Not particularly exciting. But, some folks here are under the impression we peons are not allowed to know about this Russian treatment. Not the case. Our own Dr. Hope will be glad to answer any and all questions you might have, such as, — “WTF did I just read??” Here ya go ….
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Sputnik V Vaccine Description
The COVID-19 vaccine Sputnik V (Gam-COVID-Vac) is an adenoviral-based vaccine against the SARS-CoV-2 coronavirus. Sputnik V uses a weakened virus to deliver small parts of a pathogen and stimulate an immune response.
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 the synthesis of the new coronavirus’s envelope proteins, “introducing” the immune system to a potential enemy.
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.
In May 2020, a state institute, the Gamaleya National Research Centre of Epidemiology and Microbiology, announced that it had developed the vaccine, which does not have any side effects. The first vaccination leads to humoral cellular immunity, and once a second vaccination is administered, memory cells are formed.
The Sputnik V vaccine was developed by the same government labs that created what is claimed as “effective against the Ebola virus, as well as a vaccine against the MERS virus.”
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.
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.
The Sputnik V vaccine (Gam-COVID-Vac) (Спутник V) Accession Number: DB15848.
Sputnik V Vaccine History
On August 1, 2020, the Russian Health Minister Mikhail Murashko told reporters the ‘clinical trial had been declared completed’ and was then registered.
The Russian Direct Investment Fund (RDIF) was announced on August 20, 2020. The Sputnik V coronavirus vaccine candidate will be tested on 40,000 volunteers in more than 45 medical centers to confirm clinical efficacy post-approval studies.
On August 20, 2020, the Russian Direct Investment Fund (RDIF) and the Gamaleya National Research Institute of Epidemiology and Microbiology launched an information section about “Sputnik V” www.sputnikvaccine.com.
TASS reported on September 9, 2020, ‘Russian Healthcare Minister Mikhail Murashko announced that Phase 3 of clinical trials of the Sputnik V vaccine against the novel coronavirus started in Russia.’
On October 27, 2020, RDIF announced it had submitted applications to the World Health Organization for an Emergency Use Listing and prequalification of the Sputnik V vaccine candidate. This news indicates the Russian Federation became one of the first countries in the world to apply to WHO for prequalification of its vaccine against the new SARS-CoV-2 coronavirus infection.
On November 24, 2020, positive results of the second interim analysis of Phase III data of the Sputnik V coronavirus vaccine were reported. The evaluation of efficacy was carried out among 18,794 volunteers on the 28th day after receiving the first injection (the 7th day after receiving the second injection) of the vaccine or placebo upon reaching the second checkpoint following the Clinical Study Protocol. Based on the analysis, the efficiency of Sputnik V was 95%.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, commented in a press release issued on December 11, 2020: ‘AstraZeneca’s decision to conduct a study using one of the two vectors of the Sputnik V vaccine is an important step towards joining forces in the fight against the pandemic. We welcome the beginning of a new phase of cooperation between vaccine manufacturers, intend to develop this partnership in the future, and look forward to starting co-production after the new vaccine has been demonstrated to be effective in clinical trials. We hope other vaccine manufacturers will also follow our example.’
On January 18, 2021, 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.
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.
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 Karaganda, 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 March 31, 2021.
Sputnik Light Vaccine
Moscow Mayor Sergei Sobyanin wrote in a blog post on February 18, 2021, ‘a new vaccine candidate developed at the Institute Gamaleya is intended to eliminate the main drawback of the classic “Sputnik V” – the presence of two components administered to the patient with a difference of several weeks. Vaccination with Sputnik Light, only one visit to the polyclinic is required. Immunity will begin to form a week later and peak four weeks after vaccination. The new drug is based on the same special structures (carrier vectors) as in Sputnik V. The vaccine does not contain the coronavirus itself, which means that it will be impossible to get sick with it or infect others.’
Sputnik Light international clinical trials will be attended by 6,000 people: 3,000 each from Russia and the United Arab Emirates. The Russian part of the research will take place in Moscow at 10 city polyclinics.
The Sputnik V vaccine was created at the N.F. Gamaleya Research Center for Epidemiology and Microbiology Ministry of Health of Russia.
Sputnik V Vaccine Indication
Russian COVID-19 Vaccine candidate (Gam-COVID-Vac) is indicated to build immunity to SARS-CoV-2, the virus which causes COVID-19 disease. Pediatric, pregnancy, and oncology vaccine efficacy data pending.
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).
Sputnik V Vaccine Side Effects
Offical side effect information is pending.
According to the local media source TASS, the Head of the Gamaleya Research Center for Epidemiology and Microbiology Alexander Ginzburg stated that ‘15% of those vaccinated report redness in the area of the vaccine shot and a slight headache that goes away within 24 hours.’
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), which has been modified to include the protein S-expressing gene of SARS-CoV-2. 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. Responding to a follow-up question as to whether the vaccine has any components of animal origin, he said, “Absolutely not.”
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.
Sputnik V Vaccine Distribution Agreements
As of April 13, 2021, the following 60 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 ( Entity of 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, the Republic of Iraq, Kenya, the Kingdom of Morocco, Jordan, Namibia, Azerbaijan, Cameroon, the Philippines, Seychelles, Mauritius, Vietnam, Antigua and Barbuda, Mali, the Republic of Panama, and India.
On February 19, 2021, the Africa Vaccine Acquisition TaskTeam, set up by the African Union to acquire additional vaccine doses so that Africa can attain a target immunization of 60%, is pleased to advise that it has received an offer of 300 million Sputnik V vaccines from the Russian Federation. This includes a financing package for any member states wishing to secure this vaccine.
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 CEO of the Russian Direct Investment Fund, 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 Clinical Trials
A list of relevant clinical studies is published by Sputnik V vaccine.
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 Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.
Clinical Trial NCT04436471 – An open two-stage non-randomized Phase 1/2 study with 38 healthy volunteers. This clinical trial is an open study of the safety, tolerability, and immunogenicity of the drug “Gam-COVID-Vac” solution for intramuscular administration, with healthy volunteers’ participation.
Source: Precision Vaccinations
Additional Article: The Lancet Journal
THE END
Not particularly exciting. But, some folks here are under the impression we peons are not allowed to know about this Russian treatment. Not the case. Our own Dr. Hope will be glad to answer any and all questions you might have, such as, — “WTF did I just read??” Here ya go …. ===================================== = … Continue reading “Sputnik Covid Vax: Details”
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