More Covid-19 vaccine makers apply for third phase trials in NepalThe Cabinet on August 26 allowed a Chinese company to conduct the final trial.
After the government allowed a Covid-19 vaccine developed by Chinese companies to conduct a third phase trial last week, two other foreign companies have also applied with the Nepal Health Research Council seeking permission for last-stage trials of their coronavirus vaccines.
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.
This is the first time Nepal has given permission to any Covid-19 vaccine candidate to conduct clinical trial in the country.
Now, more vaccine candidates are seeking approval from the government to conduct their third-phase trials, according to officials at the Nepal Health Research Council.
“Currently, we have received applications from the manufacturers of two other Covid-19 vaccines,” said Namita Ghimire, a member of the ethical board at the council. “Sanofi, a multinational pharmaceutical company, in coordination with the International Vaccine Institute, has applied for approval for a third-phase trial and another Chinese company—WestVac Biopharma Co, Ltd has also sought approval for the final phase trial.”
Sonafi is a French multinational company, which in partnership with GlaxoSmithKline (GSK), has developed a Covid-19 vaccine.
On May 27, they announced that they had started enrolling volunteers for the third-phase trials of the vaccine. They planned to recruit 35,000 volunteers aged 18 and older from several countries, including the United States, Asia, Africa, and Latin America.
They had requested approval for the trials from Nepal too, submitting an application to the council. The council is an autonomous health research body of the Nepal government responsible for setting standards for health research including clinical trials of vaccines and drugs as well as monitoring and evaluation of the trial process.
“We have already recommended that the Ministry of Health and Population give permission for the third-phase trial after its second-phase results have been found to be very good. The application is expected to go to the Cabinet soon for approval,” said Ghimire.
If the vaccine developed by Sonafi and GSK gets the go-ahead for trials, it will be the second Covid-19 vaccine candidate to receive such approval.
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, a regulatory body of the pharmaceutical sector, to conduct the trial.
Ghimire said that Sanofi has sought to conduct trials among 3,000 volunteers at Dhulikhel Hospital and Nepalgunj Medical College. The second phase of trials were conducted in the US and Honduras among 722 volunteers, according to the company’s statement on May 17.
Another Chinese vaccine manufacturer’s application is in the early stages of evaluation at the council. “We are compiling the necessary documents from the Chinese vaccine maker,” said Ghimire. “It is yet to notify us where it wants to conduct the trials.”
Under the third phase, each participant will receive three doses of either study vaccine or placebo on day 0, day 21, day 42, according to information available on https://clinicaltrials.gov, a website that updates clinical trials of vaccines and drugs. The Chinese company plans to enroll 40,000 volunteers worldwide.
So far, the council has received applications from four companies for conducting the third-phase of trials of Covid-19 vaccine candidates.
“One Australian company which had applied for trials in coordination with the International Vaccine Institute withdrew its application after the government delayed introducing trials guidelines,” said Ghimire. The government introduced the guidelines only in June.
The International Vaccine Institute is a nonprofit established in 1997 as an initiative of the United Nations Development Programme. The proposal was submitted to the council through COVAX, the international Covid-19 vaccine-sharing scheme backed by the United Nations, according to officials at the council.
The government came up with the guidelines nearly eight months after it amended the Drugs Act-1978 through an ordinance to pave the way for clinical trials of vaccines in the wake of the Covid-19 pandemic.
Health experts say that vaccine trials in Nepal should be taken positively, as the Covid-19 crisis has deepened and the country is struggling to secure enough doses to vaccinate its population.
As of Saturday, Nepal had administered the first doses of Covid-19 vaccine to 5.06 million people, while 4.05 million people have been fully vaccinated, according to the Ministry of Health and Population.
Dr Pradip Gyanwali, executive chief of the council, said vaccine production in Nepal would make it easier for the country to vaccinate people.
According to the officials at the council, among foreign companies willing to conduct the third phase trials, the Chinese companies which got approval from the Cabinet on August 26, have also proposed to produce the vaccine in Nepal itself if their trials become successful.
“The Chinese companies in their proposal have said that the vaccine could be manufactured even in Nepal if trials become successful,” said Gyanwali.
The Chinese companies have partnered with Nepal’s Deurali-Janta Pharmaceuticals Pvt Ltd to conduct the trials among 3,000 volunteers at the BP Koirala Institute of Health Sciences in Dharan.
Nepal so far has been relying on external supply for Covid-19 vaccines, mostly from China, to inoculate its people.
In early August, the government also announced a number of incentives for domestic and foreign companies that want to establish plants in Nepal to produce vaccines against Covid-19 and other infectious diseases. As per the notice issued on August 9, the government has promised procurement guarantee for 60 percent of the total vaccine demand in the country while assuring credit at subsidised interest, tax and duty exemptions on the import of machinery and electricity tariff waiver.
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.
“The government can set conditions that Nepal should be provided prior access to the vaccine after they are produced,” said Dr Basudev Pandey, former director at the Epidemiology and Disease Control Division. “The government however has to ensure that the health of participants won’t be at risk and it would be better if the principal investigator of the trial is a Nepali national to prevent any potential manipulation of data.”