International evidence shows Sputnik V is safe and ‘on par’ with other vaccines – El Financiero


Sputnik It was the first COVID-19 vaccine registered for use in the world, however, it has been the subject of various controversies because it has not received approval for emergency use from the European Medicines Agency (EMA) or from the World Health Organization (WHO).

Since the Russian Ministry of Health announced its registration, on August 11, 2020, part of the international scientific community has questioned its efficacy, because despite the fact that the Phase III clinical trials have not yet begun, President Vladimir Putin has given your consent.

This concern about the safety of the dose dissipated last February when results of a phase 3 trial were released, which showed that the vaccine had been administered 91.6% effective in preventing symptomatic COVID-19 infection It is 100 percent effective at preventing serious infections.

Despite the good results, “Some scientists have criticized the authors for not providing access to complete preliminary data from early stage trials, and have also expressed concern about changes to the vaccine administration protocol and inconsistencies in the data,” as an article by the journal nature.

Although it did not have the approval of international organizations, Sputnik V was indeed Accredited in 67 countriesIn addition to the fact that some countries such as South Korea, Argentina and India are already manufacturing it.

Are viral vectors better than a single vector?

Unlike other vaccines such as Oxford-AstraZeneca and Johnson & Johnson, Sputnik V usa diferentes adenovirusThey are called rAd26 and rAd5 for the first and second doses, respectively.

According to vaccine experiments, this delivery mechanism for inserting the genetic code of the SARS-CoV-2 protein into human cells was successful.

Dmitriy Kulish, a biotechnology researcher at the Skolkovo Institute of Science and Technology in Moscow, considered that “the two adenoviruses have two slightly different ways of introducing their genetic material into the host cell, which in theory It will improve the success rate To get the viral genetic material where it needs to go.”

A phase III study in Russia found that even In a single dose, Sputnik V was 73.6% effective. For the prevention of moderate to severe disease.

“This prompted Russian health authorities to approve a single dose of Sputnik Lite, which uses the rAd26 vector, in May, based on data from the country’s vaccination program, which indicated it was 79.4 percent effective for preventing disease symptoms,” the article says. .

Similarly, it was announced that in a study conducted by the Ministry of Health in Buenos Aires, Argentina, in which 40,387 and 146,194 unvaccinated people aged between 60 and 79 took part, it was found that A single dose of Sputnik Lite reduced occasional infections by 78.6 percentHospitalization cases are 87.6 percent, and deaths are 84.7 percent.

They accuse WHO and EMA of bias

International organizations argued that they did not authorize its emergency use due to efsecondary effectsHowever, “studies to date indicate that they are similar to those found in other adenovirus vaccines, with the notable exception of rare thromboembolic events.”

“I don’t think we have the exact cause of the ingredients in those vaccines that cause it,” Alison Kelvin, a virologist at Dalhousie University in Halifax, Canada, said of the bleeding disorder.

The report also indicates that Argentina has not reported any cases of thrombosisAlthough it received more than four million doses of the vaccine, so did Serbia, which was also using Sputnik V.

For their part, the vaccine developers accused the European Union of being biased and even noted that there is a “pro-Pfizer” position within the European Medicines Agency.

According to the article’s report, several studies are currently being conducted in countries that have approved Sputnik V, including Argentina, Venezuela, Russia and Turkey, in order to help form a more accurate picture of the vaccine’s safety and efficacy.

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