28. May 2018 00:00 IST
New Delhi: The outbreak of the Nipah virus in Kerala has led India's health research institute to point out the delays caused by the regulatory standard requirements for clinical trials and the rapid deployment of therapeutic candidate molecules against rare and fatal infections on "Compassionate Reasons."
At the request of the Kerala government in Australia, the Indian Medical Research Council asked research groups for a candidate molecule against the Nipah virus that had been tested on animal models and exposed to 20 people. The virus outside of India
The Director-General of the Council , Balaram Bhargava, had filed the motion within a day of confirming the Nipah infection in Kozhikode on May 1
Health authorities had confirmed to Saturday the Nipah infection in 15 people, of whom 13 have died. Twenty-six others who developed symptoms or came in close contact with Nipah patients are now being seen in two hospitals.
Bhargava's proposed molecule is a human monoclonal antibody called m102.4. It was jointly developed by the Australian Animal Health Laboratory in Victoria and the Uniformed Services University of the Health Sciences in the US under the direction of the American microbiologist Christopher Broder. It was stored by the Queensland Health Authority.
Kerala's additional Chief of Health, Rajeev Sadanandan, said the state is awaiting a shipment of 50 antibody vials.
"We take no risk" We take all possible precautions, "he said.
He said the antibody would be administered to confirmed patients with Nipah infection if necessary.
Journal PLOS One in 2009, Broder and his Australian colleagues reported that they had successfully tested the m102.4 in ferrets that received high-dose Nipah virus intra-nasal sprays survived within 10 hours after exposure to the virus.
"We are not sure if we really need to use this monoclonal antibody. The outbreak appears to be localized and under control, "said Raman Gangakhedkar, a senior scientist and head of ICMR's communicable disease department.
But the Council is considering strategies to enable India to Rapidly using therapies in future outbreaks – and not just for Nipah Virologists say that fruit bats, the reservoirs of Nipah, are widely distributed on the Indian subcontinent.
If the m102.4 antibody becomes widely available, it would be possible to to offer it as a post-exposure therapy to medical staff or family members who have come into close contact with nipah-infected patients, a nurse who took care of a Nipah patient died in Kerala.
"This antibody has already been administered to 19 people in Australia and one person in the US and found safe, "said G angakhedkar
I have chosen to use it for compassion, but we must have protocols for the rapid deployment of therapy candidates during such outbreaks. "
The regulatory standard requirements for clinical trials – mandatory before the commercial use of drugs or vaccines – require several groups of clinical trials in increasing numbers of volunteers to establish safety and efficacy." But the epidemiology and the sporadic Nature of Nipah outbreaks makes large clinical trials difficult, "Benjamin Satterfield, a senior microbiologist at the University of Texas Medical The American branch and its colleagues had written two years ago in the journal Vaccine
however, had stressed the importance of readiness: More than 250 million people in Bangladesh and Bengal are at risk of suffering from Nipah infection, and more than 2 billion people worldwide live in places where the carrier fly bats are found.
Gangakhedkar believes that this is the only possibility, the Wirksa Assessment of Medical Interventions in small but fatal epidemics are the provision of candidate molecules at each outbreak and the analysis of results using scientific protocols.
Health officials say it should be possible to offer therapies to patients, healthcare professionals, and other people who are exposed to lethal infection for benevolent reasons even without formal clinical trials.
They say that medical ethics guidelines allow physicians to provide candidate therapeutic molecules for individuals who are likely to die if successfully tested for reliable animal models.