Dhulikhel Hospital starts trial of Covid-19 vaccine candidateNepalgunj Medical College is also set to start the vaccine trial later this week.
Dhulikhel Hospital in Banepa has started the country’s first-ever trial of a Covid-19 vaccine developed by Sanofi Pasteur, a French multinational company, in partnership with GlaxoSmithKline, a British pharma company.
“Starting Friday, we have started the trial by giving jabs to around 20-30 people,” Dr Rajeev Shrestha, spokesperson for Dhulikhel Hospital, told the Post. “We have received no complaints about any side effects from those who took the jabs.”
Shrestha said that initial jabs were given to the people who were willing to take them and were in contact with the hospital.
“We will now visit communities to enrol volunteers with informed consent,” said Shrestha.
Besides Dhulikhel Hospital, the vaccine candidate will also be trialled by Nepalgunj Medical College. The French multinational company has allowed to administer its vaccine candidate among 2,000 volunteers at Dhulikhel Hospital and 1,000 at Nepalgunj Medical College.
Sonafi in collaboration with the International Vaccine Institute, a nonprofit initiative of the United Nations Development Programme, had applied with Nepal Health Research Council to conduct a third phase trial of the vaccine in Nepal.
After the recommendation of the council for allowing the vaccine candidate for a third phase trial, the Cabinet on September 1 had decided to grant approval.
In early September, the Department of Drug Administration had granted the Sanofi and International Vaccine Institute to import the vaccine and conduct a third phase clinical trial in Nepal in line with Vaccine Clinical Trial Guidelines introduced by the government in June.
The trial is expected to take place for three months.
“During this period, the volunteers will be given both doses of the vaccine. The second dose should be given within four weeks after the first dose,” said Shrestha.
He said the Dhulikhel Hospital has mobilised 27-30 health workers including eight doctors for the trial.
Meanwhile, the vaccine trial at Nepalgunj Medical College is expected to begin later this week.
“Around 100 people have given their consent to participate in the trial,” said Dr Piyus Kanodia, the principal investigator of the trial.
He said the trial would be conducted in different phases based on the dates provided by Nepal Health Research Council.
Meanwhile, Nepalgunj Medical College is currently 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.
On May 27, Sonafi had announced that they had started enrolling volunteers for a third phase trial of the vaccine candidate. It planned to recruit 35,000 volunteers of 18 years and older from several countries around the world.
According to the company’s website, India, the United States, Colombia and Honduras are participating in the third phase trial.
Besides, the vaccine developed by Sanofi and GlaxoSmithKline, 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 has also received approval from the Nepali authorities to conduct the third phase trial in Nepal.
On August 26, the Cabinet decided to allow the vaccine candidate to conduct a third phase trial while the Department of Drug Administration had issued a licence to import vaccine candidates and conduct a third phase trial in early September.
The trial of the Chinese mRNA vaccine will be conducted on 3,000 volunteers at the Dharan-based 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.
Namita Ghimire, a member of the ethical board at the council said that the Chinse vaccine candidate is yet to arrive in Nepal.
“The trial will begin after the vaccine arrives,” she said.
WestVac Biopharma Co, Ltd is another Chinese company that has also sought permission for conducting the third phase trial of its Covid-19 vaccine candidate in Nepal. The company has already submitted its proposal to Nepal Health Research Council.