Vaccine News: Russia Approves Second COVID-19 Vaccine After Only A 100 Person Safety Trial. Forget About Phase III Trials. First Vaccine Sputnik V Fails
: Russia announced two months ago that its AAV (Adeno-associated virus) vector was approved for use despite lacking proper supporting study data and a proper phase 3 trial. In reality to date, the Sputnik V vaccine has been a flop as despite the Russian health authorities not admitting it, local Russian physicians and hospitals reported that that many vaccinated candidates not only contracted the SARS-CoV-2 coronavirus but also developed more severe conditions.
Instead of sharing that data publicly so that other vaccine developers can learn from the mistakes, The Russian government this week rolled out their second vaccine, still leaps and bounds ahead of the rest of the world who’s currently engaged in rigorous testing to prove their candidate’s safety and efficacy.
This time, Russia not only bypassed the Phase III trial completely and granted regulatory approval to the peptide-based drug, EpiVacCorona
, which was developed by the Vector Institute
in Siberia, but its Phase II only involved 100 volunteers of which only 75 received the shot in Novosibirsk, the third most populous city in Russia. No results of that trial were even published!
Shockingly despite the lack of any public results at this point, President Vladimir Putin publicly announced, “We need to increase production of the first and second vaccine. We are continuing to cooperate with our foreign partners and will promote our vaccine abroad.”
He did not even mention about the failure of the first vaccine!
Medical researchers both internationally and even in Russia had already raised the alarm
in August over Russia’s first vaccine, a vector vaccine developed by Gamaleya Institute called their vaccine Sputnik V, a nod to Russia’s early success in the space race.
President Putin simply touted the safety and efficacy of this vaccine by reassuring the people that one of his own daughters was a recipient of the vaccine, which is just now ramping up Phase III testing. The Phase III testing of Sputnik started with residents of Siberia and has since administered the vaccine
to trial participants in Belarus and soon the UAE. Further expansion is expected soon in Venezuela. However disappointing results were already seen in Russia recently.
The Sputnik V is a vector vaccine, which is produced on the basis of adenovirus.
Dr Scott Gottlieb, the former U.S.FDA Commissioner had some doubts
about the efficacy of this type of delivery system for a coronavirus vaccine, due to the fact that the viral vector being used is that of the common cold. So, if the recipient has antibodies against the common cold, their bodies neutralize the viral vector that’s being used to deliver the gene sequence.
Also AAV vaccines are known to cause complications later on in the recipients. https://www.thailandmedical.news/news/breaki
The latest Russian EpiVacCorona
was created on the promising synthetic platform of peptide vaccines. These peptides are synthesized to cause the immune system to recognize and neutralize the virus. Peptide vaccines are beneficial in that they have a decreased risk of stimulating an autoimmune response or other adverse reactions.
Russian Deputy Prime Minister of Russia Tatiana Alekseevna said the Vector Institute will begin clinical trials with 40,000 volunteers soon.
The Russian’s race to “be the first” in the COVID-19 vaccine race has been called “reckless
” by the scientific community.
Typically the Phase III trial phase is the largest, and its data essential for determining whether the drug actually works and if it is considered safe for most of the population. Fast approvals mean that adverse side effects may not have yet had time to be observed.
When Russia announced in August of their first vaccine approval, Dr Francois Balloux, an expert at University College London’s Genetics Institute called it a “foolish decision.”
Dr Balloux said, “Mass vaccination with an improperly tested vaccine is unethical. Any problem with the Russian vaccination campaign would be disastrous both through its negative effects on health, but also because it would further set back the acceptance of vaccines in the population.”
Currently even without seeing Russia’s results, there has been an increasingly negative perception of the COVID-19 vaccine, with now just 12% of Americans
saying they would be willing to try a vaccine immediately once approved by the FDA.
A further mere 25% said they will plan to get it a few months after it becomes available.
Dr Kirill Dmitriev, chief executive of Russia’s sovereign wealth fund, argued
, “We’re completely transparent and open. There is a very negative narrative in some of the Western nations, and frankly we feel it’s very sad because basically it doesn’t allow people to have honest information on our vaccine. We all need to be very practical and stop this rhetoric of trying to paint each other’s vaccine black. It is very unhealthy; it is very unethical and very unproductive.”
However he refused to publicly disclose more details about both vaccines including past studies and the adverse effects from the first vaccine.
To date Russia has yet to publish the results of the early-stage trials of EpiVacCorona. Meanwhile, they encourage countries to “test for themselves” and try it out!
Dr Gotlieb reassured the American public saying that the US would not allow mass distribution of a drug that had only been tested on a few hundred patients at most.
However even having said that, there is now a growing consensus that many of the clinical data from the current vaccines that are being developed or tested have not been very transparent and if fact a lot of details are being concealed while others parts of it are being manipulated as there is greed at play due to the fact that trillions of dollars at stake.
Antibody studies are now also showing that the most the vaccines can do is to provide temporary protection for a period of about 10 to 16 weeks the maximum which actually defeats the whole purpose.
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