All the Details about Sputnik V, Production, Emergency Use Approval.
Sputnik V is an adenovirus viral vector vaccine for COVID-19 developed by the Gamaleya Research Institute of Epidemiology and Microbiology. It was registered on 11 August 2020 by the Russian Ministry of Health as Gam-COVID-Vac. The 'V' in its name is the letter and not the Roman numeral.
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 I–II studies eventually published on 4 September 2020. Approval in early August of Gam-COVID-Vac was met with media 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. On 2 February 2021, an interim analysis from the trial was published in The Lancet, indicating 91.6% efficacy without unusual side effects.
Emergency mass-distribution of the vaccine began in December 2020 in countries including Russia, Argentina, Belarus, Hungary, Serbia and the United Arab Emirates. By February 2021 over a billion doses of the vaccine had been ordered for immediate distribution worldwide.
The Gam-COVID-Vac is a two-vector vaccine. The active component for both vectors is a modified (recombinant) replication-defective adenovirus of a different serotype (Serotype 26 containing (1.0 ± 0.5) × 1011 particles of gene for the first vaccination and serotype 5 containing (1.0 ± 0.5) × 1011 particles of gene for the second vaccination), which has been modified to include the spike protein-expressing gene of SARS-CoV-2.
The other ingredients (excipients) are the same, both quantitatively and qualitatively, in the two components.
* Sodium chloride (salt)
* Sucrose (sugar)
* Magnesium chloride hexahydrate
* Disodium EDTA dihydrate (buffer)
* Polysorbate 80
* Ethanol 95%
No adjuvants and no other components or ingredients should be included in the vaccine.
Emergency use authorization:
As of December 2020, Belarus and Argentina granted emergency use authorization for the vector-based vaccine. On 21 January 2021, Hungary became the first European Union country to register the shot for emergency use, as well as the United Arab Emirates in the Gulf region.
On 19 January 2021, the Russian authorities applied for the registration of Sputnik V in the European Union, according to the RDIF. On 10 February, the European Medicines Agency (EMA) said that they had "not received an application for a rolling review or a marketing authorization for the vaccine". The developers have only expressed their interest that the vaccine be considered for a rolling review, but EMA's Human Medicines Committee (CHMP) and the COVID-19 EMA pandemic Task Force (COVID-ETF) need to give their agreement first before developers can submit their application for initiation of the rolling review process. On 4 March 2021, the Committee for Medicinal Products for Human Use (CHMP) of the EMA started a rolling review of Sputnik V. The EU applicant is R-Pharm Germany GmbH.
Emergency use has also been authorized in Algeria, Bolivia, Serbia, the Palestinian territories, and Mexico.
On 25 January 2021, Iran approved the vaccine, with Foreign Minister Mohammad Javad Zarif saying the country hopes to begin purchases and start joint production of the shot "in the near future", after Supreme Leader Ayatollah Ali Khamenei banned the government from importing vaccines from the United States and United Kingdom.
The Czech Republic is also considering buying Sputnik V, and Prime Minister Andrej Babis dismissed the minister of health, Jan Blatný, who was a loud opponent to the use of Sputnik V.
On 18 March 2021, German regional leaders including State Premiers and the mayor of Berlin called for the swift approval of the Russian vaccine by the European Medicines Agency to counteract the acute shortages of effective vaccines in Europe. German medical experts have recommended its approval also, and consider the Sputnik Vaccine "clever" and "highly safe".
On 19 March 2021, the Philippine Food and Drug Administration granted emergency use authorization for Sputnik V, the fourth COVID-19 vaccine to be given authorization. The Philippine government planned to buy 20 million doses of the vaccine.
On 12 April 2021, India approved the use of Sputnik V vaccine for emergency use against COVID-19 based on strong immunogenicity data.
As of 12 April 2021, 62 countries had granted Sputnik V emergency use authorization.
On 27 April 2021, Bangladesh approved the use of Sputnik V vaccine for emergency use.
On 30 April 2021, Turkey and Albania approved the use of Sputnik V vaccine for emergency use. - Published by The Beyond News (Breaking News).