SÃO PAULO—Brazilian health authorities have blocked the importation of Russia’s Sputnik V vaccine, citing a lack of reliable data on its safety and efficacy, raising questions over a shot that is in use around the world to contain the Covid-19 pandemic.
In a unanimous decision, the five directors of Anvisa, Brazil’s health agency, voted not to recommend importing the vaccine after its researchers reported flaws in product development in all stages of the vaccine’s clinical studies.
First authorized for use in Russia in August, Sputnik has been approved for use in 62 countries, mostly in the developing world, with a combined population of more than three billion people. Among the countries that have been administering the vaccine are Argentina, Mexico, Algeria and Serbia.
Anvisa said in its decision late Monday that it also had concerns about the mass production of the vaccine, saying a lack of quality control during manufacturing could result in potentially dangerous variations between shipments of the shot.
“[Sputnik] has not yet been able to demonstrate that its commercial-scale production is representative of its production during the pilot phase,” Anvisa said. “It also has not shown that its product meets the necessary safety standards for the vaccination of healthy individuals.”
Anvisa said it was also denied a visit to the vaccine’s Moscow-based developer, the Gamaleya Institute, as part of an inspection mission to Russia.
The agency’s decision Monday came after 10 state governments across Brazil filed for permission for emergency use of the vaccine.
Only 6% of the country’s 213 million people have been fully vaccinated so far, mostly with the CoronaVac shot from Chinese firm Sinovac Biotech Ltd.
Russia pushed back against Anvisa’s decision, saying it was politically motivated.
The decision “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 Russian Direct Investment Fund, which manages foreign sales of the shot, said in a statement. It said the vaccine’s developers had shared all the necessary information and documentation with Anvisa.
Despite the urgency to fight Covid-19 in Brazil, where the disease has killed almost 400,000 people, many health experts spoke out in favor of the decision by Anvisa, which is widely respected among the country’s medical community.
“Given the data available, Anvisa did the right thing,” said Eliseu Waldman, an epidemiologist at the University of São Paulo.
“The fact that the Sputnik vaccine was shown to have a high efficacy and safety rate during final phase clinical trials…is not enough,” Mr. Waldman said. Vaccine makers must also prove that their shots meet those same standards when produced commercially on a mass scale, he said.
Anvisa could still approve the vaccine if further information is provided, researchers said.
The ruling comes as Brazil is grappling with one of its darkest moments since the pandemic began. About a hundred Brazilians are dying every hour from the disease, as the aggressive P.1 variant from the Amazon rages across the country, overwhelming hospitals. While the rate of new infections and deaths has slowed in Brazil over the past couple of weeks, the daily death toll is still more than double last year’s peak in July.
The Gamaleya Institute, Sputnik’s maker, has said there were attempts last year by U.S. health officials to thwart the use of the Russian vaccine in Brazil. Buried in its 2020 annual report under the subheading “Combatting malign influences in the Americas,” the U.S. Department of Health and Human Services said its Office of Global Affairs had been used “to persuade Brazil to reject the Russian Covid-19 vaccine.” Donald Trump, as president, was a close ally of Brazilian President Jair Bolsonaro.
However, health experts pointed to Anvisa’s approval of China’s CoronaVac this year, despite widespread opposition from President Bolsonaro, who is a fierce critic of Beijing.
“Considering how many well-respected health experts have supported the decision by the health regulator to block Sputnik, I think this is not a political decision,” said Oliver Stuenkel, professor of international relations at Brazil’s Getulio Vargas Foundation.
Anvisa’s decision raises questions about Sputnik’s use in other developing countries. Many of them have been scrambling to secure enough vaccines in the face of dwindling supplies from India, which itself is dealing with a surge in infections. Bangladesh became the latest country Tuesday to approve the Sputnik vaccine for emergency use.
The Sputnik vaccine was criticized by Western scientists and politicians for its fast-tracked development and an initial lack of trial data. Officials in the West had said Moscow was using the shot—named after the Soviet-era satellite—to bolster its geopolitical agenda and secure part of the global vaccine market.
Since then, peer-reviewed research from a large-scale clinical trial published in the British medical journal The Lancet in February showed the jab was safe and 91.6% effective, encouraging more countries to sign up for the shot.
As the U.S. and other developed nations have laid claim to most Western-made shots, Latin America has been forced to rely on Washington’s biggest global rivals, Russia and China.
“[China and Russia] will seek to use the urgency of the vaccine crisis absolutely to strengthen their hand,” Samantha Power, President Joe Biden’s nominee to lead the U.S. Agency for International Development, said Monday on the Brazilian talk show Roda Viva.
Though she said more U.S.-made vaccines would likely be available for Brazil and other developing countries soon, the U.S. government offered little help last year. “The U.S. was struggling to provide equipment to its own health workers,” she said, “so we were not in a position to lead.”
—Georgi Kantchev in Moscow contributed to this article.
Write to Samantha Pearson at firstname.lastname@example.org and Jeffrey T. Lewis at email@example.com
Copyright ©2020 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
Brazil Rejects Russian Covid-19 Vaccine – The Wall Street Journal