Brazilian health regulators rejected Russia’s Sputnik V coronavirus vaccine on Monday, citing concerns regarding the shot’s development and production.
Brazil’s Health Regulatory Agency, or Anvisa, made its ruling based on what it said was a lack of quality control, efficacy data and information on adverse side effects, The Washington Post reports.
“Flaws … were identified in all stages of clinical studies,” the agency said in a statement. It added it did not find “any manufacturing conditions identified that demonstrate that the products are consistently produced and controlled.”
Sputnik V shot back at the agency’s assessment on Twitter soon after the decision was announced.
“Sputnik V shared with Anvisa all the necessary information and documentation, much more than that used to approve Sputnik V in 61 countries. We hope that science, not pressure from another country, will be used for decision making,” the vaccine maker wrote in Portuguese.
The comment was likely referring to claims that the U.S. government is pressuring other countries to reject the Russian vaccine.
A Kremlin spokesperson said in March that “unprecedented” pressure was being placed on some countries to reject the medicine.
“In many countries, the scale of pressure is quite unprecedented … such selfish attempts to force countries to abandon any vaccines have no prospects,” Dmitry Peskov said. “We believe that there should be as many doses of vaccines as possible so that all countries, including the poorest, have the opportunity to stop the pandemic.”
Peskov said Tuesday that the Russian government was willing to provide more information to Brazil, the Post reports.
Though recent tests have found Sputnik V to be safe and effective at preventing coronavirus infections, the shot has been criticized by many global health experts for not undergoing further testing before it was approved for use by the Russian government.
The Post notes that Slovakia’s pharmaceutical regulator dropped a batch of Sputnik V vaccines saying it did have “the same characteristics and properties” that were observed in a study published in The Lancet, a peer-reviewed medical journal.
Brazil has so far approved COVID-19 vaccines from Pfizer, Johnson & Johnson, AstraZeneca and Sinovac. The country was recently overtaken by India as the second most pandemic-impacted country.
According to the World Health Organization, Brazil has confirmed more than 14 million coronavirus cases and nearly 400,000 deaths. More than 35.5 million vaccine doses have been administered in the country so far.