Leading international scientific journal The Lancet yesterday published the results of the first two stages of clinical trials for the Russian COVID-19 vaccine.
When the story was released at 12 midday London time, the Internet positively exploded with seemingly every major news outlet in the world covering the story and putting its spin on the story, with the sole exception of Fox News, which seemed to have missed the big story entirely.
So, what was the big story?
Bottom line: The Russian scientists’ development, which turned out to be the world’s first registered coronavirus vaccine, is not only effective but safe.
The trials so far have shown that the vaccine is safe, that it has no severe side effects, and it is effective in producing an immune response.
However, that does not mean that it is game over and the vaccine is perfect and ready for mass production, because a further Stage III trial with 40,000 volunteers is still needed.
If you want to get technical here is a taste of what the article reported: In September, a complete study of the vaccine in animals, primates, Syrian hamsters, transgenic mice, in which the vaccine has shown 100% protective efficacy (results in primates and Syrian hamsters were obtained before clinical trials), will be published. The first results of the ongoing post-registration clinical trial involving 40,000 volunteers will be published in October-November”.
However, Sputnik V has not yet been tested on people older than 60– those who are at greatest risk of death from Covid-19– and other high-risk groups.
Typically older people have less resilient immune symptoms, and, for example, in the US people over the age of 65 are routinely given a double-dose of regular flu vaccines. Also, Sputnik V has not been tested in “double blind” studies in which volunteers do not know whether they are being given the real vaccine or a fake vaccine called a placebo.
This kind of test is considered the gold standard in drug testing, but could be bypassed when the need is really urgent, as with the Covid-19 pandemic.
There is no evidence one way or the other as to whether Sputnik V will work equally well on older people, or if larger doses would be needed, or would be safe.
When the Sputnik V was announced and registered in early August, there was a rash of criticism from the American vaccine experts as to whether the announcement was premature, or even foolish.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, explained that The Lancet’s publication of the clinical trial results is “the final answer in the round of questions directed against Russia” following the Sputnik V’s registration in August.
Now the Russian vaccine developers are hitting back with some questions of their own about the Oxford vaccine under development in England by Astrazeneca, and the Moderna vaccine under development in the US with huge government financial backing and orders already placed for millions of doses.
They say that the antibody levels in vaccinated volunteers were 1.4-1.5 times higher than the results reported by Britain’s AstraZeneca vaccine.
Responding to criticism about the insufficient number of volunteers for the two-vector vaccine, the scientists recalled that they used four times as many volunteers as AstraZeneca.
Last week, the US Food and Drug Administration announced the possible use of accelerated registration for vaccine candidates due to the current epidemiological situation, without a third phase of clinical trials on tens of thousands of volunteers.
The British authorities also spoke about the possibility of a similar approach. At the same time, according to these countries’ regulators, accelerated registration will only be possible for vaccines that have already proven their effectiveness and safety.
According to Russian specialists, there are not very many drugs that meet these requirements.
According to the representatives of Russia’s Gamaleya Centre, the western companies are using unverified vaccine “platforms” such as mRNA technology (Moderna’s vaccine) or chimpanzee adenovirus (AstraZeneca’s vaccine), which have never been used to create registered vaccines.
Such drugs need longer-term testing, the Russians say, because of concerns regarding, for example, their effect on pregnancy or the possibility of causing cancers.
The Russian vaccine, on the other hand, is based on a known safe platform that has produced several successful and safe vaccines including vaccines for Ebola and hepatitis, and been in use for as long as 20 years.