Suara.com – Vaccine Sputnik has become an attraction and caused controversy since the government Russia allowed its use in 2020. In fact, they allowed it before the results of the early-stage trial were published.
But now, Russia and many other countries are starting to show evidence that the Sputnik vaccine is safe and effective. However, there are still questions about the quality of surveillance for possible side effects.
Vaccine Sputnik V also known as Gam-Covid-Vac, i.e. Covid-19 vaccine first registered for emergency use. At that time, the Covid-19 vaccine had received approval from 67 countries, including Brazil, India and the Philippines.
However, the Sputnik V vaccine and the Sputnik Light vaccine have not received approval for emergency use from the European Medicine Agency (EMA) or the World Health Organization (WHO).
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Meanwhile, approval by WHO is essential for widespread distribution through the Global Access to COVID-19 Vaccine (COVAX) initiative, which provides doses for low-income countries.
The Sputnik vaccine was developed by scientists at the Gamaleya National Research Center for Epidemiology and Microbiology in Moscow. This Covid-19 vaccine was authorized for use by the Russian Ministry of Health on August 11, 2020, more than a month before the results of the phase I and II trials were published.
This has also sparked public anger, because the results of the Sputnik Covid-19 vaccine trial have not yet been published but will be distributed.
“If the government approves this vaccine before the public knows the results of the trials, then it will not build trust,” said epidemiologist Michael Toole at the Burnet Institute in Melbourne, Australia. Nature.
However, those concerns disappeared when the results of the phase 3 trial of the Sputnik vaccine were published in February 2021 by the vaccine developer. The results show that the Sputnik vaccine is 91.6 percent effective in preventing infection with symptoms of the Covid-19 corona virus and 100 percent effective in preventing severe infections.
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Even so, the scientists criticized the authors for failing to provide access to the complete raw data from the initial resistance trial. The authors respond that they have provided the authorities with all necessary data for approval.
So, they feel it is enough to just report the level of efficacy of the vaccine to the public. Although this vaccine has not yet received approval from the EMA or WHO, several countries are already producing the Sputnik V vaccine, including South Korea, Argentina and India.
The Sputnik V vaccine is an adenovirus vaccine which means it uses an engineered adenovirus. Adenoviruses are viruses that commonly cause mild disease as a delivery mechanism to insert the genetic code for the SARS-CoV-2 spike protein into human cells.
The Sputnik V vaccine is similar to the AstraZeneca and Johnson & Johnson vaccines. However, the Sputnik vaccine uses different adenoviruses, namely rAd26 and rAd5 for both doses.
According to a press release from the Gamaleya Institute, the results of trials on 3.8 million people in Russia who injected the Sputnik vaccine twice showed an efficacy rate of 97.6 percent.
Figures released by the United Arab Emirates Ministry of Health, on about 81,000 people who have received two doses of the Sputnik vaccine, show an efficacy rate of 97.8 percent in preventing coronavirus symptoms and 100 percent preventing severe illness.
The Russian phase III study also found that a single shot of the Sputnik V vaccine was 73.6 percent effective at preventing moderate to severe disease.
This led Russian health authorities to approve a dose of the Sputnik Light vaccine, which uses the rAd2 vector in May 2021. Data from Russia’s own vaccination program show that the Sputnik Light vaccine is 79.4 percent effective at preventing symptomatic disease.
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