Brazil’s health regulator, Anvisa, denied a request from several pandemic-stricken states to import Russia’s Sputnik V COVID-19 vaccine on Tuesday.
Anvisa does not approve the import of the vaccine due to “insufficiency of data on quality control, safety and efficacy of the product,” the agency said in a statement.
“Evaluation of available data to date points out flaws in the development and production of the immunizer,” it added.
The request to import Russian jab came from 14 states.
The Clinical Research Regulation for Brazil, GGMED under Anvisa, said the “flaws in product development were identified in all stages of clinical studies.”
GGMED said ”worrisome” issues in the development process of the vaccine “can lead to infections in humans and can cause damage and death, especially in people with low immunity and respiratory problems, among other health problems.”
It also confirmed the absence of reproductive toxicity tests, which allow verifying if the product may or may not be harmful to the reproductive cells.
“I express here with sincerity that we are doing everything we can to ensure that vaccines for COVID-19 reach the people of this nation and that they meet the standards of quality, safety and efficacy,” Meiruze Freitas, director of medicines at Anvisa, said. Whenever a Brazilian receives a dose of the vaccine they “need to have confidence in the work of Anvisa’s public servants,” Freitas continued.
Brazil has registered more than 14.3 million cases and over 391,000 deaths, according to data from the US-based Johns Hopkins University.