The decision by Brazil’s National Health Surveillance Agency (Anvisa) to delay the approval of Sputnik V is, unfortunately, of a political nature and has nothing to do with the regulator’s access to information or science.
The regulator’s decision also contradicts an earlier decision by Brazil’s Ministry of Science, Technology and Innovation (MCTI) which recognized the Sputnik V vaccine coronavirus as safe and permitted its production in Brazil.
The Sputnik V team has addressed the technical issues raised by Anvisa board members during the meeting on April 26 to demonstrate that these allegations have no scientific grounds and cannot be treated seriously in the scientific community and among international regulators.
1. The Gamaleya Center, which carries out strict quality control of all Sputnik V production sites, has confirmed that no replication-competent adenoviruses (RCA) were ever found in any of the Sputnik V vaccine batches that have been produced. Existing quality controls ensure that no RCA can exist in Sputnik V vaccine. Prior to the inspection the Anvisa team received an official letter from the Gamaleya Center dated March 26, 2021 which clearly says: “In addition we would like to inform you that during the release of the vaccine product at the Center site and at the contract site of JBC Generium, not a single batch containing RCA was recorded.”
2. The quality and safety of Sputnik V are, among other things, assured by the fact that, unlike other vaccines, it uses a 4-stage purification technology that includes two stages of chromatography and two stages of tangential flow filtration. This purification technology helps to obtain a highly purified product that goes through mandatory quality control, including control for RCA or any additives presence. Control for RCA is carried out not only for the finished product but also at all stages of production, including the viral seed. Sputnik V team believes that its purification technology is the best among all vaccines and is one of the pillars for vaccine safety.
3. Only E1 and E3 type non-replicating adenoviral vectors, which are harmless for the human body, are used in the Sputnik V vaccine production.
4. Anvisa team in Moscow had full access to all the relevant documents as well as to research and production sites. All the relevant scientific documents and data as well as direct access to the Gamaleya Center scientists in charge of the vaccine development were made available to the Anvisa team.
5. In response to queries about the sterilization processes validation the manufacturing sites that were being inspected provided risk assessment protocols and also the official commitment letter that clearly said that validation of sterilizing filtration will be performed and results will be provided to ANVISA.
6. The inspection scope included only the two production sites from which the deliveries to Brazil are planned.
The safety and efficacy of the Sputnik V has been confirmed by 61 regulators in countries where the vaccine has been authorized with the total population of over 3 billion people. The real-world study in Russia after vaccination of 3.8 million people demonstrated the Sputnik V efficacy at 97.6%.
Unlike with other vaccines there were no cases of cerebral venous sinus thrombosis (CVST) during the use of the Sputnik V.
Several independent real-world studies in countries where the vaccine is being used in mass vaccination programs show strong evidence confirming Sputnik V’s efficacy and safety. These publicly available studies are listed below:
1. Hungary’s government published the official data comparing 5 vaccines used in Hungary. This data shows that Sputnik V is the most efficient and safe vaccine COVID 19 has been tested Gamaleya National Center of epidemiology and microbiology.
2. The Mexican official government vaccination study confirms that Sputnik V is the safest vaccine with 7 times fewer adverse effects per doses administered than mRNA vaccines.
3. The real-world data from Argentina’s Ministry of Health showed that COVID-19 infection rate after the 1st dose vaccination is 2 times lower for Sputnik V compared with other vaccines. No cases of deaths were registered in Argentina after full-doze Sputnik V vaccination.
The Supreme Court of Brazil will review Anvisa’s decision already this week when it hears a motion by 17 Brazilian states whose governments are striving to save people lives and speed up their vaccination programs bringing more safe and efficient vaccines to the country. The Sputnik V team will continue to work with the government of Brazil, the individual states, our Brazilian partner União Química, which is ready to launch large scale production of the vaccine, as well as with all other parties in Brazil in order to save lives. Sputnik V team believes constructive cooperation between countries without politics getting involved will help the world to defeat the pandemic.
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