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Covid-19: Potential risks of fast-tracking vaccine

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The clinical development and release of an effective vaccine against any disease is essentially mandated to go through several rigorously controlled testing processes. A vaccine candidate is first identified through pre-clinical evaluations that could involve high quality screening and selecting the proper biological antigen to invoke a defensive immune response. The pre-clinical stages are also necessary to determine approximate dose ranges and proper drug formulations such as oral tablets, drops, syrups or injections. This is also the stage in which the vaccine candidate would be first tested in laboratory animals or on human cells in the laboratory, prior to moving to the clinical stage of actual human trials.

The subsequent clinical stages of human trials are a three-phase process. Each phase tests larger and larger groups of humans. During Phase I, small groups of human subjects, perhaps 50 or so in each group, receive the trial vaccine. It primarily assesses the safety of the vaccine in healthy people. In Phase II, the clinical study is expanded and vaccine is given to a larger group of people, maybe a few hundreds, who have the characteristics such as age and physical health, similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people, with as broad a cross-section of people as possible, and tested for efficacy and safety. Many vaccines also undergo Phase IV formal, on-going studies after the vaccine is approved, licensed and administered to humans. All these processes are known to take years, sometimes as much as 10 years. It is a very meticulously formulated and long drawn out route to ensure the efficacy and safety of vaccines.

In the case of a COVID vaccine, we really do not have the luxury of spending years on this process. However, if one was to try and condense the timelines from years to months, it is quite obvious that it would necessarily have to entertain compromises. Currently there is a world-wide rush to find a safe and effective vaccine against Covid-19. Experts and companies claim one could be on the market in 12–18 months. The President of the United States of America wants one by the end of the year. According to the World Health Organization (WHO), a significant number of candidate vaccines are in clinical trials, with a couple already in Phase III and several others likely to enter those final stages. The plethora of COVID-19 vaccines in development gives us many attempts at getting a potentially useful vaccine. But it has to be stated clearly and unequivocally that rushed development could mean missing information about long-term safety and the levels of protection. The accelerated speed of development of the COVID vaccines has public health experts gravely concerned that vaccines might be approved with incomplete data and analysis.

This apprehension intensifies because many of the vaccine platforms in development against Covid-19 are unproven new technologies. Byram Bridle, a viral immunologist at the University of Guelph in Canada, who has received Covid-focused funding to develop a new vaccine, has said “Developing a vaccine even in about a year is unprecedented. As a scientist with expertise in the field I am personally concerned that conducting science too fast could risk compromising the rigour needed to properly assess vaccines”.

Among the top fears is the potential that a fast-tracked vaccine will have unintended side-effects. No vaccine is 100% safe, but if a billion people are vaccinated, a one in 10,000 serious adverse event will affect 100,000 of those people. In May, it was revealed that four out of 45 people in Moderna’s Phase 1 COVID vaccine trial experienced ‘medically significant’ adverse events. The most important thing is to stringently ensure that fast tracking does not mean major compromisation on safety or efficacy. Rarer adverse events need even larger trials, and as explained by Gregory Poland, Director of vaccines research at the Mayo Clinic in Minnesota, USA, ‘We won’t know about rare events until after the vaccine is licensed”.

One potential adverse event is antibody-dependent enhancement (ADE), a type of immune reaction where vaccination makes subsequent exposure to the virus more dangerous. This condition has been observed with some vaccines for the dengue virus, as well as in animal models for the original Severe Acute Respiratory Syndrome (SARS) virus. ADE occurs when the body, primed by a vaccine, generates antibodies that do not sufficiently neutralise the virus when later exposed to it and instead encourage the virus to get into cells and replicate, exacerbating the disease.

However, there is still a lot we do not know about coronaviruses, which is another concern with speedy vaccine development. For example, the question mark over immunity; are antibodies protective and how long does immunity last? Bridle says fast tracking vaccines risks compromising assessments of immunological memory. Arguably, a vaccine against Covid-19 should confer immunity for more than one year to reduce the risk of future recurrences. But how long would it take to determine if a vaccine can confer immunological memory for one year? Of course, it would take at least one year. So how does that fit into the goal of getting a vaccine into broad public use in under a year? Any vaccine is useless if it does not confer long-term immunological memory to respond when exposed to the virus.

Currently a somewhat controversial scenario has developed in the COVID vaccine development. In Phase III trials it is necessary to give the vaccine to a group of normal individuals the test vaccine and give another comparable group a placebo and all participants then have to go about their life as usual. They are all followed up for a prolonged period to see whether the vaccine protects against the disease. This will invariably take a long time. Until enough of the participants get the disease, there will not be sufficient data to draw worthwhile conclusions. To get over this requirement of prolonged observations, some people are now starting to advocate a more controversial model. Instead of waiting for any of the participants to contract the disease naturally, if at all, what if we give a set of willing volunteers in the vaccine group, the virus on purpose? These are called ‘Human Challenge Trials’. In some countries there are volunteers who have come forward to be willing to be exposed to the virus after vaccination with the trial vaccine. They have expressed various altruistic sentiments to speed up things so that the rest of humanity would benefit. Researchers had done such trials with a Typhoid Vaccine in the UK in 2016. The researchers in that trial felt that they saved three to four years of observations by that manoeuvre. In human challenge trials of a COVID vaccine, the entire process could be shortened to a matter of months.

 

However, and this is the real crux of the matter, in the human challenge trials which had been conducted for other diseases like typhoid, cholera, malaria etc, we do have effective treatments for those diseases. No one has actually died in those studies because if the vaccine was unsuccessful, they could be treated. That is where COVID-19 is in a special group. WE HAVE NO EFFECTIVE SPECIFIC TREATMENT FOR IT. If in a human challenge trial for COVID-19, the vaccine fails, there may be deaths of some of the volunteers. Such a trial in COVID-19 vaccine would be conducted in young healthy and much narrower group of people than in a conventional Phase III trial. It is to their eternal credit that these brave volunteers are prepared to take that small risk if their participation would help wider humanity. Yet for all that the risks are very real. In addition, if it works in that set of people, we will not be able to say for sure whether the vaccine will work as well in a wider cross-section of ordinary people and particularly in the elderly. Also, there are the potential prospects of some long-term effects of COVID-19, even in young people. Some authorities have labelled the human challenge trials as a ‘morally murky way’ of speeding up the COVID-19 vaccine process

Yet for all this, any risk of harm or death in a challenge study for COVID-19 would completely set it apart from all other challenge studies. Obviously, in the face of all this, many vaccine researchers would be reluctant to go into such trials for a COVID vaccine. However, the Oxford group that is doing Phase III trials on their vaccine are considering a challenge study by the end of the year. If the conventional Phase III trials that are currently being conducted find a useful vaccine, we may never have to do human challenge studies in COVID-19.

Ensuring a vaccine is safe and effective will be essential in keeping the public trust in vaccines. There is a risk that a fast-tracked vaccine could dent this and compromise vaccination programmes. Already in the US, around 30% of the public say they would reject a COVID vaccine, according to various surveys. Poland says policies have to be driven by science and effectively communicated to the public. But with economies flagging from the health crisis, will society accept more risk in a vaccine? That could be the case with Covid-19. Poland says the risk­–benefit ratio of all vaccines will be carefully reviewed by authorities but notes that risk boundaries are subjective.

To be quite fair, even a not so perfect vaccine, that could provide at least more than 50 per cent protection, could still slow the spread of the disease and save lives. But safety and efficacy concerns aside, there is more at stake here. Covid-19 will not be the only coronavirus pandemic in the future. The risk is if we do not build on the scientific gains once this pandemic recedes and if we fail to use the data and technology to be ready to develop a safe and effective vaccine for the next coronavirus or any other blight for that matter. It is obvious that the entire world would then be at grave risk in the future.


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Islamophobia and the threat to democratic development

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There’s an ill more dangerous and pervasive than the Coronavirus that’s currently sweeping Sri Lanka. That is the fear to express one’s convictions. Across the public sector of the country in particular many persons holding high office are stringently regulating and controlling the voices of their consciences and this bodes ill for all and the country.

The corrupting impact of fear was discussed in this column a couple of weeks ago when dealing with the military coup in Myanmar. It stands to the enduring credit of ousted Myanmarese Head of Government Aung San Suu Kyi that she, perhaps for the first time in the history of modern political thought, singled out fear, and not power, as the principal cause of corruption within the individual; powerful or otherwise.

To be sure, power corrupts but the corrupting impact of fear is graver and more devastating. For instance, the fear in a person holding ministerial office or in a senior public sector official, that he would lose position and power as a result of speaking out his convictions and sincere beliefs on matters of the first importance, would lead to a country’s ills going unaddressed and uncorrected.

Besides, the individual concerned would be devaluing himself in the eyes of all irrevocably and revealing himself to be a person who would be willing to compromise his moral integrity for petty worldly gain or a ‘mess of pottage’. This happens all the while in Lankan public life. Some of those who have wielded and are wielding immense power in Sri Lanka leave very much to be desired from these standards.

It could be said that fear has prevented Sri Lanka from growing in every vital respect over the decades and has earned for itself the notoriety of being a directionless country.

All these ills and more are contained in the current controversy in Sri Lanka over the disposal of the bodies of Covid victims, for example. The Sri Lankan polity has no choice but to abide by scientific advice on this question. Since authorities of the standing of even the WHO have declared that the burial of the bodies of those dying of Covid could not prove to be injurious to the wider public, the Sri Lankan health authorities could go ahead and sanction the burying of the bodies concerned. What’s preventing the local authorities from taking this course since they claim to be on the side of science? Who or what are they fearing? This is the issue that’s crying out to be probed and answered.

Considering the need for absolute truthfulness and honesty on the part of all relevant persons and quarters in matters such as these, the latter have no choice but to resign from their positions if they are prevented from following the dictates of their consciences. If they are firmly convinced that burials could bring no harm, they are obliged to take up the position that burials should be allowed.

If any ‘higher authority’ is preventing them from allowing burials, our ministers and officials are conscience-bound to renounce their positions in protest, rather than behave compromisingly and engage in ‘double think’ and ‘double talk’. By adopting the latter course they are helping none but keeping the country in a state of chronic uncertainty, which is a handy recipe for social instabiliy and division.

In the Sri Lankan context, the failure on the part of the quarters that matter to follow scientific advice on the burials question could result in the aggravation of Islamophobia, or hatred of the practitioners of Islam, in the country. Sri Lanka could do without this latter phobia and hatred on account of its implications for national stability and development. The 30 year war against separatist forces was all about the prevention by military means of ‘nation-breaking’. The disastrous results for Sri Lanka from this war are continuing to weigh it down and are part of the international offensive against Sri Lanka in the UNHCR.

However, Islamophobia is an almost world wide phenomenon. It was greatly strengthened during Donald Trump’s presidential tenure in the US. While in office Trump resorted to the divisive ruling strategy of quite a few populist authoritarian rulers of the South. Essentially, the manoeuvre is to divide and rule by pandering to the racial prejudices of majority communities.

It has happened continually in Sri Lanka. In the initial post-independence years and for several decades after, it was a case of some populist politicians of the South whipping-up anti-Tamil sentiments. Some Tamil politicians did likewise in respect of the majority community. No doubt, both such quarters have done Sri Lanka immeasurable harm. By failing to follow scientific advice on the burial question and by not doing what is right, Sri Lanka’s current authorities are opening themselves to the charge that they are pandering to religious extremists among the majority community.

The murderous, destructive course of action adopted by some extremist sections among Muslim communities world wide, including of course Sri Lanka, has not earned the condemnation it deserves from moderate Muslims who make-up the preponderant majority in the Muslim community. It is up to moderate opinion in the latter collectivity to come out more strongly and persuasively against religious extremists in their midst. It will prove to have a cementing and unifying impact among communities.

It is not sufficiently appreciated by governments in the global South in particular that by voicing for religious and racial unity and by working consistently towards it, they would be strengthening democratic development, which is an essential condition for a country’s growth in all senses.

A ‘divided house’ is doomed to fall; this is the lesson of history. ‘National security’ cannot be had without human security and peaceful living among communities is central to the latter. There cannot be any ‘double talk’ or ‘politically correct’ opinions on this question. Truth and falsehood are the only valid categories of thought and speech.

Those in authority everywhere claiming to be democratic need to adopt a scientific outlook on this issue as well. Studies conducted on plural societies in South Asia, for example, reveal that the promotion of friendly, cordial ties among communities invariably brings about healing among estranged groups and produces social peace. This is the truth that is waiting to be acted upon.

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Pakistan’s love of Sri Lanka

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By Sanjeewa Jayaweera

It was on 3rd January 1972 that our family arrived in Karachi from Moscow. Our departure from Moscow had been delayed for a few weeks due to the military confrontation between Pakistan and India. It ended on 16th December 1971. After that, international flights were not permitted for some time.

The contrast between Moscow and Karachi was unbelievable. First and foremost, Moscow’s temperature was near minus 40 degrees centigrade, while in Karachi, it was sunny and a warm 28 degrees centigrade. However, what struck us most was the extreme warmth with which the airport authorities greeted our family. As my father was a diplomat, we were quickly ushered to the airport’s VIP Lounge. We were in transit on our way to Rawalpindi, the airport serving the capital of Islamabad.

We quickly realized that the word “we are from Sri Lanka” opened all doors just as saying “open sesame” gained entry to Aladdin’s cave! The broad smile, extreme courtesy, and genuine warmth we received from the Pakistani people were unbelievable.

This was all to do with Mrs Sirima Bandaranaike’s decision to allow Pakistani aircraft to land in Colombo to refuel on the way to Dhaka in East Pakistan during the military confrontation between Pakistan and India. It was a brave decision by Mrs Bandaranaike (Mrs B), and the successive governments and Sri Lanka people are still enjoying the fruits of it. Pakistan has been a steadfast and loyal supporter of our country. They have come to our assistance time and again in times of great need when many have turned their back on us. They have indeed been an “all-weather” friend of our country.

Getting back to 1972, I was an early beneficiary of Pakistani people’s love for Sri Lankans. I failed the entrance exam to gain entry to the only English medium school in Islamabad! However, when I met the Principal, along with my father, he said, “Sanjeewa, although you failed the entrance exam, I will this time make an exception as Sri Lankans are our dear friends.” After that, the joke around the family dinner table was that I owed my education in Pakistan to Mrs B!

At school, my brother and I were extended a warm welcome and always greeted “our good friends from Sri Lanka.” I felt when playing cricket for our college; our runs were cheered more loudly than of others.

One particular incident that I remember well was when the Embassy received a telex from the Foreign inistry. It requested that our High Commissioner seek an immediate meeting with the Prime Minister of Pakistan, Mr Zulifikar Ali Bhutto (ZB), and convey a message from Mrs B. The message requested that an urgent shipment of rice be dispatched to Sri Lanka as there would be an imminent rice shortage. As the Ambassador was not in the station, the responsibility devolved on my father.

It usually takes about a week or more to get an audience with the Prime Minister (PM) of a foreign country due to their busy schedule. However, given the urgency, my father spoke to the Foreign Ministry’s Permanent Sectary, who fortunately was our neighbour and sought an urgent appointment. My father received a call from the PM’s secretary around 10 P.M asking him to come over to the PM’s residence. My father met ZB around midnight. ZB was about to retire to bed and, as such, was in his pyjamas and gown enjoying a cigar! He had greeted my father and had asked, “Mr Jayaweera, what can we do for great friend Madam Bandaranaike?. My father conveyed the message from Colombo and quietly mentioned that there would be riots in the country if there is no rice!

ZB had immediately got the Food Commissioner of Pakistan on the line and said, “I want a shipload of rice to be in Colombo within the next 72 hours!” The Food Commissioner reverted within a few minutes, saying that nothing was available and the last export shipment had left the port only a few hours ago to another country. ZB had instructed to turn the ship around and send it to Colombo. This despite protests from the Food Commissioner about terms and conditions of the Letter of Credit prohibiting non-delivery. Sri Lanka got its delivery of rice!

The next was the visit of Mrs B to Pakistan. On arrival in Rawalpindi airport, she was given a hero’s welcome, which Pakistan had previously only offered to President Gaddafi of Libya, who financially backed Pakistan with his oil money. That day, I missed school and accompanied my parents to the airport. On our way, we witnessed thousands of people had gathered by the roadside to welcome Mrs B.

When we walked to the airport’s tarmac, thousands of people were standing in temporary stands waving Sri Lanka and Pakistan flags and chanting “Sri Lanka Pakistan Zindabad.” The noise emanating from the crowd was as loud and passionate as the cheering that the Pakistani cricket team received during a test match. It was electric!

I believe she was only the second head of state given the privilege of addressing both assemblies of Parliament. The other being Gaddafi. There was genuine affection from Mrs B amongst the people of Pakistan.

I always remember the indefatigable efforts of Mr Abdul Haffez Kardar, a cabinet minister and the President of the Pakistan Cricket Board. From around 1973 onwards, he passionately championed Sri Lanka’s cause to be admitted as a full member of the International Cricket Council (ICC) and granted test status. Every year, he would propose at the ICC’s annual meeting, but England and Australia’s veto kept us out until 1981.

I always felt that our Cricket Board made a mistake by not inviting Pakistan to play our inaugural test match. We should have appreciated Mr Kardar and Pakistan’s efforts. In 1974 the Pakistan board invited our team for a tour involving three test matches and a few first-class games. Most of those who played in our first test match was part of that tour, and no doubt gained significant exposure playing against a highly talented Pakistani team.

Several Pakistani greats were part of the Pakistan and India team that played a match soon after the Central Bank bomb in Colombo to prove that it was safe to play cricket in Colombo. It was a magnificent gesture by both Pakistan and India. Our greatest cricket triumph was in Pakistan when we won the World Cup in 1996. I am sure the players and those who watched the match on TV will remember the passionate support our team received that night from the Pakistani crowd. It was like playing at home!

I also recall reading about how the Pakistani government air freighted several Multi Barrell artillery guns and ammunition to Sri Lanka when the A rmy camp in Jaffna was under severe threat from the LTTE. This was even more important than the shipload of rice that ZB sent. This was crucial as most other countries refused to sell arms to our country during the war.

Time and again, Pakistan has steadfastly supported our country’s cause at the UNHCR. No doubt this year, too, their diplomats will work tirelessly to assist our country.

We extend a warm welcome to Mr Imran Khan, the Prime Minister of Pakistan. He is a truly inspirational individual who was undoubtedly an excellent cricketer. Since retirement from cricket, he has decided to get involved in politics, and after several years of patiently building up his support base, he won the last parliamentary elections. I hope that just as much as he galvanized Sri Lankan cricketers, his political journey would act as a catalyst for people like Kumar Sangakkara and Mahela Jayawardene to get involved in politics. Cricket has been called a “gentleman’s game.” Whilst politics is far from it!.

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Covid-19 health rules disregarded at entertainment venues?

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Believe me, seeing certain videos, on social media, depicting action, on the dance floor, at some of these entertainment venues, got me wondering whether this Coronavirus pandemic is REAL!

To those having a good time, at these particular venues, and, I guess, the management, as well, what the world is experiencing now doesn’t seem to be their concerned.

Obviously, such irresponsible behaviour could create more problems for those who are battling to halt the spread of Covid-19, and the new viriant of Covid, in our part of the world.

The videos, on display, on social media, show certain venues, packed to capacity – with hardly anyone wearing a mask, and social distancing…only a dream..

How can one think of social distancing while gyrating, on a dance floor, that is over crowded!

If this trend continues, it wouldn’t be a surprise if Coronavirus makes its presence felt…at such venues.

And, then, what happens to the entertainment scene, and those involved in this field, especially the musicians? No work, whatsoever!

Lots of countries have closed nightclubs, and venues, where people gather, in order to curtail the spread of this deadly virus that has already claimed the lives of thousands.

Thailand did it and the country is still having lots of restrictions, where entertainment is concerned, and that is probably the reason why Thailand has been able to control the spread of the Coronavirus.

With a population of over 69 million, they have had (so far), a little over 25,000 cases, and 83 deaths, while we, with a population of around 21 million, have over 80,000 cases, and more than 450 deaths.

I’m not saying we should do away with entertainment – totally – but we need to follow a format, connected with the ‘new normal,’ where masks and social distancing are mandatory requirements at these venues. And, dancing, I believe, should be banned, at least temporarily, as one can’t maintain the required social distance, while on the dance floor, especially after drinks.

Police spokesman DIG Ajith Rohana keeps emphasising, on TV, radio, and in the newspapers, the need to adhere to the health regulations, now in force, and that those who fail to do so would be penalised.

He has also stated that plainclothes officers would move around to apprehend such offenders.

Perhaps, he should instruct his officers to pay surprise visits to some of these entertainment venues.

He would certainly have more than a bus load of offenders to be whisked off for PCR/Rapid Antigen tests!

I need to quote what Dr. H.T. Wickremasinghe said in his article, published in The Island of Tuesday, February 16th, 2021:

“…let me conclude, while emphasising the need to continue our general public health measures, such as wearing masks, social distancing, and avoiding crowded gatherings, to reduce the risk of contact with an infected person.

“There is no science to beat common sense.”

But…do some of our folks have this thing called COMMON SENSE!

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