There is quite a bit of apprehension as to whether the vaccines were ‘rushed’. The scientists assure us that no safety steps were either cut down or even short-circuited.
by Dr B. J. C. Perera
Just about a year or so into the coronavirus pandemic, the thing that is in everyone’s mind, as well as in their hearts and souls, is the COVID-19 vaccine that is thought to be one of the answers to the problem. The disease has taken a frightful toll. Many have died and scores of others have suffered immeasurably, directly as well as indirectly. Many countries are in shambles and most of us are wondering as to what would come next.
As at present, there are several vaccines that have been rolled out and some are being administered in committed immunisation programmes in quite a few countries. This is no mean feat as these vaccines have been manufactured, tested and licensed in double-quick time. We, too, in this resplendent isle, have now got some stocks of the vaccine, through the generosity of several countries and institutions. The future plans are to deploy the vaccines globally in a dedicated effort towards controlling this blight that has caused all this mayhem. It speaks so much for the brilliance, dedication and commitment of many scientists that a process that normally takes several years has been shortened to just under a year.
Yet, for all that, this spectacle of the shortening of the time-frame has led to many questions being asked in several quarters and some inclinations of suspicion, and even mistrust, being expressed by some. This has been further amplified by the novel technology employed in producing the vaccines. However, there is hardly any doubt that vaccines are the principal tool by which we can challenge this pandemic which is now going onto its second year. If we are to have any worthwhile hope of getting back to some sort of “normalcy” and saving countless millions of lives, extensive immunity, through vaccine inoculation, is of the essence. There is incontrovertible evidence that the currently available vaccines do produce a reasonable degree of protection, especially against the severity of the disease, by mobilising the resources of the human immune system. They are likely to reduce the morbidity and the mortality of the disease. However, we do not know for sure whether it would prevent the spread from person to person. In addition, we also do not know for sure as to how long the immunity would last in the vaccinated people. These would need to be sorted out once more scientific information is available post-vaccination.
There is quite a bit of apprehension as to whether the vaccines were ‘rushed’. The scientists assure us that no safety steps were either cut down or even short-circuited. These vaccines have gone through the mill of testing in several Standard Phase Clinical Trials, just like any others that have been in use for many other contagious infective diseases. True enough, the timelines have been considerably shortened but the due processes have been followed. All three phases of research trials have been undertaken, albeit at a fast-tracked pace. The efficacy, safety and tolerability have been adequately looked into. None of these steps have been omitted or side-tracked for the Pfizer, Moderna or AstraZeneca vaccine development processes. In fact, mainly due to the extensive occurrence of the disease and the committed focus on developing a vaccine, there was no shortage of patients with the disease and there were more than enough subjects ready to be enrolled into trials as well as sufficient funds were available to conduct the research work that was needed. It may be a surprise but it is a fact of life in these circumstances and it is indeed most encouraging to see the way science has progressed in leaps and bounds to move that much faster through sheer necessity, to do all the work necessary in producing effective vaccines.
As for the safety of these vaccines, the detailed studies that were conducted over a period of about 9-10 months have shown them to be safe. The Phase 3 studies for all the major vaccine candidates are still ongoing. Furthermore, many side-effects from vaccines occur within a short period vaccination and as trials have been going on since April 2020, these reactions would have already been seen. There has been mild undesirable effect but so far, no major side-effects have been reported in a scale that would invalidate the vaccines. However, we have to await further results of the research endeavours to know about any possible long-term side effects. These would usually come through post-marketing surveillance.
In fact, BioNtech and Moderna have been working on their proprietary messenger ribonucleic acid (mRNA) technology long before COVID-19 came into the arena. They knew a lot even about the vagaries of the process. Scientists view this expertise as a ground-breaker when it comes to vaccine advancement; cutting down development time and thereby making mRNA candidates cheaper and more amiable to be custom-made than the traditional vaccine candidates.
There are some concerns expressed by many as to whether the mRNA vaccines could alter the deoxy ribonucleic acid (DNA) of humans. So far there is no tangible evidence that this is the case. Apparently, mRNA does not alter or interfere with DNA as it does not hang around in humans for long periods of time. It crumbles and disappears after a certain short time and thereby are thought to be even safer than old-style vaccines. Traditional live vaccines inject small amounts of the live virus and attenuated vaccines inject the inactivated virus into the body. With mRNA, it is only a kind of a blue-print of a recognisable component of the organism that is injected.
The well-known target of a vaccine is to teach the body defences to detect and recognise the causative organism of a disease. When a virus infects a host cell, the virus releases its RNA which gets into the host cell nucleus and reproduces itself using host cell machinery. Viral mRNA then copies viral RNA into proteins which then reassemble as more viruses. These newly synthesised viruses enter into the host cell blood stream and then all hell breaks loose.
The current mRNA vaccines generally recreate the blue-print of the outer shell or the spike protein of the virus. The spikes are the components that enable the virus to attach itself and get into the host cells. Therefore, anything that can interfere with these spikes will knock off the virus before it can get into the human cells. All that the vaccines do is to induce the human immune systems to recognise and interfere with the spike proteins. Our immune system recognises Sars-Cov-2 via the spike protein and by sending some “placebo-like” spike proteins into the system via the vaccine, it gives them an early start in being prepared for potential infection. Members of our immune system are usually moving around in the bloodstream looking for possible ‘none-self’ intruders. When these sentinels come across the spike proteins, they launch an immune response. That would be the end of the story for the virus.
Having said all this, there is a current dilemma that needs to be addressed urgently. Very recently, both AstraZeneca and Pfizer have reported considerable delays in production and supply of their vaccines. As if we do not have enough problems on our hands due to this blight of a virus, this adds another dimension to the equation of the equity of provision of the vaccines to those desperately needy people of our planet. This graphically highlights the massive constraint the world is facing in getting everyone, everywhere, vaccinated because of the exclusive rights pharmaceutical companies hold over who is allowed to produce and manufacture their vaccines. Given the current crisis, this is very definitely quite unacceptable. While every week higher and higher new infection records are hit, hospitals are overwhelmed, and people struggle to feed their families, pharmaceutical companies ‘cherry-pick’ as to who gets access to vaccines. Commercial interests and filthy lucre seem to rule the entire scenario. The market will not solve this challenge. What we need are exceptional measures and incomparable leadership from the statesmen and stateswomen of the world to solve this problem. It is time to call a spade, just that – a spade.
Dr. B. J. C. Perera, MBBS(Cey), DCH(Cey), DCH(Eng), MD(Paed), MRCP(UK), FRCP(Edin), FRCP(Lon), FRCPCH(UK), FSLCPaed, FCCP, Hony FRCPCH(UK), Hony. FCGP(SL), is Specialist Consultant Paediatrician
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