BRASILIA (Reuters) -The Brazilian health regulator Anvisa on Monday rejected importing the Russian-made Sputnik V COVID-19 vaccine requested by state governors battling a deadly second wave of the virus that is battering Latin America’s largest nation.
Anvisa’s five-strong board voted unanimously not to approve the Russian vaccine after technical staff had highlighted “inherent risks” and “serious” defects, citing a lack of information guaranteeing its safety, quality and effectiveness.
Ana Carolina Moreira Marino Araujo, general manager for health monitoring, said that taking into account all the documentation presented, data acquired at in-person inspections and information from other regulators, “inherent risks” were too great.
A crucial issue was the presence in the vaccine of the adenovirus that could reproduce, a “serious” defect, according to Anvisa’s medicines and biological products manager Gustavo Mendes.
The Sputnik V shot has been approved in several countries around the world. Russian scientists say it is 97.6% effective against COVID-19 in a “real-world” assessment based on data from 3.8 million people, Moscow’s Gamaleya Institute and the Russian Direct Investment Fund said last week.
But, like Anvisa, the European Union has not yet approved the vaccine, saying it needs more information on the tests and manufacturing process.
Brazil’s vaccination program has been blighted by delays and procurement failures, turning the country into one of the world’s deadliest COVID-19 hotspots this year and pushing the national health system to the brink of collapse.
So far 27.3 million people in Brazil, equivalent to 13% of the population, have received a first dose, according to health ministry data.
Brazil has registered 14.4 million confirmed cases of the virus and almost 400,000 deaths since the onset of the pandemic over a year ago, much of that in the last few months.
(Reporting by Pedro Fonseca in Rio de Janeiro and Ricardo Brito and Jamie McGeever in BrasiliaEditing by Chris Reese, Leslie Adler and Gerry Doyle)
MOSCOW (Reuters) -India will receive a first batch of Russia’s Sputnik V vaccine against COVID-19 on May 1, the head of the Russian Direct Investment Fund, Kirill Dmitriev, told Reuters on Monday.
He did not say how many vaccines would be in the first batch or where they would be made.
India, in the grip of a second wave of the pandemic, is struggling to tackle surging coronavirus infections that are overwhelming hospitals, and countries like Britain, Germany and the United States have pledged to send urgent medical aid.
“The first doses will be delivered on May 1,” Dmitriev said, adding he hoped Russian supplies would help India navigate its way out of the pandemic in time.
Russia’s RDIF sovereign wealth fund, which is marketing Sputnik V globally, has already signed agreements with five leading Indian manufacturers for over 850 million doses of the vaccine a year.
The RDIF has said it expects production of the vaccine in India to reach 50 million doses a month by the summer and to rise further.
The World Health Organization chief described the situation in the world’s second-most populous country as “beyond heartbreaking” as the WHO was planning to provide extra staff and supplies including oxygen concentrator devices.
Russian pharmaceutical firm Pharmasyntez said earlier on Monday that it was ready to ship up to 1 million packs of the remdesivir antiviral drug to India by end-May, once it has received the approval of Russia’s government.
(Reporting by Andrew Osborn and Polina Nikolskaya; Writing by Andrey Ostroukh; Editing by Sonya Hepinstall)