Three hospitals are making internal preparations for the third phase trials of new Covid-19 vaccines as the government authorities are in the process of giving approval for the trials.

Dhulikhel Hospital along with Nepalgunj Medical College have been chosen to conduct the third phase clinical trial of a Covid-19 vaccine developed by Sanofi Pasteur, a French multinational company, in partnership with GlaxoSmithKline, a British pharma company.

Last Wednesday, the cabinet had decided to grant approval to the proposal for conducting the final phase clinical trial of the vaccine developed by Sanofi and GlaxoSmithKline. As per the Vaccine Clinical Trial Guidelines introduced by the government in June, the trial can begin after the Department of Drug Administration, the regulatory body of the pharmaceutical sector, issues a license to import the new vaccine and for the trial following the Cabinet’s approval.

“Once the department gives its nod for the trial, we will first hold a discussion with stakeholders including the Dhulikhel Municipality regarding the matter,” said Dr Rajeev Shrestha, spokesperson at the Dhulikhel Hospital. “We will then invite volunteers to participate in the trial.”

But, Santosh KC, information officer at the Department of Drug Administration, said the department was yet to receive a copy of the Cabinet decision on the vaccine developed by Sonafi and GlaxoSmithKline.

As per the proposal submitted by Sonafi in collaboration with the International Vaccine Institute, a nonprofit initiative of the United Nations Development Programme, a trial will be conducted with 2,000 volunteers in Dhulikhel, according to Shrestha.

As per the proposal of Sonafi and International Vaccine Institute, trials will be conducted among 3,000 people including 1,000 volunteers at the Nepalgunj Medical College, according to the National Health Research Council.

Dr Piyus Kanodia, the principal investigator for the third phase of trials at Nepalgunj Medical College, told the Post that the hospital had prepared a team for conducting the trial and was training the team members on how to prepare documentation and sample, inject the vaccine, take care of volunteers and how to handle the situation if any volunteer encounters any problem during the trial process. “We also plan to make a public call for participation in the trial process,” he said.

On May 27, Sonafi had announced that they had started enrolling volunteers for the third-phase trial of the vaccine. It planned to recruit 35,000 volunteers of 18 years and older from several countries including the United States, and countries in Asia, Africa and Latin America. According to the company’s website, India, the United States, Colombia and Honduras are participating in the third phase trial.

The vaccine developed by Sanofi Pasteur and GlaxoSmithKline is one of the three vaccine candidates currently under the approval process in Nepal.

On August 26, the Cabinet decided to allow a messenger RNA (mRNA) Covid-19 vaccine jointly developed by China's Suzhou Abogen Biosciences, the Institute of Military Medicine under the Academy of Military Sciences, and Walvax Biotechnology Co Ltd to conduct a third and final phase trial in Nepal.

WestVac Biopharma Co, Ltd is another Chinese company that has sought permission for conducting the third phase trial of its Covid-19 vaccine in Nepal and the proposal has been submitted to the National Health Research Council.

The trial of the Chinese mRNA vaccine will be conducted on 3000 volunteers at the BP Koirala Institute of Health Sciences as per the proposal of the companies which have joined hands with the Nepali pharmaceutical company—Deurali-Janta Pharmaceutical Limited, according to the council.

According to Dr Sanjeev Sharma, the principal investigator for clinical trial at the BP Koirala Institute of Health Sciences, the hospital is awaiting the department’s approval for the trial.

“Since finances are involved in every step, the local sponsor (Deurali Janta Pharmaceutical ) is also waiting for the conclusion of the approval process. The trial process will move ahead after the government agencies concerned conclude the approval process,” he said. “We have prepared and handed over the protocol on clinical trials to the government authorities,” he said.

The protocol should state the aim of the trial and the procedures to be followed, the reasons for performing it on humans, the nature and degree of any known risks, the groups from which the trial participants are to be selected, and the means for ensuring that the participants are adequately informed before they give their consent, according to officials.

The protocol may also serve as a contract between the government and the vaccine developer company and incorporates issues related to finance, insurance, and liability delegation or distribution of responsibilities, according to the National Guidelines on Clinical Trials with the use of Pharmaceuticals Products – 2005.

According to KC, the information officer at the department, the regulatory body of the pharmaceutical sector, it has already received the cabinet’s decision regarding the Chinese mRNA vaccine. “We will come up with a decision in a day or two,” said KC.

As per the Vaccine Clinical Trial Guidelines introduced by the government in June, a company or organisation wishing to conduct a clinical trial of a vaccine in Nepal has to submit an application to the council, in a prescribed format.

After an application is received, internal and external reviews are conducted, feedback is sought and a proposal is sent to the Ethical Review Board under the council, which can approve or reject the application.

If approved by the board, the application is forwarded to the Health Ministry, which will take it to the Cabinet for approval. Once the Cabinet approves the application, the company concerned should acquire a licence from the Department of Drug Administration to conduct the trial.

Experts say while there is nothing wrong in letting foreign companies conduct clinical trials in Nepal, authorities must be cautious about some aspects related to it.