The news that emerged on 11th Aug is that Russia has a COVID-19 vaccine that has been officially approved. Here is an example of the various media reports concerning the Russian announcement. This is via the BBC …
Russian President Vladimir Putin has said a locally developed vaccine for Covid-19 has been given regulatory approval after less than two months of testing on humans.
Mr Putin said the vaccine had passed all the required checks, adding that his daughter had already been given it.
Officials have said they plan to start mass vaccination in October.
Experts have raised concerns about the speed of Russia’s work, suggesting that researchers might be cutting corners.
Amid fears that safety could have been compromised, the World Health Organization (WHO) urged Russia last week to follow international guidelines for producing a vaccine against Covid-19.
What do we actually know?
- Vladimir Putin announced on Aug 11, that Russia has approved a vaccine against SARS-CoV-2
- He claimed as part of this announcement that the vaccine is safe and effective
- They also announced mass vaccinations will commence in Oct
- It will be administered in two shots with 21 days between each one
What is a huge concern for many immunologists is that there is no actual verification for any of this. No data has been published, it is simply an announcement.
The name given to the vaccine is “Sputnik V”, and yes with a name like this, the phrase that immediately springs to mind is “Propaganda”.
What we do also know is this …
- Their vaccine consists of adenoviruses that have been given the gene for the spike protein from the coronavirus SARS-CoV-2
- This is a standard approach for a vaccine. This should in theory prime the immune system for an encounter with the actual coronavirus
When a vaccine is developed it goes through the following three phases …
- Phase I – a small number of volunteers. Used to determine a safe dose
- Phase II – more people: Does the vaccine triggers an immune response, and also this is where they look carefully for side effects
- Phase III – Does it actually work?
While Phase II might indeed confirm an actual immune response, you don’t know if it really works until you have conducted a Phase III trial.
What we do know is that they have formally registered Phase I and also Phase II trials. What we also think is that they completed Phase II trials in August.
No results for any of this have been made available, hence none of this is truly verified.
The Clear Conclusion
The rather obvious and clear conclusion here is that they are about to embark upon a mass vaccination exercise without actually verifying that what they have really does work. They will also be selling this to other nations.
- No data from their Phase I and Phase II means we don’t know if it is safe
- With no Phase III, they also don’t really know if it works.
What might go wrong?
- Side effects. Improbable, but possible.
- People take it, believe it works, and it simply does not, so we get the virus rapidly spreading
If it does indeed backfire and fail, it will greatly increase the number of people refusing to accept a fully tested and verified vaccine.
Do we have a Possible COVID-19 Vaccine coming?
WHO announced some details on Aug 13th via a “Draft landscape of COVID-19 candidate vaccines“. There we learn that a number of Phase III trials are currently in progress. Their 9 page document has the details.
COVID-19 Vaccine – Further Reading
Science Based Medicine – Russian and Other COVID Vaccines …
we don’t want to waste time and resources producing millions or billions of doses of a vaccine that doesn’t work well, or produces only short-lived immunity. Diverting production and distribution resources to a vaccine that ultimately does not produce herd immunity will only delay rolling out a more effective vaccine
Respectful Insolence – Sputnik-V: A Russian con job on its COVID-19 vaccine …
It’s a con job designed to make it look as though Russia was the first to develop a coronavirus vaccine that’s safe and effective. One could hardly make a more obvious contrast with the original Sputnik, which involved a real feat of science and technology fused with engineering. Of course, there is always an outside chance that Russia got very, very lucky and that Sputnik-V will actually turn out to be safe and effective at preventing COVID-19 infection in phase 3 trials, but that would just be luck. In the meantime, there is now the very real risk that Russia has just handed the antivaccine movement its best weapon in a very long time.
As for me, I’m as pro-vaccine as they come, but I will not accept a COVID-19 vaccine for myself or my family until it has undergone phase 3 clinical trials demonstrating safety and efficacy.