The decision by Brazil's health agency to delay the approval of Russia's Sputnik V Covid-19 vaccine is entirely political and has nothing to do with science or the body's access to information, according to the jab's developer.
A statement released on Wednesday on the vaccine's official website accused Anvisa of making a political decision instead of fairly evaluating the jab on its scientific merit.
On Monday, Brazil's regulator claimed that it believes there is a lack of documentation to guarantee the vaccine's safety, and data about its efficacy is “uncertain.” This is despite a decision from the country'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 to demonstrate that these allegations have no scientific grounds and cannot be treated seriously in the scientific community and among international regulators,” it said, accusing Brazil's regulator of making a political decision.
Also on rt.com Brazil rejects Russia’s Sputnik V Covid-19 vaccine, citing ‘uncertain’ data – creator says decision is political & driven by USAccording to Anvisa's medicines and biological products manager Gustavo Mendes, the adenovirus in Sputnik V is able to reproduce, despite claims from the Gamaleya Center, the vaccine's creator, that it is impossible.
“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,” the statement said.
Writing on Twitter, Angela Rasmussen, a research scientist at Canada's Vaccine and Infectious Disease Organization, suggested that the issue wasn't with the jab itself but quality control surrounding its production.
“Safety concerns have already reduced enthusiasm for these vaccines, and an unforced error like this further amplifies those concerns and decreases trust in the technology itself,” she wrote. “I hope Gamaleya resolves these issues and supports it with data and robust QC/QA.”
Also on rt.com ‘Longstanding and time-tested partner’: India thanks Russia after Moscow sends 22 tons of supplies to country in Covid-19 crisisHowever, the Gamaleya Center says that existing quality controls already ensure that “no RCA can exist in Sputnik V,” and that its cleaning and filtration system means that the vaccine is “highly purified.”
“Sputnik V team believes that its purification technology is the best among all vaccines and is one of the pillars for vaccine safety,” the statement says.
Thus far, Sputnik has been authorized in 61 countries. Earlier this month, a real-world study based on data from 3.8 million inoculated people showed an efficacy of 97.6%, demonstrating that it has “one of the best protection rates against coronavirus among all vaccines,” according to RDIF head Kirill Dmitriev.
Brazil's hesitance to approve the vaccine may lead to other regulators also refusing to register the jab. In particular, the EU's drug regulator, the European Medicines Agency (EMA), is yet to sign off on the Russian formula, despite clamor from within the bloc to import the vaccine. Two EU countries, Hungary and Slovakia, have already unilaterally imported and started using it to inoculate citizens.
Last Thursday, the World Health Organization revealed it would begin a new round of reviewing the Russian vaccine on May 10, along with the EMA.
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