What makes Russia's Sputnik V a sought-after COVID vaccine for developing world, including India

Sputnik V vaccine: Coronavirus vaccine by Russian Ministry of Health | Cost: The two dose vaccine price will be much lower as compared to Pfizer and Moderna’s vaccine | According to the Russian Direct Investment Fund (RDIF), which has been backing the vaccine and marketing it globally, interim results shows that Russia’s Sputnik V vaccine is 92 percent effective at protecting people from COVID-19, based on data from the first 16,000 trial participants to receive both shots of the two-dose vaccine. The Sputnik V vaccine is expected to respond from two shots administered 21 days apart each based on different viral vectors. Reports suggest the vaccine can be stored at 2-8 degrees Celsius temperature. Russia’s Sputnik V vaccine for COVID-19 has reportedly arrived in India after Dr Reddy’s Laboratories got approval from the Drug Control General of India (DGCI) to conduct phase 2 and 3 human clinical trials of the vaccine. (Image: Reuters)

Russian President Vladimir Putin on Wednesday ordered authorities to begin mass vaccinations with the Sputnik V COVID-19 vaccine from next week. Sputnik V, developed by the Gamaleya Research Center for Epidemiology and Microbiology, Moscow, and bankrolled by Russian sovereign fund RDIF, became the first registered COVID-19 vaccine in the world.

Post-registration, the testing of the vaccine began in Moscow on September 7, with the first set of volunteers getting the vaccine shot on September 9. Currently, 45,000 volunteers are taking part in Phase III of Sputnik V clinical trials globally, out of which over 22,000 have been vaccinated with the first dose, and more than 19,000 – with both the first and second doses of the vaccine.

Despite a slow start, Sputnik V has gained considerable traction. RDIF says more than 40 countries have expressed interest in the vaccine, and there were preliminary orders for 1.2 billion doses. In India, Dr Reddy's and Hetero have signed up with RDIF to manufacture and distribute 200 million doses of the vaccine. So how did Sputnik V manage to do the sprint?

Let's a take a look at the science behind the vaccine, and the factors that may make it a preferred choice for developing countries, including India.

Science behind the vaccine

Sputnik V vaccine is based on the human adenovirus vector, which is considered to be a safe and well-studied platform. In fact, its rival AstraZeneca-University of Oxford’s COVID vaccine, too, uses adenovirus as a vector but a Chimpanzee version. A vector is a modified virus that transports pieces of disease-causing pathogens in an attempt to stimulate an immune response. In this case, Sputnik carries the spike protein of the SARS-CoV-2 virus.

Adenoviruses are benign and relatively easier to engineer, and, have, therefore, become very popular as vectors. Adenovirus vectors are already in use to develop vaccines for Ebola, which were tested on humans but weren't commercialised.

The difference between Sputnik V and other vaccines is that the Russian scientists at Gamelya have used two human adenoviruses (rAd26 and rAd5) instead of one. The rAd5 adenovirus has been used in Ebola vaccine. The second vector, rAd26, is a rarer adenovirus. This, the Russians claims, stimulate a stronger immune response.

In fact, Russian authorities say that using the same Chimpanzee adenoviral vector for the first dose, called prime boost, and the second dose, called booster, makes the second shot ineffective, referring to the relatively low efficacy of AstraZeneca and University of Oxford’s vaccine in two full dosages.

Efficacy data

The RDIF announced the second interim analysis of the clinical trial data, which showed 91.4 percent efficacy for the vaccine on day 28 after the first dose; vaccine efficacy of over 95 percent on 42 days after the first dose.

The interim results have not yet been peer reviewed or published in any scientific journal. The data looks impressive but experts urge caution, as the review was done on a low number of cases reported in the Sputnik V trial. Currently, besides Russia, clinical trials are underway in Belarus, Brazil, India and the United Arab Emirates.

Cold storage

Storage and logistics are two huge issues India is facing.  Analysts say Sputnik V fits in the bill perfectly.

"It is available in two forms, liquid, to be stored at minus 18°C and lyophilised (freeze dried), would be stored at 2°C to 8°C," Dr. Debkishore Gupta, Consultant Clinical Microbiologist and Head of Infection Control, CK Birla Hospitals, India.

"The lyophilised form has been produced to ease the process of the transportation to remote places. The makers have already initiated the production of the lyophilised form of this vaccine,” Gupta said.

While Pfizer-BioNTech’s and Moderna’s COVID-19 vaccines are 95 percent effective, but they need cold chain of minus 70 degrees Celsius and minus 20 degrees Celsius for storage, it is not suited for most developing and economically poorer countries.

The cost

The cost of the vaccine would be a major consideration for developing countries, which have meagre budgets allotted for healthcare compared to the developed world. RDIF announced that the Sputnik V vaccine would be priced at less than $10 per dose. The prices are expected to come down even as production volumes expand. While AstraZeneca is offered at $3-$4 per dose, cheaper than Sputnik V, the vaccine of Pfizer would be double the cost of Sputnik, and Moderna’s would be triple the cost.

Liberal at deals

An executive who held talks with RDIF told Moneycontrol on condition of anonymity that the RDIF is open to do deals with manufacturers in India, South Korea, China and other countries.

Follow Moneycontrol's COVID-19 Vaccine Tracker here.

"They are not pesky, they are liberal on pricing, technology transfer etc. The requirement is so big that they need huge capacities, so they are looking for entering partnerships with companies in India, South Korea, China and others," he said.

"Also, this vaccine is based on two different human adenovirus vectors, so there is some complexity in manufacturing," the executive said.

Vaccine diplomacy

RDIF is aggressively promoting Sputnik V vaccine. In fact, Sputnik V vaccine is the only vaccine with a dedicated Twitter account. The Twitter account not just promotes the vaccine, but sometimes takes potshots at rival vaccines on their efficacy and prices. RDIF CEO Kirill Dmitriev is everywhere in the media promoting the vaccine.

But health policy experts say more than the press releases and social media posts, what matters is hard and transparent data, which is up for independent review.
“We still need to see the data and evidence that the vaccine is effective at preventing Coronavirus. These are still early days for Sputnik V vaccine,” said Amir Ullah Khan, who teaches Economics and Development policy at the MCRHRDI of the Government of Telangana. Khan was previously policy advisor with the Bill and Melinda Gates Foundation.