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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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Why record export earnings may not be good news

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By Gomi Senadhira

The press release by the Central Bank on the external sector performance ,in June 2022, perhaps was the first piece of good news we had received for a long time. According to the press release, “Earnings from merchandise exports, in June 2022, increased by 23.9 percent over the corresponding month, in 2021, recording US dollars 1,248 million, which is the highest ever monthly export earnings recorded. An increase in earnings of both industrial and agricultural exports contributed to this favourable outcome, …. Cumulative export earnings, from January to June 2022, also increased by 14.3 percent, over the same period in the last year, amounting to US dollars 6,514 million.” So, most of us would think we have enough dollars to cover our essential imports. But, apparently, that is not the case.

Earlier, the Central Bank Governor, Dr. Nandalal Weerasinghe, had said that exporters only converted about 20% of their export earnings into Sri Lankan Rupees and the rest was not brought back to Sri Lanka. That amounts to the US $800 million a month! The Governor had also said “… At least 40% of the total export earnings should be added to the formal financial system of the country. So exporters have a responsibility, at a very difficult time like this, to bring back their foreign exchange, through the banking system, and if that happens, then we can resolve the fuel crisis comfortably.”

(Diesel shipment that arrived in Colombo, on 16 July, still not paid for want of dollars – The Island July 30th) It appears as if the Governor is pleading with the exporters to bring back at least 40% of their export earnings. More notably, from Dr Weerasinghe’s statement, it is clear that the exporter had only converted 20% of their export earnings to rupees during the last five months. Did they convert their export earnings to rupees during the last year, or in the previous years? For how long has this been going on? When the Central Bank says “… exporters have a responsibility, at a very difficult time like this, to bring back their foreign exchange, through the banking system,” does that mean the foreign exchange earned, with the exports, is brought through the hawala network, or other similar arrangements?

Exporters deserve credit for the great service they provide and should be rewarded, appropriately. But not disproportionately. The export earnings are not earned by the exporters alone. These earnings are earned by all those who contribute to manufacturing the export products. All of them should be getting their fair share of the export proceeds. If not, there is something terribly wrong with the system. Is this normal in international trade?

During the last few years, some of the studies by Indian scholars, including Utsa Patnaik and Shashi Tharoor, have placed in the public domain some of the less known facts on the effects of the British colonial rule on India. They explain how the British seized India, “… one of the richest countries in the world – accounting for 27% of global GDP in 1700 – and, over 200 years of colonial rule, reduced it to one of the world’s poorest,” and how during the period British Raj siphoned out $45 trillion from India.

How was this done? Patnaik explains, “In the colonial era, most of India’s sizeable foreign exchange earnings went straight to London—severely hampering the country’s ability to import machinery and technology in order to embark on a modernisation path, similar to what Japan did in the 1870s. …, a third of India’s budgetary revenues was … set aside as ‘expenditure abroad’. The secretary of state (SoS) for India, based in London, invited foreign importers to deposit with him the payment (in gold and sterling) for their net imports from India, which disappeared into the SoS’s account in the Bank of England. Against these Indian earnings he issued bills… to an equivalent rupee value—which was paid out of the budget, from the part called ‘expenditure abroad’.” Patnaik underlines that this was “something you’d never find in any independent country,”

But it appears something very similar is happening in Sri Lanka, many years after the independence! If the exporters do not “bring back their foreign exchange ,through the banking system,” or only bring back 20% of it, then how do they pay for goods and services obtained locally? The local value addition for most of our exports is 70% to 80% or higher! The only major exception is cut and polished diamonds. Tea exporters buy tea with rupees. Some of the imported inputs, like fertiliser, or diesel, are sourced locally! The garment industry had moved up the value chain during the last 40 years and provide many value-added services, like designing, locally.

How do the exporters pay for all these goods and services, if they keep more than 60% of their export earnings outside the country? Do they get it through “hawala” or similar arrangements? During the British Raj, payments to local producers were done with the taxes collected by the Raj. In present-day Sri Lanka, how does one manage to raise a large amount of cash to operate such a system?

If a sizeable chunk of Sri Lanka’s foreign exchange earnings goes straight to banks in London, New York, Zurich, or elsewhere, severely hampering the country’s ability to import essential items, doesn’t that mean, Sri Lanka’s wealth is getting siphoned out through our exports? And there is not much of a difference between what happened during the colonial period and the post independent Sri Lanka!

So, June’s record export earnings also mean nearly US$ billion was siphoned off during the month! A new record for the month of June! And that means Patnaik was wrong when she said this was not “something you’d never find in any independent country”

That is not good news.

(The writer is a specialist on trade and development issues and can be contacted at senadhiragomi@gmail.com)

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Improving trend needs to be sustained on multiple fronts

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by Jehan Perera

The government appears to have secured political stability in the short term.  So far President Ranil Wickremesinghe’s efforts to restore stability appear to be working. Political stability is necessary for decisions to be made and kept.  It is a necessary element for international support to come in.  One of the IMF’s conditions to provide the country with the multi-billion-dollar loan it seeks is political stability that would ensure that commitments that are made will be kept.  The protest movement has not mobilised public demonstrations on the very large scale of the past after the appearance of Ranil Wickremesinghe in leadership positions, initially as prime minister and subsequently as president. This would be seen as an achievement by the government.  The present governmental line that protests should be within the law is difficult, and also frightening, to challenge when a state of emergency is in force.

The government has shown its ability to wield the emergency law with deterrent effect. Under the state of emergency that President Wickremesinghe declared on July 18, the period that a person may be detained before being brought before a magistrate has been increased from 24 to 72 hours. The authorities have been granted additional powers of search and arrest, and the military has been empowered to detain people for up to a day without disclosing their detention. The state of emergency also gives the president and the police broad powers to ban public gatherings, allows the police or military to order anyone to leave any public place or face arrest, and makes it an offense to cause “disaffection” or to spread “rumours.” However, in a sign that Sri Lanka’s system of checks and balances is still working, the Colombo Chief Magistrate’s Court has rejected a request by the police to ban a public protest planned by political parties and multiple organisations on September 9.

Human Rights watch has pointed out that “these provisions are vague, overly broad, and disproportionate in violation of the rights to freedom of expression, peaceful assembly, association, and movement.”  The midnight strike on the protestors who had camped for over three months at the main protest site at Galle Face would make any reasonable person think twice before getting into physical confrontation with the government.  The social media coverage of events that night showed men in black uniform and wearing masks, attacking the unarmed protestors.  As these men did not wear identification badges, there is a question whether they were part of the official security forces or drawn from other groups that work with them.  This response brought discredit to the perpetrators and disturbed both Sri Lankan people and the international community that have the welfare of Sri Lanka at heart.

The government has also used the full power of the draconian law to ensure that the leadership of the protest movement is neutralised. Several of them have been arrested, some of them given bail, others remanded, which would send a chilling message to the others.  The government has also shown its willingness to offer high positions to those who are prepared to join it.  This has led to a situation where two trade union leaders active in the protest movement have been treated very differently.  One has been offered a high post while the other has been put into prison, although he has now been given bail.  In a signal that he is sensitive to public pressure and human rights concerns, President Wickremesinghe had spoken to leader of the Ceylon Teachers Union, Joseph Stalin, after he was remanded and reportedly said he admires the members of the protest movement who talk of a system change.

ECONOMIC STABILISATION

Apart from the appearance of political stability there is also the appearance of economic stabilisation.  The shortages of cooking gas, petrol and diesel, and the 13-hour power cuts were among the main catalysts of the protest movement.  It was during the period of long power cuts, when staying at home became unbearable, that neigbourhood groups began to converge in urban centres to hold candlelight protests.  However, at this time the supply of gas, petrol and diesel has improved significantly and the kilomere-long lines in front of fuel stations are much less common.  Credit has gone to the QR code system put in place that gives to each vehicle a weekly quota.

The challenge for the government is to ensure that the economic situation continues to be stable without experiencing the acute shortages of key items that causes distress to the general population.  The QR code system can only work if there is petrol and diesel to be distributed.  The current imports of cooking gas, petrol and diesel appear to have been made possible by a World Bank loan which was re-purposed to the purchase of essential items.  However, these funds will dry up soon.  The question is what will happen after that.  There is apprehension that the country will fall once again into a situation of severe shortage.  The government needs to take the people into its confidence regarding the future.  The government also needs to be trusted if it is to be believed.

The World Bank has given an indication that they are still to be convinced regarding the provision of further assistance to Sri Lanka.  Earlier this month, the World Bank issued a statement “expressing deep concern about the dire economic situation and its impact on the people of Sri Lanka yesterday said it does not plan to offer new financing to Sri Lanka until an adequate macroeconomic policy framework is in place.  Issuing a statement, the World Bank Group said it is repurposing resources under existing loans in its portfolio to help alleviate severe shortages of essential items such as medicines, cooking gas, fertiliser, meals for school children and cash transfers for poor and vulnerable households.  To date, the World Bank has disbursed about US$160 million of these funds to meet urgent needs.”  This is extremely concerning as the World Bank is closely connected to the IMF on which Sri Lanka is pinning its hopes for a big loan.

POLITICAL STABILITY

The issue of political stability is highlighted by the government as being necessary to obtain international assistance and also as a justification for quelling the protest movement through emergency laws.  There is explicit blame being apportioned to the protest movement for creating instability in the polity that is deterring the influx of foreign assistance and investments.  However, the fuller picture needs to be seen.  The IMF as much as the World Bank, and indeed other potential sources of donor support, want their resources to be used for the intended purpose and not be squandered or siphoned away corrupt practices and in sustaining loss-making state institutions.

The hoped-for IMF-supported programme to provide assistance to Sri Lanka is being developed to restore macroeconomic stability and debt sustainability, while protecting the poor and vulnerable, safeguarding financial stability, and stepping up structural reforms to address corruption vulnerabilities and unlock the country’s growth potential. IMF mission team to Sri Lanka last month specifically mentioned the need to reduce corruption stating that “Other challenges that need addressing include containing rising levels of inflation, addressing the severe balance of payments pressures, reducing corruption vulnerabilities and embarking on growth-enhancing reforms.”

Both the international funding agencies and the protest movement are on the same page when it comes to opposing corrupt practices.  The main slogans of the protest movement during their heyday was the ouster of the then president, prime minister and cabinet of ministers, and indeed the entire parliament, on account of the corruption that they believed was responsible for having denuded the country of its foreign exchange reserves. This was not simply the replacement of one set of corrupt leaders by another. There are disturbing signs that some of those accused of corruption are once again on the ascendant.

The underlying demand of the protest movement was and continues to be the very “systems change” that the president has said he admires in his reported discussion with remanded trade union leader Joseph Stalin. Civil disobedience to obtain a government that is transparent and law abiding, that does not steal the wealth of the country, is a noble goal, no less sacred than the civil disobedience struggles engaged in by Mahatma Gandhi in India and Martin Luther King in the United States.  The ingredients for a rebound of the protest movement continue to be in place and hopefully the evidence of a systems change will become more convincing.

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Brenda Mendis… ‘Gindara Kellek’

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I first got to know Brenda Mendis when she was very much a part of the group Aquarius, before joining Mirage..

With Aquarius, her dynamism bloomed, on stage, when she partnered two other female vocalists – from the Philippines.

And…yes, they certainly did rock the scene; the three girls were the talk-of the-town and they were featured at some of the best venues in the city.

She was also, at one time, associated with the band 2Forty2.

Brenda now operates with an outfit called C Plus Band, and with whatever free time, that comes her way, the talented artiste is now working on originals.

The latest is the song ‘Gindara Kellek’ and this is what Brenda has to say:

“I have known this guy Chathurangana de Silva for a very time and he has been involved in composing certain songs for the C Plus Band.

“We then got down to discussing about putting together a song which could be classified as a fast genre in music, and Chathurangana, along with Sampath Fernandopulle, came up with the suggestion for the lyrics, and they did so, based upon a proper observation of my lifestyle and the personality portrayal of myself, and that’s how “Gindara Kellek’ came into the scene.”

Brenda went on to say that the composing was done during a tight schedule.

“As I am the female vocalist, on a full time basis, with the C Plus Band, it took us more time than what is usual spent at a recording session, because of our public performances.”

‘Gindara Kellek’ is not Brenda’s maiden effort. She has been involved in quite a few other originals, including ‘Tharu Peedena Seethale,’ ‘Obai Mage Thaththe,’ ‘Mage Raththaran,’ ‘Kaprinna (Chooty),’ ‘You Never Know,’ ‘Mea Nilwan Nimnaye, and ‘Sitha Igilee Gihin.’ And, they are all uniquely different to each other, she says.

With the country going through a tough period, Brenda, spends her free time working out and reading.

“I would take this opportunity, through your very popular music page, to thank all those who helped me throughout my journey in this wonderful field of music.

“I shall continue to keep music lovers happy, with my music, and I would also thank my followers for supporting me and for being with me throughout my career in showbiz.”

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