With a major drive for vaccination across the world, all the major countries are coming up with vaccines to save mankind. And so has Russia. Sputnik V is a viral vector vaccine for COVID-19. It is an adenovirus viral vector vaccine.
V in Sputnik V stands for the English alphabet, not for the Roman number five. On 11th August 2020, the Gamaleya Research Institute of Epidemiology and Microbiology developed the vaccine which was later approved by the Ministry of Health.
In December 2020, the vaccine was distributed to Argentina, Belarus, Hungary, Serbia and the United Arab Emirates including Russia. This distribution was on an emergency basis.
By February 2021, more than a billion doses were ordered for immediate distribution worldwide. Here is all the Latest News on the Sputnik V COVID-19 Vaccine.
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Team / Scientist / Lab Who Created Sputnik V Vaccine Vaccine
Sputnik V or Gam-COVID-Vac is a viral two-vector vaccine based on two human adenoviruses viz common cold virus contains the gene that encodes the full-length spike protein (S) of SARS-CoV-2. It is used to stimulate an immune response.
Gamaleya Research Institute of Epidemiology and Microbiology supported a cellular microbiologist team of the government to develop Gam-COVID-Vac.
MD and RAS associate member Denis Logunov guided the group that worked on vaccines for the Ebolavirus and the MERS-coronavirus.
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Latest News on Sputnik V COVID-19 Vaccine
The recombinant adenovirus types 26 and 5 are used as vectors in the vaccine. They were biotechnology-derived. They contain the SARS-CoV-2 S protein cDNA.
These vaccines are administered into the deltoid muscle. Sputnik V is a two-dose vaccine. Both vaccine doses are taken in a gap of 21 days. The first dose is Ad26-based and the second dose is the Ad5 vaccine.
E1 genes are removed by the vaccines which prevents replication. HEK 293 cells produce large quantities of both adenoviruses which are necessary for viral replication. HEK 293 cells help to acquire the E1 gene from Ad5.
It helps to restore its ability to replicate. Every vaccine dose of Gamaleya replicates 5000 viruses which is well an acceptable limit. Per dose of the tested batches contains less than 100 replicating virus particles as per quality documents.
The vaccine can be formulated in two ways. The ready-to-use solution in water which can be stored in a home freeze at a temperature of -18 Degrees C or 0 Degrees F.
This is one method to store. Dried powder is frozen at a storage temperature of 2 – 8 Degrees C or 36 – 46 Degrees F. It can also be stored in a common home refrigerator. The dried powder needs to be formulated with water before it is used.
This is another method to store the vaccines. The production of the frozen liquid formulation was developed for large-scale use as it is cheaper and easier to manufacture.
The production of the freeze-dried formulation takes much more time and resources though it is more convenient for storage and transportation. Some of the Russian areas are hard to reach. Keeping in mind this area vaccine was developed.
Efficiency of Sputnik V Vaccine
Sputnik v vaccine efficiency is based on the presumption that the country has adequate resources, the vast majority of the Russian population shall take almost 9 – 12 months to vaccinate.
It was indicated by Alexander Ginzburg, head of Gamaleya Research Institute. Russia is also looking to develop a single-dose vaccine so that it can speed up vaccination in the world.
The production of a single dose would be lesser but the efficacy would be 85%. On 2 February 2021, without unusual side effects the trial indicated 91.6% efficacy.
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Trials of Sputnik V Vaccine
Phase I–II
On 18th June 2020, the phase I safety trial began and by 4th September 2020, data for 76 participants in a phase I–II trial were published. The publication indicated preliminary evidence of safety and an immune response.
International vaccine scientists challenged the results. They indicated it to be incomplete, suspicious, and unreliable as the data indicated was identical for many trial participants.
It was countered with the size of participants and the measures of titration values. The size was just nine participants and the titration values could take only the values such as 800, 1600, 3200 and 6400.
These would reach a plateau in three to four weeks. Several participants would not show identical results for 21 to 28 days was then contended.
Phase III
In early November 2020 during Phase III clinical trials, Hadassah’s branch in Moscow’s Skolkovo Innovation Centre is collaborating. This was the statement given by Israel Hadassah Medical Center director-general Prof. Zeev Rotstein.
The phase III study involved 40,000 volunteers in Moscow to make it randomised, double–blind and placebo controlled. It is scheduled to run until May 2021.
In 2020–2021, apart from Russia, Belarus, UAE, India and Venezuela also participated in Phase II Clinical studies for the vaccines.
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Sputnik V – AstraZeneca COVID-19 vaccine trials
On 21 December 2020 the Russian Direct Investment Fund (RDIF), the Gamaleya National Center, AstraZeneca and R-Pharm signed an agreement for the development and implementation of a clinical research program.
Gamaleya Centre developed a component of the Sputnik V vaccine which will be assessed for immunogenicity and safety for combined use.
One of the components of the AZD1222 vaccine is developed by AstraZeneca and the University of Oxford.
In February 2021, the combined study of Sputnik V and AstraZeneca was allowed to be used for clinical study in the country of Republican Azerbaijan by the Ministry of Health.
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Approval From Different Authorities
By December 2020, Russia received an order for more than 1.2 billion doses of the vaccines as confirmed by Russian Direct Investment Fund.
The supplies shall be produced by global partners in various countries such as India, Brazil, China, South Korea, Hungary and other countries.
Almost 65 countries made requests for the doses. Almost 61 countries have approved Sputnik V and 28 countries are already vaccinating with it. Russian vaccine plays an important role in developing countries that do not have their vaccines.
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Side Effects of Sputnik V Vaccine
An interim analysis of phase III clinical trial data reports on the Sputnik v vaccine efficiency and safety of the vaccine. Based on the data, the most common side effects were flu-like illness, headache, fatigue and injection-site reactions.
These side effects are similar to those of the Pfizer, Moderna, and Johnson & Johnson COVID-19 vaccines, as noted by the Centers for Disease Control and Prevention (CDC)Trusted Source.
Latest News on Sputnik V COVID-19 Vaccine
Despite these data, there is still a significant controversy surrounding the vaccine. Experts Trusted Source have received the results with scepticism due to Russia’s strategy of early approval in August 2020, along with the lack of published raw data or protocol.
Mass media criticism and scientific community discussions were the response to the approval of Gam-COVID-Vac in early August.
The controversy was due to the doubt on approval in the absence of robust scientific research confirming safety and efficacy. Gam-COVID-Vac would be rejected by British and American officials as the vaccine trials were not rigorously done and followed.
Sputnik V COVID-19 Vaccine: FAQ
When will Sputnik V be available in India?
Apollo Hospitals Group has said that the Russian coronavirus vaccine, Sputnik V, will be available in India through the Apollo system from the second week of June. Sputnik V is the third vaccine to be approved in India.
Is Sputnik v approved by who
Yes,
Gamaleya Research Institute of Epidemiology and Microbiology supported a cellular microbiologist team of the government to develop Gam-COVID-Vac. MD and RAS associate member Denis Logunov guided the group that worked on vaccines for the Ebolavirus and the MERS-coronavirus.
What is Sputnik V
Sputnik V is a viral vector vaccine for Covid 19. It is an adenovirus viral vector vaccine. V in Sputnik V stands for the English alphabet, not for the Roman number five
Side Effects of Sputnik V Vaccine
Based on the data, the most common side effects were flu-like illness, headache, fatigue and injection-site reactions. These side effects are similar to those of the Pfizer, Moderna, and Johnson & Johnson COVID-19 vaccines, as noted by the Centers for Disease Control and Prevention (CDC)Trusted Source.
Is Sputnik V safe?
Based on the data, the most common side effects were flu-like illness, headache, fatigue and injection-site reactions. These side effects are similar to those of the Pfizer, Moderna, and Johnson & Johnson COVID-19 vaccines, as noted by the Centers for Disease Control and Prevention (CDC)Trusted Source.
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