Vaccine Info

Sputnik V Vaccine

Sputnik V Vaccine Description

The Russian COVID-19 vaccine candidate Sputnik V 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.

And, 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, start the synthesis of the envelope proteins of the new coronavirus “introducing” the immune system to a potential enemy.

The Russian vaccine Sputnik V (Gam-COVID-Vac) intends to reduce 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 vaccine is administered, a key feature of this vaccine kicks in—memory cells are formed.

On August 1, 2020, the Russian Health Minister Mikhail Murashko told reporters the 'clinical trial had been declared completed.'

The Russian Direct Investment Fund 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, during post-approval studies.

The Russian COVID-19 vaccine candidate was developed by the same government labs that developed what is claimed “an effective against the Ebola virus, as well as a vaccine against the MERS virus.”

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” at www.sputnikvaccine.com.

TASS reported on September 9, 2020, 'Russian Healthcare Minister Mikhail Murashko announced that Phase Three of clinical trials of the Sputnik V vaccine against the novel coronavirus started in Russia.'

RDIF was established in 2011 and provides 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.

Sputnik V Vaccine Indication

Russian COVID-19 Vaccine candidate is indicated to build immunity to SARS-CoV-2 the virus which causes COVID-19 disease.

Sputnik V Vaccine News

September 16, 2020 - The Russian Direct Investment Fund (RDIF) and Dr. Reddy’s Laboratories Ltd. have agreed to cooperate on clinical trials and distribution of the Sputnik V vaccine in India. Upon regulatory approval in India, RDIF shall supply to Dr. Reddy’s 100 million doses of the vaccine. Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India.

September 15, 2020 - Researchers highlight ‘questionable’ data in Russian coronavirus vaccine trial results.

September 11, 2020 - The Russian Direct Investment Fund and the Health Secretariat of the Brazilian state of Bahia signed a cooperation agreement to supply Brazil with up to 50 million doses of the Russian Sputnik V vaccine, beginning in November 2020, subject to Brazilian government regulatory approval. The agreement will also allow the vaccine to be shipped throughout Brazil in the future.

September 9, 2020 - The Russian Direct Investment Fund and the Landsteiner Scientific pharmaceutical company announced an agreement for the supply of 32 million doses of the Russian Sputnik V vaccine to the country of Mexico.

September 7, 2020 - Russia's Health Ministry Mikhail Murashko stated, 'that the first batch of Sputnik V vaccine has been produced for civilian circulation,' reported the Tass news agency. Previously, Minister Murashko explained that civilian production at this stage, 'meant vaccination of citizens from the risk groups, namely teachers and doctors, would be carried out simultaneously with post-registration clinical trials.'

September 4, 2020 - The Lancet study: Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomized phase 1/2 studies from Russia.

September 4, 2020 - The technology institute for the Brazilian state of Paraná has agreed to produce Russia’s “Sputnik-V” COVID-19 vaccine, said on Friday it plans to conduct phase III trials on 10,000 volunteers in Brazil at the start of 2021.

September 2, 2020 - Employees of the National Research Center for Epidemiology and Microbiology were vaccinated against COVID-19, the director of the institution, Alexander Ginsburg told RIA Novosti. According to Gunzburg, the participants in this stage will be closely monitored by doctors and they will not be hospitalized, but they will take all the necessary tests before, after, and during the research.

August 26, 2020 - The Russian Direct Investment Fund, the Government of Moscow, and the Gamaleya National Research Center of Epidemiology and Microbiology announce the start of a post-registration clinical trial of a coronavirus vaccine in Moscow. Forty thousand people will take part in the program.

August 16, 2020 - The developer of Sputnik V said the 3rd stage of trials can be called mass vaccination. The trials will be carried out in the Moscow Region and some 20,000 - 30,000 people will get the vaccine.

August 15, 2020 - Russia announced that it has produced the first batch of its coronavirus vaccine.

August 11, 2020 - The Russian Federation's President Putin said his daughter was inoculated with a new Russian coronavirus vaccine.

August 11, 2020 - OP-ED: THE SPUTNIK VACCINE AS A LIFESAVING GLOBAL PARTNERSHIP.

August 8, 2020 - Special video report on the Russian vaccine against COVID-19 07.08.2020, Russia-24.

August 6, 2020 - Russia is planning a mass vaccination campaign in October and the vaccine will be first given to doctors and teachers.

August 4, 2020 - Video interview of RDIF CEO Kirill Dmitriev with the BBC.

August 1, 2020 - Clinical trials of a coronavirus vaccine developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology are over, Russian Health Minister Mikhail Murashko told reporters.

July 19, 2020 - "Russia may be one of the first to produce a vaccine against the backdrop of the billions that are being invested by all the pharma companies working on it,” said Kirill Dmitriev, the chief executive of the Russian Direct Investment Fund, which previously signed a deal with AstraZeneca to manufacture the University of Oxford’s Covid-19 vaccine at R-Pharm, one of the largest pharmaceutical companies in Russia. 

July 16, 2020 - Russia plans to produce 30 million doses of an experimental COVID-19 vaccine domestically this year, with the potential to manufacture a further 170 million abroad, the head of the country’s sovereign wealth fund told Reuters.

July 13, 2020 - The Gamalei center's head Alexander Gintsburg told the TASS news agency that he hopes the vaccine will “enter civil circulation” on Aug. 12-14. He added that he hopes private companies would begin mass production by September. “The research has been completed and it proved that the vaccine is safe,” Yelena Smolyarchuk, the head of Sechenov University’s clinical research center, told TASS of its trial.

July 12, 2020 - Russia's Sechenov University Announced Successfully Completing Clinical Trials of World's 1st COVID-19 Vaccine. Alexander Lukashev, the director of the Institute of Medical Parasitology, Tropical, and Vector-Borne Diseases at Sechenov University, said that the objective of this stage of the clinical study was to show the vaccine’s safety for human health, which was successfully done.

July 10, 2020 - The Russian Ministry of Defense announced that it started the final stage of the Coronavirus vaccine clinical trials, which is run by the Gamalei National Research Center for Epidemiology and Microbiology. These trials began on June 18th when nine volunteers received 1 component of the vaccine. On June 23th, the vaccine was given to 20 other volunteers who will receive the booster vaccination.

July 7, 2020 - Volunteers, who tested a vaccine against the coronavirus  2-weeks ago at Burdenko military hospital, are feeling well and have not experienced any side effects, the Russian Defense Ministry told reporters.

June 11, 2020 - Hit Hard by Coronavirus, Russia Joins Global Race for a Vaccine.

June 10, 2020 - RDIF has supported the development of a Russian COVID-19 vaccine that is scheduled to commence clinical trials by mid-June 2020 and enter production by the fall.

June 4, 2020 - Russia plans to start clinical testing of a coronavirus vaccine on paid volunteers from the general public.

May 29, 2020 - Alexander Gintsburg of Moscow's Gamaleya research institute said last week he had taken a dose of a so-called viral vector vaccine that he hopes will complete clinical trials by the end of the summer.

May 22, 2020 - Russian developers of a coronavirus vaccine have developed immunity to the infection after self-administering it.

Sputnik V Vaccine Clinical Trials

Clinical Trial NCT04530396: Phase 3 Clinical Trial of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Vaccine Against COVID-19 (RESIST)

Clinical Trial NCT04436471 - last updated on July 7, 2020.

An open two-stage non-randomized Phase 1/2 study with the participation of (38) healthy volunteers. This clinical trial is an open study of safety, tolerability, and immunogenicity of the drug "Gam-COVID-Vac ", solution for intramuscular administration, with the participation of healthy volunteers.

  • Two groups of volunteers were selected out of a pool of military personnel and civilians.
  • Determination of antigen-specific antibody titer in blood serum by ELISA by comparison with baseline values before the vaccine administration and at days 14, 21, 28, and 42 after vaccination (hereinafter, the countdown comes from the first time of the vaccine administration);

  • Determination of virus-neutralizing antibody titer before and at days 14, 28, and 42 after vaccination;

  • Determination of antigen-specific cellular immunity (specific T-cell immunity) before the vaccine administration and at days 14 and 28 after vaccination.

Updated
09/16/2020 - 15:13