Sputnik V vaccine mystery in Nepal

On Tuesday news broke about an agreement between the Russian Direct Investment Fund (RDIF) and Nepal’s Trinity Pharmaceuticals to import 25 million vials of the Sputnik V vaccines against Covid-19. But the deal is shrouded in mystery because the country’s Ministry of Health had no idea about the deal.

At a first glance it could be good news at a time when Nepal is reeling under the pandemic. But it seems no one in the government is aware of the deal. But the fact that announcement of such a massive deal did not come from the government, and doubts about whether the vaccine is safe has raised eyebrows.

What is more, Trinity Pharmaceuticals is not even registered as an importer under Nepal’s Department of Drug Management list of companies.

In a statement released on 29 September, RDIF Chief Executive Officer Kirill Dmitriev said that about 90% of Nepalis will be provided with Sputnik V vaccine safely and effectively though clinics in the country.

“Unlike experimental vaccines based on monkey adenovirus or mRNA, Sputnik V vaccine was created on human adenoviral vectors platform, which has been studied over decades and has proven no negative effects in the long-term,” added Dmitriev. “We see a strong interest from other partners in Asia. RDIF is ready to supply Sputnik V vaccine to the countries of the region.”

In the same press release, the director of Trinity Pharmaceuticals in Kathmandu Kishor Adhikari is quoted as saying, ‘Trinity is waiting for results of the final trial of Sputnik V. As soon as the vaccine is approved by Government of Nepal we will make it available for the population of Nepal.’

Nepal saw a total of 1,559 new Covid-19 cases on Wednesday with 902 in Kathmandu Valley alone. With 1,057 people were discharged in the last 24 hours, the recovery rate now stands at 72.5%. Total confirmed cases now stands at 77,817 with 491 fatalities.201 patients are in ICU and 31 in ventilator support.

The Sputnik-V (trade name of Gam-COVID-Vac) vaccine was developed by Russia's Gamalia National Research Institute of Epidemiology and Microbiology on 11 August and was later registered by the country's health ministry.

Despite having been tested only in 76 people in early-stage clinical trials that lasted two months (June-July), Sputnik V was quickly approved for distribution in Russia, drawing criticism from the international scientific community as a premature decision. It normally takes a year or more to test vaccine safety and efficacy.

Gam-COVID-Vac is administered in two doses and is expected to provide immunity from SARS-CoV-2 for up to two years. The vaccine is based on the human adenovirus, a common cold virus and is fused with the spike protein of SARS-CoV-2 to stimulate an immune response.

So far, RDIF has announced supply agreements with Mexico (32 million doses), Brazil (up to 50 million doses and Uzbekistan (up to 35 million doses). India is importing another 100 million doses of the vaccine.

The results of the first and second rounds of clinical trials of the vaccine which were published in the Lancet Journal on 4 September showed no serious adverse effects, but stable immune response in all participants, said the statement.

Post-registration phase III clinical trial involving 40,000 people is underway and the first results are expected to be published by October-November. Some mild side-effects have been reported in one of every seven people so far. This phase III trial is a crucial scientific step in order to prove vaccine safety and efficacy.

But back in Nepal, officials are unaware of the agreement. Before importing any new vaccine and drug, permission must be obtained from the Department of Drug Management.

Narayan Dhakal, director of the Department of Drug Management, says he had “no idea” about a Nepali company importing the vaccine against coronavirus from Russia.

The Chief Research Officer of the Nepal Health Research Council Meghnath Dhimal also told us he had no official information about a vaccine being imported from Russia.

Apart from Russia, Chinese pharmaceutical companies and Oxford University have also expressed their interest in conducting phase III clinical trials in Nepal.

There are currently over 169 Covid-19 vaccines under development, with 26 in the human trial phase. The WHO has assured that it will facilitate equitable access and distribution of a safe and effective vaccine in all countries with priority to people at most risk once it is found.