Russia defended its Sputnik V vaccine amid controversy with Brazil

“We are going to tell you the truth about the truth about the Sputnik V vaccine. We issued a special statement in which we made it clear that the Brazilian drug regulatory office did not want to use the Russian vaccine because it believes that it is possible to have replications of the adenovirus in the human body. It’s not like that. It is not scientifically possible due to the high quality, purity and development», He explained during a world press conference in which he participated. Infobae, the doctor Kirill Dmitriev, director of the Russian Direct Investment Fund (RDIF).

The declarations take place after yesterday on National Health Surveillance Agency (Anvisa, regulator) from Brazil Ban emergency importation of Russian vaccine, given that the request for use lacks documentation this was required of other manufacturers.

“Brazil’s National Health Surveillance Agency (Anvisa) decision to delay approval of Sputnik V is unfortunately political in nature and it has nothing to do with the regulator’s access to information or science. In our view, this decision is a direct result of pressure from the United States Department of Health, which in its 2020 Annual Report several months ago publicly stated that US health attaché “persuaded Brazil to reject Russian COVID-19 vaccineAdded Dmitriev, who pointed out that the regulator’s decision also contradicts a previous decision by the Brazilian Ministry of Science, Technology and Innovation (MCTI) which recognized the Sputnik V vaccine as safe and allowed its production. in Brazil last January.

For scientists at the Gamaleya Institute, where the vaccine is produced, the Sputnik V team addressed the technical issues raised by the members of the Anvisa board of directors during the April 26 meeting to demonstrate that these claims have no scientific basis and cannot be seriously addressed in the scientific community and among international regulators.

And for this reason, they clarified some points questioned by Brazil:

1- The Gamaleya Center, which carries out strict quality control of all Sputnik V production sites, confirmed that replicable adenovirus (RCA) was never found in any of the Sputnik V vaccine lots that were produced. Existing quality controls ensure that RCA cannot exist in the Sputnik V vaccine. Prior to the inspection, the Anvisa team received an official letter from the Gamaleya Center dated March 26, 2021 which clearly states: “In addition, we are inform you that during the launch of the vaccine on the Centre’s site and on the JBC Generium contract site, not a single batch containing RCA was recorded. “

2- The quality and safety of Sputnik V are, among other things, ensured by the fact that, unlike other vaccines, it uses a 4-step purification technology which includes two chromatography steps and two tangential flow filtration steps. This purification. The technology results in a highly purified product that goes through mandatory quality control, including checking for the presence of RCA or any additives. RCA control is carried out not only for the finished product but also at all stages of production, including viral seed. The Sputnik V team believes that its purification technology is the best among all vaccines and is one of the pillars of vaccine safety.

3. In the production of Sputnik V vaccine, only non-replicating adenoviral vectors of type E1 and E3 are used, which are harmless to the human body.

4. The Anvisa team in Moscow had full access to all relevant documents, as well as to research and production sites. All relevant scientific documents and data, as well as direct access to scientists at the Gamaleya Center in charge of vaccine development, have been made available to the Anvisa team.

5. In response to inquiries about the validation of sterilization processes, the inspected manufacturing sites provided risk assessment protocols as well as the official letter of commitment clearly stating that the validation of sterilization filtration will be performed and that the results will be delivered to Anvisa.

6. The scope of the inspection included only the two production sites from which deliveries to Brazil are expected.

“The safety and efficacy of Sputnik V have been confirmed by 61 regulatory agencies in countries where the vaccine was licensed with a total population of over 3 billion people. The real-world study in Russia after the vaccination of 3.8 million people showed the effectiveness of Sputnik V of 97.6%. Unlike other vaccines, there have been no cases of cerebral venous sinus thrombosis (CVST) while using Sputnik V. Several independent real-world studies in countries where the vaccine is used in Mass vaccination programs show strong evidence confirming efficacy and safety. of Sputnik V, ”said Russian doctor Denis Logunov, head of the team that developed the antigen at the Gamaleya Institute.

These publicly available studies are listed below:

1. Hungarian government published official data comparing 5 vaccines used in Hungary. These data show that Sputnik V is the most effective and the safest vaccine.

2. The official Mexican government vaccination study confirms that Sputnik V is the safest vaccine with 7 times fewer side effects per dose administered than mRNA vaccines.

3. Real-world data from the Argentinian Ministry of Health showed that the rate of COVID-19 infection after the first dose of vaccination is 2 times lower for Sputnik V than for other vaccines. There have been no cases of death in Argentina following total vaccination with Sputnik V.

Brazil’s Supreme Court will reconsider Anvisa’s ruling this week when it hears a motion from 7 Brazilian states whose governments are working to save lives and speed up their immunization programs by providing safer and more effective vaccines in the country.

“The Sputnik V team will continue to work with the Brazilian government, individual states, our Brazilian partner União Química, which is ready to start large-scale production of the vaccine, along with all other parties in Brazil to save lives. The Sputnik V team believes that constructive cooperation between countries without involving politics will help the world to overcome the pandemic, ”Dmitriev concluded.

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