Fighting the Covid battle: India gets sites ready for Phase-3 vaccine trials

Mumbai: India is readying a number of sites for phase three clinical trials of various Covid-19 global and domestic vaccine candidates, in anticipation of the speedy development of a successful product, which can then be deployed quickly in the country.Five clinical trial sites will be ready to start phase three human trials by August 1 and a few more will be able to do so in the next few months, biotechnology department secretary Renu Swarup told ET in an interview.“The purpose of these preparations is that our vaccines will anyways be manufactured here,” she said. Any vaccine needs to go through local phase three trials before it can be introduced in India. “So, our sites should be ready. Our companies who will tie up with them should be ready,” Swarup said. The Department of Biotechnology (DBT) is leading India’s Covid-19 vaccine programme.Preparation of the sites comes in anticipation of phase three trials of the vaccine candidate of Oxford University and AstraZeneca that are expected to start in India next month. AZ has tied up with Serum Institute of India (SII) to manufacture 400 million doses of the vaccine by the end of the year if it succeeds at the clinical development stage. Phase three trials require a large number of people on whom the vaccine candidate needs to be tested.Developing an indigenous vaccine and building the capacity for manufacturing it a priority for DBT, Swarup said.India is a vaccine manufacturing hub, so whichever group comes up with a vaccine, the country will be a production centre, she said. “And we have already made that commitment… How it happens, we have to see.”77057800DBT, according to Swarup, has in the last four months strengthened and fast-tracked the regulatory framework and put it at par with global standards. “We are in constant touch with WHO, Coalition for Epidemic Preparedness and Innovations (CEPI) and others because we definitely want to be part of the global trial which will happen,” she said.Currently India has six different vaccine platforms that target different mechanism, and each have benefits of their own mostly in terms of scale up and mass production. There are 30 Covid-19 vaccine candidates in the country in various stages of development across these platforms.Candidates of Bharat Biotech and Zydus Cadila have started phase 1 and 2 of the clinical trial while companies like Gennova and Biological E are close to launching phase 1 trial.The repurposed BCG vaccine trial for Covid-19 has also started, and its results are expected by September.Bharat Biotech is also working on a vaccine candidate using its viral vector platform that is also supported by the DBT.“The fact is Indian developers have to be facilitated, as we really don’t know which vaccine will be successful,” Swarup told ET. “And even if it does, we will need more than one vaccine…we can’t have just one vaccine.” The DBT is also put in place in labs that would be able to conduct immunoassays, a test that can determine presence of antibodies- a requirement in vaccine development. On the international level India has also expressed its intent to be part of the WHO’s ACT Accelerator Program for Covid-19, a multilateral platform that looks at equitable allocation of diagnostics, drugs, vaccines and health system strengthening in fight against Covid-19.

from Economic Times https://ift.tt/39jJ7K4