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Sputnik V Vaccine Challenges Brazil's Regulators

April 28, 2021 • 7:25 pm CDT
(Coronavirus Today)

The Sputnik V website published a rebuttal to the decision by Brazil’s National Health Surveillance Agency (Anvisa) to delay the approval of the Sputnik V vaccine on April 28, 2021. This statement is excerpted below:

The Anvisa regulator’s decision contradicts an earlier decision by Brazil’s Ministry of Science, Technology, and Innovation, which recognized the Sputnik V vaccine 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, 2021, to demonstrate that these allegations have no scientific grounds.

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. Before an 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 and research and production sites. All the relevant scientific documents and data and 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 the official commitment letter that clearly said that validation of sterilizing filtration would be performed and results 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 have been confirmed by 61 regulators in countries where the vaccine has been authorized with the total population of over 3 billion people. After vaccination of 3.8 million people, the real-world study in Russia demonstrated the Sputnik V efficacy at 97.6%.

Several independent real-world studies in countries (Hungary, Mexico, Argentina) where the vaccine is being used in mass vaccination programs show strong evidence confirming Sputnik V’s efficacy and safety.

Furthermore, unlike with other vaccines, there were no cases of cerebral venous sinus thrombosis during the use of Sputnik V.

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 to save lives.

Moreover, the Sputnik V team believes in constructive cooperation between countries to help the world to defeat the pandemic,' concluded the statement.