Sputnik Light Vaccine Description
Russia's Sputnik Light is the first component (recombinant human adenovirus 26 serotype (rAd26). The Sputnik Light vaccine is based on a proven and well-studied platform of human adenoviral vectors, which cause the common cold and have been around for thousands of years, as demonstrated by the Russian Gamaleya Center during laboratory tests.
Adenoviruses, which are found in the respiratory tract and regularly cause acute respiratory infections, have become the most commonly used viruses to engineer vectors. Scientists from the Gamaleya Center have been working on adenoviral vector-based vaccines since the 1980s and now lead the world to develop these vaccines.
The effectiveness of Sputnik Light was found 79.4% based on the analysis of data from the 28th day after receiving immunization by citizens of the Russian Federation as part of the mass vaccination program in the period December 5, 2020 - April 15, 2021. The Sputnik Light vaccine elicits the development of virus-neutralizing antibodies in 91.67% of individuals on the 28th-day post-immunization. And the cellular immune response against the S Protein of SARS-CoV-2 develops in 100% of volunteers on the 10th day.
On May 6, 2021, the Ministry of Health of the Russian Federation, the National Research Center for Epidemiology and Microbiology, and the Russian Direct Investment Fund (RDIF) announced the single-component Sputnik Light vaccine registration.
The immunization of individuals with pre-existing immunity against the SARS-CoV-2 virus with Sputnik Light can elicit the increase of antigen-specific IgG antibodies by more than 40x in 100% of subjects ten days after immunization. Sputnik Light international clinical trials included about 7,000 people from Moscow, Russia, Ghana, the United Arab Emirates, and other countries.
On May 24, 2021, the RDIF announced data from a study conducted by the Institute of Virology of the National University of Cordoba (Argentina) and the authorities of Cordoba, which confirmed 85.5% of individuals developed IgG antibodies to the SARS-CoV-2 coronavirus on the 14th day after receiving the first injection of Sputnik V.
The RDIF is Russia's sovereign wealth fund established in 2011. The Federal Government Budgetary Institution, "National Research Center for Epidemiology and Microbiology," is one of Russia’s oldest scientific research centers and celebrated its 100th anniversary in 1991.
Sputnik Light Vaccine Indication
Sputnik Light is indicated to build immunity to SARS-CoV-2, which causes COVID-19 disease. CNBC reported on May 6, 2021, the Sputnik Light vaccine developed by the Gamaleya Research Institute has an efficacy rate of 79.4%.
The RDIF announced on June 2, 2021, the Sputnik Light vaccine demonstrated 78.6-83.7% efficacy among the elderly, according to real-world data collected by the Ministry of Health of the Buenos Aires province. According to the data from Argentina, over 186,000 people aged 60-79, more than 40,000 of whom received a shot of Sputnik Light, the infection rate between the 21st and 40th day from the date of receiving the first dose was only 0.446%.
On June 6, 2021, the journal Nature published an article: Mounting evidence suggests Sputnik COVID vaccine is safe and effective. In conclusion, 'Several other studies are currently underway in countries that have approved Sputnik, including Argentina, Venezuela, Russia, and Turkey, which should help build a more accurate picture of the vaccine’s safety and efficacy.'
In particular, the data from the Ministry of Health of the Buenos Aires province (Argentina) shows 78.6-83.7% efficacy among the elderly. And in Paraguay, Sputnik Light is 93.5% effective during the ongoing vaccination campaign, according to the country’s Ministry of Health.
Sputnik Light Vaccine Dosage
Sputnik Light is the first component (recombinant human adenovirus 26 serotype (rAd26) of the Sputnik V vaccine, which was Approved in Russia during August 2020.
Sputnik Light Adverse Events
As of July 18, 2021, no serious adverse events were registered after vaccination with Sputnik Light. In addition, real-world vaccination data in Serbia on May 28, 2021, confirmed no serious vaccine-related adverse events.
The Ministry of Health of the Province of Buenos Aires, Brazil, reported on July 30, 2021, according to the preliminary results of the ongoing investigation, the safety study on the combinations of the Sputnik V vaccines with Sinopharm and with AstraZeneca vaccines did not report any serious adverse events.
On August 18, 2021, the Sputnik Light vaccine was found highly effective against COVID-19 among more than 320,000 subjects who had received the vaccine based on the data collected by Paraguay's Ministry of Health, July 30, 2021.
Sputnik Light Vaccine Cost
The cost of the Sputnik Light vaccine globally could be less than $10, while it has simple storage requirements, at +2 +8, which provide for easy logistics.
Sputnik Light and AZD2816 Co-development
The Russian health ministry granted the authorization on July 26, 2021, for a phase I/II study of AZD2816 to proceed in five locations with about 150 people. The Sputnik V and Vaxzevria COVID-19 Vaccine (AstraZeneca) are both two-component adenovirus vector vaccines. However, Sputnik V's two doses use two different viral vectors.
On July 30, 2021, Irina Panarina, CEO of AstraZeneca, Russia, and Eurasia, said in a press release, “Heterologous prime-boosting, in which components of different vaccines are administered to a patient, is one of the most promising vaccination regimens for studying. It is becoming especially relevant now when preventing the spread of new strains of coronavirus infection is acute, and the need for revaccination of the population is also maturing. That is why the study results can be of great importance for those countries where both the vaccine developed by AstraZeneca and the University of Oxford and the Sputnik V vaccine are registered.
Sputnik Light Vaccine Availability
As of September 19, 2021, the Sputnik Light vaccine was available in over (19) countries: Russia, Venezuela, Angola, Bahrain, Nicaragua, Palestine, Mauritius, Argentina, Belarus, Republic of Congo, Mongolia, Kyrgyz Republic, South Korea, Kazakhstan, Syrian Arab Republic, India, Philippines, Armenia, and the Republic of Iran.
Sputnik Light Vaccine News
September 17, 2021 - According to local media, vaccine czar Carlito Galvez, Jr. confirmed The Philippines will receive the first batch of Sputnik Light vaccines in September 2021.
September 15, 2021 - Local media reported the Drugs Controller General of India has approved Sputnik Light to conduct the bridging phase 3 clinical trials in India.
September 14, 2021 - Reuters reported GL Rapha, based in South Korea, expects regulatory approval to export about 10 million Sputnik Light vaccines during September 2021. GL is awaiting a Good Manufacturing Practice review for its production facility. In November 2020, the Russian Direct Investment Fund and GL Rapha announced a vaccine production agreement.
September 12, 2021 - EClinincalMedicine / The Lancet published a news study: Effectiveness of the first component of Gam-COVID-Vac (Sputnik V) on reducing SARS-CoV-2 confirmed infections, hospitalizations, and mortality in patients aged 60-79: a retrospective cohort study in Argentina. During the study period, 415,995 registered subjects received the first component of Gam-COVID-Vac; 40387 belonged to the 60-79 age group and were compared to 38,978 unvaccinated. Vaccine effectiveness for preventing laboratory-confirmed infections was 78•6% [CI95% 74·8 - 81·7]; and for reducing hospitalizations and deaths was, respectively, 87·6% [CI95% 80·3 - 92·2] and 84·8% [CI95% 75·0 - 90·7]. Effectiveness was high across all subgroups.
September 6, 2021 - The Russian Direct Investment Fund announced the Approval of using the single-component vaccine against coronavirus Sputnik Light by the Ministry of Health of the Republic of Armenia.
September 3, 2021 - A non-peer-reviewed study concluded Sputnik V vaccination was effective against referral to hospital in patients with symptomatic SARS-CoV-2 infection in St. Petersburg, Russia. This protection is probably mediated through VE against lung injury associated with COVID-19.
August 23, 2021 - A non-peer-review study found the Sputnik V vaccine offers strong protection against hospitalization. This protection was probably mediated through vaccine effectiveness against lung injury associated with COVID-19.
August 23, 2021 - The Philippines FDA granted an emergency use authorization for the single-dose COVID-19 Sputnik Light vaccine. PFDA Director-General Eric Domingo confirmed this news.
August 20, 2021 - The Russian Direct Investment Fund, AstraZeneca, and R-Pharm announced preliminary results on the immunogenicity of combined use of the AstraZeneca vaccine known as Vaxzevria and the Sputnik Light vaccine based on human adenovirus serotype 26 from the clinical trial of vaccines combination in the Republic of Azerbaijan. 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.
August 18, 2021 - The RDIF announced the data from Paraguay’s Ministry of Health on the one-shot Sputnik Light vaccine demonstrated a high safety profile and a 93.5% efficacy against COVID-19 among more than 320,000 subjects who had received the vaccine, based on the data collected by July 30, 2021.
August 13, 2021 - Wockhardt Group confirmed it would produce Sputnik V and Sputnik Light vaccines. Wockhardt Limited is a global pharmaceutical and biotechnology company headquartered in India.
August 10, 2021 - Local media in the Philippines reported the country’s Food and Drug Administration Director-General Eric Domingo said on TV, “Sputnik Light, the single-dose Sputnik vaccine, already applied for EUA here in the country, and our vaccine experts are studying it."
August 4, 2021 - The Russian Direct Investment Fund announced the initial safety results of the randomized, single-blind study for the evaluation of the immune response and safety of heterogeneous regimens combining the Sputnik Light vaccine and vaccines produced by AstraZeneca, Sinopharm, and Moderna in the Buenos Aires province of Argentina. The data of 121 volunteers corresponding to the Sputnik V combination groups were analyzed in the following regimens: Sputnik Light/AstraZeneca, Sputnik Light/Moderna, Sputnik Light/Sinopharm, Sputnik Light/Sputnik Light compared to control group Sputnik V 1 Comp./Sputnik V 2 Comp. The data collected by the Ministry of Health of Buenos Aires demonstrates that both the combination of Sputnik Light with other vaccines and vaccination with two injections of only Sputnik Light shows a high safety profile with no serious adverse events following the vaccination. Furthermore, all of the combinations studied are safe, stated the press release.
July 30, 2021 - The RDIF and partners announced they would publish initial data in August 2021 on the immunogenicity of the combined use of the AstraZeneca vaccine and the first component of the Sputnik V vaccine Azerbaijan. Clinical trials of vaccines are being carried out in several countries as part of a global program. Volunteers are being vaccinated in UAE, and regulatory approval to conduct trials has been granted in Russia and Belarus.
July 24, 2021 - TASS reported Russia delivered a batch of Sputnik Light vaccines to Syria, an official with the Russian Defense Ministry told reporters.
July 15, 2021 - The RDIF announced the approval of the single-dose Sputnik Light vaccine by the Ministry of Health of Kazakhstan.
July 9, 2021 - A new study based on Argentina's data found that 21 days after receiving the first dose of vaccine, 94% of naïve participants developed spike-specific IgG antibodies. A single Sputnik V dose elicits higher antibody levels and virus-neutralizing capacity in previously infected individuals than in naïve ones receiving the full two-dose schedule. After a single dose in naïve participants, the high seroconversion rate suggests a benefit of delaying second dose administration to increase the number of people vaccinated.
July 7, 2021 - Korea Biomedical Review announced Huons Global said that it had secured an exclusive right for the domestic licensing and sales of the Sputnik Light vaccine from the Russian Direct Investment Fund.
June 30, 2021 - India's Subject Expert Committee (SEC) deliberated on the submission for Marketing Authorisation of the Sputnik Light vaccine from Dr. Reddy's. 'The SEC also observed that because of the safety and immunogenicity data already generated by Dr. Reddy's in India on the first dose component of Sputnik V vaccine, there was no need for a separate Phase III trial of Sputnik Light in India," Dr. Reddy's said in a statement.
June 28, 2021 - Local media in South Korea reported the Huons Global Consortium announced in a news release, “At the request of the RDIF, the consortium has decided to produce the Sputnik Light in parallel with the Sputnik V vaccine."
June 25, 2021 - Kommersant reported the Sputnik Light vaccine would be used as a booster for Russians vaccinated with the Sputnik V vaccine six months ago or more. Since the coronavirus pandemic’s total excess fatality count is around 475,000, Russia reported The Moscow Times.
June 25, 2021 - The Russian Direct Investment Fund announced the approval of the Sputnik Light vaccine against coronavirus by the Ministry of Health of the Kyrgyz Republic.
June 21, 2021 - TASS reported the first batches of the Sputnik Light vaccine would enter Russia's civilian circulation after June 25, 2021.
June 11, 2021 - The RDIF announced the approval of the single-dose Sputnik Light vaccine by the Ministry of Health of Mongolia.
June 7, 2021 - The Republic of Congo's Ministry of Health Approved the single-dose Sputnik Light vaccine.
June 4, 2021 - TASS reported foreign nationals employed in Russia would be offered the Sputnik Light vaccine, according to Russian Health Minister Mikhail Murashko.
June 3, 2021 - Reuters reported Belarus had registered the Sputnik Light vaccine against COVID-19 for use.
June 2, 2021 - The RDIF announced data from the Ministry of Health of the province of Buenos Aires, Argentina, which demonstrated the high efficiency of the Sputnik Light vaccine at the level of 78.6-83.7% when vaccinating the elderly. According to the analysis of data, more than 186 thousand people aged 60 to 79 years, more than 40 thousand of whom received an injection of the "Sputnik Light" vaccine during the mass vaccination of the population, the SARS-CoV-2 virus incidence in the period from 21 to 40 days after receiving one injection was only 0.446%. The incidence among the adult unvaccinated population for the same period was 2.74%.
June 2, 2021 – The Russian Direct Investment Fund announced the approval of the single-dose Sputnik Light vaccine by the Ministry of Health and Wellness of the Republic of Mauritius.
May 31, 2021 – The RDIF announced the approval of the Sputnik Light vaccine by the Ministry of Health of the State of Palestine.
May 24, 2021 - A study conducted by the Institute of Virology of the National University of Cordoba located in Argentina and the authorities of Cordoba confirmed 14 days after receiving the first injection of Sputnik V, 85.5% of individuals developed SARS-CoV-2 coronavirus IgG antibodies.
May 20, 2021 - The Russian Direct Investment Fund announced the approval of the single-dose Sputnik Light vaccine by the Ministry of Health of the Republic of Nicaragua.
May 15, 2021 - The Bolivarian Republic of Venezuela authorized the Sputnik Light vaccine.
May 12, 2021 - The Republic of Angola registered the Sputnik Light vaccine.
May 12, 2021 - Reuters reported the South American country of Venezuela would soon receive the Sputnik Light vaccine.
May 6, 2021 - The effectiveness of the single-component vaccine "Sputnik Light" was 79.4% based on the analysis of data from the 28th day after receiving immunization by citizens of the Russian Federation as part of the mass vaccination program in the period December 5, 2020 - April 15, 2021. An efficacy rate of about 80% exceeds that of many vaccines requiring two shots.
Sputnik Light Vaccine Clinical Trials
Sputnik Light is undergoing several clinical trials.