Registration of the Russian vaccine: shvarz – LiveJournal

I was not going to comment (it seems that everything is clear), but people come here and in FB and continue to ask, and even relatives ask, so I’ll write. Also useful to read last entry and comments to it for context.

What are we discussing
A very big problem is the lack of any coherent information about what kind of vaccine it was, how it was tested and what is happening in general. On the Gamaleya Institute websitethere is also no information other than links to news publications. There are no publications in scientific journals. Therefore, what is happening can only be guessed at from snippets from various interviews or news articles.

What kind of vaccine?
All I found: The vaccine is based on two adenoviruses, the first dose on Ad5, the second on Ad26. In both cases, the virus cannot multiply, it delivers a gene for the coronavirus protein S into cells. There are vaccine candidates based on these viruses, but at the moment there is no licensed vaccine that uses this approach.

How was the vaccine tested?
Two tests were carried out, both of the first stage, i.e. on a small number (in total – about 40) healthy relatively young (18-50 years old) people. The trials tested the safety of the vaccine and the immune response. The results have not been published anywhere, and even the main results have not been announced in a press release. All we hear is claims that the vaccine has been shown to be safe and caused antibodies to the virus. It is worth noting that today it is not known what kind of immune response will protect against coronavirus, therefore, based on the result of the immune response, it is impossible to judge whether the vaccine will be effective against the virus and, if so, what exactly it will do – prevent infection, disease, or death. Or nothing at all. Or lead to a worsening of the disease (as I wrote earlier, this is possible but unlikely).

Can you say something about the vaccine by its analogues?
Since there is no direct information, you can dream a little. Vaccines for other viral infections (including HIV) based on Ad5 and Ad26 have been previously tested in humans. By themselves, they are usually quite safe, since their base, adenoviruses, are altered so that they cannot multiply. But this also means that a lot of them have to be injected to get a good immune response. The problem with Ad5 is that it is a very common virus and 20-50 percent of people are immune to it, making the vaccine ineffective. The Chinese have already seen this with their Ad5-based vaccine. But the second dose with Ad26 can help, to Ad26 rarely anyone has immunity. So I would assume that if done correctly, the vaccine is likely to be safe, with some effectiveness, but not effective for everyone. But this must be checked, especially for Ad5 – one of the HIV vaccines based on this vector among Ad5 immune people caused an increase in the likelihood of infection. This is most likely an effect specific to HIV, but no one knows for sure.

What does vaccine registration mean?
Registration usually means that the regulatory agency in the country has reviewed all of the information provided, found it sufficiently safe and effective, and has authorized the company to sell the vaccine. In this case, a kind of “conditional registration” was made. It will allow the company (the Gamaleya Institute?) To market the vaccine from September for use in risk groups that are not well defined. Somewhere they talk about doctors and teachers. Somewhere about old people (which is strange, because it was not tested on them). In parallel, what is usually always done will be done to registration – a third stage trial will be conducted to find out the real effectiveness of the vaccine. By January, they are going to complete this test and allow the vaccine to be sold to the entire population.

Was Russia the first to achieve such results?
No, tests of the first stage have already been carried out for about a dozen vaccines, maybe a little less. Unlike the Hamaley vaccine, the results of these trials have been published and can be read about in scientific journals. These vaccines have also shown safety and immune response, which is quite different for different vaccines – some are better, some are worse. But these vaccines have not been registered because regulatory agencies in the respective countries believe that there is insufficient data on safety in a small group of people and on the immune response to register. The United States requires testing on tens of thousands of people with a proven efficacy of at least 50%. In Russia, they simply lowered the bar to an extremely low level, which is not followed practically anywhere in the world. The only country where something similar was done is China, which, based on similar data, also issued a “conditional registration” according to which the army can vaccinate soldiers in case of a crisis.

What do you think of all this?
Such registration is contrary to all international norms, which were not established from the ceiling, but as a rule in response to various kinds of problems with medicines or vaccines in the past. Bypassing them, even in a pandemic, is a rare idiocy, apparently made to please Putin, so that he could make a loud statement. I doubt that this vaccine will really vaccinate someone in the near future (or you can say – I hope that they will not), not only because the vaccine has not been sufficiently tested, but also because the Gamaleya Institute is not a pharmaceutical company, they have there is no experience in the development of large-scale production of vaccines, and even such new ones. If suddenly it really does appear, then personally I would not have been vaccinated with it until reliable data on its safety and effectiveness appear.

Any questions?

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