Sputnik V Vaccine Description
The Russian COVID-19 vaccine Sputnik V (Gam-COVID-Vac) is an adenoviral-based, two-part vaccine against the SARS-CoV-2 coronavirus. Initially produced in Russia, Sputnik V uses a weakened virus to deliver small parts of a pathogen and stimulate an immune response.
The Sputnik V (Gam-COVID-Vac) vaccine reduces the time taken for the actual development of immunity to SARS-CoV-2, the virus behind the COVID-19 pandemic.
It 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 and start synthesizing the new coronavirus's envelope proteins, “introducing” the immune system to a potential enemy.
Sputnik V is a two-component vaccine in which adenovirus serotypes 5 and 26 are used. A fragment of tissue-type plasminogen activator is not used, and the antigen insert is an unmodified full-length S-protein. Sputnik V vaccine is produced with the HEK293 cell line.
In May 2020, the Russian state institute 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 vaccination is administered, memory cells are formed.
On February 2, 2021, The Lancet published a new study: Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine, an interim analysis of a randomized controlled phase 3 trial in Russia. This peer-reviewed article concluded the phase 3 trial of Gam-COVID-Vac showed 91.6% efficacy against COVID-19 and was well tolerated in a large cohort. In a follow-up Lancet article published on May 12, 2021, the author stated: The reporting of the interim analysis in the phase 3 Sputnik V clinical trial fully complies with those standards.
On March 22, 2021, the Ulema Council confirmed 'faith does not forbid Russian Muslims from getting vaccinated with Sputnik V, after considering two components of the Covid-19 vaccine for Sharia compliance.'
On April 13, 2021, researchers from Argentina-based CONICET, under the coordination of the Ministry of Health of the Province of Buenos Aires, announced 94% of people who received a single dose of the Sputnik V vaccine produce specific antibodies. In addition, previously infected people who received only one dose produce five times more antibodies than those who completed the two-dose schedule without a history of COVID-19.
Alexander Gintsburg, M.D., Professor, Academician of the Russian Academy of Sciences, Director of the Gamaleya Research Centre stated, 'we believe it is possible to increase the minimum interval between the first and second vaccine shots the earlier approved 21 days up to three months. Extending the interval will not affect the vaccine-induced immune response and, in some cases, will enhance and prolong it.'
Data published by the Ministry of Health of the Kingdom of Bahrain per WHO guidelines involving more than 5,000 subjects reported overall vaccine efficacy beyond 14 days after administering the second dose was estimated at 94.3%. The analysis is based on the data collected between February and early May 2021.
The Russian Sputnik V vaccine (Gam-COVID-Vac) (Спутник V) Accession Number: DB15848.
Sputnik V Vaccine History
The Sputnik V vaccine was created at the N.F. Gamaleya Research Center for Epidemiology and Microbiology Ministry of Health of Russia. On August 1, 2020, the Russian Health Minister Mikhail Murashko told reporters the 'clinical trial had been declared completed' and was then registered to 'FSBI "NF Gamaleya NITsEM" of the Ministry of Health of Russia ("Medgamal" branch of NF Gamaleya NITsEM "of the Ministry of Health of Russia)' on August 8, 2020.
The Russian Direct Investment Fund announced on August 20, 2020, the Sputnik V vaccine candidate will be tested on 40,000 volunteers in more than 45 medical centers to confirm clinical efficacy post-approval studies.
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.
On November 24, 2020, positive results of the second interim analysis of Phase III data of the Sputnik V coronavirus vaccine were reported. The efficacy evaluation 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 following the Clinical Study Protocol. Based on the analysis, the efficiency of Sputnik V was 95%.
Denis Logunov and colleagues reported their interim results from a phase 3 trial of the Sputnik V COVID-19 vaccine in The Lancet on February 2, 2021. The trial results show a consistent strong protective effect across all participant age groups.
RDIF was established in 2011 and provided 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.
The RDIF and The National Research Center for Epidemiology and Microbiology announced an International Scientific Advisory Board on the Sputnik V vaccine. Leading scientists in virology, microbiology, genetics, and biotechnology from Argentina, Croatia, France, Germany, India, Russia, Sweden, UK, and the USA, representing top research and medical centers, have joined the Board.
Sputnik V Vaccine Production
The quality and safety of the Russian Sputnik V vaccine are, among other things, assured by the fact that it uses a 4-stage purification technology that includes two stages of chromatography and two stages of tangential flow filtration. This purification technology helps obtain a highly purified product that goes through mandatory quality control, including control for RCA or any additives presence. Control for RCA is carried out not only for the finished product but also at all stages of production, including the viral seed. Therefore, the Sputnik V team believes that its purification technology is the best among all vaccines and is one of the pillars for vaccine safety.
Furthermore, only E1 and E3 type non-replicating adenoviral vectors, which are harmless for the human body, are used in the Sputnik V vaccine production. Sputnik V cell lines: Design and Development: HEK293 cells; Production: HEK293 cells.
On May 20, 2021, União Quimica completed its first batch of the Sputnik V vaccine in Brazil. The vaccine will be exported to neighboring countries in South America, reported Reuters.
RDIF announced on May 24, 2021, India-based Panacea Biotec started Sputnik V vaccine production at facilities in Buddy. Full-scale production of Sputnik V is expected to begin during summer 2021.
On June 3, 2021, local media reported Bahrain Mumtalakat Holding Company announced a memorandum of understanding with the RDIF and Binnopharm Group, а subsidiary of Sistema PJSFC, to explore the establishment of a vaccine production facility in the Kingdom of Bahrain to manufacture and distribute the Sputnik V COVID-19 vaccine across the Gulf Cooperation Council and the Middle East region.
Argentina and Serbia confirmed on June 4, 2021; they have begun industrial production of the Sputnik V vaccine.
And India's DCGI granted the Serum Institute of India permission on June 4, 2021, to manufacture the Sputnik V Covid-19 vaccine at its licensed Hadapsar facility.
On June 16, 2021, TASS reported the Swiss-Italian company Adienne Pharma & Biotech had launched in Italy the production of the first test batch of the Sputnik V vaccine.
Sputnik Light Vaccine
The Sputnik Light vaccine is the first component (recombinant human adenovirus 26 serotype (rAd26) of the Sputnik V vaccine.
AstraZeneca Vaccine Co-Development
The Russian Direct Investment Fund announced on February 9, 2021, that the Ministry of Health of the Republic of Azerbaijan had issued a clinical trial permit for a combined COVID-19 vaccine candidate, which includes the Sputnik V vaccine and technology co-developed by AstraZeneca and Oxford University. These clinical trials will begin in late February 2021 and plan to evaluate the combined vaccine's immunogenicity and safety over the course of six months in several countries.
QazCovid-in Vaccine Against COVID-19
The Karaganda Pharmaceutical Complex, located in Kazakhstan, plans to use the Sputnik V vaccine to produce the QazCovid-In Vaccine in the second quarter of 2021. This COVID-19 vaccine candidate is currently undergoing a phase 3 clinical study sponsored by Research Institute for Biological Safety Problems. This study's estimated Primary Completion Date is July 20, 2021. The first batch of 50,000 vaccine doses was delivered on April 26, 2021.
Sputnik V Vaccine Indication
The Russian Sputnik V COVID-19 Vaccine (Gam-COVID-Vac) is indicated to build immunity to SARS-CoV-2, which causes COVID-19 disease. Sputnik V is available in a lyophilized (dry) form of the vaccine that significantly facilitates the logistics of its distribution in international markets due to simplified requirements for its storage temperature (+ 2 - 8 degrees Celsius).
There is limited experience using Sputnik V vaccinations in pregnant women, so it should be avoided. And it is unknown whether Sputnik V is excreted in human milk. It should be avoided.
It is unknown whether individuals with impaired immune responsiveness, including individuals receiving immunosuppressant therapy, will elicit the same response as immunocompetent individuals to the vaccine regimen. Immuno-compromised individuals may have a relatively weaker immune response to the vaccine regimen.
Sputnik V should be given with caution to individuals with thrombocytopenia, any coagulation disorder, or persons on anticoagulation therapy because bleeding or bruising may occur following an intramuscular administration in these individuals.
Sputnik V Vaccine Side Effects
On April 14, 2021, the Russian Gamaleya Center announced, 'A comprehensive analysis of adverse events during clinical trials and over the course of mass vaccinations with the Sputnik V vaccine showed no cases of cerebral venous sinus thrombosis.'
Sputnik V Vaccine Ingredients
The active components are a modified replication-defective adenovirus of a different serotype (Serotype 26 for the first component and serotype 5 for the second), modified to include the protein S-expressing gene of the SARS-CoV-2 virus. The ingredients include Tris-(hydroxymethyl)-aminomethane, Sodium chloride, Sucrose, Magnesium chloride hexahydrate, Disodium EDTA dihydrate, Polysorbate 80, Ethanol, and Water.
Interfax reported on February 12, 2021, the Sputnik V coronavirus vaccine does not contain any components prohibited by Islam, Vladimir Gushchin, head of the laboratory of mechanisms of population change of pathogenic microorganisms at the Gamaleya Center, said.
Sputnik V Vaccine Cost
The cost of 1 dose of the Sputnik V vaccine for international markets will be less than $10. Sputnik V is a 2-dose vaccine. Thus, it will cost less than $20 per person.
On May 14, 2021, local media in India reported the Sputnik V vaccine is being sold at a maximum retail price of ₹995 per dose. Members of Dr. Reddy’s senior leadership said the vaccine would be supplied at the same price, ₹948 plus 5% GST to both government and the private sector. For the consumers, additional administering charges would be applied by hospitals.
Sputnik V Vaccine Distribution Agreements
As of June 17, 2021, the following 67 countries had authorized the Sputnik V Vaccine: Russia, Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Republic of Guinea, Tunisia, Armenia, Mexico, Nicaragua, Republika Srpska (Bosnia and Herzegovina), Lebanon, Myanmar, Pakistan, Mongolia, Bahrain, Montenegro, Saint Vincent and the Grenadines, Kazakhstan, Uzbekistan, Gabon, San Marino, Ghana, Syria, Kyrgyzstan, Guyana, Egypt, Honduras, Guatemala, Slovakia, Angola, Congo, the Republic of Djibouti, Sri Lanka, Iraq, Kenya, Morocco, Jordan, Namibia, Azerbaijan, Cameroon, Philippines, Seychelles, Mauritius, Vietnam, Antigua and Barbuda, Mali, the Republic of Panama, India, Nepal, Bangladesh, Turkish Republic, Republic of Albania, Maldives, Ecuador, Slovakia Republic, Malaysia, and Brazil.
Sputnik V Vaccine Legal Matters
The Russian news agency TASS reported on March 22, 2021; a US company may have violated patent rights to the Sputnik V vaccine. The Russian Direct Investment Fund CEO, Kirill Dmitriev, commented, "One of the US companies manufacturing the vaccine violates our patents. We have notified this company and want to start a dialog. We will not claim any funds from them during the pandemic period, but we will definitely take the protection of our intellectual property rights seriously."
Sputnik V Vaccine News
June 17, 2021 - SputnikVaccine.com tweeted 'SputnikV will soon offer a booster shot, adjusted to work against the Delta variant of the SARS-CoV-2 beta coronavirus.' The RDIF recently confirmed that it had submitted its research on the vaccine's effectiveness against the variant to an international peer-reviewed journal.
June 15, 2021 - Anvisa granted authorization, this Tuesday (6/15), through the Circuit 539 / 2021, for the exceptional importation of the Sputnik V vaccine by the states of Rio Grande do Norte, Mato Grosso, Rondônia, Pará, Amapá, Paraíba and Goiás. As decided on June 4, 2021, at the 9th Extraordinary Public Meeting of the Collegiate Board, the importation approved today must also be carried out under controlled conditions. For this purpose, the same responsibilities and conditions for the applicants were established.
June 13, 2021 - TASS reported Alexander Gintsburg, who heads the Gamaleya Institute, indicated a nasal spray form of its COVID-19 vaccine suitable for children aged 8-12 may be available in September 2021.
June 11, 2021 - Russian media reported Greece's National Vaccination Committee had approved the entry into the country of tourists vaccinated with the Sputnik V vaccine.
June 10, 2021 - The RDIF announces the data of the Ministry of Health of the Kingdom of Bahrain. An efficacy study collected between February and early May 2021 was conducted in accordance with WHO guidelines involving more than 5,000 subjects. Overall efficacy beyond 14 days after administering the second dose was estimated at 94.3%. The data from Bahrain also demonstrates that 98.6% of all COVID-19 cases 14 days after receiving the second dose were mild among those vaccinated with Sputnik V. Vaccination data indicates high safety of Sputnik V: No serious adverse events associated with vaccination; No deaths related to the vaccination; No cerebral vein thrombosis cases after vaccination.
June 5, 2021 - Moscow's Mayor Sergei Sobyanin stated the city had vaccinated 1.3 million people in roughly six months.
June 4, 2021 - Brazil's drug regulator announced 'the Sputnik V vaccine may be imported on an exceptional basis by Brazil, in specific quantities, for distribution and use under controlled conditions determined by Anvisa.' The main conditions for the use of Sputnik are 1) import only vaccines at the inspected factories by Anvisa in Russia (Generium and Pharmstandard UfaVita); 2) obligation of batch-to-batch analysis that proves the absence of replicating viruses and other quality characteristics; and 3) reporting of serious adverse events up to 24 hours.
June 3, 2021 - RDIF, Mumtalakat Holding Company, and Binnopharm Group confirmed an agreement for a Sputnik V vaccine production facility in the Kingdom of Bahrain.
June 3, 2021 - Local media reported Snowman Logistics's high-capacity temperature-controlled warehouses in Mumbai, Delhi-NCR, Kolkata, Chennai, and Bengaluru entered into a partnership with Dr. Reddy’s Laboratories Ltd to deliver the Sputnik V vaccine across India.
June 1, 2021 - Duopharma Biotech Berhad, through its wholly-owned subsidiary Duopharma Sendirian Berhad has with the recent signing with the Government of Malaysia, represented by the Ministry of Health, concluded execution of separate definitive supply agreements with the Government and a subsidiary of the Russian Direct Investment Fund for the supply of 6.4 million doses of the Sputnik V vaccine.
May 28, 2021 - The RDIF announced official vaccination data in Serbia, which confirms No serious vaccine-related adverse events were reported; No deaths due to vaccination; There had been no cases of cerebral vein thrombosis. Today in Serbia, more than a quarter of the population (28%) are fully vaccinated with various drugs - twice as much as the average in Europe (14%).
May 27, 2021 - Human Vaccine LLC announced signing an agreement to supply 220 million doses of two-dose Sputnik V vaccine with the United Nations International Children's Emergency Fund (UNICEF). The procurement and delivery of the vaccine by UNICEF are subject to the vaccine receiving WHO Emergency Use Listing. Human Vaccine is a wholly-owned subsidiary of the Russian Direct Investment Fund.
May 26, 2021 - ABC News reported Slovakia became the second European Union country to authorize the use of the Sputnik V vaccine, which the EMA has not approved.
May 24, 2021 - The Russian Direct Investment Fund announced data from a study conducted by the Institute of Virology of the National University of Cordoba (Argentina) and the authorities of Cordoba, which confirm the neutralizing effect of the two-component Sputnik V vaccine against the Brazilian strain of SARS-CoV-2 coronavirus, first identified in the city of Manaus, as well as a high immune response in those vaccinated with the drug.
May 24, 2021 - RDIF and India-based Panacea Biotec announced Sputnik V vaccine production began in Buddy. The company's facilities comply with GMP standards and are WHO prequalified.
May 17, 2021 - Local media reported Shilpa Biologicals Pvt Ltd. disclosed a 3-year definitive agreement with Dr. Reddy's Laboratories in a regulatory filing for the production and supply of the Sputnik V vaccine from its manufacturing center at Dharwad, Karnataka.
May 15, 2021 - The Russian Direct Investment Fund announced the registration of the Sputnik V vaccine in the Republic of Ecuador.
May 14, 2021 - The Russian Direct Investment Fund (RDIF) announced the first vaccinations with the Sputnik V vaccine were given today in Hyderabad following the delivery to India on May 1st. The delivery of the second batch of the drug to India is expected by the end of this week. The Sputnik V vaccine was approved in India on April 12, 2021, as part of the fast-track registration process. India is the leading manufacturing hub for the Russian vaccine. RDIF has entered into agreements with the largest pharmaceutical manufacturers in India (Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech) to produce more than 850 million doses of Sputnik V vaccines per year.
May 13, 2021 - The Food and Drug Authority of the Republic of Maldives announced the registration of the Sputnik V vaccine.
May 12, 2021 - The Russian Direct Investment Fund announces the single-component Sputnik Light vaccine registration by the Ministry of Health of the Republic of Angola.
May 12, 2021 - The Lancet published an author's response: An important detail in the report from Argentina is the observation that vaccination of people with a history of COVID-19 leads to a quick and significant increase in antibodies after a single dose of vaccine. Thus, to date, the safety and immunogenicity of the Sputnik V vaccine have been confirmed in multiple studies.
May 12, 2021 - The Moscow Times reported a poll by the Levada Center reported 10% of respondents indicated they have already been vaccinated.
May 10, 2021 - The Russian Direct Investment Fund announces the positive results of using the Sputnik V vaccine in San Marino, showing a decrease in new infection rates to zero.
May 10, 2021 - Zuzana Eliasova, a Slovakia health ministry spokeswoman, stated to Reuters that 'a Hungarian lab has confirmed that the first batch of Russia’s Sputnik V COVID-19 vaccines sent to Slovakia were satisfactory. Thus, Hungary is the only EU country to have begun inoculations with Sputnik V without waiting for EMA approval.
May 7, 2021 - The BMJ reported: 'The editors and peer reviewers of the Sputnik V paper are likely to have had only the 20 or so pages of PDF documents that were ultimately published. The Lancet’s website makes it clear that, like many journals, it does not have access to “raw data related to research studies.” Such limitations affect trust in journal publications generally. Still, they are most concerning when published data on important public health interventions, such as vaccines, have not yet been scrutinized by a stringent regulator.
May 6, 2021 - The single-dose Sputnik Light Vaccine was Approved for use in the Russian Federation.
April 29, 2021 - Reuters reported South Korea's Ministry of Food and Drug Safety had submitted the Sputnik V Vaccine for preliminary regulatory approval.
April 28, 2021 - Sputnik V Vaccine.com issued a statement that says, 'The decision by Brazil’s National Health Surveillance Agency (Anvisa) to delay the approval of Sputnik V has nothing to do with the regulator’s access to information or science. The regulator’s decision contradicts an earlier decision by Brazil’s Ministry of Science, Technology, and Innovation (MCTI), which recognized the Sputnik V vaccine as safe and permitted its production in Brazil.
April 26, 2021 - The RDIF and the Turkish pharmaceutical company Viscoran İlaç announce cooperation to produce the country's first-ever registered Sputnik V vaccine. Viscoran İlaç has made preparations for the localization of production and plans to start production of "Sputnik V" in the coming months at several enterprises.
April 25, 2021 - The Mexican government published its vaccine safety review, which indicates the Sputnik V Vaccine is very safe.
April 22, 2021 - The Russian Direct Investment Fund (RDIF), the Egyptian pharmaceutical company Minapharm and its subsidiary, ProBioGen (Germany), announced an agreement to produce more than 40 million doses of the Sputnik V vaccine per year, beginning in the 3rd quarter of 2021, produced at Minapharm's biotechnology facilities in Cairo.
April 20, 2021 - The Russian Direct Investment Fund and Laboratorios Richmond SACIF pharmaceutical company announced the first batch of the Sputnik V vaccine in Argentina. Full-scale production of the vaccine is due to start in June 2021.
April 19, 2021 - National Research Center for Epidemiology and Microbiology and the Russian Direct Investment Fund announced the effectiveness of the Sputnik V vaccine at the level of 97.6% based on the analysis of rea;-world data on the incidence of coronavirus infection among Russians vaccinated with both doses of the vaccine.
April 19, 2021 - Austrian Chancellor Sebastian Kurz confirmed that the government has agreed to buy one million Sputnik V vaccines. However, the vaccine requires approval by the European Medicines Agency.
April 19, 2021 - Russian Direct Investment Fund and China-based Hualan Biological Bacterin Inc. announced an agreement to produce more than 100 million doses per year in China's Sputnik V vaccine. In addition, RDIF and Hualan Biological Bacterin stated they aim at long-term cooperation for the production of a Russian vaccine.
April 15, 2021 - The Russian Direct Investment Fund, GL Rapha, one of South Korea's leading biotechnology companies, and ISU ABXIS (a division of ISU GROUP) announced an agreement on the technology transfer and production of the Sputnik V vaccines in Korea.
April 13, 2021 - Dr. Reddy’s Laboratories Ltd. announced that it had received permission from the Drug Controller General of India to import the Sputnik vaccine into India for restricted use in emergencies as per the provisions of the New Drug and Clinical Trials rules, 2019 under the Drugs and Cosmetics Act. As a result, India became the 60th country where the use of the COVID-19 vaccine is approved. Sputnik V is one of only three coronavirus vaccines approved for use in India.
April 5, 2021 - The Russian Direct Investment Fund and Panacea Biotec, one of India's leading vaccine and pharmaceutical producers, announce cooperation to produce 100 million doses per year of the Sputnik V vaccine.
April 1, 2021 - The Russian Direct Investment Fund and TopRidge Pharma (a subsidiary company of Tibet Rhodiola Pharmaceutical Holding) have agreed to cooperate to produce over 100 million Sputnik V vaccine doses per year in China.
March 29, 2021 - The Russian Direct Investment Fund and Shenzhen Yuanxing Gene-tech Co., Ltd. have agreed to produce over 60 million doses of the Sputnik V in China. This amount of the vaccine will be sufficient to vaccinate over 30 million people. The commercial production is due to start in May 2021.
March 25, 2021 - The Russian Direct Investment Fund announced the Republic of Serbia would become the first state in Southern Europe to produce the Sputnik V vaccine. The Torlak Institute of Virology, Vaccines, and Serums will begin producing the vaccine in May 2021.
March 24, 2021 - According to a recent survey, 54% of respondents named Russia the most trusted state of vaccine production. The results of the survey conducted by YouGov are based on 9,417 respondents in 9 countries.
March 22, 2021 - The Russian Direct Investment Fund and Virchow Biotech Private Limited (part of the Virchow Group), one of the leading manufacturers of vaccines and pharmaceuticals in India, announced an agreement to manufacture in the country annually up to 200 million doses of the Sputnik V vaccine.
March 19, 2021 - Russian Direct Investment Fund and Stelis Biopharma Pvt. Ltd. announced a partnership to manufacture and supply at least 200 million doses of the Sputnik V vaccine, vaccinating 100 million people. The parties intend to begin deliveries of Sputnik V in the third quarter of 2021.
March 19, 2021 - The BMJ published a Feature: Covid-19: What do we know about Sputnik V and other Russian vaccines?
March 16, 2021 - India-based Gland Pharma Ltd. announced an agreement with the Russian Direct Investment Fund to produce and supply up to 25.2 million doses of the Sputnik V COVID-19 vaccine. The estimated delivery is late in 2021.
March 8, 2021 - Local media reported the Italian-Russian Chamber of Commerce announced the Italian-Swiss firm Adienne Pharma & Biotech signed an agreement to manufacture the Sputnik V vaccine near Milan, in Lombardy. Adrienne is an integrated biopharmaceutical group of companies based in Lugano, Switzerland.
March 4, 2021 - The European Medicines Agency announced the human medicines committee had started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology. The applicant for this medicine is R-Pharm Germany GmbH.
February 26, 2021 - Russian Direct Investment Fund, JSC Generium, and RUE Belmedpreparaty, the largest pharmaceutical company in the Republic of Belarus, launched the Sputnik V vaccine.
February 18, 2021 - Moscow's mayor reported specialists had developed a nasal form of "Sputnik V," which forms immunity in the nasopharynx area. All three phases of clinical trials of the drug are also planned to be carried out in Moscow.
February 16, 2021 - South Africa’s health ministry stated that the Sputnik V COVID-19 vaccine manufacturers had submitted documentation to local medicines regulator SAHPRA for registration.
February 12, 2021 - Interfax reported the Sputnik V coronavirus vaccine does not contain any components prohibited by Islam, Vladimir Gushchin, head of the laboratory of mechanisms of population change of pathogenic microorganisms at the Gamaleya Center, said.
February 12, 2021 - Hungary became the first EU nation to use the Sputnik V vaccine.
February 4, 2021 - ANSA reported the Sputnik V vaccine arrived at Ben Gurion airport and transferred to the Palestinian National Authority.
February 3, 2021 - The Russian Direct Investment Fund announced Sputnik V's registration with the Federal Commission for Protection against Sanitary Risks of Mexico. Mexico became the first state in North America to register the Sputnik V vaccine.
February 2, 2021 - The Lancet published the Phase III clinical study results of the Sputnik V vaccine, confirming its high efficacy safety. An interim efficacy analysis based on data from a randomized, double-blind, placebo-controlled clinical trial of 19,866 volunteers who received both doses of the Sputnik V vaccine 21 days apart demonstrated its effectiveness against the coronavirus at 91.6%. Additionally, an efficacy analysis was performed based on the distribution of 78 confirmed cases of coronavirus detected in the placebo group (62 patients) and the vaccine group (16 patients). Sputnik V has developed a stable humoral and cellular immune response.
January 26, 2021 - The Moscow Times reported Russia's Foreign Minister Mohammad Javad Zarif announced Iran had approved the Sputnik V coronavirus vaccine.
January 24, 2021 - GAVI article: Coronavirus: why combining the Oxford vaccine with Russia's Sputnik V vaccine could make it more effective.
January 13, 2021 - The Russian Direct Investment Fund and one of Brazil's leading pharmaceutical companies, União Química, have agreed to supply 10 million doses of the Sputnik V vaccine in the first quarter of 2021.
January 11, 2021 - India - based Dr. Reddy’s Laboratories Ltd. announced that the independent Data and Safety Monitoring Board has reviewed the safety data from the phase 2 clinical trial of the Sputnik V vaccine and recommended the phase 3 recruitment and continue the clinical trial without any modifications.
December 21, 2020 - Russian Direct Investment Fund, N.N. N.F. Gamaleas and the pharmaceutical companies AstraZeneca and R-Pharm announced the signing of an agreement on developing and implementing a clinical research program to assess the immunogenicity and safety of the combined use of one of the components of Sputnik V vaccine of the Center.
December 15, 2020 - Presented by the Orthodox Union and the Rabbinical Council of America: our poskim conclude that, according to the advice of your personal health care provider, the Torah obligation to preserve our lives and the lives of others requires us to vaccinate for COVID-19 as soon as a vaccine becomes available.
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 vaccine.
November 13, 2020 - The Russian Direct Investment Fund and GL Rapha, one of South Korea's leading biotechnology companies, announced an agreement to manufacture more than 150 million doses of the Sputnik V vaccine.
October 27, 2020 - Russian application for WHO prequalification of the Sputnik V vaccine was the first since the start of applications.
October 2, 2020 - The Russian Direct Investment Fund announced the Sputnik V vaccine's first batch to Venezuela's Bolivarian Republic.
September 29, 2020 - The Russian Direct Investment Fund and one of the leading pharmaceutical distributors in Nepal, Trinity Pharmaceuticals, have agreed to supply 25 million doses of the Sputnik V vaccine.
September 18, 2020 - The Lancet published 'Safety and efficacy of the Russian COVID-19 vaccine: more information needed,' and the related reply.
September 9, 2020 - The Russian Direct Investment Fund and the Landsteiner Scientific pharmaceutical company announced an agreement to supply 32 million doses of the Russian Sputnik V vaccine to Mexico.
September 4, 2020 - The Lancet study: Safety and immunogenicity of a rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomized phase 1/2 studies from Russia.
August 16, 2020 - Sputnik V's developer said the 3rd stage of trials could be mass vaccination. The tests will be carried out in the Moscow Region, and some 20,000 - 30,000 people will get the vaccine.
July 12, 2020 - Alexander Lukashev, the director of the Institute of Medical Parasitology, Tropical, and Vector-Borne Diseases at Sechenov University, said that this stage of the clinical study's objective was to show the vaccine’s safety for human health, which was successfully done.
June 4, 2020 - Russia plans to start clinical testing of a coronavirus vaccine on paid volunteers from the general public.
May 22, 2020 - Russian developers of a coronavirus vaccine have developed immunity to the infection after self-administering it.
Sputnik V Vaccine Clinical Trials
The Sputnik V vaccine publishes a list of relevant clinical studies.
Clinical Trial NCT04530396: Phase 3 Clinical Trial of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Vaccine Against COVID-19 (RESIST).
Clinical Trial NCT04436471 - An open two-stage non-randomized Phase 1/2 study with 38 healthy volunteers.