Russian-made Covid vaccine Sputnik V, the third vaccine to be approved by India, will be manufactured by five pharma firms in the country and 850 million doses are going to be produced annually
Sputnik V ranks second among coronavirus vaccines globally in terms of the number of approvals issued by government regulators.
Sputnik V is a viral vector vaccine for COVID-19 developed by the Gamaleya Research Institute of Epidemiology and Microbiology. Registered on 11 August 2020 by the Russian Ministry of Health as Gam-COVID-Vac.
Gam-COVID-Vac was initially approved for distribution in Russia on the preliminary results of Phase I–II studies eventually published on 4 September 2020.
Emergency mass-distribution of the vaccine began in December 2020 in multiple countries including Russia, Argentina, Belarus, Hungary, Serbia, and the United Arab Emirates. As of February 2021, over a billion doses of the vaccine were ordered for immediate distribution globally.
Technology
Gam-COVID-Vac is a viral two-vector vaccine based on two human adenoviruses – a common cold virus – containing the gene that encodes the full-length spike protein (S) of SARS-CoV-2 to stimulate an immune response. The Gam-COVID-Vac vaccine was developed by a cellular microbiologist’s team of the government-backed Gamaleya Research Institute of Epidemiology and Microbiology. The group was led by MD and RAS associate member Denis Logunov, who also worked on vaccines for the Ebolavirus and the MERS-coronavirus
The recombinant adenovirus types 26 and 5 are both used as vectors in the vaccine. They were biotechnology-derived and contain the SARS-CoV-2 S protein cDNA. Both are administered into the deltoid muscle.
The Ad26-based vaccine is used on the first day and the Ad5 vaccine is used on the 21st day to boost immune response
The vaccine can be formulated in two ways: as a ready-to-use solution in water that is frozen at the common home-freezer storage temperature of −18 °C or 0 °F or lower and as a freeze-dried powder, “Gam-COVID-Vac-Lyo”, whose storage temperature is above freezing, 2–8 °C or 36–46 °F, at the common home-refrigerator temperature. The freeze-dried powder must be reconstituted with water for before use.
The production of the frozen liquid formulation was developed for large-scale use, it is cheaper and easier to manufacture.
A single-dose version is also being developed to speed up vaccination outside Russia. It will offer less protection than the two-dose versions, but it is still expected to reach an efficacy of 85%.
Composition
The Gam-COVID-Vac is a two-vector vaccine. The active component for both vectors is a modified replication-defective adenovirus of a different serotype (Serotype 26 for the first vaccination and serotype 5 for the second vaccination), which has been modified to include the protein S-expressing gene of SARS-CoV-2.
The other ingredients are the same, both quantitatively and qualitatively, in the two components. Tris(hydroxymethyl)aminomethane, Sodium chloride, Sucrose, Magnesium chloride hexahydrate, Disodium EDTA dihydrate (buffer), Polysorbate 80, Ethanol 95%, Water
As per the official datasheet, no further components, or ingredients, including other adjuvants, should be included in the vaccine.
Clinical Research
An interim analysis from the Moscow trial was published in The Lancet, indicating 91.6% efficacy (95% CI 85.6–95.2) after the second vaccination, without unusual side effects. The trial started on 7 September 2020 using the frozen liquid form of the vaccine, and data was analyzed up to the second database lock on 24 November 2020. The over-60-years-old group in the trial (oldest participant was 87) had essentially the same efficacy (91.8%) as for all ages. The lowest age participants were 18 years old.
The results suggest Sputnik V is among the top performing vaccines, along with the Pfizer/BioNTech and Moderna jabs that also reported more than 90% efficacy.
Production
As of March 2021, the Russian Direct Investment Fund (RDIF) has licensed production in India, China, South Korea, and Brazil. In the EU, RDIF has signed production agreements, subject to European Medicines Agency approval, with companies in Germany, Spain, and France, and is in negotiations with a Swiss/Italian company. By the end of March 2021 RDIF anticipates 33 million doses will have been manufactured in Russia, less than 5% of which will have been exported.
An agreement to produce over 100 million doses of vaccine in India has been made with Dr. Reddy’s Laboratories, who on 11 January 2021 submitted mid-stage trial data to the Indian regulator and recommended moving onto late-stage trials. The RDIF announced plans to sell 100 million doses to India, 35 million to Uzbekistan, and 32 million to Mexico, as well as 25 million each to Nepal and Egypt.
The Sputnik V doses to be manufactured in South Korea are not for domestic use. The vaccine is to be exported to Russia, Algeria, Argentina, Hungary, Iran, and the United Arab Emirates.
Sputnik V COVID Vaccine in India
India has become the 60th country to approve Sputnik V. Sputnik V is one of only three vaccines registered in India. The Russian vaccine has been approved for use in countries with total population of 3 billion people
The approval to Russia’s Sputnik V vaccine in India also assumes significance as several states have flagged the depleting stock of the vaccine doses, demanding an urgent supply of them.
The Russian Direct Investment Fund (RDIF) partnered with Dr. Reddy’s in September 2020 to conduct clinical trials of Sputnik V in India. The pharma major sought the government’s approval for the vaccine to be used in India.
India now has a set of three vaccines — Serum Institute’s Covishield, Bharat Biotech’s Covaxin and Russia’s Sputnik V — for immunization against the infection in the country which has lately been witnessing a record spike in virus cases.
Sputnik V dosage
Deepak Sapra of Dr. Reddy’s Laboratories said, “It is a two-dose vaccine. You take the first dose on day zero and the second one on day 21. The peak immunity develops somewhere between day 28 to day 42.”
Side Effects
Alexander Gintsburg, director of the Gamaleya National Research Centre, earlier said earlier there are no concerns that the vaccine could potentially cause harm to a person’s health. Some people naturally have a fever when immune system of the person being vaccinated receives a powerful boost, but this “side-effect” can easily be overcome by taking paracetamol.
Clinical Research in India
Conducted trials in India and evaluated the vaccine on the Indian population for both safety as well as for immunogenicity,” official of Dr Reddy’s said.
key advantages
- Efficacy of Sputnik V is 91.6% as confirmed by the data published in the Lancet, one of the world’s oldest and most respected medical journals; it is one of only three vaccines in the world with efficacy of over 90%; Sputnik V provides full protection against severe cases of COVID-19.
- The Sputnik V vaccine is based on a proven and well-studied platform of human adenoviral vectors, which cause the common cold and have been around for thousands of years.
- Sputnik V uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration than vaccines using the same delivery mechanism for both shots.
- The safety, efficacy, and lack of negative long-term effects of adenoviral vaccines have been proven by more than 250 clinical studies over two decades.
- There are no strong allergies caused by Sputnik V.
- The storage temperature of Sputnik V at +2+8 C means it can be stored in a conventional refrigerator without any need to invest in additional cold-chain infrastructure.
- The price of Sputnik V is less than $10 per shot, making it affordable around the world.