KATHMANDU: The article ‘Phase 3 Efficacy Analysis of a Typhoid Conjugate Vaccine Trial in Nepal’ published in The New England Journal of Medicine, has brought commotion in Nepal especially raising concerns over Nepali children being treated as ‘guinea pig’.

The typhoid conjugate vaccine (TCV) for infants and children over six months of age was also a WHO-recommended vaccine added to its list of the prequalified vaccines in 2018.

Patan Academy of Health Sciences, Patan Hospital, Nepal Family Development Foundation, and Wasa Pasa Polyclinic Private Lalitpur Cooperation were involved in the experiment that was carried on the 20 thousand children aged 9-16 years. The news has raised the public concern regarding Nepal being used as experimentation platform, right to information of the children and ethics of the practitioners, along with the safety of the patients.

According to the Journal, the vaccine experiment was conducted by a few Nepali doctors and Oxford Vaccine Groups Department of Pediatrics, Oxford University in the financial assistance of Bill and Malinda Gates Foundation.

Delighted at the positive findings of the test carried from 2017- 2019, the New England has recently published the report.

After the publication of the report, BBC published the news about the success of typhoid conjugate vaccine (TCV) tested on 20 thousand Nepali children.

The BBC news brought a commotion in Nepal. Some human right activists reacted to it as ‘Nepal being used as a lab’ and ‘the negligence towards the children’s health.’

Asked for his comment on the issue, Gauri Pradhan, former Human Rights Commissioner and Social Activist, stated it as a sad fact. “Use of any ‘medicine’ on child without proper verification and validation from the concerned authority, and formal authentication of the substance as drug is illegal and a serious violation of child rights,” said Pradhan while speaking to Khabarhub.

He further reiterated the need to protest against the negligence towards child health. “Provided the vaccination in Nepal was carried out prior to its final authentication as medicinal vaccine, the use of third world’s children in experiment as ‘guinea pig’ is absolutely wrong.”

However, the medical researchers and pediatricians of Nepal do not regard the ‘research’ as wrong.

Prof. Dr. Sharad Onta, a retired Prof. of Institute of Medicine, thinks the ‘research’ not wrong as it is in accord with the provisions made in the Nepal Medical Research Council Act.

“I studied about the issue, consulted the researchers and found that it is properly designed both technically and methodically.” Dr. Onta told Khabarhub.

Oxford University has given ethical permission to it, our Medical Research Council has given permission as well, hence, there is no point to say it is ethically incorrect,” Onta further added.

Citing World Health Organization (WHO) consent to the TCV vaccine, he opined that it was not a new trial in Nepal.

“Rather than creating a fuss, it’s better to lobby for its free-of-cost availability in Nepal as the test turned out to be successful here.” Onta said to Khabarhub.

Dr. Ramhari Chapagain, a pediatrician at Kanti Child’s Hospital also opined the TCV test ‘not improper.’

“After the success of first and second phase test of TCV vaccine, the third one conducted in Nepal is merely an effectiveness test not the first trial.” Dr. Chapagain said.

According to Dr. Chapagain, every vaccine goes through 3 phases of experimentation. Under phase 1, the new vaccine is used on animals to see whether it harms any animals or not. At the success of phase 1, the test is carried on people. This test cannot be conducted on more than 200-300 people and only after the success of the 2^nd phase test 3^rd phase test is executed. “Even phase 3 has 3 ‘A’ or 3 ‘B’ to be adopted. This, too, cannot be tried in more than 300 people, but not in the children directly,” Dr. Chapagain added, “the current research has been carried out after the WHO validation to the vaccine as eligible to everyone, it is merely an effectiveness test only hence, acceptable.”

Chapagain thinks there is nothing to panic about the term ‘trial’ as it is not a new medicine. “It’s not a new medicine, it has been in use in Nepal since long,” Chapagain added, “they have tried to see the effectiveness offering the vaccine free-of-cost only.”

According to Chapagain, the TCV vaccine is already available in Nepali market and it costs 3500 to 5000 rupees. He said that they have requested the government to distribute the TCV free of cost as the vaccine is relatively more expensive than others. He further added that the doctors have been lobbying requesting the government to arrange for the free-of-cost distribution of TCV including it in the national vaccination program.

Dr. Prakash Ghimire, the head of Code of Ethics Department at Nepal Health Research Council affirmed that the TCV trial had been conducted as per the code of ethics of the board.

“No medicine is permitted here for phase one trial. Only after the successful completion of phase one and phase two trial, we permit the trial of the medicine permitted by WHO; however, such trial has to be directed towards finding whether such medicine can be useful in Nepal or not.” Ghimire added.

At Khabarhub’s query about what he would have done provided the vaccine had impacted the children adversely, Dr. Anajani Kumar Jha, the executive chairperson of the Council said, “ Our legal provision held the researchers responsible provided the trial had any adverse impact on the children.”

Affirming that many other clinical trials are also undergoing in Nepal, Dr. Jha, the council head added, “ In case of adverse effect or reaction, in consultation with the local level authority the council forms a probe committee which  decides whether to let the research on or stop it there and then.”

Dr. Jha claimed that the researchers ensure the health insurance of the participants in the trial as a precondition to apply at the council for the permission.

Despite the doctors’ claim, the ethical questions on should the children of the third world be the subject to such trial, just because they are born in the economically backward nations remains unanswered.