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The conundrum of Covid vaccines for children, adolescents and youth

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By 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).

Specialist Consultant Paediatrician and Honorary Senior Fellow, Postgraduate Institute of Medicine, University of Colombo, Sri Lanka.

There is a lot of interest as well as differences of opinion and even misinformation regarding many aspects of vaccination of children, and young people, against Covid-19. This has led to a considerable amount of anxiety in the minds of parents, and even the youth themselves, regarding the different facets of vaccinating these subjects against the coronavirus infection that is running riot, all over the world, including Sri Lanka. Against this background, it is also pertinent to point out that there is a very definite recent increase in the numbers of children who have tested positive for the coronavirus disease, especially in some of the developed countries with facilities available for large scale testing of the general population.

There is a considerable number of differing opinions expressed regarding the need to vaccinate these age groups of subjects. True enough, it is argued that children, and young people, are not as susceptible to major effects. However, there are documented cases, though quite rare, of children, and young people, getting the Multisystem Inflammatory Syndrome (MIS-C) complication of Covid-19. That particular problem could affect several body systems and organs. It is a somewhat delayed but a rather nasty complication which, if it is not properly and promptly treated, could even lead to death. Then, of course, there is the spectacle of ‘Long Covid’, where there are persistent symptoms, particularly of a respiratory nature, for quite some time, after apparent recovery from symptomatic Covid-19. There are some reports of persistent vague symptoms, even in those who were originally not sick with symptomatic disease. It is also noteworthy that there are reports of significant x-ray changes that have been detected in some completely asymptomatic positive cases. It must also be considered that the clinical picture of Covid-19, in children, seems to fluctuate considerably, over different time periods. There is no guarantee that there is no risk at all of the disease suddenly turning quite virulent and starting to produce marked and severe symptoms, even in children. This is particularly of relevance in view of the propensity for the coronavirus to undergo mutations, as it keeps on replicating.

Children rarely become severely ill from Covid-19. However, in the US, in August, 2021, the Delta variant has landed nearly 30,000 of them in hospital. According to the American Academy of Pediatrics, nearly 5.9 million Americans younger than 18, have been infected with the coronavirus. Of the roughly 500 Americans, under 18, who have died, about 125 were aged 5 to 11. “It really bothers me when people say kids don’t die of Covid”, said Dr. Grace Lee, an Associate Chief Medical Officer, at Stanford Children’s Health, who also leads a key Advisory Committee to the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia. She also said “They die of Covid. It’s heart-breaking”. About one in six Americans infected, since the beginning of the pandemic, was under 18. But with the surge of the Delta variant, children accounted for as many as one in four infections in recent times, according to the American Academy of Pediatrics.

Then, of course, there is the problem of asymptomatic afflicted children carrying the virus around and spreading it, and, perhaps, much more importantly, the scenario of them taking it home and infecting susceptible adults and the elderly. With rather close gatherings during transport, to and from schools, and also in the classrooms themselves, the risks of these children contracting the virus is something quite real. There are some sporadic studies that indicate that there is some protection provided by the vaccines in actually preventing, to a certain degree, the exposed individuals from contracting the virus. This is, of course, is not 100% protection by any means, but is a rather minor but a positive reason for vaccination.

At this point in time, the only coronavirus vaccine that is universally authorised to be administered to children and, young people, over the age of 12, is the mRNA Pfizer – BioNTech Covid-19 (BNT162b2) vaccine, with the brand name “Comirnaty”. The European countries, and Australia, have been provided provisional authorisation for the use of the Moderna mRNA-1273 vaccine with the brand name “Spikevax” in those over 12 years of age. In several studies, the effectiveness of these vaccines, as well as their safety, have been established.

Yet for all that, there are some of the more recent reports of the occurrence of the extremely rare complications of myocarditis and pericarditis occurring, especially in adolescent and young males with all mRNA Covid-19 vaccines, particularly after the second dose of the vaccine, occurring typically within a few days after vaccination. Myocarditis is an inflammation of the heart muscle and pericarditis is an inflammation of the lining that surrounds the heart. Available data suggest that the immediate course of myocarditis and pericarditis, following vaccination, is generally mild and responds to conservative treatment. So far, major problems, with long-term heart functions, have been see in these cases and follow-up is ongoing to determine possible long-term outcomes. All young recipients of mRNA vaccines should be instructed to report for medical attention if they develop symptoms, indicative of myocarditis or pericarditis such as new onset and persisting chest pain, shortness of breath, or palpitations, following vaccination against Covid-19. It has to be reiterated that these complications are extremely rare. In the USA there have been no deaths reported in young people developing myocarditis, following mRNA Covid-19 vaccines.

In a most reassuring publication, released on 22nd October 2021, hot off the oven so to speak, both BNT162b2 (Pfizer-BioNTech) and ChAdOx1 nCoV-19 (AstraZeneca) vaccines offered substantial protection against death from coronavirus disease 2019 (COVID-19) caused by the B.1.617.2 (Delta) variant, according to a study published in The New England Journal of Medicine. Meanwhile, another study, also published recently in The New England Journal of Medicine, suggests that the BNT162b2 (Pfizer-BioNTech) vaccine was highly effective against both documented infection and symptomatic COVID-19 with the Delta variant among adolescents, between the ages of 12 and 18 years. The latest information available to us seem to confirm the benefits of Covid-19 vaccinations in adolescents and young people.

The most recent development, from the standpoint of Covid-19 vaccinations for children, is the application due to be made by Pfizer to the Food and Drugs Administration (FDA) of USA for authorisation for usage of its Covid-19 vaccine for children, 5 to 11 years of age. In a highly anticipated announcement, Pfizer has said that a Phase 2/3 trial showed its Covid-19 vaccine was safe and generated a “robust” antibody response in children, aged 5 to 11.

These are the first such results released for this age group for a USA Covid-19 vaccine.

The trial included 2,268 participants, ages 5 to 11, and used a two-dose regimen of the vaccine, administered 21 days apart. This trial used a 10-microgram dose, which is one third of the 30-microgram dose that has been used for those 12 and older. Pfizer has said that the 10-microgram dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age.

Participants’ immune responses were measured by looking at neutralising antibody levels in their blood and comparing those levels to a control group of 16 to 25-year-olds who were given a two-dose regimen with the larger 30-microgram dose. Pfizer has said the levels compared well with older people who received the larger dose, demonstrating a “strong immune response in this cohort of children, one month after the second dose”. They have further stated that the vaccine was well tolerated, with side effects generally comparable to those observed in participants, 16 to 25 years of age.

However, it is a matter for some concern that this data has not yet been peer-reviewed or published in a reputed medical journal. Pfizer has said that it plans to submit the data directly to the US Food and Drug Administration for emergency use authorisation. Apparently, the FDA officials have said that once the data is submitted, the agency could authorise the vaccine for younger children, in a matter of weeks.

Albert Bourla, Chairman and Chief Executive Officer of Pfizer, said in a statement “Since July 2021, pediatric cases of COVID-19 have risen by about 240 percent in the USA, underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorisation of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency”. Pfizer also said that it is expecting trial data for children as young as six months as soon as the fourth quarter of this year.

In addition, Moderna Incorporated plans for double enrolment in a trial of its Covid-19 vaccine in children under age 12, following a request from U.S. regulators to collect additional safety data. Moderna’s study will enrol an estimated 13,275 participants aged 6 months up to 12 years old, according to a listing on the clinicaltrials.gov website. In a post from late July, the Cambridge, Massachusetts-based company said it would seek to enrol about 7,000.

As things stand now, the scientific information regarding the feasibility of administering the Covid-19 vaccination to very young children is, at best, in a state of flux at the present time. We need to await the results of several on-going Clinical Trials. The Sri Lanka College of Paediatricians will keep a close watch on the developments and would take all necessary steps to advise the authorities on the best course of action, when more tangible evidence from Clinical Trials emerge in the future.

The gut-feeling of a lot of authorities involved in child healthcare is that it would be possible to vaccinate even young children against Covid-19 in the not-too-distant future. The benefits due to be gained seemingly appear to be that much more important and would override the very rare undesirable effects in our quest towards victory over this pandemic that has brought the entire world to its knees.



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Features

The heart-friendly health minister

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Dr. Ramesh Pathirana

by Dr Gotabhya Ranasinghe
Senior Consultant Cardiologist
National Hospital Sri Lanka

When we sought a meeting with Hon Dr. Ramesh Pathirana, Minister of Health, he graciously cleared his busy schedule to accommodate us. Renowned for his attentive listening and deep understanding, Minister Pathirana is dedicated to advancing the health sector. His openness and transparency exemplify the qualities of an exemplary politician and minister.

Dr. Palitha Mahipala, the current Health Secretary, demonstrates both commendable enthusiasm and unwavering support. This combination of attributes makes him a highly compatible colleague for the esteemed Minister of Health.

Our discussion centered on a project that has been in the works for the past 30 years, one that no other minister had managed to advance.

Minister Pathirana, however, recognized the project’s significance and its potential to revolutionize care for heart patients.

The project involves the construction of a state-of-the-art facility at the premises of the National Hospital Colombo. The project’s location within the premises of the National Hospital underscores its importance and relevance to the healthcare infrastructure of the nation.

This facility will include a cardiology building and a tertiary care center, equipped with the latest technology to handle and treat all types of heart-related conditions and surgeries.

Securing funding was a major milestone for this initiative. Minister Pathirana successfully obtained approval for a $40 billion loan from the Asian Development Bank. With the funding in place, the foundation stone is scheduled to be laid in September this year, and construction will begin in January 2025.

This project guarantees a consistent and uninterrupted supply of stents and related medications for heart patients. As a result, patients will have timely access to essential medical supplies during their treatment and recovery. By securing these critical resources, the project aims to enhance patient outcomes, minimize treatment delays, and maintain the highest standards of cardiac care.

Upon its fruition, this monumental building will serve as a beacon of hope and healing, symbolizing the unwavering dedication to improving patient outcomes and fostering a healthier society.We anticipate a future marked by significant progress and positive outcomes in Sri Lanka’s cardiovascular treatment landscape within the foreseeable timeframe.

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A LOVING TRIBUTE TO JESUIT FR. ALOYSIUS PIERIS ON HIS 90th BIRTHDAY

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Fr. Aloysius Pieris, SJ was awarded the prestigious honorary Doctorate of Literature (D.Litt) by the Chancellor of the University of Kelaniya, the Most Venerable Welamitiyawe Dharmakirthi Sri Kusala Dhamma Thera on Nov. 23, 2019.

by Fr. Emmanuel Fernando, OMI

Jesuit Fr. Aloysius Pieris (affectionately called Fr. Aloy) celebrated his 90th birthday on April 9, 2024 and I, as the editor of our Oblate Journal, THE MISSIONARY OBLATE had gone to press by that time. Immediately I decided to publish an article, appreciating the untiring selfless services he continues to offer for inter-Faith dialogue, the renewal of the Catholic Church, his concern for the poor and the suffering Sri Lankan masses and to me, the present writer.

It was in 1988, when I was appointed Director of the Oblate Scholastics at Ampitiya by the then Oblate Provincial Fr. Anselm Silva, that I came to know Fr. Aloy more closely. Knowing well his expertise in matters spiritual, theological, Indological and pastoral, and with the collaborative spirit of my companion-formators, our Oblate Scholastics were sent to Tulana, the Research and Encounter Centre, Kelaniya, of which he is the Founder-Director, for ‘exposure-programmes’ on matters spiritual, biblical, theological and pastoral. Some of these dimensions according to my view and that of my companion-formators, were not available at the National Seminary, Ampitiya.

Ever since that time, our Oblate formators/ accompaniers at the Oblate Scholasticate, Ampitiya , have continued to send our Oblate Scholastics to Tulana Centre for deepening their insights and convictions regarding matters needed to serve the people in today’s context. Fr. Aloy also had tried very enthusiastically with the Oblate team headed by Frs. Oswald Firth and Clement Waidyasekara to begin a Theologate, directed by the Religious Congregations in Sri Lanka, for the contextual formation/ accompaniment of their members. It should very well be a desired goal of the Leaders / Provincials of the Religious Congregations.

Besides being a formator/accompanier at the Oblate Scholasticate, I was entrusted also with the task of editing and publishing our Oblate journal, ‘The Missionary Oblate’. To maintain the quality of the journal I continue to depend on Fr. Aloy for his thought-provoking and stimulating articles on Biblical Spirituality, Biblical Theology and Ecclesiology. I am very grateful to him for his generous assistance. Of late, his writings on renewal of the Church, initiated by Pope St. John XX111 and continued by Pope Francis through the Synodal path, published in our Oblate journal, enable our readers to focus their attention also on the needed renewal in the Catholic Church in Sri Lanka. Fr. Aloy appreciated very much the Synodal path adopted by the Jesuit Pope Francis for the renewal of the Church, rooted very much on prayerful discernment. In my Religious and presbyteral life, Fr.Aloy continues to be my spiritual animator / guide and ongoing formator / acccompanier.

Fr. Aloysius Pieris, BA Hons (Lond), LPh (SHC, India), STL (PFT, Naples), PhD (SLU/VC), ThD (Tilburg), D.Ltt (KU), has been one of the eminent Asian theologians well recognized internationally and one who has lectured and held visiting chairs in many universities both in the West and in the East. Many members of Religious Congregations from Asian countries have benefited from his lectures and guidance in the East Asian Pastoral Institute (EAPI) in Manila, Philippines. He had been a Theologian consulted by the Federation of Asian Bishops’ Conferences for many years. During his professorship at the Gregorian University in Rome, he was called to be a member of a special group of advisers on other religions consulted by Pope Paul VI.

Fr. Aloy is the author of more than 30 books and well over 500 Research Papers. Some of his books and articles have been translated and published in several countries. Among those books, one can find the following: 1) The Genesis of an Asian Theology of Liberation (An Autobiographical Excursus on the Art of Theologising in Asia, 2) An Asian Theology of Liberation, 3) Providential Timeliness of Vatican 11 (a long-overdue halt to a scandalous millennium, 4) Give Vatican 11 a chance, 5) Leadership in the Church, 6) Relishing our faith in working for justice (Themes for study and discussion), 7) A Message meant mainly, not exclusively for Jesuits (Background information necessary for helping Francis renew the Church), 8) Lent in Lanka (Reflections and Resolutions, 9) Love meets wisdom (A Christian Experience of Buddhism, 10) Fire and Water 11) God’s Reign for God’s poor, 12) Our Unhiddden Agenda (How we Jesuits work, pray and form our men). He is also the Editor of two journals, Vagdevi, Journal of Religious Reflection and Dialogue, New Series.

Fr. Aloy has a BA in Pali and Sanskrit from the University of London and a Ph.D in Buddhist Philosophy from the University of Sri Lankan, Vidyodaya Campus. On Nov. 23, 2019, he was awarded the prestigious honorary Doctorate of Literature (D.Litt) by the Chancellor of the University of Kelaniya, the Most Venerable Welamitiyawe Dharmakirthi Sri Kusala Dhamma Thera.

Fr. Aloy continues to be a promoter of Gospel values and virtues. Justice as a constitutive dimension of love and social concern for the downtrodden masses are very much noted in his life and work. He had very much appreciated the commitment of the late Fr. Joseph (Joe) Fernando, the National Director of the Social and Economic Centre (SEDEC) for the poor.

In Sri Lanka, a few religious Congregations – the Good Shepherd Sisters, the Christian Brothers, the Marist Brothers and the Oblates – have invited him to animate their members especially during their Provincial Congresses, Chapters and International Conferences. The mainline Christian Churches also have sought his advice and followed his seminars. I, for one, regret very much, that the Sri Lankan authorities of the Catholic Church –today’s Hierarchy—- have not sought Fr.

Aloy’s expertise for the renewal of the Catholic Church in Sri Lanka and thus have not benefited from the immense store of wisdom and insight that he can offer to our local Church while the Sri Lankan bishops who governed the Catholic church in the immediate aftermath of the Second Vatican Council (Edmund Fernando OMI, Anthony de Saram, Leo Nanayakkara OSB, Frank Marcus Fernando, Paul Perera,) visited him and consulted him on many matters. Among the Tamil Bishops, Bishop Rayappu Joseph was keeping close contact with him and Bishop J. Deogupillai hosted him and his team visiting him after the horrible Black July massacre of Tamils.

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A fairy tale, success or debacle

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Ministers S. Iswaran and Malik Samarawickrama signing the joint statement to launch FTA negotiations. (Picture courtesy IPS)

Sri Lanka-Singapore Free Trade Agreement

By Gomi Senadhira
senadhiragomi@gmail.com

“You might tell fairy tales, but the progress of a country cannot be achieved through such narratives. A country cannot be developed by making false promises. The country moved backward because of the electoral promises made by political parties throughout time. We have witnessed that the ultimate result of this is the country becoming bankrupt. Unfortunately, many segments of the population have not come to realize this yet.” – President Ranil Wickremesinghe, 2024 Budget speech

Any Sri Lankan would agree with the above words of President Wickremesinghe on the false promises our politicians and officials make and the fairy tales they narrate which bankrupted this country. So, to understand this, let’s look at one such fairy tale with lots of false promises; Ranil Wickremesinghe’s greatest achievement in the area of international trade and investment promotion during the Yahapalana period, Sri Lanka-Singapore Free Trade Agreement (SLSFTA).

It is appropriate and timely to do it now as Finance Minister Wickremesinghe has just presented to parliament a bill on the National Policy on Economic Transformation which includes the establishment of an Office for International Trade and the Sri Lanka Institute of Economics and International Trade.

Was SLSFTA a “Cleverly negotiated Free Trade Agreement” as stated by the (former) Minister of Development Strategies and International Trade Malik Samarawickrama during the Parliamentary Debate on the SLSFTA in July 2018, or a colossal blunder covered up with lies, false promises, and fairy tales? After SLSFTA was signed there were a number of fairy tales published on this agreement by the Ministry of Development Strategies and International, Institute of Policy Studies, and others.

However, for this article, I would like to limit my comments to the speech by Minister Samarawickrama during the Parliamentary Debate, and the two most important areas in the agreement which were covered up with lies, fairy tales, and false promises, namely: revenue loss for Sri Lanka and Investment from Singapore. On the other important area, “Waste products dumping” I do not want to comment here as I have written extensively on the issue.

1. The revenue loss

During the Parliamentary Debate in July 2018, Minister Samarawickrama stated “…. let me reiterate that this FTA with Singapore has been very cleverly negotiated by us…. The liberalisation programme under this FTA has been carefully designed to have the least impact on domestic industry and revenue collection. We have included all revenue sensitive items in the negative list of items which will not be subject to removal of tariff. Therefore, 97.8% revenue from Customs duty is protected. Our tariff liberalisation will take place over a period of 12-15 years! In fact, the revenue earned through tariffs on goods imported from Singapore last year was Rs. 35 billion.

The revenue loss for over the next 15 years due to the FTA is only Rs. 733 million– which when annualised, on average, is just Rs. 51 million. That is just 0.14% per year! So anyone who claims the Singapore FTA causes revenue loss to the Government cannot do basic arithmetic! Mr. Speaker, in conclusion, I call on my fellow members of this House – don’t mislead the public with baseless criticism that is not grounded in facts. Don’t look at petty politics and use these issues for your own political survival.”

I was surprised to read the minister’s speech because an article published in January 2018 in “The Straits Times“, based on information released by the Singaporean Negotiators stated, “…. With the FTA, tariff savings for Singapore exports are estimated to hit $10 million annually“.

As the annual tariff savings (that is the revenue loss for Sri Lanka) calculated by the Singaporean Negotiators, Singaporean $ 10 million (Sri Lankan rupees 1,200 million in 2018) was way above the rupees’ 733 million revenue loss for 15 years estimated by the Sri Lankan negotiators, it was clear to any observer that one of the parties to the agreement had not done the basic arithmetic!

Six years later, according to a report published by “The Morning” newspaper, speaking at the Committee on Public Finance (COPF) on 7th May 2024, Mr Samarawickrama’s chief trade negotiator K.J. Weerasinghehad had admitted “…. that forecasted revenue loss for the Government of Sri Lanka through the Singapore FTA is Rs. 450 million in 2023 and Rs. 1.3 billion in 2024.”

If these numbers are correct, as tariff liberalisation under the SLSFTA has just started, we will pass Rs 2 billion very soon. Then, the question is how Sri Lanka’s trade negotiators made such a colossal blunder. Didn’t they do their basic arithmetic? If they didn’t know how to do basic arithmetic they should have at least done their basic readings. For example, the headline of the article published in The Straits Times in January 2018 was “Singapore, Sri Lanka sign FTA, annual savings of $10m expected”.

Anyway, as Sri Lanka’s chief negotiator reiterated at the COPF meeting that “…. since 99% of the tariffs in Singapore have zero rates of duty, Sri Lanka has agreed on 80% tariff liberalisation over a period of 15 years while expecting Singapore investments to address the imbalance in trade,” let’s turn towards investment.

Investment from Singapore

In July 2018, speaking during the Parliamentary Debate on the FTA this is what Minister Malik Samarawickrama stated on investment from Singapore, “Already, thanks to this FTA, in just the past two-and-a-half months since the agreement came into effect we have received a proposal from Singapore for investment amounting to $ 14.8 billion in an oil refinery for export of petroleum products. In addition, we have proposals for a steel manufacturing plant for exports ($ 1 billion investment), flour milling plant ($ 50 million), sugar refinery ($ 200 million). This adds up to more than $ 16.05 billion in the pipeline on these projects alone.

And all of these projects will create thousands of more jobs for our people. In principle approval has already been granted by the BOI and the investors are awaiting the release of land the environmental approvals to commence the project.

I request the Opposition and those with vested interests to change their narrow-minded thinking and join us to develop our country. We must always look at what is best for the whole community, not just the few who may oppose. We owe it to our people to courageously take decisions that will change their lives for the better.”

According to the media report I quoted earlier, speaking at the Committee on Public Finance (COPF) Chief Negotiator Weerasinghe has admitted that Sri Lanka was not happy with overall Singapore investments that have come in the past few years in return for the trade liberalisation under the Singapore-Sri Lanka Free Trade Agreement. He has added that between 2021 and 2023 the total investment from Singapore had been around $162 million!

What happened to those projects worth $16 billion negotiated, thanks to the SLSFTA, in just the two-and-a-half months after the agreement came into effect and approved by the BOI? I do not know about the steel manufacturing plant for exports ($ 1 billion investment), flour milling plant ($ 50 million) and sugar refinery ($ 200 million).

However, story of the multibillion-dollar investment in the Petroleum Refinery unfolded in a manner that would qualify it as the best fairy tale with false promises presented by our politicians and the officials, prior to 2019 elections.

Though many Sri Lankans got to know, through the media which repeatedly highlighted a plethora of issues surrounding the project and the questionable credentials of the Singaporean investor, the construction work on the Mirrijiwela Oil Refinery along with the cement factory began on the24th of March 2019 with a bang and Minister Ranil Wickremesinghe and his ministers along with the foreign and local dignitaries laid the foundation stones.

That was few months before the 2019 Presidential elections. Inaugurating the construction work Prime Minister Ranil Wickremesinghe said the projects will create thousands of job opportunities in the area and surrounding districts.

The oil refinery, which was to be built over 200 acres of land, with the capacity to refine 200,000 barrels of crude oil per day, was to generate US$7 billion of exports and create 1,500 direct and 3,000 indirect jobs. The construction of the refinery was to be completed in 44 months. Four years later, in August 2023 the Cabinet of Ministers approved the proposal presented by President Ranil Wickremesinghe to cancel the agreement with the investors of the refinery as the project has not been implemented! Can they explain to the country how much money was wasted to produce that fairy tale?

It is obvious that the President, ministers, and officials had made huge blunders and had deliberately misled the public and the parliament on the revenue loss and potential investment from SLSFTA with fairy tales and false promises.

As the president himself said, a country cannot be developed by making false promises or with fairy tales and these false promises and fairy tales had bankrupted the country. “Unfortunately, many segments of the population have not come to realize this yet”.

(The writer, a specialist and an activist on trade and development issues . )

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