Sputnik V will be the first imported vaccine to join the indigenously produced Covishield and Covaxin that have been in use since January. This article provides information on the Russian vaccine, covering its effectiveness and current usage status around the world. 

For our comprehensive coverage and latest updates on COVID-19 click here.

---

Use of Sputnik in India

The Drug Controller General of India (DCGI) approved the vaccine under the emergency use authorisation process recently, citing promising outcomes from clinical trials performed in Russia and additional Phase III clinical trials conducted in India in collaboration with Dr Reddy's Laboratories. India has been the 60th nation to approve the use of Russia's Sputnik V coronavirus vaccine.

The government agreed to expedite emergency approvals for all coronavirus vaccines that have received equivalent approvals from the World Health Organisation or authorities in the United States, Europe, the United Kingdom, or Japan. This step could result in the availability of many vaccines in India, including those manufactured by Pfizer, Moderna, and Johnson & Johnson.

Sputnik is India's third coronavirus vaccine. Presently, India uses two vaccines for immunisation: Covaxin by Bharat Biotech and Covishield by the Serum Institute of India (SII). This month, India will get the first shipment of Russia's COVID-19 vaccine Sputnik V. According to the Russian Direct Investment Fund, over 850 million doses of Sputnik V will be manufactured annually in India. Hence, it is essential to know about this new vaccine.

---

History of Sputnik V

Prior to when the phase III clinical trials had even begun, Russia's President shocked the world by authorising the country's first domestically produced COVID-19 vaccine in August 2020. Russia's first approved vaccine was invented and manufactured entirely domestically, and its name is a deliberate reference to the 1950s space race. By the time the World Health Organisation proclaimed COVID-19 a pandemic in early March 2020, the Gamaleya National Center of Epidemiology and Microbiology in Moscow had already begun work on a prototype of Sputnik V, with funding from the Russian Direct Investment Fund (RDIF), the country's sovereign wealth fund.

---

The research process of sputnik V

Gamaleya researchers developed a vaccine prototype using common cold viruses. Importantly, they chose to administer two distinct adenovirus vectors (rAd26 and rAd5) in a first and second dose, 21 days apart. By using the same adenovirus for both doses, the body may produce an immune response against the vector, killing it upon administration of the second dose. This is less likely for two distinct vectors. To create the vaccine, adenoviruses are mixed with the SARS-CoV-2 spike protein, which elicits an immune response from the body. It utilises identical adenovirus (adenovirus-26) as J&J for the initial dose but a distinct adenovirus (adenovirus-5) for the subsequent dose. This eliminates the risk of first-dose immunity impairing the second dose's ability to function effectively.

---

Is Sputnik V secure and efficient?

Phase I and II findings from an open, non-randomised study involving 76 participants were released in The Lancet in September., 2020 According to the article, all participants formed antibodies against SARS-CoV-2. There were no significant adverse effects observed. The majority of adverse effects were minor, with just more than half reporting discomfort at the injection site.

In early February 2021, interim phase III data were released. Between 7th September and 24th November 2020, approximately 22,000 adults aged 18 years or older were enrolled through 25 hospitals and clinics in Moscow. Each individual got two doses of the vaccine or a placebo, separated by 21 days.

Interim findings (based on evidence from 14,964 vaccination patients and 4902 placebo participants) suggest that the vaccine is 91.6 per cent successful at preventing symptomatic infection. At least 21 days after the first dose, there were no reports of mild or extreme COVID-19 in the vaccinated population. Approximately 94 per cent of confirmed adverse events are considered to be very moderate (grade 1). Four deaths recorded during the review were determined not to be vaccine-related.

---

Consensus among experts

Suspicions were sown when the Russian President stunned the world by declaring Russia's support for emergency use of Sputnik V as early as August 2020, prior to the publication of phase I or II data and the start of phase III experiment. Scientists expressed scepticism about the vaccine's early acceptance and Russia's grandiosity around it.

In September, an open letter co-signed by 30 scientists from around the world questioned the phase I and II research paper for discrepancies. In a letter published in The Lancet, the team behind Sputnik V debunked the complaints, stating that some of the suspected inconsistencies as suspiciously matching antibody counts among participants were actually coincidences triggered in part by factors such as limited sample size and averaging of data points.

Phase III data has been greeted with greater enthusiasm. Some critics also noted that the primary result was announced relatively early, 21 days after the first dose, rather than after the second dose because the trial's initial protocol has not been released. It is impossible to determine if this decision was made before or after the trial. However, others contend that the phase III data that have been released so far legitimise Russia's decision to proceed with Sputnik V vaccinations.

---

Russia's vaccination strategy

On 2nd December, the same day the United Kingdom allowed the use of the Pfizer BioNTech vaccine, the Russian President announced that mass vaccinations using Sputnik V would begin within days. Indeed, Sputnik V administration started much earlier. Gamaleya workers were among the first to collect prototype doses in the spring of 2020, ahead of the start of phase I and II trials in autumn. The Russian President disclosed that one of his daughters had already received two vaccine doses. About 2500 Russian troops have already been vaccinated. School and healthcare staff became the first members of the public to obtain a dose of Sputnik V, who were given appointments via an online booking system.

However, drop-in clinics that provide vaccinations to those without an appointment have opened. One of the hubs is located in Moscow's Red Square, at the GUM shopping centre. Individuals will queue for a vaccination injection, and those who receive one receive a complimentary ice cream. According to Russia's Health Minister, as of 10 February, they had vaccinated over two million people with at least 1 dose of Sputnik V. According to the most recent available evidence, this equates to about three vaccine doses per 100 individuals (as a comparison, the UK has given nearly 10 times as many). The rollout could be delayed by public scepticism about Sputnik V in Russia. Sixty per cent of 1600 Russians surveyed online by the Moscow Times expressed opposition to obtaining it. The expedited clearance has also raised suspicions among some Russian physicians.

---

Which other nations have administered Sputnik V to their citizens?

In a vaccine lobbying effort, Russia has taken steps to spread Sputnik V outside its borders, pledging that it would cost foreign consumers only about $10 (£7.2; €8.4) per dosage. The RDIF claims to have signed contracts with over a dozen vendors in ten countries to deliver 1.4 billion doses in all.

Sputnik V had been authorised for urgent use by more than 50 nations, including Russia. Hungary is the only EU country to do so until now, despite claims at the time that the European Medicines Agency (EMA) was investigating the vaccine (EU states are able to approve vaccines bilaterally for use). The European Medicines Agency (EMA) later confirmed that a study of Sputnik V had started.

The President of the European Commission has openly asked why Russia is 'providing potentially millions and millions of doses despite not succeeding enough in vaccinating their native people'. A large number of doses have been sent to a variety of countries. According to sources, Sputnik V has also been launched in Argentina and Montenegro. Additionally, the University of Oxford and AstraZeneca has initiated a trial in Russia to determine if combining doses of their vaccine with Sputnik V may result in additional benefits.

---

Click here to see references

Disclaimer- The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.

The author is a practising super specialist from New Delhi.