Public health experts and some government officials have suspected foul play in the purported deal between Russian Direct Investment Fund and a private Nepali firm to supply the Russian vaccine for the coronavirus to Nepal.

Reports on Tuesday suggested that Russian Direct Investment Fund, Russia's sovereign wealth fund, would supply 25 million doses of its potential Covid-19 vaccine to Nepal through Trinity Pharmaceuticals.

“It looks like some government officials’ ploy to help a private company benefit,” an official at the Department of Health Services told the Post requesting anonymity because he feared retribution. “It reminds of an earlier deal in which the government had asked Omni Business Corporate International Pvt Ltd to import medical equipment to fight the pandemic.”

Government officials, from the health and foreign ministries to the Department of Drug Administration and Nepal Health Research Council, however, had told the Post on Tuesday that they were unaware of any deal between Russia and the Nepali private firm to import the vaccine for Covid-19.

Not much is known about the Russian vaccine, which was approved by Russian President Vladimir Putin last month, amid reports that global health authorities suspected that it could have missed several stages.

Even if the Russian or any other vaccine, which has passed all stages of testing, is to be brought to Nepal, public health experts say, it should be directly imported by the government, just like it does in cases of other vaccines that are administered through the regular immunisation programme.

The Oli administration, which has been facing criticism for its poor handling of the pandemic, has also been censured for its involvement in corruption in the name of its fight against the coronavirus. At least two of Oli Cabinet’s ministers—Bhanubhakta Dhakal and Ishwar Pokhrel—face allegations of corruption and supporting private firms like Omni to import health equipment for their personal benefits.

Many suspect there could be similar cloak-and-dagger dealings to allow a private firm to import the vaccine.

Experts say such vaccines should be imported by the government itself rather than allowing any private firm to do so, as the lives of many people are at stake.

“Britain has secured 190 million doses of the potential coronavirus vaccine for its citizens. Our government too can reach out to vaccine-developing countries if it is serious about saving its citizens’ lives,” said professor Prakash Ghimire, chairperson of the National Ethical Review Board under the Nepal Health Research Council.

“Instead, a private company is taking initiatives to import the vaccine and government officials are feigning ignorance.”

What is even more concerning is that the Russian vaccine’s status is not known yet. The international scientific community has said Russian scientists are yet to conduct a large trial involving tens of thousands of people, a mandatory procedure to demonstrate that the vaccine works.

The Lancet journal on September 4 reported that there were no adverse effects on those who were given the Russian vaccine, which has completed Phase I and Phase II trials, but experts say no one will know if the vaccine is safe and effective until large-scale trials are run.

Of over 200 vaccines being developed throughout the world, nine vaccines are in the Phase III trial stage.

“None of the vaccines has completed the Phase III trial so far,” said Dr Shyam Raj Upreti, coordinator of Covid-19 Vaccine Advisory Committee, which was recently formed by the Health Ministry to recommend effective vaccines and ways to introduce them in the country.

Last month, Russia as well as China and the United Kingdom had expressed their interests to conduct Phase III clinical trials of their vaccines in Nepal. In separate interviews with the Post, experts had called for full compliance with the procedures if the vaccines were to be brought for the Phase III clinical trial in Nepal.

While China has been pushing for its vaccine in Nepal, with the proposal to inoculate at least 1,000 employees at Hongshi Shivam Cement factory, Russian Ambassador to Nepal Alekesei Novikov too has been lobbying for the Russian coronavirus vaccine. Last month, during a meeting with National Assembly Chairman Ganesh Prasad Timilsina, Novikov said that Russia would provide the vaccine to Nepal and that the vaccine would be available for the world’s markets starting November.

China has already started inoculating their front line workers.

“But as per Immunization Act, a vaccine must get the pre-qualification status or emergency use approval from the World Health Organization,” Upreti told the Post. “All vaccine manufacturing countries/companies should first complete the Phase III trial and data analysis and submit all related documents to the UN health organisation.”

The government's lackadaisical and nonchalant approach towards the most pressing public health concern of the day is already condemnable and if some officials are involved in getting a deal done through a private company to import the vaccine, it could spell a catastrophe, public health experts say.

“It is still uncertain if the vaccine really works. Its efficacy rate and side effects are yet to be confirmed,” said Ghimire of the National Ethical Review Board under the Nepal Health Research Council. “Even if everything goes as expected and the vaccine passes the Phase II trial, it still takes months for it to come to widespread use.”

Trinity Pharmaceuticals, however, defended the deal, saying that the agreement is aimed at “booking” the vaccine.

“If the Phase III trial of Russian vaccine succeeds and agencies under our government grant the permission, we will supply the vaccine,” Kishor Adhikari, director of Trinity Pharmaceuticals, told the Post. “The government can buy the vaccine from us or let us sell it in the market.”

According to Adhikari, the deal signed with the Russian company is a company-to-company deal.

“But how can a private firm sign a deal to import the vaccine either to sell it to the government without even getting registered for the purpose?” said Narayan Dhakal, director general at the Department of Drug Administration.

For any vaccine or drug to be imported in Nepal, every firm has to apply to the Department of Drug Administration, whose approval is mandatory before they start importing.

“The vaccine manufacturing company also has to get registered in Nepal.

Suppliers need to furnish all necessary documents at the department,” Dhakal told the Post. “The department takes a decision after the recommendation by a panel of experts.”

Dhakal told the Post on Tuesday that no company has applied to his department so far to supply a vaccine for Covid-19, leave alone the Russian vaccine.

“To supply vaccines, the Department of Drug Administration’s approval is a must,” said Dhakal. “The approval process starts with the aspiring company registering with our department.”

The private firm in question itself seems to have no history of importing drugs and vaccines.

Experts say how Russia got involved with a little-known company in Nepal for the vaccine deal is a mystery.

Adhikari of Trinity Pharmaceuticals, however, said that his company has been supplying rabies, tetanus and polio vaccines to Nepal. According to him, his company was trying to make deals with Covid-19 vaccine manufacturing companies for the last four months and finally succeeded with the Russian company—Gamaleya National Research Institute of Epidemiology and Microbiology.

“There are two ways of bringing vaccines—either it is imported under a government-to- government deal or supplier companies import them,” Adhikari told the Post.

The Immunisation Section of the Family Welfare Division under the Department of Health Services, which is responsible for running regular immunisation programmes, however, said that it does not know anything about Trinity Pharmaceuticals.

“Yes, the government does purchase rabies, tetanus and polio vaccines through a public procurement process but we do not know about the supplier companies,” said Dr Jhalak Sharma, chief of the section.

Public health experts say the incumbent government has already failed in its fight against the pandemic and now it is shirking its fundamental duty towards its citizens by not taking initiatives on its own to import the coronavirus vaccine.

“The government must take the lead and try to import a vaccine which is efficacious and safe,” said Dr GD Thakur, former director at the Epidemiology and Disease Control Division.

“First, it should try to get the vaccine from agencies like the Global Alliance for Vaccine and Immunization, which can bear the cost of the vaccine. Only if the government cannot acquire the vaccine for free, should it go for a government-to-government deal attempting to buy the vaccine at the lowest price possible.”

The Global Alliance for Vaccine and Immunization provides measles and rubella vaccines, rotavirus vaccine and Pentavalent vaccine, which protects against five major diseases—diphtheria, tetanus, whooping cough, hepatitis B and Haemophilus influenzae type b. The vaccine alliance shares the cost that developing countries pay for vaccines.

The government also must put in place an effective vaccine policy so as to ensure who will get the vaccine and how, according to Thakur.

“Once the government starts importing the vaccine, it must ensure total coverage. It should guarantee that the poor are not deprived of the vaccine,” said Thakur. “It’s the government’s duty to uphold citizens’ fundamental right to life. If the government sits quietly and allows private companies to sell the vaccine, it will mean it will remain out of poor people’s reach.”