Few takers for vaccine trials as vaccination coverage increasesSanofi aimed to have 3,000 Nepalis as volunteers but only around 20 percent people have participated so far.
The Dhulikhel Hospital in Kavrepalanchok was supposed to conduct the third phase clinical trial of an experimental Covid-19 vaccine developed by Sanofi Pasteur, a French multinational company, on 2,000 people.
But the trial has been conducted on only one fifth of the target population since it began in late September, according to the hospital.
Dr Rajeev Shrestha, spokesperson for the Dhulikhel Hospital, said that around 400 people have so far participated in the trial.
“It is a relatively low number compared to the target and there is no indication that the number will increase substantially in the days to come,” Shrestha told the Post.
It is the first Covid-19 vaccine whose clinical trial is being conducted in Nepal. Sanofi Pasteur, in partnership with GlaxoSmithKline, a British pharma company, developed the vaccine.
Sonafi in collaboration with the International Vaccine Institute, a nonprofit initiative of the United Nations Development Programme, brought the vaccine candidate to Nepal for the late stage trial.
The vaccine is also being trialled at Nepalgunj Medical College where 1,000 volunteers are to be vaccinated with the experimental vaccine.
“But only 270 people have participated in the trial so far,” Dr Piyus Kanodia, the principal investigator of the trial at the hospital, told the Post.
Doctors at the hospitals concerned and officials at the Nepal Health Research Council attributed poor participation of the people in clinical trials to the recent acceleration in vaccination drive in the country.
Despite some initial hiccups after launching the vaccination campaign, Nepal lately has managed to secure substantial doses of Covid-19 vaccines. And more and more people are being administered vaccines.
The Covid-19 cases too have decreased in the recent weeks.
“The trial is conducted on unvaccinated people but around 95 percent people aged above 18 years have already received at least the first doses of Covid-19 vaccines in Kavrepalanchowk district,” said Shrestha.
According to Shrestha, it would be challenging to bring in more people for trials.
“Besides the government’s vaccination drive, Dashain and Tihar festivals also affected people’s participation in the trials,” he said.
Another reason these two hospitals are struggling to find more people to participate in the trial is that they cannot invite people from far away.
“We need to follow up the experimental vaccine recipients. So they should be from nearby areas,” said Shrestha.
Kanodia also admitted that his hospital is struggling to find people willing to participate in the trial amid a growing number of people being vaccinated against Covid-19.
“Vaccinated people cannot participate in the trial. When people are getting the vaccines which are already authorised for use against Covid-19, why would they participate in a trial of an experimental vaccine?” said Kanodia.
According to the Ministry of Health and Population, as many as 8.81 million people have received at least one dose of Covid-19 vaccine while 7.52 million people have been fully vaccinated as of Friday.
As many as 29 percent of the country’s 30 million population have received the first dose, while 24.8 percent have been fully vaccinated, according to the ministry.
More than two-thirds of the population are yet to be vaccinated, but the government is confident about vaccinating all by the end of April, as vaccines have been arriving from different sources.
Nepal needs to vaccinate around 78 percent of its 30 million population—or around 25 million people, as per the government’s new plan that includes those aged between 12 and 18 years. Earlier, the government had planned to vaccinate only those aged 15 years and above.
Nepal has so far received 23,629,810 doses of Covid-19 vaccines–Vero Cell, AstraZeneca, Janssen and Pfizer-BioNTech.
Officials and doctors say that fewer people will be interested to participate in the trial when more and more people get the opportunity to get jabbed with vaccines already authorised for use.
“There were some people who were waiting for vaccines developed in the Western countries. Some of them participated in the trial. Now we have started getting Western vaccines too so such people also won’t be interested in the trial,” said Shrestha.
Doctors from both hospitals, however, said that the side effect of the vaccine under trial has been minimal.
“A little pain in the injected area and in some participants slight fever has been reported. But no one has required hospitalization so far,” said Shrestha.
With less than targeted people participating in the trials at Dhulikhel Hospital and Nepalgunj Medical College, preparations are underway to trial the vaccine at the Tribhuvan University Teaching Hospital at Maharajgunj, Kathmandu too.
“As all preparations have been completed, the trial is likely to begin at the Teaching Hospital from next week,” said Dr Pradeep Gyanwali, executive chief of the Nepal Health Research Council, an autonomous health research body of the government responsible for approving clinical trials of vaccines and drugs.
According to the council, despite the addition of the Teaching Hospital for conducting the trial, the targeted maximum participants won’t be more than 3,000 in total.
Initially, the target was to enroll 4,000 participants.
But the target of conducting the trial on 3,000 is not required to be met compulsorily, according to doctors and officials.
“There is a global target of participants from around the world. If the entire target is met from the trials conducted in other countries, it is not necessary to meet the target set in Nepal,” said Gyanwali.
On May 27, Sonafi announced that it had started enrolling volunteers for the third phase trial. It planned to recruit 35,000 volunteers aged 18 and above in countries around the world.
Sonafi in collaboration with the International Vaccine Institute had applied at the Nepal Health Research Council to conduct the third phase trial in Nepal.
After the recommendation of the council to allow the vaccine candidate for the third phase trial, the Cabinet on September 1 had granted approval.
In early September, the Department of Drug Administration had granted Sanofi and the International Vaccine Institute permission to import the vaccine and conduct the third phase clinical trial in Nepal in line with Vaccine Clinical Trial Guidelines introduced by the government in June.
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 had also received approval from the Nepali authorities to conduct the third phase trial in Nepal.
But Gyanwali said the company is yet to bring the vaccine candidate to Nepal for the trial.
“We have been informed that the vaccine candidate will arrive within weeks,” he said.
The trial of the Chinese mRNA vaccine is to 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 Private Limited, according to the council.
“Likewise, another Covid-19 vaccine developed by China’s WestVac Biopharma Co Ltd is also in the final process of getting approval for late stage trails from the council,” said Namita Ghimire, a member of the ethical board at the council.