COVID-19 pandemic is a war against humanity. The problem here is, the enemy is invisible and the characteristics of the enemy and modus operandi, both are still unknown. Nonetheless, the race of making a vaccine seems to surpass all speed records. In a way, the Covid-19 vaccine is the only hope because other hopes, for example, herd immunity looks like a fading optimism.
In the case of vaccine development, a popular maxim is “fast is slow, and slow is fast”. There is a specific timeline for completing each stage of vaccine development. In case of emergency, obviously, things can be fast-tracked, but one can’t just drastically condense the timeline from years to months, which inevitably implies certain compromises.
The global rush for finding an effective vaccine against Coronavirus is essentially led to shortcut methods, and as a result, vaccines might be approved with incomplete data and analysis. Vaccines can be developed from activated and inactivated virus, for example, one SARS-CoV2 vaccine was developed by an inactivated virus and tested in several large cohorts of rhesus monkeys. The result showed that there was no evidence of ADE (Antibody-dependent enhancement). This result surely encouraging data, but there is a need to make sure that any vaccine developed from whether an active or inactive viral strain is safe.
While pharmaceutical companies claim that they take appropriate precautions, needless to say, there should be a proper discussion on how to ethically perform experimental infection studies in humans. On one hand, these studies provide us with significant data in vaccine research, on the other, there are extreme risks associated with it, which can’t be avoidable.
What Actually Covid-19 Vaccine Does Mean to Public Health?
There is no shred of doubt that vaccines are critical to public health, and these are essential to prevent life-threatening or non-life-threatening diseases at a population level. The goal of almost all vaccines is to curb community transmission, and an important objective is to develop a cure that can essentially restrain community transmission. Nonetheless, the process of making a vaccine is tedious and certainly needs to be approved by various complicated channels.
The problem with the Covid-19 vaccine is the authorities, whether government or health organizations, which are obviously funded by governments, are in a frantic rush that apparently makes the outcome being chipped away. We have witnessed in Russia where marketing approval of Covid-19 vaccine was in such a hurry that they didn’t even provide with appropriate data. Well, you may say it’s “Russia”. In the US “Operation Warp Speed” vaccine developers and health authorities are now stressed on speed over fully proved evidence of effectiveness and data. They construct a narrative that is certainly not justifiable when you are dealing with human lives. You can lower the bar of a medicine, obviously if you want to make a fast-tracking antibiotic so to speak, but certainly not for a vaccine.
The supporters of fast-tracking vaccines say that first generation vaccine diminishes the severity of illness, rather than protect against infection. They hope for better research and development, which will be required over the next 2-3 years. Well, that is a sensible statement but not good enough to vouch for the safety of people’s lives. There is a side, proponents of a fast-tracking vaccine who want a rapid mobilization of resources and save millions of lives in the next one year. However, they just leave a significant question unanswered about a cure that would be turned out to be a mess if not test better.
Clinical Trials – Bigger Challenges
One of the biggest challenges of clinical trials of the Covid-19 vaccine is the exclusion of more vulnerable participants. It is a common practice in vaccine initial trials to include only healthy volunteers with homogenous characteristics in terms of age, health, ethnicity, etc. Mostly older people with ailments, pregnant women, children, and people with comorbidities are excluded. Covid-19 vaccine trials have their flaws because these include groups that could result in products that work best in those needing the least.
Since SARS-CoV2 or popularly known as Coronavirus has different strains, it means one single vaccine is highly unlikely to be effective in all populations. In order to make a complete cure, we need different types of vaccines that induce different kinds of immunity. Therefore, a portfolio-driven approach is needed, in which the scientific community collectively works together to complement each other, rather than competing for the same niche.
A potential risk of taking a priori stance for speed over suboptimal trials is the erosion of trust in science by communities at risk. The pandemic has already created a gap between science and practice, and any adverse effect of vaccines will further widen the gap. Suboptimal experiments or ethical practices will definitely roll out suboptimal solutions, which will further create distrust, give reasons to anti-vaxxers to shout and misinformation.
In 1976, the swine flu vaccine was administered resulted in developing a rare neurological disorder called Guillain-Barre Syndrome (GBS). The disorder causes the body’s immune system to damage the nerve cells that could even lead to paralysis. Although among 45 million immunized people, only 450 people were developed this rare disease, that’s not the point. The point is, there is always a chance when a small number of people become the real victim of the pandemic.
What are the Technologies Behind Covid-19 Vaccine?
A significant part of developing a vaccine is to make sure that the safety risks associated with the cure are identified, quantified, and weighed against the benefits. Pathogen-specific antibodies have been associated with disease enhancement, called antibody-dependent enhancement (ADE). This is an immune response when the vaccine is injected or orally administered generates antibodies that are not sufficient enough or neutralize the virus, but further encourage the virus into cells to replicate, aggravating the disease.
There is a good example when in the 1960s children were given formalin-inactivated whole-virus vaccines against the respiratory syncytial virus (RSV) and measles virus. RSV is the main cause of bronchiolitis and pneumonia in the first 1 to 2 years of life. In older people, it causes severe respiratory illness. VAED (Virus-Induced Enhanced Disease Illness) was observed when the vaccine was given to infants and young children in clinical trials.
The studies were quite surprising because RSV infection was not accelerated in unimmunized or an in these studies, the overall incidence of RSV infection was not increased when compared with either an unimmunized or a formalin-inactivated parainfluenza-vaccinated group (FI-PV). Nonetheless, the hospitalization rate was increased for RSV infected children when they were vaccinated with FI-RSV from 6-11 months of age. The severity was studied in a lesser amount in immunized children aged 12-23 months.
Two leading Covid-19 vaccine makers Pfizer Inc. and Moderna come up with first-ever messenger RNA (mRNA) vaccines for human patients. It means a sequence of genetic RNA material developed in a lab, which when injected into a body must invade the cells and hijack cells’ protein-making mechanism called ribosomes. It further produces viral components that train the immune system to fight against the virus.
Obviously, it doesn’t change the genetic code but it works like a USB driver and plugged into a body to run the program without changing anything in the hard drive. Nonetheless, there is no scientific data that there wouldn’t be any unknown risks associated with messenger RNA vaccines, including the local and systematic inflammatory response that could lead to autoimmune disorders.
This new technology doesn’t do anything new but simply asks the body to do the job that it does every day: protein synthesis. The vaccine delivers a sequence of mRNA to our cells, and the rest of human biology takes over.
Here the concern is not the use of mRNA but the long-term efficacy of the vaccine. There are other challenges such as what would be the adverse reactions or lead people to believe that they are immunized but actually they are not. It is nothing less than administration of placebo. This is probably the worst part of this technology when people are complacent because they feel they are immunized and they spread the infection.
So, the moot question is whether we need to take the vaccine or not. The answer is not so straightforward. An elderly person has different priorities because he or she knows the fragility of life and the brevity of their lifespan. However, for a person who is healthy, an informed decision is a much better option. One can think over it and won’t jump to a conclusion right there and see for at least a year whether it really works.