by Dr B. J. C. Perera

Specialist Consultant Paediatrician

Many portals of information of various types of media are agog, enthusiastic and terribly excited with the so-called ‘fantastic news’ of the possibility of the arrival of a vaccine against SARS-CoV-2, the coronavirus that causes the disease COVID-19. This little blight of a virus has been responsible for causing a pandemic that has spread through the entire world like an uncontrollable wildfire, practically causing chaos, disorder and bringing untold misery to virtually every nation on our planet. The Homo sapiens have been eagerly waiting and even praying, for something, be it a medicine or a vaccine, which can be used to tame this microorganism. They, the public, are practically wailing for a respite. There is intense expectation that a vaccine, against this bug would be the panacea for all ills of this nasty disease. There are reports of vaccines in the pipeline that are thought to produce intense protection against the disease. If that is the case, it would indeed be like ‘Manna from Heaven’ for suffering humanity.

There is intense expectation among the general public of the entire world and most definitely in the people of this emerald isle as well, that an effective vaccine against COVID-19 is just round the corner and would be available even within one or two months from now. Yet for all that, it is time, and time well spent at that, to somewhat critically examine the realities of the publicity and hype that has been catalysed by these reports. The general populace is of course totally justified in their expectations following these promulgations from a variety of sources. However, is it really the truth and nothing but the truth? Or is it somewhat far from the real and genuine truth?

Many claims have been made, at least by two of the purported manufacturers of vaccines that their trial vaccines are kind of around 95 per cent effective. These claims seem to be based on provisional and interim results of all phases of animal and human 

clinical trials, announced grandiosely in the public domain, even before proper completion of Phase 3 Clinical Trials. It is pertinent to remind people that Phase 3 Clinical Trials by sheer definition, should involve tens of thousands of human volunteers. By virtue of the lack of completeness of Phase 3 Clinical Trials, none of these claims have been substantiated through publication in reputed Scientific Journals. That really means that there has not been any intense and rigorous scientific scrutiny and peer-review of the results that have been claimed. What we have today are outwardly impressive and dazzlingly attractive statements made by the manufacturers of these vaccines, whose claims have not been

 validated and accepted by a discerning scientific community.

So far, no vaccin e against COVID-19 has been registered under any internationally recognized regulatory authority, or for that matter, even the World Health Organisation (WHO). True enough, the WHO has been examining the feasibility of securing an effective vaccine, its provision to the entire world and the tremendously complicated logistics of its distribution. However, that is really in anticipation of the arrival of a scientifically effective and safe vaccine. It is of course a very wise course of action to follow. If and when such a vaccine arrives, we should not be caught napping.

At least one manufacturer of a vaccine, that has claimed around 95 per cent effectiveness, has suggested that their vaccine would be available for the general public by the first half of 2021, which is just next year and perhaps just a few months from now on. Even then, are we likely to get it in Sri Lanka? Even if we manage to get it, is it for everybody in the country?

It is on record that millions and even billions of doses of the vaccine have already been contracted for and even paid for by some of the countries of the developed Western world. It will probably become a despicable tragedy of vaccine nationalism. ‘I’ and ‘We’ before all others seem to be the buzz phrase. The administration of one notorious leader from a very affluent Western country has compared the global allocation of vaccines against COVID-19 to oxygen masks dropping inside a depressurizing aircraft. They have so pontificated; “You put on your own first, and then we want to help others as quickly as possible”. Incidentally, Sri Lanka has no such contracts with the manufacturers of these vaccines. As these vaccines have not completed safety studies and as no recognized regulatory body has registered them, Sri Lanka is not in a position to make upfront payment and reservations for them either, even if we can garner the money in the face of an economic downfall caused by the virus itself.

At the time of writing of this article in the evening of 23^rd November 2020, it was reported in the media that the G-20 Summit declared that their members would take all necessary steps to ensure equal and equitable distribution of a COVID vaccine to all countries of Mother Earth. To some in the know-how, this may definitely appear to be wishful thinking. Some of these very same countries that made this pledge are the same worthies who, not all that long ago and in the face of global shortages, hoarded supplies of respirators, surgical masks, and gloves for their own hospital workers’ use. Overall, more than 70 countries plus the European Union imposed export controls on local supplies of personal protective equipment, ventilators, or medicines during the first four months of the pandemic. That group also includes most of the countries where potential Covid-19 vaccines are likely to be manufactured. In fact it is well recorded that such hoarding of vital equipment, medicines and vaccines is not new. A case in point is that of a vaccine that was developed in just seven months for the 2009 pandemic of the influenza A virus H1N1, also known as swine flu. That contagion killed as many as 284,000 people globally. But wealthy countries bought up virtually all the supplies of the vaccine. After the World Health Organization appealed and intervened, several of these very same countries agreed to share just 10 per cent of their vaccines with poorer countries. However, the caveat of that ‘magnanimous’ gesture was the stipulation that they would do so only after determining that their remaining supplies would be sufficient to meet their domestic needs. As for the future behaviour patterns of these very same countries regarding a COVID vaccine, your guess is as good as mine. If history is anything worthwhile to go by, they would get up to their tricks, once again.

We have an organisation, The Vaccine and Infectious Diseases Forum of Sri Lanka, which was established over a decade ago. Its objectives are to educate healthcare workers and the public regarding vaccines and vaccination and to have a dialogue with the Ministry of Health on vaccine related matters. It consists of, among others, immunologists, microbiologists, paediatricians, community physicians and family physicians, who practice vaccination and/or have an interest in vaccines. In a recent communiqué, published in The Island Newspaper on 24^th November 2020, they have decreed that the only way that Sri Lanka would get the COVID vaccine would be through COVAX, the initiative of the Global Alliance on Vaccines and Immunization (GAVI), WHO and others. COVAX pledges to give all low and middle income countries equitable access to vaccines. The vaccines will be made available to priority groups. These include healthcare and social care workers, elderly, and persons with chronic non-communicable diseases. However, the most likely chances are that WHO/COVAX would be able to provide some vaccine doses to Sri Lanka only towards the end of 2021. WHO/COVAX has pledged that they would reserve a supply of vaccines necessary for only about 20% of our total population, and Sri Lanka will have to pay for them. They have also indicated that they do not wish to buy vaccines that exceed a cost of 20 US dollars per dose for any country. Apart from anything else, what the reaction of the general public would be to a scenario where only 20 per cent of the population is provided with a vaccine that is claimed to protect against a potentially fatal infection, is indeed mind-boggling. It would not be a surprise at all if the populace decides to get on to the roads in protest. There might even be combative riots.

In a truly scientific sense, the COVID vaccine research studies that have been carried out so far, apart from the claims of around 95 per cent efficacy, have not given us reliable information as to how long the immunity would last, how it might wane over time, the degree of protection in different age groups, whether yearly vaccination like the influenza vaccine would be necessary, whether the effectiveness would be just to prevent symptomatic disease rather than preventing infection by the virus, the absolutely essential logistics of transport of the vaccines, possibilities of major adverse effects that may come on after a protracted period of time, the manufacturing capabilities of the providers and the actual cost of bulk purchases of these vaccines. These are just a few among several other hitherto unanswered questions. In particular, we have no information about the use of the vaccine together with or without physical distancing, hand washing and mask wearing. Would the usage of even an effective vaccine contribute to our getting on with life as it was in the Pre-COVID era? Would it allow us to abandon all the measures advocated by health professionals as proven preventive strategies? These seem to be queries that need to be addressed most urgently and ever so decisively, well before a vaccine is released for general usage.

We need to face the spectre of stark reality in the face of many unknowns in this novel virus infection. There are many significant questions and very few answers. Real and rigorous scholarly science dictates that these have to be firmly and truthfully dealt with before we can claim that we would be able to defeat this marauding virus by using a vaccine. Scientifically unsubstantiated sensational proclamations that trigger public hysteria and the vision of a bright light at the end of the tunnel, are certainly not of the essence, and are very definitely not in the dominion of the desperate need of the hour.

In such a scenario, the general public should consider these contemplations ever so carefully and, of course, sanity should prevail. For at least the time being, it is vitally essential to implement mechanisms to educate the public on getting vulnerable persons to hospital early for management of complications of COVID-19 and to prevent unnecessary deaths. As so eloquently expounded by The Vaccine and Infectious Diseases Forum of Sri Lanka, it cannot be stressed too strongly that it is absolutely essential and undoubtedly crucial to continue vigorously with the public health recommendations on wearing face masks, physical distancing, hand washing and related mechanisms, which have stood the acid test of time, even from the era of the Spanish Flu of 1918.

There is a recent movement known as ‘BLACK LIVES MATTER’ in the Western world. It has taken those countries by storm to protest against injustices to people whose skin colour is black. The Westerners sometimes label South Asians as ‘Brown Sahibs’ because our skin colour is more akin to brown than to real black. In case there comes a time when this world has a safe and effective vaccine against COVID-19, all we can tell the foreign powers who control such a vaccine is that ‘BROWN LIVES MATTER TOO’.