine procurement and distribution. They are currently into mapping cold storage facilities both in the government and private sector,” said Rajesh Bhushan, health secretary, Government of India.

While three vaccine candidates are in advance stages of testing in India, according to the department of biotechnology and department of science and technology, at least 30 vaccine candidates have been supported by the government that are currently in different stages of development.

Responding to a question on extending financial support to vaccine manufacturers, Bhushan said through the department of biotechnology, the government is providing direct financial assistance to designated vaccine manufacturers to assist in research and development activities, which currently include pre-clinical trials, and in the future, may be extended for clinical trials also.

Experts, however, stressed that social factors such as hand hygiene and wearing masks will remain crucial even if a vaccine is mass produced.

“While it is good to have a vaccine but we must realise that no vaccine has 100% efficacy, especially the ones meant to prevent from respiratory illnesses. The flu vaccine that is available currently is also has the efficacy of about 50%, which is why it is important to observe Covid-19 appropriate behaviour such as wearing a mask, maintaining hand hygiene and observing physical distancing,” said Dr GC Khilnani, former head, pulmonary medicine department, All India Institute of Medical Sciences, Delhi.