补个金融时报的报道 https://www.ft.com/content/75b83fd9-1b45-4b11-bb41-fefaff59e503 Russia criticises Brazil’s rejection of Sputnik V vaccine Health regulator identifies risks with Covid jab and says information lacking The Russian sovereign wealth fund backing the country’s Sputnik V coronavirus vaccine said the decision from Brazil’s health regulator not to authorise imports of the jab was politically motivated. Brazilian officials late on Monday rejected a request to import the vaccines made by state governors in Latin America’s largest nation, which is still fighting a second wave of the Covid-19 pandemic and has faced supply shortages in its inoculation campaign. Anvisa, the country’s healthcare and medicines watchdog, cited risks with Sputnik V and said there was not enough information about its safety, effectiveness and quality. It added that failings were identified in the development of the product and all stages of clinical studies. “All of these uncertainties can directly interfere with the control of the pandemic in our country, because if the vaccine’s efficacy is not adequate, it can generate a false sense of security,” Anvisa director Alex Machado Campos wrote in his report. The decision deals a blow to Russia’s efforts to further boost exports of the vaccine, which has been built around sales to large emerging market nations such as Brazil. Developed by the Russia’s state-run Gamaleya Institute, Sputnik V has been approved by Moscow and 60 foreign governments. The two-shot vaccine showed 91.6 per cent efficacy against symptomatic Covid-19 in clinical trials, a Lancet peer review confirmed this year. A consortium of states in north-east Brazil had already agreed to buy 37m doses, while the federal government has an order for 10m. Sputnik V’s backers accused the Brazilian health agency of bowing to political pressure from the US to block Russian vaccines, insisting that all necessary documentation and information had been shared with the authorities. “Anvisa’s delays in approving Sputnik V are, unfortunately, of a political nature and have nothing to do with access to information or science,” the Russian Direct Investment Fund, which is managing Sputnik V’s global sales, wrote on a Twitter. “We hope that science, not pressure from another country, will be used for decision making,” it said. Anvisa said its agents were not permitted to undertake an inspection of Gamaleya Institute facilities during a visit to Russia last week. Another concern highlighted by the agency was related to the adenovirus vector, the common virus used to carry the genetic code of a part of Sars-Cov-2 in the Sputnik vaccine, as well as the AstraZeneca and Johnson & Johnson shots. Anvisa said the presence of adenoviruses with the ability to replicate — a naturally occurring process that has to be neutralised for immunisations — had been detected, which can “lead to infections in humans and could cause damage and death, especially in people with low immunity and respiratory problems, among other health problems”. RDIF said in a statement that Anvisa’s decision “contradicts an earlier decision by Brazil’s Ministry of Science . . . which recognised the Sputnik V vaccine as safe and permitted its production in Brazil”. Anvisa’s team in Moscow “had full access to all the relevant documents as well as to research and production sites”, it added. On Tuesday, RDIF said: “The Gamaleya Center, which carries out strict quality control of all Sputnik V production sites, has confirmed that no replication-competent adenoviruses (RCA) were ever found in any of the Sputnik V vaccine batches that have been produced.” The ruling threatens to slow Brazil’s vaccination programme, which has delivered at least one dose to roughly 27.5m people, or 12.9 per cent of the population. Most have received the Chinese-developed CoronaVac shot. The Oxford/AstraZeneca jab is also being deployed. However, repeated delays in shipments of pharmaceutical ingredients from overseas for producing both vaccines domestically has dragged on distribution, as Brazil’s Covid-19 death toll nears 400,000. “The refusal by Anvisa [to authorise Sputnik imports] will lead to a big reduction in the number of doses estimated under the national immunisation programme,” said Fernando Aith, a professor of public health at the University of São Paulo. “Millions of doses for the states and city halls will no longer enter the country.”
好像强生的没事。俄罗斯这个是没把一个叫E1或者E3的东西删除，不删除腺病毒就可以无限复制。 Adenovirus-vectored vaccines like J&J, AstraZeneca, and Sputnik V use infection with adenoviruses, common pathogens that usually cause common colds. But to increase safety and decrease risk of side effects, most vaccine vectors delete the AdV E1 and E3 genes.E1/E3 deletions are standard in Ad-vectors. Deleting E1 prevents the virus from replicating and deleting E3 prevents it from interacting with the immune system. This results in a vaccine vector that causes a transient infection, due to the vector’s inability to complete its replication cycle. When I got J&J it infected my cells, began expressing viral proteins, including SARS-CoV-2 spike, and then hit a block because of the E1 deletion.
好像强生的没事。俄罗斯这个是没把一个叫E1或者E3的东西删除，不删除腺病毒就可以无限复制。 Adenovirus-vectored vaccines like J&J, AstraZeneca, and Sputnik V use infection with adenoviruses, common pathogens that usually cause common colds. But to increase safety and decrease risk of side effects, most vaccine vectors delete the AdV E1 and E3 genes.E1/E3 deletions are standard in Ad-vectors. Deleting E1 prevents the virus from replicating and deleting E3 prevents it from interacting with the immune system. This results in a vaccine vector that causes a transient infection, due to the vector’s inability to complete its replication cycle. When I got J&J it infected my cells, began expressing viral proteins, including SARS-CoV-2 spike, and then hit a block because of the E1 deletion.
好像强生的没事。俄罗斯这个是没把一个叫E1或者E3的东西删除，不删除腺病毒就可以无限复制。 Adenovirus-vectored vaccines like J&J, AstraZeneca, and Sputnik V use infection with adenoviruses, common pathogens that usually cause common colds. But to increase safety and decrease risk of side effects, most vaccine vectors delete the AdV E1 and E3 genes.E1/E3 deletions are standard in Ad-vectors. Deleting E1 prevents the virus from replicating and deleting E3 prevents it from interacting with the immune system. This results in a vaccine vector that causes a transient infection, due to the vector’s inability to complete its replication cycle. When I got J&J it infected my cells, began expressing viral proteins, including SARS-CoV-2 spike, and then hit a block because of the E1 deletion.
巴西的监管机构在疫苗严重短缺的情况下，全票拒绝了俄罗斯的大卫星疫苗，原因是发现俄罗斯疫苗里面作为载体的Ad5腺病毒仍然具有自我复制能力！腺病毒本身也是一种呼吸道传染的病毒，一般只会导致普通感冒，但是也有Ad5腺病毒导致血栓的动物实验结果。如果疫苗里面的腺病毒载体能够自我复制的话，相当于给人打了一个可以复制和传染的“转基因病毒”，这个病毒能够在体内不断生成新冠病毒上面的spike protein，这个风险是不可控的。现在还不知道这个问题有多么普遍，也不知道这是不是俄罗斯疫苗没有用S-2p抗原却仍然能够达到那么高有效性的原因。（三期临床实验91%，另外有一个实战有效率97.6%的报道）
下面这个Twitter thread讲的更详细一些
https://twitter.com/angie_rasmussen/status/1387397186372005893
更新：仔细读了一下那个twitter thread，我觉得更严谨的说法是目前还不知道这些能复制的腺病毒载体上面到底有没有带着spike protein（因为不知道问题到底出在生产的哪一步）
Russia criticises Brazil’s rejection of Sputnik V vaccine Health regulator identifies risks with Covid jab and says information lacking
The Russian sovereign wealth fund backing the country’s Sputnik V coronavirus vaccine said the decision from Brazil’s health regulator not to authorise imports of the jab was politically motivated. Brazilian officials late on Monday rejected a request to import the vaccines made by state governors in Latin America’s largest nation, which is still fighting a second wave of the Covid-19 pandemic and has faced supply shortages in its inoculation campaign.
Anvisa, the country’s healthcare and medicines watchdog, cited risks with Sputnik V and said there was not enough information about its safety, effectiveness and quality. It added that failings were identified in the development of the product and all stages of clinical studies.
“All of these uncertainties can directly interfere with the control of the pandemic in our country, because if the vaccine’s efficacy is not adequate, it can generate a false sense of security,” Anvisa director Alex Machado Campos wrote in his report.
The decision deals a blow to Russia’s efforts to further boost exports of the vaccine, which has been built around sales to large emerging market nations such as Brazil. Developed by the Russia’s state-run Gamaleya Institute, Sputnik V has been approved by Moscow and 60 foreign governments.
The two-shot vaccine showed 91.6 per cent efficacy against symptomatic Covid-19 in clinical trials, a Lancet peer review confirmed this year. A consortium of states in north-east Brazil had already agreed to buy 37m doses, while the federal government has an order for 10m.
Sputnik V’s backers accused the Brazilian health agency of bowing to political pressure from the US to block Russian vaccines, insisting that all necessary documentation and information had been shared with the authorities.
“Anvisa’s delays in approving Sputnik V are, unfortunately, of a political nature and have nothing to do with access to information or science,” the Russian Direct Investment Fund, which is managing Sputnik V’s global sales, wrote on a Twitter.
“We hope that science, not pressure from another country, will be used for decision making,” it said.
Anvisa said its agents were not permitted to undertake an inspection of Gamaleya Institute facilities during a visit to Russia last week.
Another concern highlighted by the agency was related to the adenovirus vector, the common virus used to carry the genetic code of a part of Sars-Cov-2 in the Sputnik vaccine, as well as the AstraZeneca and Johnson & Johnson shots.
Anvisa said the presence of adenoviruses with the ability to replicate — a naturally occurring process that has to be neutralised for immunisations — had been detected, which can “lead to infections in humans and could cause damage and death, especially in people with low immunity and respiratory problems, among other health problems”.
RDIF said in a statement that Anvisa’s decision “contradicts an earlier decision by Brazil’s Ministry of Science . . . which recognised the Sputnik V vaccine as safe and permitted its production in Brazil”. Anvisa’s team in Moscow “had full access to all the relevant documents as well as to research and production sites”, it added.
On Tuesday, RDIF said: “The Gamaleya Center, which carries out strict quality control of all Sputnik V production sites, has confirmed that no replication-competent adenoviruses (RCA) were ever found in any of the Sputnik V vaccine batches that have been produced.”
The ruling threatens to slow Brazil’s vaccination programme, which has delivered at least one dose to roughly 27.5m people, or 12.9 per cent of the population. Most have received the Chinese-developed CoronaVac shot. The Oxford/AstraZeneca jab is also being deployed.
However, repeated delays in shipments of pharmaceutical ingredients from overseas for producing both vaccines domestically has dragged on distribution, as Brazil’s Covid-19 death toll nears 400,000. “The refusal by Anvisa [to authorise Sputnik imports] will lead to a big reduction in the number of doses estimated under the national immunisation programme,” said Fernando Aith, a professor of public health at the University of São Paulo. “Millions of doses for the states and city halls will no longer enter the country.”
好像某些东欧国家用过
陈巍将军的疫苗
天津康希诺
匈牙利打很大一部分打的俄罗斯的。
将军的疫苗上市了没？泪流满面激动得不能自已那个，对吧？
目前看还是指望mRNA疫苗，接下来的重组蛋白疫苗希望也可以，放弃腺病毒疫苗吧。
是
这也是的
但不仅限于某一类疫苗吧…… 各类疫苗都有的血栓血小板减少搞不好也是生产的瑕疵
不是有种说法，新冠病毒本来就是为了给艾滋疫苗做载体的，然而出了意外么。
possible
匈牙利还是辉瑞疫苗打的多。辉瑞总共打了两百万剂，大卫星一百万剂，国药也是一百万剂。
当然啦，灭活疫苗如果有万分之一次品率没灭，就等于打了活新冠啊 宏观制造至少还看得见摸得着可以QC，微观制造根本没办法啊，只能每个环节尽量接近100%，环节越少越好
好像强生的没事。俄罗斯这个是没把一个叫E1或者E3的东西删除，不删除腺病毒就可以无限复制。 Adenovirus-vectored vaccines like J&J, AstraZeneca, and Sputnik V use infection with adenoviruses, common pathogens that usually cause common colds.
But to increase safety and decrease risk of side effects, most vaccine vectors delete the AdV E1 and E3 genes.E1/E3 deletions are standard in Ad-vectors. Deleting E1 prevents the virus from replicating and deleting E3 prevents it from interacting with the immune system.
This results in a vaccine vector that causes a transient infection, due to the vector’s inability to complete its replication cycle. When I got J&J it infected my cells, began expressing viral proteins, including SARS-CoV-2 spike, and then hit a block because of the E1 deletion.
好吧，战斗民族！！
人类要是没点冒险精神，现在还在非洲爬树呢
不可能吧，大妈网都贴出来的事，俄国一流科学家不懂？ 大概率还是生产次品率的问题，没删除干净呗
大妈网里藏龙卧虎，美国院士都好几个
我也同意 次品的概率大一点
中国军队里面就打的这个。
一种可能是一开始就没敲除干净，还一种可能是敲掉了以后又和没敲掉的腺病毒或者是宿主细胞发生了基因重组
不断复制带病毒的spike protein的话，就会不断产生抗体，然后可能出现ADE？
赞同
强生这方面技术应该比俄罗斯强 俄罗斯这属于基本技术太粗糙
匈牙利前几天不是出数据了吗，说俄罗斯的疫苗效果最好。
俄国的生物不是强项
宿主细胞怎么会有E1/E3基因?
我看的Twitter上面的讨论，E1有的时候可以被整合到host cell里面，JNJ为了这个特地换了一个细胞系。
https://twitter.com/mholkers/status/1387433643304538122
是的。灭活是最老应用最广的方法，局限性大家都很清楚。mRNA是最新的技术，确实too good to be true，也是现在最大规模施打的，后面陆续应该会有一些缺点显现出来，毕竟每种方法都会有局限性和improve的空间，只希望不要critical。