This Is How DBT Is Helping Companies Accelerate Development Of COVID-19 Vaccine

The Department of Biotechnology has prepared 11 clinical trial sites across the country that would help developers test the COVID-19 vaccine candidates quickly.

Viswanath Pilla

Dec 7, 2020 / 07:08 PM IST

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The Department of Biotechnology (DBT), the agency that leads the government's Mission COVID Suraksha or Indian COVID-19 Vaccine Development Mission, has prepared 11 clinical trial sites across the country that would help vaccine developers test the vaccine candidates quickly.

Each site will have access to a cohort of about 50,000 to 100,000 healthy volunteers, who can be tracked for prolonged periods of time.

The government has upgraded the infrastructure at these sites, trained the staff extensively on good clinical practices (GCP), harmonised protocols and ensured that participants are communicated in local languages. In addition, the government is also setting up a network of laboratories for immunogencity testing, based on globally recognised assays. The entire exercise was funded under the National Biopharma Mission at Biotechnology Industry Research Assistance Council (BIRAC).

Immunogenecity testing means measuring antibodies specifically generated against the vaccine.

During the COVID-19 vaccine development process, makers from countries such as the US and the UK took the lead, as they have a long history of new drug development and experience of running large multi-centre late-stage clinical trials, with the ability to quickly recruit thousands of participants in a short span of time. In India, where drug discovery is very nascent, it was a challenge to identify good clinical trial sites that can recruit a large number of people. This is where the government stepped in.

COVID-19 Vaccine

Frequently Asked Questions

How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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In the first phase, six trial sites have been added; these are INCLEN Trust International, Palwal, Haryana; KEM, Pune; ICMR-National Institute of Epidemiology, Tiruneleveli; Christian Medical College, Vellore and Societiy for Health Allied Research Education (SHARE), Hyderabad. Another five clinical trial sites were added later such as Maulana Azad Medical College, Delhi; Society for Applied Studies, Delhi; INCLEN Trust International, Shillong, Meghalaya; ICMR-Regional Medical Research Centre, Bhubaneshwar, Odisha; Andhra Medical College, Visakhapatnam, Andhra Pradesh; and Pondicherry Institute of Medical Sciences, Pondicherry.

DBT said 11 sites are scattered across the country covering the diverse population groups of India, including urban, rural and tribal segments.

Moreover, the DBT also created a cohort of 5,000 subjects at each of the sites to follow up on them for a year, to study immunological response to disease like COVID, Dengue and Chikungunya.

In addition, a vaccine expert committee under DBT meets every two weeks. It provides scientific and technical inputs to research groups and vaccine developers to help them meet regulatory requirements with the DCGI.

"Vaccine development is a complex journey that requires a lot of scientific input as we move on. We need to make sure that quality data is generated that meets the regulatory requirement of not just India but globally," said Renu Swarup, DBT Secretary and BIRAC Chairperson.

Dr Reddy's earlier announced that it was receiving advisory support from DBT for the clinical trials of Russia’s Sputnik V vaccine. Dr Reddy's is doing a phase-2 trial of Sputnik V vaccine in India. The company will be using BIRAC’s clinical trial centres for testing the vaccine.

Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.

TAGS: #Business #Companies #coronavirus #Health

first published: Dec 7, 2020 07:08 pm