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. The cells will use the gene to produce the spike protein. The person’s immune system will treat this spike protein as foreign and produce natural defenses, antibodies, and T cells, against this protein.
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 a 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 that 94% of people who received a single dose of the Sputnik V vaccine produced specific doses of 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.
On June 29, 2021, the RDIF and the UAE Ministry of Health published an analysis based on 81 thousand people vaccinated with both components of the Sputnik V vaccine demonstrated full (100%) effectiveness against severe COVID-19.
The journal Nature published an article on July 6, 2021; mounting evidence suggests the Sputnik COVID vaccine is safe and effective.
On July 12, 2021, the Russian Ministry of Health confirmed Sputnik V’s efficacy against the Delta variant. The vaccine is 83.1% effective and shows a 6x reduction of infection risk. Sputnik V is also 94.4% effective against hospitalizations with an 18x reduction in hospitalization risk.
A non-peer-reviewed study based in Argentina published on August 25, 2021, concluded by saying, 'Our observations suggest that protection increases over the six months following vaccination as a consequence of antibody maturation, resulting in improved potency of antibodies to viral escape mutations. This increase was more evident for the Beta and Gamma SARS-CoV-2 virus variants, which showed the highest propensity for neutralization escape.'
The Sputnik V vaccine offered completely vaccinated patients 81% protection against being hospitalized during the SARS-CoV-2 virus Delta variant surge in Argentina during July-August 2021, a non-peer-reviewed study reported on August 25, 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%.
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.
RDIF was established in 2011 and provided support to facilitate partnerships, including Gamaleya National Research Institute of Epidemiology and Microbiology and the Central Research Institute of the Radiation, Chemical, and Biological Defense Troops.
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.
And 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 Booster (3rd) Vaccination
Bahrain's National Medical Taskforce for Combatting the Coronavirus (COVID-19) announced on September 4, 2021, the formal authorization of Sputnik V as a booster shot for those 18 and above who received their second dose of the Sputnik V vaccine at least six months ago. The authorization of the Sputnik V booster shot is the first of its kind globally.
Sputnik V Vaccine Production
'Sputnik V vaccine has built 20 production partnerships with producers in 14 countries and intends to double its capacity in September 2021,' stated the Sputnik V website on August 11, 2021. And, 'Sputnik V will accelerate work with other vaccine producers on the mix and match approach.'
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 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.
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.
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 that the Swiss-Italian company Adienne Pharma & Biotech had launched the first test batch of the Sputnik V vaccine in Italy. Reuters reported on June 18, 2021. The Argentine laboratory Richmond produced almost half a million doses of the Sputnik V vaccine in the country.
On June 23, 2021, following an application for Emergency Use Listing of the Gamaleya COVID-Vac vaccine, the WHO conducted inspections at the four manufacturing sites named in the application. Following the inspection of Open Joint-Stock Company Pharmstandard - Ufa Vitamin Plant, (28 Khudayberdina str, Ufa, Republic of Bashkortostan, 450077, Russia) (hereinafter, the “manufacturer”), during the period from May 31, 2021, to June 4, 2021, the WHO’s PQT Inspection Team reported various findings at this plant, but not the other three vaccine production facilities. According to the WHO, any vaccine proven to be safe, efficacious, and quality assured, and otherwise meets the requirements outlined in the EUL Procedure will be granted a EUL recommendation.
The RDIF and Actoverco, one of Iran’s leading pharmaceutical companies, confirmed on June 26, 2021, the production of a test batch of the Sputnik V vaccine. These vaccines will be used in Iran.
On July 5, 2021, the RDIF and Mexican pharmaceutical company Laboratorios de Biológicos y Reactivos de México (BIRMEX) announce the production of a test batch of the Russian Sputnik V vaccine. Mexico has become the first country in North America to register Sputnik V and launch the local production of Sputnik V. On July 20, 2021, the Laboratorios de Biológicos y Reactivos de México SA de CV (Birmex), sent the Gamaleya National Research Center for Epidemiology and Microbiology the pilot tests. The batches with the pilot tests of components 1 and 2 were kept in the facilities of the National Institute of Virology of Birmex in conditions of -20ºC.
The RDIF and Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume, announced cooperation to produce the Sputnik V vaccine. The first batch of Sputnik is expected to be produced at SII’s facilities in September 2021. The parties stated that they intend to produce over 300 million vaccine doses in India per year in a press release.
The Times of India reported on August 5, 2021; Panacea Biotec Ltd agreed to produce up to 25 million doses of the Sputnik V vaccine drug substance produced by Russia-based Generium. Panacea will then supply the vaccines to Dr. Reddy's Laboratories for distribution in India.
Argentina-based Laboratorios Richmond delivered the first batch of the Sputnik V vaccine on August 12, 2021. And Serbian leaders confirmed that 18 parameters were controlled on 960 samples according to the highest world standards and that they all showed an excellent result, noting that the 500k Sputnik V vaccines are ready for use as of September 1, 2021.
Hanoi, Vietnam-Vabiotech confirmed plans to start commercial production of the Sputnik V vaccine on September 24, 2021. The Company for Vaccine and Biological Production No.1 is a State-Owned Company which used to belong to The National Institute of Hygiene and Epidemiology.
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 AB and Oxford University.
QazCovid-in Vaccine Against COVID-19
The Karaganda Pharmaceutical Complex, located in Kazakhstan, used the Sputnik V vaccine to produce the QazCovid-In Vaccine. The first batch of 50,000 vaccine doses was delivered on April 26, 2021.
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.'
On July 8, 2021, The Lancet - EClinicalMedicine published a study that found 'Mean age of the 2558 vaccine recipients was 66±14 years. First-dose AEFI incidence was 53.3% (systemic reactions at 42.2%), while second-dose AEFI incidence was 66.8% (systemic reactions at 50.4%) (n = 1288). In general, 76.0% of two-dose recipients reported some AEFIs after either vaccine dose, and 2.1% suffered severe reactions; in 60- to 89-year-olds (n = 1021), AEFI incidence was 70.0%, with 53.0% of subjects describing systemic reactions and 0.8% reporting severe symptoms. The most frequent symptoms were local pain, asthenia, headache, and joint pain.'
The RDIF stated on August 11, 2021, 'Real-world data obtained during mass vaccinations in Argentina, Bahrain, Hungary, Mexico, Russia, Serbia, the Philippines, and UAE demonstrate lack of serious adverse events such as CVTs or myocarditis.'
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. Dr. Reddy’s senior leadership members 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 September 24, 2021, the following 70 countries had authorized the Sputnik V Vaccine: Russia, Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Peru, 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, Panama, India, Nepal, Bangladesh, Turkish Republic, Republic of Albania, Maldives, Ecuador, Slovakia Republic, Malaysia, Brazil, Nigeria, Chile, and Indonesia.
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. Of course, 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
September 22, 2021 - TheHindu reported India-based Hetero Biopharma has been approved to manufacture the Sputnik V vaccine.
September 16, 2021 - VOA reported an official at the World Health Organization says the group has suspended its approval process for Russia’s Sputnik V coronavirus vaccine, after a number of manufacturing infringements were uncovered during an inspection in Russia. This was announced by Dr. Jarbas Barbosa.
September 15, 2021 - Local media reported India’s drugs regulator has granted permission to Dr Reddy’s Laboratories to conduct phase 3 clinical trials for the single-dose, first component of the Sputnik V vaccine.
September 15, 2021 - The Russian Direct Investment Fund announces data from the Ministry of Health of the Republic of Belarus. The effectiveness of the Sputnik V vaccine against coronavirus in Belarus was 97.2%. The effectiveness assessment was carried out on the basis of data from more than 860 thousand people who received vaccination in the period from January to July 2021.
September 9, 2021 - The Moscow Times reported the European Medicines Agency (EMA) requires more data on the Sputnik V vaccine prior to EU Authorization. The EMA’s human medicines committee started a rolling review of Sputnik V (Gam-COVID-Vac) on March 4, 2021.
September 7, 2021 - The president of Peru announced the country would manufacture Sputnik V vaccines.
September 6, 2021 - Pakistan intends to purchase at least 10 million doses of Russia's Sputnik V coronavirus vaccine; Pakistani Ambassador to Moscow Shafqat Ali Khan stated this in an interview with TASS.
September 2, 2021 - The Russian Direct Investment Fund announced the Ministry of Health of San Marino confirmed the Sputnik V vaccine's high efficacy during the vaccination campaign in the country, including against new variants of COVID. Between 25 February and 23 August 2021, the overall efficacy 21 days after administering the first vaccine dose was estimated at 94.8%, while efficacy against hospitalizations was estimated at 95.9%.
September 2, 2021 - Taiwan's Central Epidemic Command Center reported Taiwan's first known 'breakthrough' case to have been fully vaccinated with the Sputnik V vaccine.
August 31, 2021 - Russian media reported Slovakia's Ministry of Health announced the Sputnik V vaccination program would be discontinued after delivering about 40,000 doses since July 2021.
August 27, 2021 - Argentina announced receiving 307,500 doses of component 2 of the Sputnik V vaccine after that batch passed the quality control of the Gamaleya Scientific Institute in Russia and the local regulator ANMAT.
August 26, 2021 - A non-peer-reviewed study of nearly 13,900 people showed the two-dose vaccine reduced the risk of hospitalization with COVID-19 by 81% and helped prevent severe lung injury. “We were able to get this unique data because no one in the world seems to perform as many CT scans for patients with mild disease as Russia does,” Barchuk says.
August 25, 2021 - A non-peer-reviewed observational study in Argentina: Temporal Increase in Neutralization Potency of SARS-CoV-2 Antibodies and Reduced Viral Variant Escape after Sputnik V Vaccination suggest that protection increases over the six months following vaccination as a consequence of antibody maturation, resulting in improved potency of antibodies to viral escape mutations. The analysis indicates that while anti-spike IgG levels significantly wane over time, the neutralizing potency to the first-wave linages of SARS-CoV-2 and VOC increases within four months of vaccination, suggesting that antibody maturation occurs. This increase was more evident for the Beta and Gamma variants, which showed the highest propensity for neutralization escape.
August 25, 2021 - The Russian Direct Investment Fund announced the approval of the two-dose Sputnik V vaccine in the Republic of Indonesia.
August 24, 2021 - SeeNews reported Montenegro's government plans to Approve the import of the Sputnik Light vaccine to expand the range of immunization options available in the country.
August 23, 2021 - A non-peer-reviewed case-control study based in St. Petersburg, Russia, reported the adjusted Sputnik V vaccine VE against referral to a hospital was 81% (95% CI: 68–88) for complete vaccination.
August 21, 2021 - The SputnikVaccine website Tweeted 'Russia extends the use of Sputnik Light vaccine to include 60+-year-olds.
August 20, 2021 - The RDIF, AstraZeneca, and R-Pharm announce preliminary results on the immunogenicity of combined use of the AstraZeneca vaccine and the Sputnik Light vaccine based on human adenovirus serotype 26) from the clinical trial of vaccines combination in the Republic of Azerbaijan. Clinical trials in Azerbaijan began in February 2021. To date, 64 volunteers have been vaccinated, the enrollment of volunteers is ongoing. Preliminary data from the first 20 participants show antibodies to the SARS-CoV-2 virus spike protein elicited in 100% of cases. The interim analysis of data has previously demonstrated a high safety profile for the combined use of the vaccines with no serious adverse events or cases of coronavirus infection after vaccination.
August 19, 2021 - Thailand's Centre for Covid-19 Situation Administration now includes the Sputnik vaccine as one of the accepted vaccine brands for international travelers entering certain destinations in Thailand.
August 15, 2021 - Local media reported Richmond Laboratories produced a total of Sputnik V vaccines that were distributed: 994,500 doses correspond to component #1, and 152,500 are component #2.
August 12, 2021 - Laboratorios Richmond has delivered 995,125 doses of the first component of Sputnik V to the Ministry of Health of Argentina. The Company has also supplied about 152,000 doses of the second component of the vaccine out of three million doses to be produced and supplied in August 2021.
August 11, 2021 - The RDIF announced the results of its joint work with Ministries of Health and regulators of the leading countries to collect and analyze real-world vaccination data.
August 8, 2021 - Bolivia's president Luis Arce announced the arrival of second doses of the Sputnik V vaccine via Twitter.
August 4, 2021 - The Russian Direct Investment Fund announced the preliminary results of a blind randomized study to assess the immunogenicity and safety of the combined use of the first component of the Sputnik V (human adenovirus serotype 26) and vaccines from AstraZeneca, Sinopharm, and Moderna in the province of Buenos Aires (Argentina). Data from the Buenos Aires Provincial Ministry of Health show that the combination of Sputnik Light with other vaccines and vaccination with two injections of Sputnik Light alone is safe with no serious vaccine-related side effects. All combinations used in the study were found to be safe.
August 3, 2021 - Argentina’s Laboratorios Richmond SACIF pharmaceutical announced the Sputnik V vaccine produced at Company’s facilities will become available for vaccination in Argentina starting this week following successful quality control of test samples at the Gamaleya Center in Russia on August 3rd. Thus, Argentina was the first country in Latin America to authorize Sputnik V and start its production.
August 3, 2021 - The European Commission recognized COVID-19 vaccine certificates issued in San Mario that had approved the Sputnik V vaccine. The EU Digital COVID Certificate Regulation was launched in July 2021.
August 2, 2021 - According to the Moscow Times, the prime minister of St. Vincent and the Grenadines Gonsalves recently ordered 100,000 vaccine doses to vaccinate 50,000 people with Sputnik V’s two-shot formula fully. The Lancet publication of clinical trial data was the most important factor in securing Sputnik V's approval.
July 31, 2021 - Local media reported the Minister of Health of Argentina, Carla Vizzotti, confirmed that next week a new batch of the Sputnik V vaccine would arrive in the country to complement the vaccination scheme.
July 31, 2021 - The RDIF and one of the leading pharmaceutical companies of Uzbekistan, Jurabek Laboratories, announced the first batches of the Sputnik V vaccine had been produced at company facilities.
July 26, 2021 - The journal Natures published a study that found 'Using de novo generated replication-competent vesicular stomatitis virus expressing various SARS-CoV-2-S in place of VSV-G (rcVSV-CoV2-S), coupled with a clonal 293T-ACE2 + TMPRSS2 + cell line optimized for highly efficient S-mediated infection, we determine that only 1 out of 12 post-vaccination serum samples shows effective neutralization (IC90) of rcVSV-CoV2-S: B.1.351 at full serum strength. The same sera set efficiently neutralizes S from B.1.1.7 and exhibits only moderately reduced activity against S carrying the E484K substitution alone. '.
July 21, 2021 - The Republic of Chile’s Institute of Public Health announced via Twitter it approved the Sputnik V Covid-19 vaccine for emergency use.
July 21, 2021 - Reuters reported Vietnam produced its first batch of the Sputnik V COVID-19 vaccine.
July 19, 2021 - The Ministry of Sports of the Russian Federation, with the support of the Russian Direct Investment Fund, sent the Sputnik V vaccine for athletes from the national teams of the Arab Republic of Egypt and other African teams. As a result, almost 3,000 athletes will be able to take advantage of the vaccine.
July 19, 2021 - ANI reported 'Current vaccines (in India are) effective against SARS-CoV-2 coronavirus Delta variant.
July 15, 2021 - The Russian Direct Investment Fund announced the registration of the Sputnik V vaccine by the National Food and Drug Administration of Nigeria.
July 13, 2021 - A single dose of the Sputnik V vaccine may elicit significant antibody responses against SARS-CoV-2, finds a study published in the journal Cell Reports Medicine.
July 13, 2021 - Ana María Franchi, president of Argentina's CONICET, reaffirmed: "The effectiveness of Sputnik V against the Delta variant exceeds 90%."
July 12, 2021 - The Gamaleya National Research Center of Epidemiology and Microbiology and the RDIF announced strong study results on neutralizing sera activity from individuals vaccinated with the Sputnik V vaccine against new variants of SARS-CoV-2. Vaccination with Sputnik V has produced protective neutralizing titers against new variants, including Alpha B.1.1.7 (first identified in the UK), Beta B.1.351 (first identified in South Africa), Gamma P.1 (first identified in Brazil), Delta B.1.617.2, and B.1.617.3 (first identified in India) and Moscow endemic variants B.1.1.141 and B.1.1.317 with mutations in the receptor-binding domain.
July 12, 2021 – The Russian Direct Investment Fund announced a study in Argentina on the Sputnik V vaccine’s IgG anti-spike titers and neutralizing capacity in non-infected and previously infected persons among healthcare workers published in healthcare workers an international peer-reviewed, open-access Cell Reports Medicine journal. Among key findings in the article, they note that the first dose of Sputnik V induced a strong immune response in 94% of individuals previously not infected with COVID. However, it is also noted that there is no evident benefit of using a second dose in previously infected individuals.
July 11, 2021 - The RDIF announced positive safety data of the Sputnik V vaccine in San-Marino obtained during the vaccination campaign in the country and published in EClinicalMedicine. This preliminary analysis suggests a higher or equal tolerability profile of the Sputnik V vaccine in the 60+ age group, compared with other widely adopted COVID-19 vaccines after both doses. Our results align with the findings of phase 1 and 2 previously conducted studies, then confirmed by phase 3 of the vaccine trial regarding overall safety and tolerability. No hospitalizations or deaths were reported. Nearly all reported AEFIs were mild or moderate and/or lasted less than 2 days.
July 9, 2021 - Peru 21 reported the Minister of Health, Óscar Ugarte, said on TV Peru, “Negotiations with Gamaleya are practically culminating. There will be announcements about it shortly, and that is progress both in terms of the subscription contract and its conditional registration in the country."
July 9, 2021 - TASS reported Chile’s government plans to buy the Sputnik V vaccine to ensure the possibility of immunization of the population with the third dose of the coronavirus vaccine.
July 6, 2021 - The journal Nature published: The evidence is stacking up for the Sputnik V vaccine. Real-world results look good.
July 6, 2021 - The RDIF and Morepen Laboratories announce the production of a test batch of the Sputnik V vaccine at the company's facilities in the state of Himachal- Pradesh.
July 4, 2021 - The Drugs Controller General of India granted a license to Panacea Biotec for manufacturing the Sputnik V vaccine in India, reported local news media.
July 3, 2021 - The Guatemala Ministry of Public Health confirmed on Twitter @MinSaludGuate the 200 thousand doses of Sputnik V vaccines entered the National Biological Center of the Ministry of Health, where they will be kept under the relevant freezing level.
July 1, 2021 - The journal Nature published: Mix-and-match COVID vaccines: the case is growing, but questions remain. A slew of studies suggests that mixing vaccines provokes potent immune responses, but scientists still want answers on real-world efficacy and rare side effects.
June 30, 2021 - CNBC reported Russian President Vladimir Putin confirmed he had received the Sputnik V vaccine.
June 29, 2021 - The RDIF announced data from the UAE Ministry of Health using the Sputnik V vaccine. The vaccine's effectiveness based on data analysis from more than 81 thousand people vaccinated with both components of the Sputnik V preparation was 97.8%. At the same time, the Sputnik V vaccine also demonstrated full (100%) effectiveness against severe coronavirus cases. Data analysis was carried out as of June 8, 2021.
June 24, 2021 - Local media in Oman reported: Dr. Saif Salim Al Abri, Director General of Disease Surveillance and Control at the Ministry of Health, said at a press conference of the Supreme Committee, “Emergency use license has also been granted in the Sultanate for the Sputnik V vaccines."
June 23, 2021 - The WHO published an interim report outlining six production infringements at a Pharmstandard plant located in Ufa, Russia, one of four sites the WHO inspection team visited.
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.
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.'
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.
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 announced the first vaccinations with the Sputnik V vaccine were given today in Hyderabad following the delivery to India on May 1st.
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 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 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 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 localization 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 to produce 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 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 in India announced an agreement to manufacture 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 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 Sputnik V COVID-19 vaccine doses. The estimated delivery is late in 2021.
March 4, 2021 - The European Medicines Agency announced the human medicines committee had started a rolling review of the Sputnik V vaccine. The applicant for this medicine is R-Pharm Germany GmbH.
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 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.
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.
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 the Sputnik V vaccine.
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 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 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 Russian Sputnik V vaccine doses 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.
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.