As Kerala grapples with its fourth outbreak of Nipah virus, the Indian Council of Medical Research (ICMR) will be procuring limited doses of the monoclonal antibody treatment from Australia, said Dr Rajiv Bahl, Director General of ICMR, at a press meet on 15 September.
The doses already available in India, from a 2018 procurement have, reportedly, been supplied to the Kerala government, in light of the Nipah virus outbreak in the state.
While underscoring that it is not an approved treatment for Nipah virus, he said that the antibody treatment has been allowed to be used in Kerala on compassionate grounds.
What is the monoclonal antibody treatment? Who is it meant for? Why is India acquiring more doses if it hasn't been approved for treating Nipah virus?
Here's what to know.
'Antibody Use Not Approved, But...': ICMR on Treatment for Nipah Virus Outbreak
1. What We Know About the Monoclonal Antibody Treatment for Nipah
Dr Rajiv Bahl explained that the monoclonal antibody treatment was developed in the US and the technology for it was transferred to the University of Queensland in Australia. This is where India acquired a limited number of doses in 2018 when the first Nipah virus outbreak hit Kerala.
"It is produced in a lab at the University of Queensland, not for Nipah but for Hendra virus. Then they found that it is useful in Nipah too because the two viruses are similar," said Dr Bahl.
In 2018, India had acquired 20 doses (enough for 10 patients), however, the infection was contained by the time ICMR received them, and they were never used.
Is it affective against Nipah Virus?
"In the case of viral infections, monoclonal antibodies are the only 'anti-viral treatment' that have been found to be effective," said Dr Bahl.
However, in the same breath, he added, that the treatment has not received an Emergency Use Authorisation (EUA), and cannot even be considered an experimental treatment for Nipah either.
“They are safe. But whether they are effective, we don't know," he added.
"There was a phase 1 trial so they were found to be safe. After that, there has been no opportunity to do an efficacy trial of this treatment. Because for that you need a lot of people being infected with the virus, which has fortunately not happened."
Dr Rajiv Bahl, Director General, ICMRExpand2. Will It Be Used in Kerala?
So far, the monoclonal antibody treatment has been used in 14 patients of Nipah globally and all of them have survived. It hasn’t been given to anyone in India yet.
Based on the use in these patients, some SOPs for the use of the treatment were also developed.
One patient typically needs two doses.
It must be given relatively early in the course of the disease for it to be effective.
"It's too late to give it if the patient is already having encephalitis," said Dr Bahl.
Dr Bahl said that ICMR still has the 20 doses that were acquired in 2018, but since they’re over 5-years-old, there isn't data on if they are still stable.
"The Kerala Health Department asked us we we could acquire more. So, we have requested 20 more doses from them (University of Queensland) and they have agreed to give it, and we are trying to get it as we speak. Whether we will be using it is not ICMR's decision."
Dr Rajiv Bahl, Director General, ICMR"Our job is to make sure that if it can be made available, we will bring it to India. If there is a need and people think it could be of use, we will make it available," said Dr Bahl.
"The decision to use is not ICMR’s. The decision to use has to be the Kerala Government’s, the people who are treating the patient, and most importantly, the patients and their families," he added.
Expand3. The Bottomline: ‘Only for Compassionate Use'
The bottom line is, since its not been clinically tested in humans for Nipah virus, and since its not approved, it can't be recommended as a 'treatment' for Nipah virus, not even as an experimental treatment.
"If at all it is to be used, it must be used for compassionate use. Compassionate use of drugs is not experimental medicine."
Dr Rajiv Bahl, Director General, ICMR"This means you can use it for a situation where you have one in two chances of dying and you choose to use it," he explains.
Basically you may choose to take it at your own discretion (along with the discretion of your doctors) if you have a high risk of mortality after getting infected with the virus.
As for protection from the infection, Dr Bahl says the precautionary measures are similar to that of COVID.
Maintain good hand hygiene.
Mask up f you or someone around you has flu-like symptoms.
Avoid going to areas where the known hosts (infected fruit bats and pigs) exist.
Avoid eating raw fruits, fruits plucked from trees in these areas.
(At The Quint, we are answerable only to our audience. Play an active role in shaping our journalism by becoming a member. Because the truth is worth it.)
Expand
What We Know About the Monoclonal Antibody Treatment for Nipah
Dr Rajiv Bahl explained that the monoclonal antibody treatment was developed in the US and the technology for it was transferred to the University of Queensland in Australia. This is where India acquired a limited number of doses in 2018 when the first Nipah virus outbreak hit Kerala.
"It is produced in a lab at the University of Queensland, not for Nipah but for Hendra virus. Then they found that it is useful in Nipah too because the two viruses are similar," said Dr Bahl.
In 2018, India had acquired 20 doses (enough for 10 patients), however, the infection was contained by the time ICMR received them, and they were never used.
Is it affective against Nipah Virus?
"In the case of viral infections, monoclonal antibodies are the only 'anti-viral treatment' that have been found to be effective," said Dr Bahl.
However, in the same breath, he added, that the treatment has not received an Emergency Use Authorisation (EUA), and cannot even be considered an experimental treatment for Nipah either.
“They are safe. But whether they are effective, we don't know," he added.
"There was a phase 1 trial so they were found to be safe. After that, there has been no opportunity to do an efficacy trial of this treatment. Because for that you need a lot of people being infected with the virus, which has fortunately not happened."Dr Rajiv Bahl, Director General, ICMR
So far, the monoclonal antibody treatment has been used in 14 patients of Nipah globally and all of them have survived. It hasn’t been given to anyone in India yet.
Based on the use in these patients, some SOPs for the use of the treatment were also developed.
One patient typically needs two doses.
It must be given relatively early in the course of the disease for it to be effective.
"It's too late to give it if the patient is already having encephalitis," said Dr Bahl.
Will It Be Used in Kerala?
Dr Bahl said that ICMR still has the 20 doses that were acquired in 2018, but since they’re over 5-years-old, there isn't data on if they are still stable.
"The Kerala Health Department asked us we we could acquire more. So, we have requested 20 more doses from them (University of Queensland) and they have agreed to give it, and we are trying to get it as we speak. Whether we will be using it is not ICMR's decision."Dr Rajiv Bahl, Director General, ICMR
"Our job is to make sure that if it can be made available, we will bring it to India. If there is a need and people think it could be of use, we will make it available," said Dr Bahl.
"The decision to use is not ICMR’s. The decision to use has to be the Kerala Government’s, the people who are treating the patient, and most importantly, the patients and their families," he added.
The Bottomline: ‘Only for Compassionate Use'
The bottom line is, since its not been clinically tested in humans for Nipah virus, and since its not approved, it can't be recommended as a 'treatment' for Nipah virus, not even as an experimental treatment.
"If at all it is to be used, it must be used for compassionate use. Compassionate use of drugs is not experimental medicine."Dr Rajiv Bahl, Director General, ICMR
"This means you can use it for a situation where you have one in two chances of dying and you choose to use it," he explains.
Basically you may choose to take it at your own discretion (along with the discretion of your doctors) if you have a high risk of mortality after getting infected with the virus.
As for protection from the infection, Dr Bahl says the precautionary measures are similar to that of COVID.
Maintain good hand hygiene.
Mask up f you or someone around you has flu-like symptoms.
Avoid going to areas where the known hosts (infected fruit bats and pigs) exist.
Avoid eating raw fruits, fruits plucked from trees in these areas.
(At The Quint, we are answerable only to our audience. Play an active role in shaping our journalism by becoming a member. Because the truth is worth it.)