Sputnik V Vaccine 2023
The COVID-19 vaccine Sputnik V (Gam-COVID-Vac) is an adenoviral-based, two-part vaccine against the SARS-CoV-2 betacoronavirus. Initially produced in Russia in 2020, 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 beta coronavirus that caused the COVID-19 pandemic. Sputnik V is a two-component vaccine used by adenovirus serotypes 5 and 26. A fragment of tissue-type plasminogen activator is not used, and the antigen insert is an unmodified full-length S-protein. The Sputnik V vaccine is produced with the HEK293 cell line.
The Sputnik vector vaccine is 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 synthesize the SARS-CoV-2 virus's envelope proteins, "introducing" the immune system to a potential enemy. The cells then use the gene to produce the spike protein. A person's immune system will treat this spike protein as foreign and produce natural defenses, antibodies, and T cells, against this protein.
In May 2020, the Russian state institute Gamaleya National Research Centre of Epidemiology and Microbiology announced that it developed a 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 that 'faith does not forbid Russian Muslims from getting vaccinated with Sputnik V, after considering two components of the Covid-19 vaccine for Sharia compliance (for medicine).'
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 amounts of antibodies. In addition, previously infected people who received only one dose had 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, demonstrating full (100%) effectiveness against severe COVID-19.
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 in infection risk. Sputnik V is also 94.4% effective against hospitalizations, with an 18x reduction in hospitalization risk. The Sputnik V vaccine offered completely vaccinated patients 81% protection against being hospitalized during the SARS-CoV-2 virus Delta variant surge in Argentina from July-August 2021, a non-peer-reviewed study reported on August 25, 2021. The journal Nature published results from a clinical study conducted in Israel on November 4, 2021 - This preliminary finding of vaccine waning as a factor of time from vaccination should prompt further investigations into long-term protection against different SARS-CoV-2 virus strains.
The Gamaleya National Research Center of Epidemiology and Microbiology announced on August 23, 2022, a new version of Sputnik V has been Delta- and Omicron-adapted. This new version is also addressing the L-452-R mutation in the Omicron BA5 variant, which was not present in the BA1 variant.
The U.S. National Institutes of Health (NIH) posted a Public Health in Practice, Volume 4, December 2022, 100313, a study that contributes to the information published on the safety and immunogenicity of Gam-COVID-Vac heterologous vaccination regimens. This study found that in patients aged ≥65 years, the standard two doses of Gam-COVID-Vac (rA26/rdA5) [SPUTNIK-V] and the combination of rAd26/ChAdOx1 (Oxford-Astra Zeneca) significantly increased anti-S titres at 28 days post-second-dose vaccination.
The Sputnik V vaccine was Authorized in August 2020 and Approved in Russia on February 4, 2020. The Sputnik V vaccine (Gam-COVID-Vac) (Спутник V) Accession Number: DB15848. Registered on August 11, 2020: ЛП-006395.
Sputnik V Vaccine Effivesness
A peer-reviewed study published on June 23, 2022, found the Sputnik vaccine demonstrated the highest antibody response against Omicron variants among people previously infected by the SARS-CoV-2 virus. This finding suggests broad population immunity to SARS-CoV-2 will eventually be achieved but by heterogeneous paths. The Gamaleya National Research Center of Epidemiology and Microbiology announced on June 15, 2022, that a joint study found the two-dose Sputnik V vaccine is 97% effective against hospitalization caused by the Omicron variant of coronavirus (B.1.1.529) among those vaccinated with 3 or 4 components (re-vaccination with Sputnik Light or Sputnik V after Sputnik V). Previously, on January 20, 2022, a unique independent comparative, non-peer-reviewed study conducted in Italy showed that two doses of Sputnik V provide more than two times higher geometric mean titers of virus-neutralizing antibodies to the SARS-CoV-2 virus Omicron variant than 2 doses of Pfizer vaccine (2.1 times higher in total and 2.6 times higher 3 months after vaccination).
On May 21, 2022, the peer-review journal Vaccines published a new study: Retention of Neutralizing Response against SARS-CoV-2 Omicron Variant in Sputnik V-Vaccinated Individuals -that concluded 'Vaccination with Sputnik V allows the formation of neutralizing antibodies that can neutralize the Omicron variant. A non-peer-reviewed study, funded by the RDIF, reported on December 21, 2021, study results showed that a decrease in the level of neutralizing antibodies was observed against the SARS-CoV-2 Omicron (B.1.1.529) variant in comparison to B.1.1.1 variant.
Sputnik V 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 Gamaleya Center used the same human adenoviral platform for their earlier research, including but not limited to vaccines against Ebola in 2017 and MERS in 2019.
The Russian Direct Investment Fund announced on August 20, 2020, that the Sputnik V vaccine candidate would 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. 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, the UK, and the US, representing top research and medical centers, have joined the Board.
RDIF was established in 2011 and provided support to facilitate partnerships, including the Gamaleya National Research Institute of Epidemiology and Microbiology and the Central Research Institute of the Radiation, Chemical, and Biological Defense Troops.
Sputnik V Dosage
The Sputnik V vaccine is manufactured as a liquid formulation containing 10¹¹ vp per 0·5 mL/dose. For intramuscular injection composition for one dose (0.5 ml): Active substance: recombinant serotype 26 adenoviral particles containing the SARS-CoV-2 S protein gene, in the amount of (1.0±0.5) x 10*11 particles per dose.
Sputnik Light Vaccine
The Sputnik Light vaccine is the first component (recombinant human adenovirus 26 serotype (rAd26) of the Sputnik V vaccine.
Sputnik M Vaccine
Sputnik M vaccine doses contain 20% of the Sputnik V vaccine dose. Moscow City Deputy Mayor Anastasia Rakova told local media on November 19, 2021, that the first component of the Sputnik M coronavirus vaccine has been administered to about 400 teenagers, and early results show it's safe and efficient. And on January 31, 2021, BNA reported Moscow has started offering the 12-17 age group Sputnik M vaccinations.
Sputnik V Booster
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. A. Gintsburg, Gamaleya Center head: “Sputnik nasal vaccine, world’s 1st registered СOVID vaccine in nasal form, is especially effective vs. highly transmissible #Omicron & other emerging variants not only in terms of protection from infection but also at preventing transmission”t was the first of its kind.
India's central government approved the use of the Sputnik V vaccine as a booster, as reported by the Hindustan Times on May 7, 2022.
Sputnik V Nasal Spray
The Atlantic published an article on December 21, 2022 - Nasal Vaccines Are Here. A Twitter post on October 27, 2022, stated Moscow accelerated mass vaccination with the Sputnik vaccine in nasal form. The nasal vaccine is available in multiple vaccination centers & clinics in Moscow, according to Deputy Mayor Anastasia Rakova.
On August 31, 2022, the Gamaleya National Research Center of Epidemiology and Microbiology announced a publication in Emerging Microbes & Infections, a peer-reviewed medical journal, sharing the results of a study on the intranasally delivered Sputnik V coronavirus vaccine. The study shows this type of vaccine induces a strong and durable immune response in animals.
On June 12, 2021, Alexander Gintsburg, with Gamaleya Institute, stated the nasal spray for children uses the same vaccine technology "only instead of a needle, a nozzle is put on," the TASS reported. A review published in May 2016 presented an understanding of mucosal immunity to illustrate the distinct challenges of developing successful vaccines and to outline potential solutions.
Sputnik V 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.
A non-peer-reviewed, multicenter, observational, and analytical non-peer-reviewed study of a prospective cohort of hemodialysis patients in the Autonomous City of Buenos Aires, Brazil, published on October 25, 2021, found 'that dialysis patients constitute a vulnerable population for SARS-Cov-2 infection, beyond the recommendations that were implemented by dialysis units, full vaccination is a priority and necessary. The Sputnik V vaccine has been shown to be safe and effective in this patient population.'
Sputnik V and HIV
Data presented in The Lancet eClinicalMedicine on March 23, 2022, are scientific results on the preventive efficacy of a COVID vaccine to protect against infection in people living with HIV (PLWH). Based on data from more than 24,000 HIV+ patients in Moscow on antiretroviral therapy (ART), Sputnik V’s efficacy was 79%. The vaccine’s efficacy against hospitalization was more than 90%. Sputnik V is also more than 97% effective against moderate or severe disease development among PLWH. The analysis was conducted by the Gamaleya Center and Moscow City Center for AIDS Prevention and Control.
The Lancet published a non-peer-reviewed HIV study on October 25, 2021 - Sputnik V Protection from COVID-19 of HIV-Infected Individuals Under Art. Conclusion: The study demonstrated the high epidemiological effectiveness of full immunization with Sputnik V in HIV-infected ART-treated patients with CD4 + T-cell counts ≥ 350 cells/μl. Moreover, the epidemiological effectiveness of vaccination was documented for both – the original and the delta SARS-CoV-2 variants, with the latter predominating in the Moscow region since June 2021. Although the efficiency of the vaccine declined in immunocompromised individuals (T-cell count < 350 cells/μl), it is still sufficient to recommend vaccination with Sputnik V for this cohort.
Sputnik V 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. 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, that India-based Panacea Biotec started Sputnik V vaccine production at facilities in Buddy. Full-scale production of Sputnik V is expected to begin during the summer of 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, that they had 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 the 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 that used to belong to The National Institute of Hygiene and Epidemiology.
South Korea-based GL Rapha was certified to produce Sputnik vaccines on October 26, 2021. GL Rapha has agreed to produce more than 150 million Sputnik V and Sputnik Light vaccine doses per year. On December 1, 2021, the RDIF, Binnopharm Group, and Vietnam's T&T GROUP signed an agreement to create a full-cycle production of Sputnik V in Vietnam.
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 Side Effects
The peer-review journal NEJM published a Correspondence on October 13, 2022: Vaccine-Induced Immune Thrombocytopenia and Thrombosis after the Sputnik V Vaccine. The results of repeated searches of the literature indicated that no cases were reported after the administration of the Sputnik V vaccine as of August 12, 2022.
The peer-review journal The Lancet published: ROCCA cohort study: Nationwide results on safety of Gam-COVID-Vac vaccine (Sputnik V) in the Republic of San Marino using active surveillance on May 20, 2022. After the first dose, systemic reactions were reported by 57·5% of the participants, while injection site reactions were reported by 46·7%. The most common AEFIs were pain at the injection site, fatigue, and headache. Grade 3 or 4 AEFIs were reported by 0·8% and 0·3% of the participants, respectively. After the second dose, systemic reactions were reported by 63·1% of the participants, while injection site reactions by 54·7%. The most common AEFIs were malaise, pain at the injection site, and myalgia. Grade 3 or 4 AEFIs were reported by 2.7% and 1.1% of the participants, respectively. Interpretation: Our results confirm a good tolerability profile for the adult population.
The Lancet published a study on November 2, 2021, that found 'most of the solicited adverse reactions were mild (66.4% from all vaccinees), few were moderate (5·5%). No serious adverse events were detected.' TASS reported on November 19, 2021, that the deputy CEO of the Gamaleya Center, Denis Logunov, stated, 'There have been no confirmed cases of deaths triggered by Sputnik V.'
Sputnik V 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, that 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 Cost
The cost of one dose of the Sputnik V vaccine for international markets will be less than $10. Sputnik V is a 2-dose vaccine. Thus, it may cost less than $20 per person.
Sputnik V Vaccine Distribution Agreements
As of 2023, about 71 countries had authorized the Sputnik V Vaccine: Algeria, Australia, Argentina, Belarus, Bolivia, Serbia, Palestine, Venezuela, Peru, Paraguay, Turkmenistan, Hungary, UAE, Iran, Republic of Guinea, Tunisia, Armenia, Mexico, Nicaragua, Srpska, 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, 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, Indonesia, Cambodia, and Gaza.
Sputnik V Vaccine Legal Matters
The Russian news agency TASS reported on March 22, 2021, RDIF 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.'
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). 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. Last Update Posted: January 22, 2021.
Clinical Trial NCT04436471 - An open two-stage non-randomized Phase 1/2 study with 38 healthy volunteers.