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Wednesday, November 25, 2020

Eye on joint clinical trials, India training nations in South Asia

According to the sources, the Indian team has focused its training on conducting crucial phase 2 and phase 3 human clinical trials of the potential vaccine candidate along lines of India’s regulatory mechanism.

Written by Kaunain Sheriff M | New Delhi | November 10, 2020 1:00:55 am
Testing in Delhi Monday. (AP)

As India prepares to administer a vaccine against the novel coronavirus infection to its population early next year, it is working with countries in its neighbourhood on possible collaborative clinical trials of vaccine candidates in the future.

A specialist team of scientists and researchers from the Indian Council of Medical Research and the Department of Biotechnology under the Union Ministry of Science and Technology, has imparted training to doctors and regulators in at least seven countries, top government sources who are also part of the high-level expert group on vaccine administration, told The Indian Express.

“With select countries, India is training and building capacity with their doctors, scientists, as well as their regulators. The team of DBT and ICMR have visited Bangladesh twice to take this forward. The aim of this exercise is to facilitate future collaborative clinical trials,” the sources said.

According to the sources, the Indian team has focused its training on conducting crucial phase 2 and phase 3 human clinical trials of the potential vaccine candidate along lines of India’s regulatory mechanism. In phases 2 and 3, reactogenicity (ability to produce common, adverse reactions), immunogenicity (ability to provoke an immune response), and safety of the vaccine candidate are assessed in a larger population.

“There is electronic and digital content… this training has been imparted to regulators and doctors. The content has been designed by India, and training has been imparted to Sri Lanka, Myanmar, Bangladesh, Bhutan, Nepal, and Afghanistan,” a source said.

This exercise will allow India to explore the option of buying the potential Covid-19 vaccine from these neighbouring countries, the sources said.

“While the aim currently is to facilitate a future collaborative clinical trial, going forward if a vaccine is clinically tried in these neighbouring countries (in accordance with India’s regulatory framework), India could be amenable to eventually buying that vaccine,” the sources said.

Three indigenous vaccine manufacturers are at present conducting clinical trials of Covid-19 vaccine candidates. Hyderabad-based Dr Reddy’s Laboratories has received approval to conduct phase 2/3 trials of Russia’s Sputnik V vaccine. India is a stakeholder in the tripartite arrangement among the WHO, the vaccine alliance group GAVI, and the Coalition for Epidemic Preparedness Innovations (CEPI) which is seeking to ensure that the vaccine, when available, reaches everyone.

India’s collaborative exercise with other countries in the region comes in the backdrop of Prime Minister Narendra Modi highlighting, during the last review meeting on vaccine delivery, distribution, and administration, the request from neighbouring countries for clinical trials. The Prime Minister had also directed that India should “not limit efforts” to its immediate neighbourhood, and reach out to the world at large to provide vaccines, medicines, and IT platforms for the vaccine delivery system.

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