News
New Year brings hopes of vaccine by end February
A glimmer of hope is being seen in the New Year with regard to controlling COVID-19 with vaccination as early as February, but many experts caution against letting down the guard and urge that the public keep resorting to all precautions.
“We are working out how to get the vaccines for the people through COVAX and also our good bilateral relations with several countries,” said Principal Advisor to the President, Lalith Weeratunga who is spearheading the vaccination programme.
Lalith Weeratunga
He says that “it is preliminary stuff I am doing – engaging all stakeholders”. Discussions are underway to determine whether the vaccines against the new coronavirus should be administered in hospitals or Medical Officer of Health (MOH) offices, where usually immunization takes place.
Explaining that he is working out a “cohesive and coherent” system to get the vaccines, Mr. Weeratunga who has been appointed as the overall ‘Coordinator’ in this regard reiterated that he was hoping to cut out any unnecessary expenditure and prevent this being used as a money-making opportunity.
The Sunday Times learns that he is working with all stakeholders including the different committees of the Health Ministry and State Ministries (as they are the technical experts), institutions such as the State Pharmaceuticals Corporation (SPC) and also the World Health Organization (WHO).
Mr. Weeratunga has already been in contact not only with the WHO’s Country Representative, Dr. Razia Pendse, but also Regional Director Dr. Poonam Khetrapal Singh who has been seeking assurances that Sri Lanka is ready for the vaccine, while acknowledging that Sri Lanka is a good model with regard to its immunization programme.
Commending the country’s efficient immunization programme, he said that “we can reach every household in three days”.
He explained that his “main” task is to use Sri Lanka’s strong bilateral ties with India, Russia and China to try and get vaccines free of charge through government-to-government negotiations. Five factories in India are producing the AstraZeneca/Oxford University vaccine and that country is hoping to rollout 300 million doses shortly.
“Therefore, we are in a great position for President Gotabaya Rajapaksa to speak to Indian Prime Minister Narendra Modi and try and secure vaccines for 50% of our people. This would help save a lot of precious money for Sri Lanka,” he said, adding that “China and Russia have also indicated willingness to give us the vaccine and we are negotiating”.
| The types of vaccines have not been decided yet : DG
 Dr. Asela Gunawardena Discussions are underway to get the vaccines against COVID-19 under the guidance of Presidential Advisor Lalith Weeratunga, said the Director-General (DG) of Health Services, Dr. Asela Gunawardena. “Mr. Weeratunga is looking at bilateral bonds to secure the vaccines promptly,” said the DG, adding that Sri Lanka may be able to get vaccines either end-February or early March. This is our target. The types of vaccines have not been decided yet. This is while the country is expecting part of the vaccines promised by COVAX for 20% of Sri Lanka’s population by the middle of this year. Once again, what vaccines have not been ascertained yet, he added. COVAX (COVID-19 Vaccine Global Access) is a global initiative which works with vaccine manufacturers to provide countries worldwide equitable access to safe and effective vaccines once they are approved and licensed. The global initiative is co-led by GAVI (the Vaccine Alliance), the Coalition for Epidemic Preparedness Innovations (CEPI) and the WHO. | |
| WHO lists Pfizer vaccine for emergency use The Pfizer-BioNTech vaccine, BNT162b2, has been listed by the WHO for emergency use, the world body announced on Friday (January 1). |
Dhammika paniya gets ethical nod for clinical trials
The Ethics Review Committee (ERC) of the Rajarata University’s Faculty of Medicine and Allied Sciences has granted ethics approval, with conditions, for Dhammika Bandara’s so-called syrup (paniya) against COVID-19 to undergo clinical trials.
The research proposal for the syrup was developed by the Expert Committee appointed by the Health Ministry to conduct a clinical trial to evaluate the efficacy and safety of the herbal medicine preparation of Mr. Bandara. On the approval of this herbal preparation by the Department of Ayurveda, the research proposal was submitted to the ERC for evaluation, a statement from the Expert Committee said.
“The study has been approved by the ERC with conditions. Therefore, a duly conducted clinical trial will take place upon the approval of the Director-General of Health Services. The study is intended to establish preliminary information on the safety and efficacy of the syrup. Based on the outcomes further studies would be warranted,” the Expert Committee pointed out.
The clinical trials are due to be carried out at two state hospitals treating
COVID-19 positive patients in the North Central Province.
Reiterating that ethical approval does not imply that the product is approved to be used for COVID-19, the Expert Committee said it expected to conduct the study at the earliest possible and keep the public informed about its outcomes on completion of the study.
It added: “The experiences we and the Department of Ayurveda have gained in the process of preparing for this study would help future researchers on the use of indigenous preparations in COVID-19 and other illnesses.
“The research team will not be discussing the details of the progress publicly until the study is completed and data are analysed. This is necessary for any form of research to avoid bias.”
‘No evidence yet of new strain’
There is no evidence up to now to indicate that the new strains of COVID-19 have come to Sri Lanka, said a top health official on Thursday.
Explaining that a country could detect whether a new strain has come in through genetic sequencing, the Health Ministry’s Deputy Director-General (Public Health Services I), Dr. Hemantha Herath said that the University of Sri Jayewardenepura does genetic sequencing depending on epidemiological requirements.
When asked about opening up the country to tourism, he said that it is a positive measure and the authorities are attempting to restore new normalcy so that the badly-hit economy can bounce back.
Repatriation & tourism
“We have identified the probable risks and taken every measure to minimize those risks. We have been repatriating our people from other countries and tourism is an extension to that when considering the risks,” he said.
So far, two flights have arrived, both to the Mattala Rajapaksa International Airport, on December 28 and 29, with 126 and 204 tourists respectively from Ukraine. All the designated hotels for these tourists are in the south. More groups, all from Ukraine, were expected yesterday and then on January 4 and 7.
Comparing repatriation and tourism, Dr. Herath said that those who are repatriated are kept in quarantine either at state-run centres or designated hotels with strict movement restrictions, while the staff at these quarantine centres or designated hotels have a little more freedom to move around. In the case of tourists, they are allowed to move around within the designated hotels they would be staying at and also the beach but staff movement is severely restricted. The staff cannot go out of the hotel throughout the stay of that specific group of tourists in the hotel and also for another 14 days after the last guest has left. This is while the tourists cannot go into any public areas close to the hotel during their stay.
He said that if, however, the tourists wish to travel out of the hotel, once again to designated places, their RT-PCR tests should be negative and they should do so under stringent conditions of the bio-security bubble.
Status of the spread of the virus
There is containment now to certain areas, unlike the Peliyagoda fish market cluster, which had many tentacles snaking to different areas bringing out cases from different places, said Dr. Herath looking at the current situation.
He said that there is optimism that some sort of control would come about in 6-8 weeks, if there are no new clusters. This is why they are appealing to people to support them by adhering to the precautions.
There are one or two cases from the community but a majority are linked to known cases. This is because detection is happening in many ways including random testing. When the case history of those positives outside the Western Province (WP) is taken, a clear link can be established to those in the WP,” said Dr. Herath.
Referring to the COVID-19 spread, he said that at present, there is a slight downward trend but it is too early to say it is on the decline. Compared to October last year, the Minuwangoda cluster has gone down completely, the Katunayake cluster has also waned, the Peliyagoda cluster has cleared, the Wattala cluster is still giving more cases and the Colombo Municipal Council (CMC) cluster is giving fewer cases. Those testing positive are also having a low viral load now (found through the Ct or Cycle threshold value – defined as the number of cycles required for the fluorescent signal of the PCR assay to cross the threshold. A low Ct value indicates a high viral load and a high Ct value means a low viral load).
“This is an indication that the disease is on the wane. This was evident in the Dematagoda cases where a majority have a low viral load. So there is hope that the numbers are going down,” said Dr. Herath.
| Positive Ukranians at KDU hospital Six Ukranian tourists who were diagnosed as positive for COVID-19 are being treated at the Kotelawala Defence University Hospital at Werahera, said Dr. Hemantha Herath. | |
New variants already in many countries – Expert
It is both on the new strains of the virus causing COVID-19 which have spread fear and concern among people and hopes of vaccines that the Sunday Times sought the expert views of well-known Virologist Prof. Malik Peiris.
Pointing out that the virus variants in the United Kingdom (UK) and South Africa have arisen independently, Prof. Peiris says that they, however, do share one particular mutation – spike protein N501Y, while the other mutations are different.
“The UK variant has acquired 23 mutations in all and this suggests that the virus that gave rise to this was undergoing acceleration evolution in an unusual setting – perhaps an immune-compromised patient. We know that SARS-CoV-2 can persist for a long time in immune-compromised patients and this can lead to the emergence of increased mutations within a single patient,” says Prof. Peiris who is Professor of Virology at the School of Public Health Hong Kong University (HKU). He is also the Director of the World Health Organization’s Reference Laboratory for providing confirmatory testing for COVID-19 at HKU.
Prof. Peiris explains that both these mutations arose many months ago and gradually increased in the two places. They have had ample chances to spread out of those countries by now. The UK variant (B.1.1.7) is already reported in many countries – sometimes due to incoming travellers but also as in the United States of America (USA) in people who have not travelled, suggesting that local transmission is already taking place.
“So we cannot assume that the risk only comes from UK and South Africa. Another factor is that there is a lot of virus genome sequencing going on in the UK, even more than the USA. Detecting these mutations will only occur in places where they are being looked for, with large-scale virus sequencing,” he points out.
He says that from the information we have so far, what we can say is that both these mutations increase transmission (as did the previous D614G mutation). There is no evidence of increased disease severity.
We are still awaiting experimental data to inform us if these mutations have any effect on vaccine protection.
“It is unlikely to lead to complete loss of vaccine protection. But it is possible that there may be some marginal effect. We hope not. But we have to wait for the data which should come in the next two weeks or so,” added Prof. Peiris.
Vaccines – side-effect profile good
When asked whether there have been side-effects in people who have got the vaccines against the new coronavirus around the world, Prof. Peiris said that he believes that over 1.6 million doses of Pfizer and Moderna vaccines have been administered already.
There have been very few adverse effects, except for some allergic reactions in a handful of persons who had severe allergic histories in the past. Overall, it appears that the side-effect profile is very good, as indeed the clinical trials had suggested, he says.
With regard to the nurse in the USA who got infected with the virus after taking the first dose of the vaccine, Prof. Peiris says that the nurse got infected 1 week after getting the first shot of the Pfizer vaccine. This is not surprising as vaccines take at least 3 weeks to begin to elicit antibodies and thus protect the person who has been vaccinated. According to him optimal protection from the vaccine will follow the second dose although there will be some protection after 3 weeks after the first dose.
“Just to be clear, there is ABSOLUTELY no possibility that the vaccine caused the infection. There is no live virus in the vaccine,” reiterates this expert, allaying such fears that people may have.
Referring to Hong Kong where he is based, Prof. Peiris says that the country took the pre-emptive step to advance purchase order three vaccines in addition to the COVAX 20% because we have no certainty when COVAX will roll-out. That was a difficult decision as it had to be taken prior to Phase 3 clinical trial data being available and we had to take a guess back in July.
“I was involved in those decisions. Hong Kong chose Pfizer, AstraZeneca and the Chinese inactivated vaccine. Some of the vaccines will arrive in January,” he says, adding when asked whether he would take the vaccine: “I will, of course, take it, when my turn comes.”
| People flouted precautions during season: PHI Union The repercussions of guests flouting health precautions at hotels during the New Year and season celebrations will be seen in about a week, said the Secretary of the Public Health Inspectors’ Union, M. Balasooriya, adding that they are ready to face them. | |
Vaccines: How can Sri Lanka benefit?
In this in-depth piece, Consultant Paediatrician and dengue expert Dr. LakKumar Fernando looks at the issues around the vaccines against COVID-19.
With more than a couple of million people in the world getting their vaccine doses already, Sri Lanka should move fast to make the best use of this opportunity.
When can Sri Lanka get the vaccine?
If we are ready with all the logistical requirements and communicate with COVAX and the World Health Organization (WHO) efficiently and professionally, we can get it from as early as next February.
How many doses we can have and over what period of time, will depend on many factors which also include the degree of our local effort and commitment.
Dr. LakKumar Fernando
Whom should we vaccinate first?
There should be a priority order which should include the elderly; those with co-existing illnesses like diabetes, heart and kidney disease and other chronic illnesses; and those in high-risk groups such as healthcare workers and security forces involved in control activities.
Why should we vaccinate healthcare workers?
We cannot afford to isolate healthcare workers or quarantine them after exposure to infection as they are needed to look after COVID-19 patients and other patients.
Due to the fear of contracting COVID-19, there is a breakdown in routine medical and surgical care for patients in most healthcare institutions. This is responsible for most parallel deaths and morbidity even in non-COVID-19 patients, while some of the COVID-19 deaths, especially home deaths, are a result of the malfunctioning of routine standard follow-up and care for those with co-morbidities.
If case numbers increase, the healthcare workers will need more Personal Protective Equipment (PPE) for everyday use and we will not be able to face it if the situation escalates further.
What of vaccination for others – can we afford it?
Sri Lanka is outstanding when it comes to immunization coverage for routine vaccines, where our strong public health set-up and infrastructure have beaten even many developed countries.
Our vaccination acceptance rates are remarkably high. Mass vaccination is nothing new to us. Being an island with secure borders and a limited population of only 21 million compared to eg. India’s 1.3 billion, we are a country where vaccinating the entire population is a realistic, feasible option if money and doses to cover them can be found.
With about 25% (6 million) below 16 years of age, for whom there is no vaccine yet, we need vaccines only for less than 15 million people. Our over-65 population is just about 10% (2 million). We will get at least 4 million free doses from COVAX. We must spend money only for 11 million doses. If we buy a dose at US$ 2 (Indonesia is possibly getting the AstraZeneca – AZ vaccine from Serum Institute for US$ 1.64 per dose), we will need less than Rs. 5 billion to buy the vaccine, added to which there will be a logistical cost.
This Rs. 5 billion would be needed over many months. Sri Lanka has already spent close to Rs. 10 billion for RT-PCR testing alone since March. When compared to this, the vaccine expenditure is a worthwhile investment. It is also not essential to give the vaccine free to everybody. With good motivation through awareness campaigns there will be many who will not mind paying for their vaccine which can be as little as Rs. 500 for both doses. We can start a public campaign to raise funding for the vaccine without overburdening the Treasury.
It is also important to strengthen the vaccination system by allowing the private sector also to be part of the programme. This will not only ease the burden on the government, but will also help reduce unrest among the people.
It is worth noting that many rich countries have already placed orders far in excess of their true requirement. Eg. The UK has placed orders for 350 million doses though they need only 120 million doses for its less than 60 million eligible population. There are many examples like Canada pre-ordering almost 9 doses per person, very much more than they need and countries needing more doses can take advantage of this situation, by being proactive.
It is unlikely that the cost of the vaccines will go up or the availability of doses will become a huge issue. With time, most will be solved. Already 18 vaccines are in Phase 3 clinical trials and they too will be competing in the market soon. The early successors have no room for monopoly and when vaccines by manufacturers like Johnson & Johnson which is single dose, also come into the market, the competition will be even more. India’s Serum Institute can produce 2 billion doses of the AZ vaccine in 2021 and Russia’s Gamaleya Institute 500 million more doses to be used outside Russia.
The WHO and the National Medicines Regulatory Authority (NMRA) will do the regulatory evaluations for each vaccine fast. However, if we do not actively look for avenues, we will end up at the bottom of the waiting list.
Therefore, Sri Lanka can be one of the first countries in this part of the world to vaccinate its entire population. It is never an impossible task. This will place us in a unique situation. It will enable us to open the country fully with factories working and tourists coming in. Then our economy can jump ahead of many others, making Sri Lanka one of the safest countries in the world to travel to and deal with.
For the best outcome, extreme efficiency is a must and we will need top officials with a proven track record handling our vaccine effort.
What are the vaccines we can buy or get?
With the huge global demand, it is unlikely that any country (with the possible exceptions of Singapore and Canada) can vaccinate the entire population with only one type of vaccine. We will have to keep shopping for different vaccines, while COVAX will also be giving the countries their free quota from different makes. Last week, COVAX offered 200,000 doses of the Pfizer vaccine to Sri Lanka through a proposal, as it believes that we are a model in this part of the world to successfully execute the distribution of an ultra-cold vaccine to a limited population like healthcare workers.
Though -70°C appeared not practical at the beginning, Pfizer has already found a good transport solution where vaccine doses can be taken in a separate storage unit filled with dry ice (liquid carbon dioxide) and there are reputed local logistics companies that can handle their delivery up to a hospital.
Pfizer’s storage units can maintain the ultra-cold temperature for 10 days if unopened and can be kept for 30 days if re-filled with dry ice every five days. Once taken out of these storage units, the vaccine can be kept under normal refrigeration of 2-8°C up to a further five days. If we commit to take this free offer (has to be a firm commitment done fast), we can vaccinate healthcare workers on the frontlines early.
The same Pfizer vaccine can also be made available to the private sector in the future.
Our preparedness to complete our vaccinations using different vaccines will be the best way to achieve the ‘not-impossible target’ of vaccinating our entire population early.
What about side-effects of the vaccine and duration of immunity? What of new strains that will appear?
Any vaccine or drug can have side-effects, like allergy in people known to have severe allergies. With over millions of vaccinations now being administered, the safety of approved vaccines appears very good and comparable to the vaccines we have already taken in our childhood. This has been systematically tested in Phases 2 and 3 of the trials.
With regard to efficacy and long-lasting immunity, we can only be hopeful. When compared to the influenza virus that mutates fast, the SARS-CoV-2 is relatively stable, where mutations are slower.
Indications are that even the new variants of COVID-19 that have emerged in the UK and South Africa will still be prevented by the vaccine. There are interesting reports about the survivors of the 2002-2004 SARS epidemic infected by SARS-CoV-1 showing protection against the current SARS-CoV-2.
If immunity does not last long, a booster will be needed. With so many restrictions affecting our day-to-day lives, the vaccine option is the best available solution we have now.
Background
It is almost one year since the world started battling the COVID-19 pandemic with over 80 million confirmed cases and 1.8 million deaths. The WHO estimates that 10% of the world’s 7.8 billion population is already infected. If that is so, the true case number is ten times higher.
However, we are still without proper treatment that can cure all the patients. Sri Lanka is nearing the 200th COVID-19 death and has exceeded 40,000 cases. Fortunately, there is light at the end of the tunnel with several vaccines lining up to end the pandemic before the end of 2021.
Vaccines have become the best solution against nearly all important infections that threaten human existence and COVID-19 is the most recent threat that demands the biggest-ever ‘vaccine solution’ in recent history.
Normally, a vaccine takes 5-15 years of serious medical research before it is delivered for licensing and marketing. However, with all the tools ready with several vaccine makers to bring in a vaccine for similar infections, the race for the COVID-19 vaccine became fast and efficient. Researchers worked round-the-clock to fast-track the solutions and the result is that vaccination has begun in several parts of the world.
With the WHO declaring COVID-19 a pandemic, close to 200 vaccine developers began their research with huge investments and after completing pre-clinical animal studies, 44 vaccine candidates are currently in Phase 1; 21 in Phase 2; and 18 are in Phase 3. About 85 vaccines are still in animal testing and just one vaccine has been abandoned after trials.
Five vaccines have approvals for limited use and three have emergency approval for full use. The 4th was approved on December 30, which can be a turning point with regard to the cost and storage temperature of vaccines.
Most vaccines need 2 doses for complete immunity. However, trials have also shown significant immunity or protection (70%) after few weeks of the first dose itself. As a result, now the UK government is to delay the 2nd dose to 12 weeks instead of 3 weeks, so that more people could be vaccinated with the first dose, protecting many while giving the manufacturers more time to produce more doses.
Pfizer and BioNTech’s BNT162b2 is the first vaccine that got approval in most countries, including the USA, Canada, UK and EU with more being added to the list almost daily.
Moderna was the next that got approved in the USA and Canada.
The Russian manufacturer Gamaleya’s Sputnik V vaccine is in early use in Russia, while being approved in Belarus and Argentina.
The Chinese vaccine Sinopharm has limited use in China and been approved in the UAE and Bahrain. Two other Chinese vaccines, CanSino and Sinovac, are in limited use in China.
The British-Swiss Oxford University combined AstraZeneca (AZ) vaccine AZD1222 which also has its biggest manufacturing site at the Serum Institute in India has just got approval from the UK’s regulatory authority, Medicines and Healthcare products Regulatory Agency (MHRA). This possibly would be the cheapest, with the cost being as low as US$ 2 per dose with the storage temperature being within 2-8°C under normal refrigeration. The Serum Institute also has over 50 million doses ready for dispatch after approval. AZ with about 30 manufacturing sites has the capacity to produce bigger quantities of the vaccine than most others.
Another Indian vaccine by Bharat Biotech is also in Phase 3 and will complete trials early this year.
| COVAX commitment COVAX set up with WHO’s help with funding from rich countries is to provide vaccines to populations in over 90 poorer countries. It has already ordered 2 billion vaccines from different manufacturers of which it has secured 1 billion doses. It has agreed to give Sri Lanka vaccines for 4.1 million or 20% of the population free of charge. No COVID-19 vaccine is still intended for the under-16 age group as the trials were in populations older than this. Fortunately, in this younger group, COVID-19 has so far remained a largely asymptomatic disease with minimal deaths or need for hospitalization. | |
| Need to vaccinate all There is a need for a multi-pronged effort to vaccinate everybody, which would be a useful investment towards economic development, even more than a health solution. Sri Lanka should secure and use: The free vaccine it gets from COVAX for 20% of its population Negotiate with various sources and countries to obtain or buy more doses to cover the balance population Permit the private sector to import, distribute and vaccinate, under state monitoring, to facilitate effective coverage of those who could afford the vaccine privately. |