Sputnik V Vaccine Description
The Russian COVID-19 vaccine Sputnik V (Gam-COVID-Vac) is an adenoviral-based vaccine against the SARS-CoV-2 coronavirus. Sputnik V uses a weakened virus to deliver small parts of a pathogen and stimulate an immune response.
And, is a vector vaccine based on adenovirus DNA, in which the SARS-CoV-2 coronavirus gene is integrated. Adenovirus is used as a “container” to deliver the coronavirus gene to cells, start the synthesis of the envelope proteins of the new coronavirus “introducing” the immune system to a potential enemy.
The Russian vaccine Sputnik V (Gam-COVID-Vac) intends to reduce the time taken for the actual development of immunity to SARS-CoV-2, the virus behind the COVID-19 pandemic.
In May 2020, a state institute, the Gamaleya National Research Centre of Epidemiology and Microbiology, announced that it had developed the vaccine, which does not have any side effects. The first vaccination leads to humoral cellular immunity and once a second vaccine is administered, a key feature of this vaccine kicks in—memory cells are formed.
The Sputnik V vaccine was developed by the same government labs that developed what is claimed “an effective against the Ebola virus, as well as a vaccine against the MERS virus.”
On August 1, 2020, the Russian Health Minister Mikhail Murashko told reporters the 'clinical trial had been declared completed.'
The Russian Direct Investment Fund (RDIF) announced on August 20, 2020, the Sputnik V coronavirus vaccine candidate will be tested on 40,000 volunteers in more than 45 medical centers to confirm clinical efficacy, during post-approval studies.
On August 20, 2020, the Russian Direct Investment Fund (RDIF) and the Gamaleya National Research Institute of Epidemiology and Microbiology launched an information section about “Sputnik V” at www.sputnikvaccine.com.
TASS reported on September 9, 2020, 'Russian Healthcare Minister Mikhail Murashko announced that Phase 3 of clinical trials of the Sputnik V vaccine against the novel coronavirus started in Russia.'
On October 27, 2020, RDIF announced it had submitted applications to the World Health Organization for an Emergency Use Listing and prequalification of the Sputnik V vaccine candidate. This news indicates the Russian Federation became one of the first countries in the world to apply to WHO for prequalification of its vaccine against the new SARS-CoV-2 coronavirus infection.
On November 24, 2020, positive results of the second interim analysis of Phase III data of the Sputnik V coronavirus vaccine. The evaluation of efficacy was carried out among 18,794 volunteers on the 28th day after receiving the first injection (the 7th day after receiving the second injection) of the vaccine or placebo, upon reaching the second checkpoint in accordance with the Clinical Study Protocol. Based on the analysis, the efficiency of Sputnik V was 95%.
RDIF was established in 2011 and provides support to facilitate partnerships, including that with Gamaleya National Research Institute of Epidemiology and Microbiology and the Central Research Institute of the Radiation, Chemical, and Biological Defense Troops.
Sputnik V Vaccine Distribution Agreements
RDIF agreed on September 30, 2020, to secure the supply of 25 million doses of the Sputnik V vaccine to Egypt.
As of September 29, 2020, RDIF announced more than 50 countries in Asia, Middle East, Latin America, Europe, and CIS have applied for access to the Sputnik V vaccine. RDIF has announced earlier supply agreements with Mexico for 32 million doses, with Brazil for up to 50 million doses, India for 100 million doses, and Uzbekistan for up to 35 million doses.
South Korea biotechnology company, GL Rapha, announced on November 13, 2020, an agreement to manufacture more than 150 million doses of the Russian Federation's Sputnik V vaccine candidate.
On November 22, 2020, TASS reported the first batch of Sputnik V will be laboratory-produced in Belarus during 2020, Belarus’ acting Health Minister Dmitry Pinevich stated.
Additionally, on November 27, 2020, RDIF and Hetero, one of India’s leading generic pharmaceutical companies announced an agreement to produce in India over 100 million doses per year of the Sputnik V vaccine. The parties intend to start the production of Sputnik V in the beginning of 2021.
Sputnik V Vaccine Indication
Russian COVID-19 Vaccine candidate (Gam-COVID-Vac) is indicated to build immunity to SARS-CoV-2 the virus which causes COVID-19 disease.
Pediatric and pregnancy vaccine efficacy data pending.
Sputnik V Vaccine News
November 27, 2020 - HYDERABAD based Hetero Labs has joined RDIF to manufacture over 100 million doses of the Sputnik V vaccine in India during 2021.
November 24, 2020 - Article published by Science.org: 'The developers of Russia’s Sputnik V vaccine today reported 91.4% efficacy from a second interim analysis of more than 18,000 people, bolstering a claim the team made on 11 November with scant evidence. Whereas the initial report rested on a mere 20 cases of COVID-19, with no details on how they were split between vaccinated and placebo groups, the new analysis is based on 39 cases total, eight among the vaccinated group versus 31 in the much smaller placebo arm.'
November 24, 2020 - N.N. N.F. The Gamaleis of the Ministry of Health of the Russian Federation and the Russian Direct Investment Fund announced the positive results of the second interim analysis of Phase III data of the largest double-blind randomized placebo-controlled clinical post-marketing clinical trial of the Sputnik V coronavirus vaccine in Russian history with the participation of 40,000 volunteers.
November 17, 2020 - The Russian Direct Investment Fund announced the results of a survey of more than 12 thousand respondents in 11 countries about their attitude to vaccination against coronavirus infection. According to the survey, 73% of respondents are ready to be vaccinated against coronavirus.
November 13, 2020 - The Russian Direct Investment Fund and GL Rapha, one of South Korea's leading biotechnology companies, announced an agreement to manufacture in the country more than 150 million doses of the world's first registered vaccine against coronavirus Sputnik V. The parties intend to start production in December of this year and begin deliveries of the vaccine for export in January 2021. More than 150 million doses of the Sputnik V vaccine produced in South Korea will enter the world market.
November 12, 2020 - Hungary's foreign affairs and trade minister Peter Szijjarto announced on national TV that Budapest would receive a sample of Sputnik V within a week-and-a-half for laboratory testing. Clinical trials and licensing are to begin in December 2020, and depending on the results, Hungary will begin to procure the vaccine in January 2021.
November 11, 2020 - Reuters reported Russia’s Sputnik V vaccine is 92% effective at protecting people from COVID-19 according to interim trial results. 'The uniqueness of the Russian vaccine lies in the use of two different vectors based on the human adenovirus, which allows for a stronger and longer-term immune response as a result of the second immunization.'
November 9, 2020 - The Russian Direct Investment Fund and the N.F. The Gamaleis announced the launch of an international social media campaign that will provide social media users with the latest and most reliable information on the Russian vaccine. The campaign uses the #SputnikV hashtag.
October 30, 2020 - Russian Direct Investment Fund, União Química Farmacêutica Nacional, and the Government of the State of Parana announce the preliminary submission of a set of documents for registration of a Russian vaccine to the Brazilian National Sanitary Inspection Agency. The documents were sent on October 29, 2020.
October 29, 2020 - Dr. Reddy’s Laboratories announced its partnership with the Biotechnology Industry Research Assistance Council, Department of Biotechnology, Government of India, for advisory support on clinical trials of the Sputnik V vaccine in India.
October 27, 2020 - Russian application for WHO prequalification of the Sputnik V vaccine was one of the first since the start of applications.
October 26, 2020 - About 19,000 people have been administered the first component of the Sputnik V vaccine in Moscow and the Moscow Region, about 6,500 of whom have already received the second component, Director of the Gamaleya National Research Center for Epidemiology and Microbiology of the Russian Healthcare Ministry that developed the vaccine, Alexander Gintsburg said in an interview with the Russia-24 TV channel. The vaccination against coronavirus infection with the Russian drug Sputnik V is tolerated without side effects by 85% of those vaccinated.
October 17, 2020 - Russian Direct Investment Fund and Dr. Reddy's Laboratories Ltd (Dr. Reddy's), one of the leading global pharmaceutical companies, has been approved by the Controller General of Medicines of India to conduct Phase 2-3 clinical trials of Sputnik V vaccine in India. The country will conduct multicenter, randomized controlled trials, which will include safety and immunogenicity trials.
October 14, 2020 - According to a statement: '13,000 of our citizens, volunteers, are already participating in them, and, as you know, the vaccine has already arrived in the constituent entities of the Russian Federation, albeit not in large quantities, but it has already arrived.'
October 12, 2020 - The Russian Direct Investment Fund (RDIF) announced the approval by the Ministry of Health and Prevention of the UAE to conduct Phase III clinical trials of the Sputnik V vaccine. The clinical trials will be overseen by the Abu Dhabi Department of Health and the UAE Ministry of Health and Prevention, and the Abu Dhabi Health Services Company, a state-owned Abu Dhabi hospital management company, will process medical protocols.
October 2, 2020 - In a video posted on YouTube, the Russian Federation's capital city of Moscow stated: 'Moscow could receive bulk shipments of Russia’s coronavirus vaccine by the end of 2020 while the vaccine continues to undergo final clinical trials. And, around 6,000 volunteers and 600 medics have been inoculated with the Sputnik V vaccine in the Russian capital as part of post-registration, double-blind trials so far.
October 2, 2020 - The Russian Direct Investment Fund announced the delivery of the first batch of the Sputnik V vaccine to the Bolivarian Republic of Venezuela. Vaccination of volunteers in Venezuela will begin in the coming days as part of double-blind, randomized, placebo-controlled clinical trials of the Sputnik V vaccine.
October 1, 2020 - The Lancet published an article: The arrival of Sputnik V.
September 30, 2020 - The Russian Direct Investment Fund and Pharco, one of the leading pharmaceutical groups in Egypt (acting through its key operational subsidiary – Biogeneric Pharma) have agreed to secure the supply of 25 million doses of the Sputnik V vaccine to Egypt.
September 29, 2020 - The Russian Direct Investment Fund and one of the leading pharmaceutical distributors in Nepal, Trinity Pharmaceuticals, have agreed to supply to the country 25 million doses of the Sputnik V vaccine based on a well-studied human adenoviral vectors platform.
September 25, 2020 - The Russian Direct Investment Fund said it is in talks with a number of countries, including Iran, about the possibility of locally-producing the Sputnik-V vaccine to reduce the number of coronavirus infections.
September 22, 2020 - The Gamaleya National Research Center for Epidemiology and Microbiology of the Russian Healthcare Ministry said it is developing a protocol of the coronavirus vaccine study for cancer patients.
September 18, 2020 - The Lancet published 'Safety and efficacy of the Russian COVID-19 vaccine: more information needed,' and they related reply.
September 16, 2020 - The Russian Direct Investment Fund and Dr. Reddy’s Laboratories Ltd. have agreed to cooperate on clinical trials and distribution of the Sputnik V vaccine in India. Upon regulatory approval in India, RDIF shall supply to Dr. Reddy’s 100 million doses of the vaccine. Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India.
September 16, 2020 - The Russian Direct Investment Fund announced discussions with the Republic of Korea the possibility of production of the Russian Sputnik V vaccine, the negotiations are at their final stage.
September 15, 2020 - Researchers highlight ‘questionable’ data in Russian coronavirus vaccine trial results.
September 11, 2020 - The Russian Direct Investment Fund and the Health Secretariat of the Brazilian state of Bahia signed a cooperation agreement to supply Brazil with up to 50 million doses of the Russian Sputnik V vaccine, beginning in November 2020, subject to Brazilian government regulatory approval. The agreement will also allow the vaccine to be shipped throughout Brazil in the future.
September 9, 2020 - The Russian Direct Investment Fund and the Landsteiner Scientific pharmaceutical company announced an agreement for the supply of 32 million doses of the Russian Sputnik V vaccine to the country of Mexico.
September 7, 2020 - Russia's Health Ministry Mikhail Murashko stated, 'that the first batch of Sputnik V vaccine has been produced for civilian circulation,' reported the Tass news agency. Previously, Minister Murashko explained that civilian production at this stage, 'meant vaccination of citizens from the risk groups, namely teachers and doctors, would be carried out simultaneously with post-registration clinical trials.'
September 4, 2020 - The Lancet study: Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomized phase 1/2 studies from Russia.
September 4, 2020 - The technology institute for the Brazilian state of Paraná has agreed to produce Russia’s “Sputnik-V” COVID-19 vaccine, said on Friday it plans to conduct phase III trials on 10,000 volunteers in Brazil at the start of 2021.
September 2, 2020 - Employees of the National Research Center for Epidemiology and Microbiology were vaccinated against COVID-19, the director of the institution, Alexander Ginsburg told RIA Novosti. According to Gunzburg, the participants in this stage will be closely monitored by doctors and they will not be hospitalized, but they will take all the necessary tests before, after, and during the research.
August 26, 2020 - The Russian Direct Investment Fund, the Government of Moscow, and the Gamaleya National Research Center of Epidemiology and Microbiology announce the start of a post-registration clinical trial of a coronavirus vaccine in Moscow. Forty thousand people will take part in the program.
August 16, 2020 - The developer of Sputnik V said the 3rd stage of trials can be called mass vaccination. The trials will be carried out in the Moscow Region and some 20,000 - 30,000 people will get the vaccine.
August 15, 2020 - Russia announced that it has produced the first batch of its coronavirus vaccine.
August 11, 2020 - The Russian Federation's President Putin said his daughter was inoculated with a new Russian coronavirus vaccine.
August 11, 2020 - OP-ED: THE SPUTNIK VACCINE AS A LIFESAVING GLOBAL PARTNERSHIP.
August 8, 2020 - Special video report on the Russian vaccine against COVID-19 07.08.2020, Russia-24.
August 6, 2020 - Russia is planning a mass vaccination campaign in October and the vaccine will be first given to doctors and teachers.
August 4, 2020 - Video interview of RDIF CEO Kirill Dmitriev with the BBC.
August 1, 2020 - Clinical trials of a coronavirus vaccine developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology are over, Russian Health Minister Mikhail Murashko told reporters.
July 19, 2020 - "Russia may be one of the first to produce a vaccine against the backdrop of the billions that are being invested by all the pharma companies working on it,” said Kirill Dmitriev, the chief executive of the Russian Direct Investment Fund, which previously signed a deal with AstraZeneca to manufacture the University of Oxford’s Covid-19 vaccine at R-Pharm, one of the largest pharmaceutical companies in Russia.
July 16, 2020 - Russia plans to produce 30 million doses of an experimental COVID-19 vaccine domestically this year, with the potential to manufacture a further 170 million abroad, the head of the country’s sovereign wealth fund told Reuters.
July 13, 2020 - The Gamalei center's head Alexander Gintsburg told the TASS news agency that he hopes the vaccine will “enter civil circulation” on Aug. 12-14. He added that he hopes private companies would begin mass production by September. “The research has been completed and it proved that the vaccine is safe,” Yelena Smolyarchuk, the head of Sechenov University’s clinical research center, told TASS of its trial.
July 12, 2020 - Russia's Sechenov University Announced Successfully Completing Clinical Trials of World's 1st COVID-19 Vaccine. Alexander Lukashev, the director of the Institute of Medical Parasitology, Tropical, and Vector-Borne Diseases at Sechenov University, said that the objective of this stage of the clinical study was to show the vaccine’s safety for human health, which was successfully done.
July 10, 2020 - The Russian Ministry of Defense announced that it started the final stage of the Coronavirus vaccine clinical trials, which is run by the Gamalei National Research Center for Epidemiology and Microbiology. These trials began on June 18th when nine volunteers received 1 component of the vaccine. On June 23th, the vaccine was given to 20 other volunteers who will receive the booster vaccination.
July 7, 2020 - Volunteers, who tested a vaccine against the coronavirus 2-weeks ago at Burdenko military hospital, are feeling well and have not experienced any side effects, the Russian Defense Ministry told reporters.
June 11, 2020 - Hit Hard by Coronavirus, Russia Joins Global Race for a Vaccine.
June 10, 2020 - RDIF has supported the development of a Russian COVID-19 vaccine that is scheduled to commence clinical trials by mid-June 2020 and enter production by the fall.
June 4, 2020 - Russia plans to start clinical testing of a coronavirus vaccine on paid volunteers from the general public.
May 29, 2020 - Alexander Gintsburg of Moscow's Gamaleya research institute said last week he had taken a dose of a so-called viral vector vaccine that he hopes will complete clinical trials by the end of the summer.
May 22, 2020 - Russian developers of a coronavirus vaccine have developed immunity to the infection after self-administering it.
Sputnik V Vaccine Clinical Trials
On October 17, 2020, RDIF stated the Sputnik V vaccine (Gam-COVID-Vac) is undergoing post-registration clinical trials on 40,000 volunteers in Russia. Also, Sputnik V phase 3 studies are ongoing in Belarus, Venezuela, and the United Arab Emirates.
Clinical Trial NCT04530396: Phase 3 Clinical Trial of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Vaccine Against COVID-19 (RESIST) - Last Update Posted: October 27, 2020. Randomized, double-blind (blinded for the trial subject and the study physician), placebo-controlled, multi-center clinical trial in the parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.
Clinical Trial NCT04436471 - An open two-stage non-randomized Phase 1/2 study with the participation of (38) healthy volunteers. This clinical trial is an open study of safety, tolerability, and immunogenicity of the drug "Gam-COVID-Vac ", solution for intramuscular administration, with the participation of healthy volunteers. last updated on August 12, 2020.