CPCSEA recommends use of stray dogs for new vaccine trials and challenge studies of vaccines

New Delhi, September 26, 2022:

The Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) under the ministry of fisheries, animal husbandry and dairying, has recommended that stray dogs may be used for new vaccine trials and challenge studies of vaccines subject to adhering the guidelines of the Committee.

The development comes at a time when the country has developed vaccines against Covid-19 on its own and more vaccine research projects are on the development. The ministry of science and technology is looking at strengthening the indigenous capabilities for vaccine development in the country.

The Committee, in its 101st meeting, “recommended that stray dogs may be used for new vaccine trials and challenge studies of vaccines, however, they must be quarantined and rehabilitated as per the guidelines of CPCSEA.”

In cases of the batch testing of established vaccines except for challenge studies, dogs coming to the clinics can be used for safety and/or potency trials, it said in a circular to all registered research and other establishments and nominees of the Committee.

However, experts in the research industry has raised doubts on how practical the decision could be, considering that the quality studies are conducted on healthy animals and considering the stray dogs might already infested by various bacteria or virus, the result from the trails on these animals might not be acceptable to many countries where the regulations are stringent. This could also raise protests from animal protection groups, since a potential demand for stray dogs will further threaten the lives of these animals in the country.

“In India conducting animal studies on dogs and monkeys is not allowed. Even if they allow people to conduct studies using stray dogs, I don’t think the industry would jump at that opportunity," said Dr Arun Bhatt, consultant, clinical research and drug development. Ultimately a company developing a new drug would like to market outside India and the question is whether you can rely on preclinical studies done in stray dogs which are unlikely to be healthy, he added.

The decision also comes at a time when the country has developed its own vaccine for Covid-19 pandemic and continues various research activities on vaccines related to Covid and other diseases. With the spread of Covid-19 pandemic, the Department of Biotechnology and Biotechnology Industry Research Assistance Council (BIRAC) launched the “DBT –BIRAC COVID-19 Research Consortium” as part of the comprehensive efforts to facilitate development of indigenous research solutions to tackle Covid-19. Meritorious proposals from academia and industry for development of Covid-19 vaccine candidates and allied research resources, are being supported, with funding routed through DBT or BIRAC as appropriate.

The Mission Covid Suraksha- The Indian Covid-19 Vaccine Development Mission’, was announced as part of the third stimulus package, Atmanirbhar Bharat 3.0, for promoting research and development of Indian Covid-19 vaccines. Due approval of Hon’ble Finance Minister has been accorded for implementation of the Mission vide. Order dtd. 23.11.2020, at a total cost of Rs. 900 crore.

The Mission is led by the Department of Biotechnology (DBT) and is implemented by Biotechnology Industry Research Assistance Council (BIRAC), a Public Sector Undertaking (PSU) of DBT. A total of 40 entities across industry and academia have been recommended for support under the Mission towards development of Covid-19 vaccine candidates; capacity enhancement for conduct of clinical trials; setting up of animal challenge facilities and immunoassay laboratories; augmentation of capacities for vaccine manufacturing. The project is implemented in a PAN-India manner.  

Following these efforts, the world's first DNA Vaccine for Covid-19 (ZyCoV-D) by Cadila Healthcare, received Emergency Use Authorisation (EUA) on August 20, 2021.

Mission Covid Suraksha supported the nation's first protein subunit vaccine for Covid-19, Corbevax developed by Biological E, received Emergency Use Authorisation (EUA) for the 12-18 years age group on February 21, 2022. Based on interim results of the ongoing phase II/III clinical study, Biological E has received approval for restricted use in an emergency situation in adolescents aged 12 to 18 years. Corbevax has already been approved for restricted use in emergency situations among adults on December 28, 2021.

Nation’s first mRNA vaccine for Covid-19 by Gennova Biopharmaceuticals and intranasal vaccine by Bharat Biotech are also in trial stage. Thirteen out of the 19 clinical trial sites supported under the Mission, are facilitating trials for Covid-19 vaccine candidates, said Department of Biotechnology.  Pharambiz