Brazil and Russia face off over vaccine contamination charge

doi:10.1126/science.372.6542.554-a

GSTDTAP > 气候变化

DOI	10.1126/science.372.6542.554-a
	Brazil and Russia face off over vaccine contamination charge
	Sofia Moutinho; Meredith Wadman
	2021-05-07
发表期刊	Science
出版年	2021
英文摘要	Science's COVID-19 reporting is supported by the Heising-Simons Foundation. A high-stakes international fight broke out last week over the Russian COVID-19 vaccine known as Sputnik V, after Brazil declined to authorize its import. Although the Brazilian Health Regulatory Agency (Anvisa) cited a litany of reasons, including being denied access to the vaccine's quality control center and some production sites in Russia, its most surprising allegation was that the vaccine's second dose contains adenoviruses capable of replication, a potential danger to vaccine recipients. The confrontation escalated when the vaccine's official Twitter account accused Brazil of bowing to “political” pressure and said “Sputnik V is undertaking a legal defamation proceeding” against the regulators. Anvisa officials fired back with a press conference, displaying documentation from the vaccine's maker and video clips of a meeting with its representatives. Although some observers initially took Anvisa's side, others soon wondered whether it had misinterpreted information from the vaccine's developer, the Moscow-based Gamaleya National Center of Epidemiology and Microbiology. Many outside the fray also felt Anvisa indicated originally it had directly tested for replicating viruses, but the agency later clarified it had relied on Gamaleya's reports. “The data we evaluated shows the presence of replicating virus,” Gustavo Mendes, general manager of medicines and biological products at Anvisa, said at the press conference. Gamaleya issued a detailed rebuttal, declaring that Anvisa's allegations “have no scientific grounds and cannot be treated seriously.” It added that a four-stage purification process prevents contamination. The furor comes as Brazil, which has one of the highest burdens of COVID-19 in the world, has vaccinated only about 15% of its people with a first dose. Governors from 14 of its 26 states want to import 30 million doses of Sputnik V. Although it has not yet received the green light from the World Health Organization or the European Medicines Agency, more than 60 countries have authorized its use, and it is seen as an important weapon against the global pandemic. “We need this vaccine. It's cheap. It's effective. It's easy to store and transport,” says Hildegund Ertl of the Wistar Institute, who studies adenovirus-based vaccines. Several COVID-19 vaccines use adenoviruses to deliver the gene for the spike protein of SARS-CoV-2. Sputnik V relies on two, Ad26 and Ad5, in sequential doses. Both adenoviruses are stripped of E1 , a gene that allows them to replicate, then mass-produced by cultured human cells with a stand-in copy of E1 . But Ad5 is known to reacquire the gene from them on rare occasions. A source of common colds, adenoviruses typically cause mild symptoms, but are occasionally lethal, and immunocompromised people could be at particular risk. Vaccinemakers therefore test for replicating adenoviruses. Anvisa said that although the standard worldwide is zero tolerance, Gamaleya set a much higher limit. Its documents displayed by Anvisa stated the tested vaccine batches had “less than 100” replication-capable particles per dose. Some scientists suspect that wording merely reflects the sensitivity of Gamaleya's test or an arbitrary limit it established, not evidence that the vaccine contains active adenoviruses. Anvisa rejects that explanation. The 14 governors sent new quality control documents from Gamaleya to Anvisa late last week and asked immunologist Amilcar Tanuri, at the Federal University of Rio de Janeiro's main campus, to independently review them. He tells Science that the additional information on the tested vaccine batches makes it clear that they had no replicating viruses. Ricardo Gazzinelli, president of the Brazilian Immunology Society, calls the impasse “unnecessary turmoil.” “Sputnik should have responded to [Anvisa's concerns] instead of starting a fight.” Anvisa officials say that if Gamaleya clarifies the issues raised by the regulatory agency, the import ban can still be reversed. “Sputnik V is not out of the question” for use in Brazil, Mendes says.
领域	气候变化 ; 资源环境
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文献类型	期刊论文
条目标识符	http://119.78.100.173/C666/handle/2XK7JSWQ/325912
专题	气候变化资源环境科学
推荐引用方式 GB/T 7714	Sofia Moutinho,Meredith Wadman. Brazil and Russia face off over vaccine contamination charge[J]. Science,2021.
APA	Sofia Moutinho,&Meredith Wadman.(2021).Brazil and Russia face off over vaccine contamination charge.Science.
MLA	Sofia Moutinho,et al."Brazil and Russia face off over vaccine contamination charge".Science (2021).