India Mulls Radical Change For Faster Vaccine Availability

NEW DELHI/ MUMBAI, 9 OCT 2019:

 India wants to halve the time taken to get vaccines approved for use from the 15 years that the process usually takes by introducing new protocols and sidestepping animal testing to improve public health. Vaccine makers, however, advised abundant caution and adherence to high standards of medical ethics before allowing such a radical departure from standard practice.

The health ministry is working with the Indian Council of Medical Research (ICMR), Department of Biotechnology and the Drug Controller General of India (DCGI) on the changes, according to people with knowledge of the matter. This exercise is being watched closely by key international health regulators, which are meeting next month in India to discuss controlled human infection model (CHIM) guidelines.

India is working on a framework that will allow scientists and clinicians to observe the progress of infection in healthy volunteers and the efficacy of a vaccine-induced immune response. Gagandeep Kang, a scientist credited with working on India’s indigenously produced rotavirus vaccines, is spearheading the efforts under the India Volunteer Infection Research Consortium.

Stress on Strict Standards

“Basically we are trying to think better about human experimental medicine,” Kang, executive director, Translational Health Science and Technology Institute (THSTI), told ET on the sidelines of a recent conference on next generation genomics in Mumbai. “What we have done so far is to start with cell systems, animal systems, and what we know of humans is through naturally infected people or those who have developed chronic diseases over time and we try to figure out what happened to them that they were in that situation, like how did the disease develop and so on.”

THSTI is an autonomous institute under the science and technology ministry’s biotechnology department.

Researchers from different countries along with regulators including the US Food and Drug Administration (FDA), DCGI, European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA) and experts from the World Health Organisation (WHO) are gathering in India in November to work on broad guidelines on CHIM studies. This could ease vaccine accessibility and, if results are positive, they could be developed in a shorter span of time.

Vaccines are currently approved only after they undergo extensive approvals. They involve tests on animals and, most critically, thousands of volunteers across different age groups. However, for many infectious diseases, animal models do not exactly replicate the way a disease progresses in humans, experts said. “In certain situations, animal models don’t tell us enough,” Kang said. “They lead us on the wrong path even after spending years doing these things and then at the final stages when we work on drugs and vaccines, we find that it is not right.”

While India has never conducted a CHIM study, experts in the country are prepared to embark on such research while maintaining high standards of ethical rigour.

“Arising from those discussions are suggestions that initially such studies should only be allowed in high-quality academic institutions, so that issues of trust, control and scientific rigour involved in complex study designs are well balanced to protect the research participants,” said YK Gupta, principal advisor, THSTI projects, and a policy veteran. “Similarly, at least initially, only healthy, educated adults should be included in a CHIM study.”

According to experts, CHIM studies could be the answer to various infectious diseases such as malaria and typhoid, which contribute about 20% of the disease burden in India and are increasingly proving resistant to medication.

“For malaria, the vaccines and drugs tried on humans, we should infect with the strain that is sensitive to an anti-malarial, so that the infection can be stopped,” Kang said. “If you look at how infection studies are done around the world and then compare it to the actual clinical trials, you actually see fewer side effects.”

In CHIM studies, healthy participants are infected with a weakened strain of a pathogen in controlled settings. While controversies over clinical trials are not new to India, researchers vouch for CHIM studies though they require “very tight controls,” said an expert.

Krishna Ella, chairman and managing director of vaccine maker Bharat Biotech Ltd, said CHIM studies will pave the way for early introduction of vaccines and will strengthen the credibility of Indian manufacturers. However, he stressed the need for stringent regulations, robust safety measures and transparent systems before India embarked on the new trial process. Kang agreed.

“These kinds of studies require a level of screening, selection that are very critical and need very high standards and done at the best centres that have strong controls,” she said.

“There is no need to expose anyone to unnecessary dangers. In the UK, people are doing more work on typhoid than we are doing here in India. We are thinking how to set up this and we can study these diseases in our set-up. More than leapfrogging research, it is building resources for immunology, genomics and use those technologies for human biology across a range of areas.”

Earlier this year, typhoid vaccines developed in India underwent CHIM studies in the UK, as India had no established provisions to test them in humans. Later, after WHO approval, the vaccines were made available to Pakistan, which was battling drugresistant typhoid. ET Healthworld