On August 11th, a conference took placededicated to the registration of the first Russian vaccine against coronavirus, Sputnik V.
Russian President Vladimir Putin announced the registration of the first vaccine. It is due to enter mass production soon, and will be available to the general public from January 2021. Despite being registered, the vaccine will still go through more clinical trials in Russia and the Middle East.
Director General of the Russian Direct Investment Fund (RDIF) Kirill Dmitriev said that the fund had already received requests for 1 billion doses of the vaccine.
They came from 20 countries, in particular, negotiations are underway in the markets of Latin America, the Middle East and Asia.
The vaccine was developed by the Russian National Research Center for Epidemiology and Microbiology (NF Gamaleya NITsEM). In addition to NITsEM itself, the pharmaceutical plant Binnopharm, which is part of AFK Sistema, will also produce the product.
Gamaleya has developed vaccines before, and Mikhail Murashko, the Russian minister of health, said in a government press release that the COVID-19 vaccine showed “high efficacy and safety” and there were no serious side effects. The same release suggested the vaccine would confer 2 years of immunity to SARS-CoV-2, the virus that causes COVID-19. That estimate is apparently based on vaccines Gamaleya has made with similar technology.
There is still very limited information regarding the vaccine.
According to it, Binnopharm in Zelenograd produces it.
The vaccine consists of two shots that use different versions of adenoviruses, some of which cause the common cold, that Gamaleya researchers have engineered to carry the gene for the surface protein, or spike, of SARS-CoV-2. Apparently, the studies are comparing a single shot of adenovirus 26 with the spike gene to a scheme, known as prime-boost, that also gives a second dose 21 days later of a vaccine that contains the spike gene in adenovirus 5.
As expected, some vaccine experts have raised concerns about COVID-19 vaccines that use adenovirus 5 in this way. In 2007, researchers stopped an HIV vaccine trial that used adenovirus 5 to shuttle in the gene for the surface protein of that virus after they found that it increased the likelihood of its transmission.
In 2017, Gamelaya received approval in Russia for a vaccine that also used the adenovirus 5 vector to deliver the surface protein gene from the virus that causes Ebola. Researchers there used a similar strategy for a vaccine for Middle East respiratory syndrome, a disease caused by a coronavirus like the one responsible for COVID-19. It is still under development and has entered early stage clinical trials.
Regardless, clinical trials of Sputnik V began in June 2020 at the Sechenov University and the Burdenko Military Hospital in Moscow, 38 volunteers took part in each of them. In the third phase of the clinical study, according to the Ministry of Health, 2 thousand people will take part.
According to the head of the RDIF, the third phase of clinical trials of the Russian vaccine will also take place abroad. The Fund has reached agreements on this with partners from the UAE, Saudi Arabia and several other countries.
A website for Sputnik V says a phase III efficacy trial involving more than 2000 people will begin on 12 August in Russia, the United Arab Emirates, Saudi Arabia, Brazil, and Mexico. Mass production of the vaccine is slated to begin in September.
The vaccine production is financed by RDIF in cooperation with its portfolio companies Alium and R-Pharm, as well as with strategic partners – international pharmaceutical companies (which are not specified), the volume of investments amounted to 4 billion rubles ($54.6 million).
MSM are losing no time in attempting to discredit the vaccine immediately after it was registered.
According to the Guardian “the only discernible difference between Russia’s vaccine and others is that this one has skipped most of the testing phases.”
It describes, in brief, how the usual four-stage trials go for medication and that Russia has essentially rushed through the first two and the third is yet to happen, the fourth, apparently is less important.
“This is why we do these studies. It’s not for fun, it’s because sometimes things that look really good early on turn out to be pretty useless.
Which brings us back to Russia. While phase one and two trials of the vaccine have been pre-registered, they are reportedly ongoing and have not yet posted any results. There is no evidence a phase three trial has even been started, never mind completed.
This leaves us with the obvious conclusion: no one really knows if this vaccine actually works. Phase one and two trials can inform this question, but because they only measure antibody titers or another surrogate outcome they can’t tell us whether the vaccine prevents the disease it’s meant to stop. By all accounts, people inoculated with the Russian vaccine do have antibodies, but these may not last, may not provide enough protection, or may fail for another reason because the immune system is fiendishly complex. We just don’t know.”
MORE ON THE TOPIC:
- Russia To Begin Industrial Production Of COVID-19 Vaccine In September 2020, Mass Production By 2021
- “Putin Hacked Our Coronavirus Vaccine” Is The Dumbest Story Yet