Katana VentraIP

Sputnik V COVID-19 vaccine

Sputnik V (Russian: Спутник V, the brand name from the Russian Direct Investment Fund or RDIF) or Gam-COVID-Vac (Russian: Гам-КОВИД-Вак, the name under which it is legally registered and produced[3]) is an adenovirus viral vector vaccine for COVID-19 developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Russia. It is the world's first registered combination vector vaccine for the prevention of COVID-19, having been registered on 11 August 2020 by the Russian Ministry of Health.[4][5]

"Sputnik V" redirects here. For the Soviet satellite known as Sputnik 5, see Korabl-Sputnik 2.

Vaccine description

  • Sputnik V[1]
  • Спутник V

  • Gam-COVID-Vac
  • Гам-КОВИД-Вак

  • BR: Exceptional import[2]
  • RU: Registered on 11 August 2020
Full list of Sputnik V vaccine authorizations

Gam-COVID-Vac was initially approved for distribution in Russia and then in 59 other countries (as of April 2021) on the preliminary results of Phase III studies eventually published on 4 September 2020.[6] Approval in early August of Gam-COVID-Vac was met with criticism in mass media and discussions in the scientific community as to whether approval was justified in the absence of robust scientific research confirming safety and efficacy.[4][5][7][8][9] A large-scale Brazilian study from Dec. 2020 to May 2021 confirmed its effectiveness and safety, as of Oxford–AstraZeneca's, i.e. above Sinopharm BIBP's.[10]


Emergency mass-distribution of the vaccine began in December 2020 in countries including Russia, Argentina, Belarus, Hungary, Serbia, Pakistan (in limited quantities), the Philippines (in limited quantities), and the United Arab Emirates. The Sputnik V is currently registered and certified in 71 countries.[11] However, as of April 2022 less than 2.5% of the people vaccinated worldwide have taken a Sputnik V dose.[12] In early 2022, as a result of the 2022 Russian invasion of Ukraine, the United States and other countries placed the Russian Direct Investment Fund (RDIF) on the list of sanctioned Russian entities and people,[13][14] significantly reducing Sputnik V's future commercial prospects.[13][12]


The Gam-COVID-Vac vaccine itself is available in two forms: frozen (vaccine storage: below −18 °C) and liquid (vaccine storage: from +2 to +8 °C, produced a little). In addition to the main vaccine, vaccines and its derivatives were registered: Gam-COVID-Vac-Lyo (Russian: Гам-КОВИД-Вак-Лио, no data on use), Sputnik Light (Russian: Спутник Лайт, used for revaccination, as well as vaccination of foreigners in Russia), Gam-COVID-Vac-M (Russian: Гам-КОВИД-Вак-М, for vaccination of adolescents 12–17 years old[15]).

Adverse effects[edit]

Side effects are mostly mild and similar to other adenovirus vector vaccines such as the Oxford-AstraZeneca and the Janssen vaccines. However, unlike the Oxford-AstraZeneca and Janssen vaccines evidence does not suggest a risk of vaccine-induced immune thrombotic thrombocytopenia.[40] Although a report from Argentina published in the New England Journal of Medicine described fatal vaccine-induced thrombocytopenia and thrombosis in a young woman after receipt of Sputnik-V.[41]

(buffer)

Tris(hydroxymethyl)aminomethane

(salt)

Sodium chloride

(sugar)

Sucrose

hexahydrate

Magnesium chloride

dihydrate (a chelation ligand; sequestrant)

Disodium EDTA

Polysorbate 80

95%

Ethanol

Water

The other ingredients (excipients) are the same, both quantitatively and qualitatively, in the two doses.[52][53]


No adjuvants[54] and no other components or ingredients should be included in the vaccine.[1]

the adenovirus carrier in all samples was actually able to replicate in spite of manufacturer's declaration it was incapacitated

the methodology used by Gamaleya to check immune system response was unreliable and documentation provided made its verification impossible

the procedure of registering adverse effects was insufficient

Anvisa delegation was also not allowed into the Gamaleya laboratory for inspection

all presented studies were performed on vaccine doses produced in laboratory, rather than in the manufacturing facility supplying vaccine for the mass market, which makes the results not representative

Anvisa found issues in one of the factories in Russia that could impact sterility of the doses.

[142]

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