Features
Covid-19: Potential risks of fast-tracking vaccine
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.
Sri Lanka needs to take full stock of its current economic situation and use to the maximum the potential in its GSP+ facility for export sector growth. In the process, it should ensure that it cooperates fully with the European Union. The urgency of undertaking these responsibilities is underscored by the issues growing out of the recent US decision to sweepingly hike tariffs on its imports, though differentially.
These were principal ‘takes’ for participants in the Pathfinder Foundation’s Ambassadors’ Roundtable forum held on April 8th at the Colombo Club of the Taj Samudra. The main presenter at the event was Ms. Carmen Moreno Raymundo, Ambassador of the European Union to Sri Lanka and the Maldives. The forum was chaired by Ambassador Bernard Goonetilleke, Chairman, Pathfinder Foundation. The event brought together a cross-section of the local public, including the media.
Ms. Moreno drew attention to the fact Sri Lanka is at present severely under utilizing its GSP+ facility, which is the main means for Sri Lanka to enter the very vast EU market of 450 million people. In fact the EU has been Sri Lanka’s biggest trading partner. In 2023, for instance, total trade between the partners stood at Euros 3.84 billion. There is no greater market but the EU region for Sri Lanka.
‘However, only Sri Lanka’s apparel sector has seen considerable growth over the years. It is the only export sector in Sri Lanka which could be said to be fully developed. However, wider ranging export growth is possible provided Sri Lanka exploits to the fullest the opportunities presented by GSP+.’
Moreno added, among other things: ‘Sri Lanka is one among only eight countries that have been granted the EU’s GSP+ facility. The wide-ranging export possibilities opened by the facility are waiting to be utilized. In the process, the country needs to participate in world trade in a dynamic way. It cannot opt for a closed economy. As long as economic vibrancy remains unachieved, Sri Lanka cannot enter into world trading arrangements from a strong position. Among other things, Sri Lanka must access the tools that will enable it to spot and make full use of export opportunities.
‘Sri Lanka must facilitate the private sector in a major way and make it possible for foreign investors to enter the local economy with no hassle and compete for local business opportunities unfettered. At present, Lanka lacks the relevant legal framework to make all this happen satisfactorily.
‘Sri Lanka cannot opt for what could be seen as opaque arrangements with bilateral economic partners. Transparency must be made to prevail in its dealings with investors and other relevant quarters. It’s the public good that must be ensured. The EU would like to see the local economy further opening up for foreign investment.
‘However, it is important that Sri Lanka cooperates with the EU in the latter’s efforts to bring about beneficial outcomes for Sri Lankans. Cooperation could be ensured by Sri Lanka fully abiding by the EU conditions that are attendant on the granting of GSP+. There are, for example, a number of commitments and international conventions that Sri Lanka signed up to and had promised to implement on its receipt of GSP+ which have hitherto not been complied with. Some of these relate to human rights and labour regulations.
‘Successive governments have pledged to implement these conventions but thus far nothing has happened by way of compliance. GSP+ must be seen as an opportunity and not a threat and by complying with EU conditions the best fruits could be reaped from GSP+. It is relevant to remember that GSP+ was granted to Sri Lanka in 2005. It was suspended five years later and restored in 2017.
‘The importance of compliance with EU conditions is greatly enhanced at present in view of the fact that Sri Lanka is currently being monitored by the EU with regard to compliance ahead of extending GSP+ next year. A report on Sri Lanka is due next year wherein the country’s performance with regard to cooperating with the EU would be assessed. The continuation of the facility depends on the degree of cooperation.
‘A few statistics would bear out the importance of Sri Lanka’s partnership with the EU. For example, under the facility Sri Lanka benefits from duty free access in over 66% of EU tariff lines. The highest number of tourist arrivals in Sri Lanka in 2023 was from the EU’s 27 member states. Likewise, the EU’s 27 member states rank second in the origin of inflows of foreign exchange to Sri Lanka; with Italy, France and Germany figuring as the main countries of origin. Eighty five percent of Sri Lanka’s exports to the EU market benefits from GSP+. Thus, the stakes for the country are high.’
Meanwhile, President, In-house Counsel & Legal Advisor, The European Chamber of Commerce of Sri Lanka, John Wilson said: ‘GSP+ should be seen as not only an opportunity but also as a necessity by Sri Lanka in the current international economic climate. ‘Implementation of local laws is what is needed. Considering the pressures growing out of the US imposed new tariff regime, a good dialogue with the EU is needed.
‘Sri Lanka’s level of business readiness must be upped. Among the imperatives are: An electronic procurement process, Customs reforms, a ‘National Single Window’, stepped-up access to land by investors, for example, a clear policy framework on PPPs and reform of the work permits system.’
It ought to be plain to see from the foregoing that Sri Lanka cannot afford to lose the GSP+ facility if it is stepped-up economic growth that is aimed at. It would be in Sri Lanka’s best interests to remain linked with the EU, considering the aggravated material hardships that could come in the wake of the imposition of the US’ new tariff regime. Sri Lanka would need to remain in a dialogue process with the EU, voice its reservations on matters growing out of GSP+, if any, iron out differences and ensure that its national interest is secured.
Chit-Chat
Chiara Tissera
Mrs. Queen of the World Sri Lanka 2024, Chiara Tissera, leaves for the finals, in the USA, next month
I had a very interesting chat with her and this is how it all went:
1. How would you describe yourself?
I am a sensitive and passionate individual who deeply cares about the things that matter most to me. I approach life with a heart full of enthusiasm and a desire to make meaningful connections.
2. If you could change one thing about yourself, what would it be?
Actually, I wouldn’t change a thing about myself because the person I am today, both inside and out, is the result of everything I’ve experienced. Every part of me has shaped who I am, so I embrace both my strengths and imperfections as they make me uniquely me.
3. If you could change one thing about your family, what would it be?
If there’s one thing I could change about my family, it would be having my father back with us. Losing him six years ago left a void that can never be filled, but his memory continues to guide and inspire us every day.
4. School?
I went to St. Jude’s College, Kurana, and I’m really proud to say that the lessons I gained during my time there have shaped who I am today. My school and teachers instilled in me values of hard work, perseverance and the importance of community, and I carry those lessons with me every day. I was a senior prefect and was selected the Deputy Head Prefect of our college during my tenure.
5. Happiest moment?
The happiest moment of my life so far has been winning the Mrs. Sri Lanka 2024 for Queen of the World. It was a dream come true and a truly unforgettable experience, one that fills me with pride and gratitude every time I reflect on it.
6. What is your idea of perfect happiness?
Happiness is a deeply personal and multifaceted feeling that often comes from a sense of contentment, fulfillment and well-being. For me, perfect happiness is in moments of joy, peace and accomplishments … and also being surrounded by my loved ones.
7. Are you religious?
Yes, I’m a very religious person. And I’m a firm believer in God. My faith guides me through life, providing strength, dedication and a sense of peace in every situation. I live by the quote, ‘Do your best, and God will do the rest.’
8. Are you superstitious?
I’m not superstitious. I believe in making my own decisions and relying on logic and faith rather than following superstitions.
9. Your ideal guy?
My ideal guy is my husband. He is compassionate, understanding and is always there to support me, no matter what. He’s my rock and my best friend – truly everything I could ever want in a partner.
10. Which living person do you most admire?
The living person I admire the most is definitely my mummy. Her strength, love and unwavering support has shaped me into who I am today. She is my role model and she inspires me every day with her wisdom and kindness.
11. Your most treasured possession?
My most treasured possession is my family. They are the heart of my life, providing me with love, support and strength. Their presence is my greatest blessing.
12. If you were marooned on a desert island, who would you like as your companion?
I would like to have my spouse as my companion. Together, we could make the best of the situation, supporting each other, sharing moments of laughter and finding creative ways to survive and thrive.
13. Your most embarrassing moment?
There’s quite a few, for sure, but nothing is really coming to mind right now.
14. Done anything daring?
Yes, stepping out of my comfort zone and taking part in a pageant. I had no experience and was nervous about putting myself out there, but I decided to challenge myself and go for it. It pushed me to grow in so many ways—learning to embrace confidence, handle pressure, and appreciate my own uniqueness. The experience not only boosted my self-esteem but also taught me the value of taking risks and embracing new opportunities, even when they feel intimidating.”
15. Your ideal vacation?
It would be to Paris. The city has such a magical vibe and, of course, exploring the magical Eiffel Tower is in my bucket list. Especially the city being a mix of history culture and modern life in a way that feels timeless, I find it to be the ideal vacation spot for me.
16. What kind of music are you into?
I love romantic songs. I’m drawn to its emotional depth and the way they express love, longing a connection. Whether it’s a slow ballad, a classic love song or a more modern romantic tune these songs speak to my heart.
17. Favourite radio station?
I don’t have a specific radio station that I like, but I tend to enjoy a variety of stations, depending on my mood. Sometimes I’ll tune into one for a mix of popular hits, other times I might go for something more relaxing, or a station with a certain vibe. So I just like to keep it flexible and switch it up.
18. Favourite TV station?
I hardly find the time to sit down and watch TV. But, whenever I do find a little spare time, I tend to do some spontaneous binge – watching, catching whatever interesting show is on at that moment.
19 What would you like to be born as in your next life?
Mmmm, I’ve actually not thought about it, but I’d love to be born as someone who gets to explore the world freely – perhaps a bird soaring across continents.
20. Any major plans for the future?
Let’s say preparing and participating in the international pageant happening in the USA this May. It’s an exciting opportunity to represent myself and my country on a global stage. Alongside this, I am dedicated to continuing my social service work as a title holder, striving to make a meaningful difference in the lives of others through my platform.
The formation of wrinkles and fine lines is part of our ageing process. However, if these wrinkles negatively impact appearance, making one look older than they actually are, then trying out some homemade remedies, I’ve listed for you, this week, may help in giving your skin a fresher look.
* Banana:
Bananas are considered to be our skin’s best friend. They contain natural oils and vitamins that work very perfectly to boost our skin health. Skincare experts recommend applying the banana paste to the skin.
Take a ripe banana and mash a quarter of it until it becomes a smooth paste. Apply a thin layer of the banana paste on your skin and allow it to sit for 15 to 20 minutes before washing it off with warm water.
* Olive Oil:
Olive oil works as a great skin protector and many types of research suggest that even consuming olive oil may protect the skin from developing more wrinkles. Olive oil contains compounds that can increase the skin’s collagen levels. Yes, olive oil can be used as a dressing on your salads, or other food, if you want to consume it, otherwise, you can apply a thin layer of olive oil on your face, neck and hands and let it stay overnight.
* Ginger:
Ginger serves to be a brilliant anti-wrinkle remedy because of the high content of antioxidants in it. Ginger helps in breaking down elastin, which is one of the main reasons for wrinkles. You can have ginger tea or grate ginger and have it with honey, on a regular basis.
* Aloe Vera:
The malic acid present in Aloe Vera helps in improving your skin’s elasticity, which helps in reducing your wrinkles. Apply the gel once you extract it from the plant, and leave it on for 15-20 minutes. You can wash it off with warm water.
* Lemons:
Lemons contain citric acid, which is a strong exfoliant that can help you get rid of your dead skin cells and wrinkles. Also, as an astringent and a cleansing agent, it helps to fade your wrinkles and fine lines. You can gently rub a lemon slice in your wrinkled skin and leave it on for 10-15 minutes. Rinse afterwards and repeat this process two to three times a day.
* Coconut Oil:
Coconut oil contains essential fatty acid that moisturises the skin and helps to retain its elasticity. You can directly apply the coconut oil, and leave it overnight, after gently massaging it, for the best results.
Sun directly overhead Hatthikuchchi, Kalankuttiya, Halmillewa, Ipalogama, Palugaswewa and Habarana at about 12:11 noon. today [10]
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