Why Sputnik V’s first COVID-19 vaccine sounds grim
Sputnik V is it the real deal?
If you’ve seen the most recent headlines, news are springing about Russia finally developing the “first” coronavirus vaccine and has even gained approval for usage. Hearing such news undoubtedly stirs a mix of excitement and relief in us, but is also one that will make you stop in your tracks to ask the most important question: Is it the real deal? With this budding invention, Russia may be initiating another arms race to show off its scientific prowess to the world. Ironically enough, they named their newfound pandemic-ending vaccine “Sputnik V”. Sounds all too familiar, doesn’t it?
At present, we are encountering collapsing economies and a vast majority of countries all over the globe are on the brink of going through a pandemic-induced recession. Collapsing stock markets and unemployment are on the rise during these trying times. Yet there is a thought lingering on my mind: Is Russia railroading the development of this vaccine to gain favours from other countries? There may be points for hesitation from some first world countries as they could possibly be in the process of developing their own vaccine, but what about the third world countries that Russia has extended its hand to be of help to? Are they the experimental subject for further clinical evaluation? Whatever their intent, we can perceive this as a breakthrough that will only surge forth in helping us rebuild the future.
How Does This Affect Us?
There are allegations that this vaccine was done in a timesaving method compromising the quality as it skips doing the third phase of the clinical trials. Before developing the candidate vaccines, there are stages and phases to be followed.
According to educational resources by the College of Physicians of Philadelphia, the history of vaccines:
The first step is laboratory and animal studies. Here you have them:
· Exploratory Stage — This involves basic laboratory research and often lasts 2–4 years.
· Pre-Clinical Stage — Pre-clinical studies use tissue-culture or cell-culture systems and animal testing to assess the safety of the candidate vaccine and its immunogenicity, or ability to provoke an immune response.
· Investigational New Drug (IND) Application — The sponsor describes the manufacturing and testing processes, summarises the laboratory reports, and describes the proposed study. Once presented, the FDA has 30 days to approve the application.
Next step is the Clinical Studies with Human Subjects.
· Phase I Vaccine Trials — A small group of adults around 20–30 subjects will receive the vaccine. The goal of phase 1 testing is to assess the safety of the candidate vaccine and determine the type and extent of the immune response that the vaccine brings about.
· Phase II Vaccine Trial — For Phase II, a requirement of a larger group of several hundred individuals should participate in the candidate vaccine. The goal of Phase II is to study the vaccine’s safety, immunogenicity, proposed dosage, schedule of immunisations, and method of delivery.
· Phase III Vaccine Trials — This stage involves thousands to tens of thousands of people. Successful Phase II candidate vaccines also join this group. One of the goals of Phase III is to assess vaccine safety in a large group of people as specific rare side effects may not appear in a smaller group of subjects tested in the earlier phase.
And the final step is Approval and Licensure.
So the question here is, who would want to be the guinea pig in this desperate time? There are a lot of things to consider whether you’ll open your mind to possibilities or think about other aspects such as what other hazards could happen halfway of its supposed recovery.
Once this vaccine has made its way to the markets, we can only wait in optimism as our global situation slowly goes back to how things used to be, and nations can work on bringing their economies back. Society will start to feel safe again though there are things that we need to reconsider — the side effects. A question of “what if it all fails?” Will Russia be responsible for it? Given that the CDC will investigate the adverse impact, how will VAERS respond to it? Or is it going to be another blame game? Presently, healthcare systems are now crippled, and adding more to the damage will certainly not just collapse one entity but the whole nation itself. If this hits developing countries, chances of survival rate will only be for the affluent, and the depressed community might be eliminated in no time either of sickness or hunger.
As much as I want to live free from worry, my initial instinct was that this is far from what they claim. It is not that I’m sceptical that it might have been done too soon. We have yet to receive evidence that a patient recovered from this COVID-19 using this vaccine. If it is a preventive shot, there are no sufficient reports about its efficacy, We currently standby for a zero result of transmission without using a face mask or any personal preventive equipment (PPE) even when exposed to high potential risk.
Personally, I lean more towards the production of a vaccine that has passed the clinical testing and could provide a data sample of their research to further explain the after-effects of taking the shot. For now, it is still best to stay at home, boost your immune system as much as you can and follow preventive measures to shield yourself from this deadly virus until a vaccine that completed the phases is fully developed. As to date, Wikipedia updated the statistics and there are 20M confirmed cases around the world, making a total of 735K deaths globally.
So, would you dare play the Russian roulette, or see first how the cards play out? It’s your choice.