The Ministry of Health has decided to allow foreign companies to perform Phase III clinical trials of the coronavirus vaccine in Nepal. According to Dr Sameer Kumar Adhikari, joint spokesperson for the Health Ministry, the ministry has directed the Nepal Health Research Council to grant permission to companies fulfilling all necessary procedures.

As the coronavirus continues to spread across the world, posing an unprecedented challenge to humanity, major world powers are racing to develop and produce the vaccine.

China has said it began inoculating high-risk groups in July. Russian President Vladimir Putin said two weeks ago that Russia was the first country to register a vaccine offering sustainable immunity to Sars-Cov-2, the virus that causes Covid-19. The United States has invested billions of dollars. Reports suggest the Oxford University vaccine is one of the most promising to become successful. India is set to begin Phase-II clinical trials of the vaccine being developed by Oxford University.

Multiple experts the Post talked to said that Phase III clinical trials should be allowed in Nepal, if the results of Phase I and II have shown that vaccines are safe and do not have adverse side effects.

“Phase III trials are being performed throughout the globe, and we should not hesitate to do that here in Nepal,” Dr Anup Subedee, an infectious disease expert, told the Post.

Vaccines in general take years of research and testing before they are available for the public, but given the growing number of coronavirus cases across the globe and rising number of deaths, scientists are moving at a record speed to produce a safe and effective vaccine.

According to the New York Times, researchers around the world are developing more than 165 vaccines against the coronavirus and 32 vaccines are in human trials.

Experts say that vaccine manufacturing companies throughout the globe want to perform Phase III clinical trials in many countries to study the feasibility and effects in multiple ethnicities and races.

Phase III clinical trials refer to efficacy trials as part of which scientists inoculate a large number of population–in thousands–and wait to see how many become infected. For the vaccine to be declared effective, at least 50 percent of the vaccinated people during trials have to be protected against the virus.

Phase III trials are initiated after Phase I and Phase II trials.

In Phase I, the vaccine is given to a small number of people and scientists test safety and dosage while confirming if that stimulates the system.

In Phase II, the vaccine is given to a larger number of people–in hundreds–who are split into different age groups, children to the elderly, to see if the vaccine acts differently in them. These trials also tell researchers about the vaccine’s safety as well as ability to stimulate the system.

But even before the Phase I trial, the vaccine is tested on animals, like monkeys or mice, to see if it produces an immune response.

Phase III also compares the vaccine to a placebo to determine whether it works in preventing disease. A placebo is a substance that has no therapeutic effect, used as a control in testing new drugs.

Vaccines, actually, teach the immunity system to recognise and block viruses.

Several countries including, India, Pakistan and Bangladesh among others have already allowed Phase III clinical trials. China’s Sinovac Biotech Ltd vaccine is being trialled in the United Arab Emirates, according to reports.

The government move to give the green signal to companies that are willing to conduct Phase III clinical trials in Nepal comes amid the rising number of coronavirus cases in Nepal. The number of Covid-19 cases on Monday rose to 32,678 and the death toll hit 157.

Experts say that ethical principles should not be compromised while allowing clinical trials. While granting the approval, the authorities must extract assurances from the respective companies and countries that if found effective, Nepal should be on priority to receive the vaccine and that they must ensure that the country gets the vaccines at an affordable price.

Dr Kiran Pandey, an infectious disease expert, said that there is nothing wrong in beginning the Phase III clinical trials of the vaccine.

“We always get suspicious whenever we talk about vaccine trials,” said Pandey. “But we should not forget that such trials are needed for the larger benefit of the people. If the vaccines are not tested on us, how would we know they really work on us. Trials are also necessary to know the vaccine’s efficacy and side effects.”

There, however, is a need to make a studied decision on which companies’ or which countries’ vaccines should be allowed for Phase III clinical trials in Nepal, according to experts.

“Companies have to fulfil all the required procedures, follow our national protocols and guidelines,” said Professor Prakash Ghimire, chairperson of the National Ethical Review Board under the Nepal Health Research Council. “They have to submit their proposals accordingly. We have an independent ethical review committee, which gives the approval after meticulously going through their submissions.”

According to Ghimire, the Health Ministry might have taken a policy decision to send across the message that the door is open for companies to Nepal to conduct Phase II clinical trials.

According to a statement issued by the Nepal Health Research Council, China, Russia and the UK’s Oxford University Group have shown interest to perform Phase III trials in Nepal.

“The council has already started the process regarding this,” said the council.

It takes about four to eight weeks to fulfill all procedures but the council could expedite the process in the emergency condition.

The respective company must have one Nepali principal investigator, who should be an expert on respective field to carry out trials in Nepal for accountability issues, should adverse results come.

Vaccine manufacturing companies of the respective companies should take responsibilities of the participants and those participating in the trial must be insured, according to Ghimire.

“Informed consent taken from the participants is necessary, and the proposal should clearly mention what benefits the participant(s) and the country will get from the trial,” said Ghimire. “Likewise, trials should not be performed on the people who are under a chain of command, as they can be forced or coerced into participating in the trials.”

Dr Megnath Dhimal, chief researcher at the Nepal Health Research Council, said that if Phase III clinical trials of the vaccines against the coronavirus are performed in Nepal, this won’t be the first such experience for the country.

“Nor will Nepal be the only country to do so,” said Dhimal. “In the past too, clinical trials of Vitamin A vaccine, typhoid vaccines and pneumonia vaccines among others have been performed in Nepal. Even the Remdesivir vaccine is in the trial phase and we have allowed it for research purposes.”

Once the Phase III clinical trials are successful, the vaccine gets the patent and the registration process begins.

According to the Health Ministry, Hongshi Shivam Cement in Nepal has already sought permission to inoculate its 1,000 employees as part of Phase III clinical trials of the Chinese vaccine.

“The ministry has directed the council to fulfil all required procedures and give permission to the interested companies,” said Adhikari of the Health Ministry.

Subedi, the infectious disease expert, however, reiterated what Ghimire of the ethical committee stressed: clinical trials of the vaccine should be performed without compromising ethical values.

“While a clinical trial is fine and there is no need to make a fuss about it,” said Subedee, “it must be made sure that not a single person is inoculated by force or coercion.”