Abigail BanerjiMay 07, 2021 21:19:04 IST
Russia made news last year when it launched and registered the first COVID-19 vaccine named Sputnik V. However, many looked at it with suspicion, as the vaccine hadn’t completed all the phases of clinical trials and the volunteer groups it was tested on were too small. Fast forward to less than a year later, and the vaccine has been approved in over 60 countries around the world (including in India), and as of 5 May, more than 20 million people have received at least one dose of this vaccine. However, the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) are still holding out. The two-dose Sputnik V vaccine showed efficacy of 91.4 percent in clinical trials, but according to real-world data, it is 97.6 percent effective against COVID-19.
About Sputnik Light
Now, Russia has released a new single-dose vaccine named Sputnik Light. Like its previous counterpart, Sputnik Light was also developed by the Russian Ministry of Health, the Gamaleya National Research Centre of Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF). It has also been registered and given authorisation for use.
Sputnik V is a two-dose vaccine made from recombinant adenovirus 26 (Ad26) and adenovirus 5 (Ad5) (Common cold-causing viruses). The first dose (Ad26) is the prime vaccine and the second (Ad5) is the booster shot. The Sputnik Light vaccine is made from Ad26, which is the first part of the Sputnik V vaccine.
A recombinant vaccine uses specific parts of the virus. Since they are made using only pieces of the virus, they result in an extremely strong immune response that targets key parts of the virus. They can be administered to everyone and even people with weak immune systems and long-term health problems. However, a limitation of this vaccine is it may need booster shots to continue to provide protection against diseases.
28 days after vaccination, the Sputnik Light vaccine was 79.4 percent effective against the virus. According to a statement released by the RDIF, the efficacy rate is based on data from Russia’s vaccination program, which ran from from 5 December, 2020 to 15 April, 2021. It has also proved to be effective against “all-new strains of coronavirus”. However, there is no clarification on the SARS-CoV-2 strains it has proved to be effective against, as several mutations of the virus have surfaced.
After the Johnson and Johnson vaccine, this is only the second vaccine that has shown relatively high efficacy against the virus with just a single dose. Compared to Sputnik Light, the J&J vaccine has an efficacy of 66.9 percent against symptomatic, moderate and severe SARS-CoV-2 infection.
During Phase I and II clinical trials, the study focused only on Russians who were not administered the second dose. Phase III clinical trials, according to an RDIF statement, involved 7,000 people, and was conducted in various countries including Russia, the UAE and Ghana.
While interim results from Phase III are expected later this month, the results from Phase I/II of the vaccine trials are as follows:
- People who have previously been infected with the virus showed 40 times more antigen-specific IgG antibodies, 10 days after vaccination.
- The vaccine did not cause any adverse events.
- It produces antigen-specific IgG antibodies in 96.9 percent of individuals 28 days after vaccination.
- SARS-CoV-2 virus-neutralising antibodies developed in 91.67 percent of individuals 28 days post vaccination.
- All vaccinated volunteers developed a cellular immune response against the S Protein of the SARS-CoV-2 on the 10th day after vaccination.
Price, storage of Sputnik Light
The vaccine is easy to store at temperatures ranging from two to eight degrees Celsius. It is also expected to cost less than $10. This one-dose jab will also allow for a large population to be inoculated.
Alexander Gintsburg, Director of the Gamaleya National Research Center of Epidemiology and Microbiology, said, “Sputnik Light will help to prevent the spread of coronavirus through the faster immunisation of larger population groups, as well as supporting high immunity levels in those who have already been infected previously.”
CNBC-TV18 quoted Kirill Dmitriev, CEO of RDIF, as saying, “Since Sputnik Light is the same as the first dose of Sputnik V, we believe that by June, the one-shot vaccine will be registered pretty much in most of the countries that registered Sputnik V.”
Gintsburg added, “Sputnik Light offers strong value in initial vaccination and re-vaccination, as well as boosting efficacy when taken in combination with other vaccines.”
While it can act as a standalone vaccine, the Sputnik Light can also be used as a booster jab for other vaccines. Trials are being conducted along with the AstraZeneca vaccine, reported Hindustan Times.
“Sputnik Light makes a greater booster shot with other vaccines. We are doing trials with AstraZeneca, but it can also be used with others. It can be a booster shot to upgrade other vaccines for all mutations, subject to additional trials,” Dmitriev said.
The two-dose Sputnik V vaccine will be the main source of vaccination for Russia. Currently, eight million people have been fully inoculated, while the one-shot Sputnik Light will be exported to the country’s international partners.
Sputnik V and India
The Drugs Controller General of India (DCGI) approved the Sputnik V in April after Dr Reddy’s Laboratories conducted a successful bridge trial. Russia will develop the vaccine, and Dr Reddy’s will sell the vaccine in India. The first batch of 1.5 lakh doses of the vaccine has already arrived in Hyderabad, and another batch (with an identical amount of vaccines) is expected in a few days. RDIF signed a contract with Dr Reddy’s to market and distribute 250 million doses, reported The Hindu, which translates into vaccine doses for 125 million people.
RDIF has tied up five Indian vaccine makers to produce over 850 million doses of the Sputnik V vaccine. Including Dr Reddy’s, other drugmakers include Gland Pharma, Hetero Pharma, Stellis Bio and Virchow Biotech.
Dmitriev also said India, South Korea and China are among 10 countries that will be producing Sputnik Light.
“We have partnerships with more than 20 producers in 10 countries and they will make both versions of the vaccine,” Dmitriev said.
Russia’s animal vaccine
No one is being left behind in the vaccination drive. In April, Russia announced it has developed and registered a COVID-19 vaccine for animals as well. It said this is an important step to disrupt the virus’ mutation, and mass production of this vaccine also began that month. The vaccine is called Carnivak-Cov, and has been tested on dogs, cats, mink, foxes and other animals since October. Researchers said it was effective in all subjects it was tested on.