Russian Vaccine : First In The World

Vaccine created in Russia has shown signs of an immune response  Reuters

"I am not a vaccine specialist. So, I called the doctors who deal with vaccinations, I called immunologists. They said, 'don't do it, by no means, the vaccine is raw.'"

"Explain to me: how could it be that such powerful European and international organizations could not do it, but a relatively small Gamaleya Institute could? I cannot understand it."

"Totalitarianism remains [in Russia]. The two most helpless sectors are education and health care. Everything is done forcefully here. Last year I had a flu shot, everyone was told they needed to be vaccinated. And everyone did it, because if you don't, there will be penalties."

Unnamed surgeon at hospital in northeast Moscow

Russian President Vladimir Putin receives a video report about the approval of a coronavirus vaccine. Credit: Alexei Nikolsky/Sputnik/EPA-EFE/Shutterstock

"The two 42-day trials -- including 38 healthy adults each -- did not find any serious adverse effects among participants, and confirmed that the vaccine candidates elicit an antibody response."

"Large, long-term trials including a placebo comparison, and further monitoring are needed o establish the long-term safety and effectiveness of the vaccine for preventing COVID-19 infection."

The Lancet report

An antibody response in all participants in early-stage trials points the way to vaccination success on the part of Russia's 'Sputnik-V' COVID-19 vaccine. The Lancet medical journal published the results which appears to completely validate Moscow's claims to success and a head-start on the world community of scientists all racing against time to produce a vaccine to release the world from its  hostage situation, cowering in helpless fear of the still-relatively unknown SARS-CoV-2 virus.

The two trials referred to, conducted in June-July of this year involved 76 participants and demonstrated that every single trial member developed antibodies to the novel coronavirus with no serious side effects occurring. The double-shot inoculation has been licensed by Russia for domestic use as of August, making it the first country and only one to date to do this. And it was licensed in advance of data being published, much less a large-scale trial initiated, as recommended by The Lancet.

All those who took part in the initial trials were volunteers. A tentative list of professions that Russian authorities feel should be inoculated first off included doctors and teachers, for obvious reasons. But it would seem that many doctors are hesitant to be inoculated with the as-yet unproven vaccine, as are teachers and their unions, unwilling to become part of a large trial, as they see it, of an as-yet fully safety-and-efficacy-untested vaccine.

Named in honour of the Soviet Union's coup in launching the world's first satellite in 1957, Moscow clearly is anxious for a repeat of those glory days. To which ambition, among experts in the West there is unease about the precipitate use, even in the current emergency circumstances, to make wide use of the vaccine until all internationally approved testing and regulatory steps have been taken.

"With this [publication] we answer all of the questions of the West that were diligently asked over the past three weeks", stated Kirill Dmitriev, head of the Russian Direct Investment Fund, the nation's sovereign wealth fund which backed the vaccine. Moscow clearly feels justified in proceeding since its initial results were published in a prestigious international peer-reviewed journal, its 40,000-strong later-stage trial just launched.

There can be no denial that this global pandemic is a world-wide emergency which has caused the death of over 850,000 people on a global scale. On the other hand, a World Health Organization spokeswoman has noted that the organization has no expectations that widespread vaccinations will be available until mid-2021, in recognition of the need for rigorous scientific checks on effectiveness and safety. 

'This is just naked 'vaccine nationalism', which is really the last thing we need right now. I don’t want to see any country [including the US] beating its chest in this fashion and using the pandemic to declare the superiority of its system or its scientists. Coronavirus research needs to be as international as possible, with ideas, approaches, publications, and trials coming from around the world. This sort of stunt is taking us backwards – now people will be agitating for the 'approved' Russian vaccine and wondering why the others aren’t ready yet, etc. It just creates confusion and discord – don’t we have enough of those already? Unless, of course, creating confusion and discord is the point. . ."

Derek Lowe, Science Translational Medicine

On the other hand, one country or another which felt with confidence it had mastered a new, effective and safe vaccine and intended to use it internally on its population to enable it to emerge from the straitened circumstances forced on the world by the appearance of this novel coronavirus, would with little doubt act no differently than Russia has. It is yet to be seen whether any other country, satisfied it has achieved its goal in producing such a vaccine, would first coordinate with other nations and take steps to ensure that all have equal access rather than service itself first.

 

Putin said one of his own daughters had been inoculated (AFP)

"On Aug 11, 2020, Russia became the first country in the world to approve a vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The vaccine, which is based on two adenovirus vectors, was developed by the Gamaleya National Center of Epidemiology and Microbiology (Moscow, Russia). Its approval was announced by President Vladimir Putin. “I know [the vaccine] works quite effectively, helps to develop strong immunity, and has gone through all the necessary tests”, declared Putin at a cabinet meeting. Nonetheless, there are widespread concerns that the approval is premature. At the time of approval, the vaccine had not even started phase 3 trials, nor had any results on the earlier stage trials been published.

Since then, the phase 1/2 results have been published in The Lancet. The vaccine induced a strong immune response in all 76 participants. Presumably these results were available to the Russian Ministry of Health. For regulators such as the US Food and Drug Administration (FDA) and the European Medicines Agency, however, data on immune response alone would not generally be an adequate basis for approving a vaccine. “Immune response might not be directly proportional to the degree of protection—you can only find this out in large-scale trials”, explains Peter Openshaw, professor of experimental medicine at Imperial College London (London, UK).

“We have no idea whether this vaccine is safe or whether it works”, cautions Ashish Jha, Dean of the Brown University School of Public Health (Providence, RI, USA). “It is really worrying when people start to bypass the standard process we have for vaccine development.” Those behind the Russian vaccine have offered a combative response to such criticism. The official website was established with the stated aim to “provide accurate and up-to-date information about Sputnik V and to combat the misinformation campaign launched against it in the international media”.'

Dmitriev has confirmed that Russia has received international requests for 1 billion doses of its vaccine. On Aug 26, 2020, Russian news agency TASS reported that the country would supply more than 2 million doses of Sputnik V to Kazakhstan. Openshaw points out that the places that have expressed interest in the vaccine are unlikely to start mass administration until they are assured that it is safe and effective. “There is a huge difference between Russia registering a vaccine within its own borders, which it is entitled to do, and international approval or WHO prequalification”, he said.

Talba Khan Burki, The Lancet Respiratory Medicine

In this handout photo taken on Thursday, Aug. 6, 2020, and provided by Russian Direct Investment Fund, a new vaccine is on display at the Nikolai Gamaleya National Center of Epidemiology and Microbiology in Moscow, Russia. Russian President Vladimir Putin's announcement that his country is the first to approve a coronavirus vaccine hasn't provoked the awe and wonder of the Soviet Union’s launch of the first satellite into orbit in 1957. Instead the announcement was met by doubts about the science and safety of the vaccine. (Alexander Zemlianichenko Jr/ Russian Direct Investment Fund via AP)