I need help! Who will volunteer?

I had said earlier that I would be moving more into writing my next book. It has not been easy. My regular ongoing commitments make it difficult to spend the time I need for writing. This is only one part of the process. 

Publishing requires a number of more steps. Much of that work is software related. I am poor in that area. Trying to learn the skills needed is very time consuming and it affects my writing work. 

This is precisely where I need help. Someone with software skills in three specific areas could be of great help. The first is designing the book cover. The second is to format the book ready for publishing. The third is to do the follow up in publishing such as uploading the formatted book as well as promoting the books.

Even if you do not have these specific skills as anyone with software skills could learn these skills quite quickly. Basically, the template is there. Anyone who has access to the Indesign package of Adobe will find it easy to move in. There are other software packages that could be used as well.

Volunteer? Free? Yes and no. I am a new author. I have published five books online. I have many more in the pipeline based on the good Lord giving me the length of life. My published books have not moved much in the market. They say that once you publish more books the market will pick. At the same time, I am also building up my author platform which should help in marketing. Besides, I have started actively promoting my books also.

Where does the volunteer fit in? It is almost like a venture capitalist. Instead of putting in money you put in time and skills. Both parties will grow together. There is a reasonable assumption that this venture will be successful.

As an author, whatever knowledge and skills I have gained over a lifetime, will be freely shared with the volunteer. The volunteer would gain new skills in cover designing and in formatting the final book. The volunteer can make this skill available as a freelance designer and formatter for many like me who are looking for this professional support. The volunteer can charge at lower or market rates for such services and continue to earn money.

What about my own contribution to the volunteer? At some point along the pathway of growth, a formal or informal agreement may have to be made. This would indicate the financial relationship and how the volunteer would be paid for services done. There are a number of options available which can be finalised that is mutually agreeable.

More than money it is a process of professional growth that would initially take place which I hope would make it possible for the volunteer to earn independently. Of course, I would continue to be available to the volunteer’s growth as long as necessary and feasible. 

I have expressed my need. Although my need is only one volunteer, I would like to start with at least three volunteers if possible. The relationship would be one of growth as well as sharing my experiences in a number of areas that could contribute to the professional growth of the volunteers as a mentor.

Please respond to my email ids as follows. We can discuss individually and come to a mutually agreed conclusion.

abel_rajaratnam@hotmail.com

drabelindia@gmail.com

It has been some time since I made my e-books available for free download. 

With December being a cheerful giving month, I would like to make my e books available for free downloads according to the dates mentioned below. Please feel free to download it. Also do not have second thoughts on sharing this free download with others. Ultimately, it is my desire that this book should reach as many people as possible free or paid versions. The first book I would like to make available for free is the ‘Businessmen for the Poor.’ It is available at the link given below.

Dates for free download of eBook ‘Businessmen for the Poor.’

December 6

December 20

December 25

January 1 2022

January 14 2022

Global eBook Businessmen for the Poor http://tiny.cc/f801tz  

Indian eBook Businessmen for the Poor http://tiny.cc/k901tz 

There are some who prefer to pay and read from a hard copy rather than download even a free eBook. For those interested in only a print version, you can order it through the links given below.

Global Paperback Businessmen for the Poor http://tiny.cc/q901tz

Paperback Indian Businessmen for the Poor http://tiny.cc/6f71tz 

I will make my other books available in my subsequent blog.

You can expect my next blog shortly after this one.

Rajaratnam Abel

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How Hong Kong controlled Covid-19

My last blog post was made considerable time back. I had indicated that I was moving from Covid to writing my next book on development economics. I had been kept busy writing. It was a new area for me and it is taking a longer time than I envisaged.

Some of you may recall my last book entitled, ‘Businessmen for the Poor.’ This new book is building on that book. I will share snippets from that forthcoming book from time to time.

With covid coming under control worldwide, I just want to write probably one last blog on Covid-19. As the title indicates it is about how Hong Kong managed it and the possible price paid by the people.

My first encounter with Covid-19 was Hong Kong and a request for masks. My daughter who lives in Hong Kong with her family considered herself providential that she could manage to get hold of some masks before they completely went out of the shelves in the market. She made an innocent request that I send some masks for some of the poorer church members who were struggling to lay their hands on masks.

So, I requested my professional contacts who are in active service to get me some masks. The request was circulated further down the line. The first response was that India had banned the export of masks. With that door closed, we worked with one of the acquaintances travelling from India to Hong Kong to hand carry some masks. Pat came the reply, “The customs are selectively identifying masks in passenger baggage and taking them out.” That was the end of my efforts at providing masks from India.

This experience motivated me to publish my third book entitled Covid-19. It was widely distributed by the Seventh Day Adventist Church in India to a wide variety of readers. Having failed with supplying masks for Hong Kong, I followed the manner in which Hong Kong managed to keep the country relatively free of the disease.

Masking was the first and foremost intervention carried out in Hong Kong. There were laws promoting the wearing of masks. However, masking was a habit formed over the years even before Covid-19 came on the scene. It was natural for people who had upper or lower respiratory infections to wear masks in public places. If one did not wear a mask in public places with a respiratory infection, then people looked down upon such individuals. Masking was a natural habit and it formed the first line of defence against Covid-19.

The second line of defence was maintaining a distance of two meters. The third line of defence was frequent hand washing and sanitisation. In fact, these three precautions constitute the main defiance against Covid-19.

The other intervention very consciously and rigidly implemented were isolation and quarantine. It started with isolation and or quarantine whenever there was risky contact with a local positive case. Over time they were able to control the community spread of the disease. 

Then they moved to the international level. Under pressure from the people, the Wuhan Hong Kong Express train was stopped very early in the pandemic. Depending on the level of new cases in different countries, anywhere from one to three wee weeks of hotel-based quarantine was insisted upon, with longer periods from countries where the new cases are high. This has been applied quite strictly. 

With these measures, Hong Kong managed to keep Covid-19 under check with very few new cases emerging daily in single digits and deaths being zero on a number of days.

What this means is that by applying Covid appropriate behaviour (CAB) Hong Kong has been able to effectively control the disease in the country. Hong Kong is a safe country for its citizens to live in. 

The proportion of the citizens of Hong Kong receiving Covid vaccines has been a little over sixty-one per cent. Even when the proportion of vaccination was low, CAB was able to keep the incidence of new cases low, even as they are cut off from the world. 

The price paid by the economy of Hong Kong to keep Covid out of the country is very high. Only time will tell if the consequences of the CAB measures followed in Hong Kong have helped them in the long run.  

The following link will show the pattern of Covid-19 in Hong Kong as well as in other countries.                                                                                               

https://graphics.reuters.com/world-coronavirus-tracker-and-maps/countries-and-territories/hong-kong/

Immersed in development economics and poverty: No time

In my last blog, I mentioned that I am moving over to poverty reduction related work from COVID-19. Sure enough, as I mentioned I got myself immersed into development economics. Ultimately poverty reduction is an economics subject. Even to share my experience I need to use economics language and jargon.

I had been wanting to learn development economics. I thought of some of the institutions offering courses on this topic. They were all costly beyond my affordability. Fortunately, I came across a course offered online free of cost by Marginal Revolution University, a unit of George Mason University, USA. I had started the course a few months back. I needed to increase the pace of learning.

Shortly after I posted my last blog, I went full stream into learning development economics. I had to go though about 200 videos on different topics on development economics. Not all were very long, with the longest ones being about eighteen minutes. But in the last two days, I would have viewed about twenty-five videos. I learnt so much about development economics. After some attempts, I managed to pass the final exam and got an online certificate for the same. It just increases my knowledge without adding to my cv.

Immediately I sat down to bring in all I learnt on this new subject into my next book. As I was going through the course, I came across a number of sub topics around which I had real life practical experiences in poverty reduction. I was able to write those experiences. Now I have reached a bottle neck as I try to look at research designs for measuring poverty reduction. My writing has slowed down considerably.

Now you can understand why I have been delayed in posting my blogs. My sincere apologies for the delay. I am thankful to the many readers of my blog in LinkedIn. It is your enthusiasm that makes me write more often.

That’s where I stand in my blogging. I had assumed that with the second wave in India coming down, there may not be anything more to write about Covid 19. Maybe I was wrong. There are four different variant strains of SARS CoV-19. First is the alpha virus from China, the original one. The second is the beta variant from S. Africa. The third one is gamma variant from Brazil. Fourth is the delta variant from India. Now we also have delta plus. So, I may be forced to write about these variants at some time if they are problematic.

Those of you who would like to keep abreast of the news relating to Covid-19, may want to see and subscribe to the YouTube videos posted by Dr David Campbell. He provides most up-to-date information on this disease.

In one of my next blogs, I will share about what I am learning about development economics and poverty reduction.

Now I am entering an area where I would like professionals to be critical of what I write. That is how knowledge is built.

Of course, you can also ask very specific and pointed questions relating to any area that I am communicating through my blogs. Your questions will focus my responses.

Thanks

Rajaratnam Abel

Transitioning from Covid-19 to Poverty Reduction and Health

Poverty and health were the areas of my lifetime work and focus. I had started publishing my experiences in this area. With Covid-19 taking a centre stage throughout the past year, I did not get into my area of interest.

Recognising that prevention of Covid-19 is the primary strategy to handle the disease, the focus of responsibility falls on each one to take steps to avoid the risk of contracting the disease. Should any important information on Covid-19 become available, I will share through these pages. Otherwise, I will begin focusing on lessons I learnt in reducing poverty and its impact on health.

God blessed me by enabling me to spend twenty-seven out of thirty-five years of my active service being associated one way or the other with reducing poverty through the Rural Unit for Health and Social Affairs popularly known as RUHSA of Christian Medical College, Vellore, India.

In the year 2000, as part of the silver jubilee celebration of RUHSA and based on taking a sabbatical break, I was able to write and publish a book on RUHSA, under the title, ‘Sustainable Health and Development: RUHSA’s experiences.’ It is out of print with only PDF copies being available.

So even as I move away from Covid-19, I wanted to use this opportunity to make my book on Covid-19 available for free download on two days of May 31st and 1st of June. The link to the book is given below.

About two years ago, I published my next book entitled, ‘Businessmen for the Poor: Reducing poverty by creating small businessmen and businesswomen.’ I am in the process of editing this book to bring out the second edition, focusing much more on the strategies to reduce poverty with more data being thrown in. The draft title is ‘Pathways to reduce poverty.’

There is more to poverty reduction than just the social dimension. Its economic dimension is also significant. While I am not an economist, I have learnt that the process of poverty reduction is closely related to development economics.

There are simple online courses that teach the basic principles of development economics. As I started learning these concepts it was clear how some of these were observed in my work. That has motivated me to look at micro-level principles of development economics. With God’s help, I am toying with the idea of bringing out the next book based on our experiences in the area of development economics. 

So even as I move into poverty reduction in my blogging, I thought it appropriate to make available my E-book on ‘Businessmen for the Poor’ as well, as a free book to those who are interested in owning a free copy of my book. The link is available below.

I have a third book on biography. Being a graduate of CMC Vellore, I read about the life history of the ancestors of Dr Ida Sophia Scudder. Her grandfather, Dr John Scudder was the first fully trained doctor who went to any country to serve. His life is a story of sacrifice. Those who would be interested in having this book as well may get a free book, with the link given below.

I hope you will find the topic of poverty reduction interesting and useful for a country like India or even some of the states in particular or even any other country of the world. I would value your downloading and sharing this with your friends, relatives and other professional contacts as well as by posting through your own social media pages.

Rajaratnam Abel

Links to my books

1.Book Businessmen for the Poor

Global eBook Businessmen for the Poor http://tiny.cc/f801tz

Indian eBook Businessmen for the Poor http://tiny.cc/k901tz

2.Book COVID-19

Global eBook COVID-19 http://tiny.cc/gb01tz

Indian eBook COVID-19 http://tiny.cc/bb01tz

3.Book Dr John Scudder

Global eBook Dr John Scudder http://tiny.cc/ob01tz

Indian eBook Dr John Scudder http://tiny.cc/wb01tz

 

With Covid 19 hitting the roof in India what should you do?

It’s been more than a month since I last posted my blog on Covid 19.

Of course, there’s nothing much to write now except the increase in cases and deaths in India and now in Tamilnadu.

The big question is what should be done in such a situation?

I’ll share with you what I am doing under the circumstances.

I recommend the advice of those who have come back alive from the Covid 19 experience; “Take every step to prevent contracting the disease. Even the mildest infection is a difficult experience.”

Here’s what I am doing to prevent Covid 19.

I am staying put in my home over 90% of the time. I go out only when my presence is absolutely needed to obtain food, medicines and cash from the ATM. I avoid going into crowded shops or places and try to avoid airconditioned shops except when absolutely necessary.

I try to maintain safe distances and force others to maintain distances by not coming closer to me than needed.

I wear mask always while going out, having increased to double masking recently. I try to force others with whom I have to come in contact to wear masks whenever possible.

I wash my hands with soap and water as often as possible as well as sanitising whenever needed.

I started steam inhalation twice a day- breathing in through nose and breathing out through the mouth and then reversing it by breathing in through the mouth and breathing out through the nose with each done 15 times. (Recommended 10 times). I have not kept up the habit as the first Chinese made inhaler that I bought was so flimsy it conked out within a few weeks. I have not got into the habit again after purchasing a second one.

We try to consume immune boosting foods including mixed vegetable juice as well as juice made of varieties of greens. Whenever possible we add thulsi or royal basil leaves and thuthuvalai leaves.

Most important of all, both my wife and I have taken two shots of the Covishield with six weeks gap.

What more can I do to prevent Covid 19?

It does not mean that what I am doing is 100% risk free.

With the circle of Covid 19 infections and associated deaths getting closer, I am not ashamed to say that I do have fear at times.

On the other hand, I have tremendous faith in my God, that He will not allow this disease to strike me without His divine permission. Even in such a situation, I am at peace with my God as to whatever should be the outcome.

There is so much confused advice coming out on immunisation, the effective ones, the complications of differing vaccines and the intervals being recommended between the first and the second dose. I do not intend to get into that muddled area.

Whenever you get the opportunity to have the vaccine against Covid 19 take it. In spite of apparent failure in some, over all the benefit is worth the vaccine.

Very gradually, I’ll move out of blogging on Covid 19 and move on to my major work on poverty reduction.

As in the past, I am offering free download of my three eBooks with the links given below on the 31 of May and the 1st of June.


Links to my books 

1.Book Businessmen for the Poor

Global eBook Businessmen for the Poor http://tiny.cc/f801tz  

Indian eBook Businessmen for the Poor http://tiny.cc/k901tz  

2.Book COVID-19

Global eBook COVID-19 http://tiny.cc/gb01tz 

Indian eBook COVID-19 http://tiny.cc/bb01tz 

3.Book Dr John Scudder

Global eBook Dr John Scudder http://tiny.cc/ob01tz 

Indian eBook Dr John Scudder http://tiny.cc/wb01tz

I trust that you will find these eBooks useful and that you can share with your friends and relatives.        

Rajaratnam Abel

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I’ve Completed my Covid Vaccines. Am I fully safe?

It’s been some time since I posted my last blog. I told you I was going to share about the complications of the vaccines. But I am sorry, I did not get sufficient information to pass on through a blog.

I am happy that at least the companies are now willing to accept that there are complications. In the initial stages, they just kept saying, even deaths were not related to the vaccines. At least powerful governments have forced some of the companies to review more systematically their vaccines and the suspected complications. I am not going to talk about complications yet.

Last week both my wife and I have completed the second dose of Covishield vaccine. By God’s grace, both of us did not have any side effects-no fever or pain.

I want to share a message posted by a doctor from India in Whatsapp. This narrates how even after he got both the shots of the vaccine, he still came down with the disease. Just read below the story of Dr Rajgopal Shenoy, Surgeon at Kilpauk Medical College, Chennai, India.

I just wanted to let you all know that both myself Dr Rajgopal and my wife Dr Anitha contracted COVID-19 ten days ago. We had taken both doses of the vaccine and three weeks after the second dose, we went to Vapi via, Mumbai (airport transit only) to attend a wedding reception and inauguration of a new hospital.

We both had been so careful all through last year but let our guard down just this one time thinking we are safe because we have taken the vaccine. Please remember that the vaccine does not prevent us from contracting COVID-19 (we are examples).

We can still get it if we are not careful. So, I request those of you who have got the vaccine, to continue to take care as before (wearing mask, social distancing etc). Don’t let your guard down.

Yes, the vaccine reduces the severity of COVID and that is how we have got through it successfully. Our disease was categorised as mild. Even then, it was not just a bit of a cold and sore throat. It was pneumonia, our oxygen levels came down and it affected our coagulation system.

Luckily, we did not need oxygen. We have both recovered are back home now but the experience is something we could have done without. 7 days home isolation and 3 days hospitalisation at Udupi and 7 more days now home.

No need to really isolate but need rest. Take care, my dear family & friends! This is for your information. Wish you all good health!!

He is not the only one who has got the infection after the vaccine. We still do not know the full benefit and impact of the vaccines. Of course, all vaccines are not 100% effective. So, there is that margin. But this seems beyond that ineffective range.

Instead of getting into discussions on the merits and demerits of the vaccines, those who have taken the vaccines, and those will take the vaccines in the future, still need to take precautions.

What people say as this doctor has said, the disease that comes on after vaccine is not severe. No one is reported to have died, getting the disease after the vaccine.

Knowing the possible complications as presented in the news, those who choose to have the vaccine should go ahead and have it. We do not know who will react negatively. It will take some time before we know the full story of the complications associated with the vaccine.

So, continue to take the precautions- mask, safe distance, sanitising/soap washing, etc. Avoid large gatherings and don’t go out more than what is absolutely essential. With the current wave of Covid in India, those living here should take care.  

You’ll be surprised. The church where I grew up and worked has published my book COVID-19 and distributed it free to church leaders in India, Nepal, Bhutan and the Maldives. Additionally, they are distributing it free to some of the teachers of schools.

To my readers, I am making the eBook COVID-19 available for free download for two days. Please feel free to download a copy for yourself and even share the information with your family members, friends and colleagues. It is available in the following link.

Free downloads on 17th and 18th of April 2021

Book COVID-19

Global eBook COVID-19 http://tiny.cc/gb01tz 

Indian eBook COVID-19 http://tiny.cc/bb01tz 

My other book Businessmen for the Poor is also available for free download on 17th and 18th of April 2021 in the following link.


Book Businessmen for the Poor

Global eBook Businessmen for the Poor http://tiny.cc/f801tz  

Indian eBook Businessmen for the Poor http://tiny.cc/k901tz

For your good health,

Rajaratnam Abel

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Before and after taking my Covid-19 vaccine

On Friday the 19th of February, I had my first shot of the Covishield Covid-19 vaccine. Earlier, I had decided to take the vaccine whenever it was available. But then I felt the need to give some time to see the possible side effects of the vaccines available.

In my last blog, I indicated that I would indicate who should not take the vaccine. Unfortunately, I do not have full information on who should not take the vaccines. Early on, I got the impression that those who are on blood thinners after coronary bypass surgery, should not take the vaccines as some patients had blood clotting problem.

I checked with my cardiac surgeon. He said that it is not contraindicated. He advised two precautions. First, the injection should be administered using a very fine bore needle. Second, after the injection, that site must be kept under pressure for about 10 minutes.

I spoke to a senior citizen friend of mine. He said that he had the vaccine and that he did not have any side effects after the vaccine.

I cross-checked with my physician. He advised me to go ahead and have the vaccine. He said that there were no major problems with the large numbers vaccinated in his centre.

So, without much delay, I arranged for the vaccine and had it over with last Friday. Fortunately, I had it at a centre where there were no crowds during the time of the injection

I am preparing this blog over five days after the vaccine was administered. By God’s grace, I had no complications of pain or fever. 

Yesterday, while taking a class for online students, many of who were doctors were asked a question on whether they had the Covid-19 vaccine and if so any complications. Many said that they did not have any complications. A few said that they experienced fever, pain and malaise. One mentioned diarrhoea.   

There was one interesting feedback. This person had taken the Sinovac or China made vaccine about three months back. Now he tested positive for Covid-19.          

Surprisingly many throughout the world are passing up the opportunity to take the vaccine. What are some of the possible reasons that people are not willing to take up the vaccine?

There is first of all some apprehension that there is not enough information published or reported relating to complications of the vaccine trials at different phases. There is conflicting information on the level of efficacy or % of protection of each of the major vaccines in use. The third point is there is uncertainty as to how long the immunity of the vaccines would last.

When I had completed the first dose of the vaccine, I was told that when I take the second dose 28 days later, I would get a ‘Vaccine Passport.’ It is creating an impression that soon without this type of ‘passport’ people would not be able to travel freely. I would be happy to be corrected on this.

Even as I was writing this blog, I came across the following information relating to the expansion of the Covid-19 vaccine programme.

“People aged more than 60 years and those who are 45 plus and have comorbidities will be able to get a vaccine against Covid-19 at a government centre or a private hospital from March 1.

Announcing this, the central government on Wednesday said people above 45 years of age will have to show a certificate stating they have comorbidities.”

I am sure more information regarding will become available in due course of time.

New information on Covoid-19 has been continuously coming forward as new interventions are being introduced. Updating this type of information continuously is necessary. I am happy to share this information through these blogs. I would value it if many readers raise questions and make additional feedback and comments as that would add value to the whole knowledge building process.

At a personal level, I was able to update some information that emerged regarding Covid-19 in my book COVID-19. The updated eBook is currently available at the following link. Readers may utilise as needed and convenient. I hope to bring out the print version soon.

Book COVID-19

Global eBook COVID-19 http://tiny.cc/gb01tz 

Indian eBook COVID-19 http://tiny.cc/bb01tz

I hope to share some information on Covid mutants or variants in my next blog.

Rajaratnam Abel

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Vaccine preparation and clinical trials

In my last blog, I mentioned that I will present various aspects of clinical trails in the preparation of vaccines. So, here it is.

Peter Piot who played a key role in the HIV epidemic and then the Ebola crisis has made this statement. “Let us be clear: without a corona vaccine we will never be able to live normally again. The only real exit strategy from this crisis is a vaccine that can be rolled out worldwide.” If a vaccine is so important, then you may be interested in knowing as well as find it useful to know how we reached this stage where we have a number of vaccines available.

Research centres and companies throughout the world worked at breakneck speed to develop a vaccine for this disease. There are certain biases that come in such haste. If the disease attacked only the developing world, there normally would not have been such a big hurry. Since this has hit the developed countries far out of proportion to the developing world, there is a certain urgency in this process. In this blog, I would like to explain the steps or phases involved in developing and making a vaccine available for wider use public use.

Phases of vaccine research

There are at least six steps in carrying out research on developing a vaccine. I’ll take you through these six steps briefly for your understanding.

Step 1. Identifying the antigen or the substance that would be administered to an individual that would produce the desired response of generating the antibodies to these antigens. In some vaccines, live but half-killed or attenuated organisms are used as the antigen. The Covishield or the Oxford vaccine belongs to this category, using chimpanzee adenoviruses. The Covaxin of Bharat Biotech uses inactivated or killed SARS CoV2 virus. In other vaccines such as the Pfizer vaccine, parts of the organism are used as the antigen using a technology called mRNA. This explains the three broad types of vaccines available today.

Step 2. In this step, the selected antigen is tried out in test tubes in laboratories and then on animals. Effectiveness and safety are looked at this stage.

Step3. – Phase 1 clinical trials. In this phase what has been developed in the laboratory is now tested on actual human volunteers. Again, effectiveness and safety in the humans are looked at this stage. Very few individuals are used at this stage.

Step 4 – Phase 2 clinical trials. In this phase, a small number of volunteers get the vaccine and then they are challenged with the disease. The immunised volunteers actually receive the disease germs and then they determine whether the vaccine actually prevents the disease or not. Safety is an important consideration here.

The difficulty with COVID-19 is that there are no one hundred percent effective medicines for the disease. What if the vaccine fails and the volunteer gets the disease and even dies? These considerations have always slowed the pace at which these early phases have gone through.

Step 5. – Phase 3 clinical trials. In this phase, the vaccine is made available to a larger population but still under research supervision and based on the written consent given by those in the trial. Over forty years ago, I had the privilege of being an administrator for a major research on injectable polio vaccine, a killed polio vaccine, under the Head of Virology Department, Dr Jacob T John. At the end of phase 3 trials, we were able to prove that the injectable polio vaccine was effective and safe in a rural Tamilnadu population in India.

The issue with COVID-19 vaccines has been that different vaccines had their phase 3 trials completed at different points in time. In India this has become an issue, that the Covaxin of Bharat Biotech has not completed the phase 3 trial and it has been given emergency use license. This is why, those who receive this vaccine have to sign a consent form agreeing to be part of the phase 3 trails, till the number to be involved in the phase 3 is completed. Many experts are questioning the reason for this hurry without phase 3 trials. Even a case has been initiated in the Supreme Court.

Step 6. – Phase 4 clinical trials. In this phase, it is carried out as a marketing exercise. It is freely used in the ongoing health care delivery system. The administering of Covishield comes under phase 4 as they have completed the phase 3 trials. Generally, after phase 3 trials, it is expected that the results of the trial must be published in a reputed medical journal refereed and reviewed by subject experts before phase 4 is started. In India both Covishield and Covaxin have not published their Indian experience. This is another drawback of the Indian vaccination programme.

In my experience mentioned earlier, after the phase 3 trials with injectable polio, it went on to phase 4. Phase 3 was in a small geographic area of one development block or county. In phase 4 it covered the whole district consisting of nearly forty such blocks or units. I was not directly responsible at this stage, but I was involved with the team. There were certain design issues which resulted in not showing the same level of effectiveness of the injectable vaccine seen in phase 3. Therefore, this injectable vaccine was rejected then. Only after repeated difficulties faced with the oral polio programme using live attenuated polio virus drops was the injectable vaccine brought back in the final assault on polio.

Before I go further on vaccine trials, I must highlight handling some of the ethical issues involved in such type of research. The first is recruiting volunteers for such trials. There are clear international guidelines that state how volunteers could be brought into the research and their rights and protection.

In such research, the participants have the right to comply or not comply with the research protocols at any stage. Always a signed written consent statement is obtained from anyone who participates in such research.

One last ethical decision concern is the need to have a comparable group. One group will have the vaccine and the other may not get anything or they get what is called a placebo. In this case it being water or saline which is an inert or inactive substance that is harmless. Again, there are strict guidelines followed by research institutions when control groups are used.

Now you can understand the complexity of developing a new vaccine for COVID-19. There are strict protocols to be followed, although there are temptations to shortcut the steps because of the suddenness of the disease and the rapidity of its spread. By the time a vaccine goes through these phases, it was predicted that it could be a year or more before it was available for immunisation. But then the vaccines arrived much earlier than expected.

There is then always the question, whether there were short cuts in this vaccine race. Very clearly the phase 3 trials have not been completed in all vaccines. Not all vaccine trials have been published in journals. The manner in which reactions to the vaccines have been handled have also raised questions and doubts. There have been a number of deaths associated with the vaccines. It is not clear that these have been reviewed by competent neutral experts to determine if there is any relationship with the vaccines.

I am going back to the statement made Dr Peter Piot indicating the need for a vaccine before we can go back to the type of normal living of the pre COVID-19 era. Even with a number of vaccines available today, there are certain issues associated with it discussed below.

The companies which have invested in vaccine research have the primary purpose of making profits. The initial indications are that they are not going to be cheap. Richer countries may be able to afford them. Even there the poor in those countries may not get it easily unless the governments intervene in an equitable manner. WHO has called this vaccine nationalism.

The next issue to be addressed is to produce millions or even billions of vaccines if it has to be effective. Whether these large quantities could be produced so quickly is one important consideration. The price fixed by the companies would determine how freely these large quantities are available for those who need.

We are witnessing around this time a community backlash against any vaccines to be given. The anti-vaccine lobby is very powerful in some of the countries. The US which had successfully controlled measles as a disease has seen it come back in epidemics, because parents have refused to give the measles vaccines to their children. Similar objections to this vaccine could also create problems in controlling the disease. A large number of potential recipients are refusing to take the vaccine in different countries.

Only now after the initial round of experience with the different vaccines, for those whom it is contraindicated is beginning to emerge. In my next blog, I’ll share a list of those who should not take this vaccine.

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Karan Thapar Interview with Dr Gagandeep Kang of Christian Medical College Vellore COVID Vaccines in India

This interview is based on the situation that two vaccines are now available in India for administering to the general population. Certain questions have been raised which are addressed in this interview. While this may be relevant for India, even readers from other countries may find this useful.

New Delhi: In an interview where she addresses in detail the concerns raised by both Bharat Biotech’s vaccine Covaxin and the Oxford-AstraZeneca vaccine made by the Serum Institute, called ‘Covishield’, India’s top vaccine scientist has said that whilst she is willing to participate in clinical trials of any vaccine she will not take Bharat Biotech’s Covaxin as a vaccine until its required efficacy data is made public.

Professor Gagandeep Kang said that without efficacy data no vaccine should be cleared and agreed that this means the clearance given to Bharat Biotech’s Covaxin without efficacy data has been done on the wrong basis. She said she found the limited approval given to the Bharat Biotech vaccine without Phase 3 trial efficacy “extremely confusing”.

In a 48-minute comprehensive interview to Karan Thapar for The Wire, Gagandeep Kang, who works at The Wellcome Trust Research Laboratory at the Christian Medical College in Vellore, said the precedent set by the Ebola and Nipah vaccines, both of which were cleared without completing their Phase 3 trials and obtaining their efficacy data, does not apply to COVID-19.

She said this is both because of the differences in the disease and its mortality as well as the fact that we have other licenced products to tackle COVID-19. “I would ask why would you want to give a vaccine without efficacy emergency use authorisation in these circumstances?” she said.

Commenting on the claim made by Dr. Krishna Ella, the chairman of Bharat Biotech, that the 2019 Clinical Trial Rules permit in an emergency the clearance of an untested vaccine on the grounds that its Phase 2 data, which establish safety and immune response, are acceptable, Kang made it clear that she did not agree. She said whilst the rules allow the bypassing of all clinical trials this was, she believed, to avoid bridging studies in the case of foreign vaccines that have undergone trials abroad.

In her belief the rules do not permit authorising the use of a vaccine without completing the Phase 3 trial. That is what has happened in the case of the Bharat Biotech vaccine.

Questioned by The Wire about the head of the ICMR Dr. Balram Bhargava’s claim that Bharat Biotech’s efficacy has been established by animal trials and Phase 1 and Phase 2 trials, Kang once again made her disagreement very clear. She said whilst animal trials are used in America to clear drugs its only when you can properly mimic the human disease in the animal. She said that is not the case with COVID-19. Secondly, she said Bharat Biotech’s Phase 1 and Phase 2 trials involved a total of 800 participants and that is far too small a number to rely on for efficacy data.

Speaking to The Wire about a claim made by both Dr. Balram Bhargava and Dr. Vinod Paul that the Bharat Biotech vaccine has been cleared because it could be better at tackling new strains of the virus and, in particular, the British mutation, Prof. Kang said “I wish we had data to establish this”. She added: “At the moment we don’t”. She said the Bhargava-Paul claim is simply “a hypothesis”.

Kang told The Wire she is “really confused” by the language that the Bharat Biotech vaccine has been cleared for use “in clinical trial mode”. She said she’s “not sure what that means”. In the interview she seemed to accept that this could mean that people who get the vaccine will actually end up being part of the continuing clinical trials.

Asked if the international community will conclude that India has cleared the Bharat Biotech vaccine in a way that is similar to how the Russians and Chinese cleared their vaccines her reply was short, sharp and simple: “absolutely”. She said there’s “very little difference between the way the Chinese and Russian vaccines have been cleared and this one”.

Speaking to The Wire about the Oxford-AstraZeneca vaccine, Kang said the fact it ended up with two outcomes from its trials – 60% efficacy from two full doses and 90% efficacy from a half dose followed by a full dose – is “really messy”. She said if she had been the regulator she would have set aside and disregarded the serendipitous 90% outcome because that was not the procedure Oxford AstraZeneca initially intended to follow. She would have been gone by the efficacy result that emerges out of the procedure they had originally said they were going to pursue i.e. the 60% outcome.

However, Kang said that if it is true that Oxford AstraZeneca gave paracetamol to suppress side effects this would not be “a deal breaker for licensure”. She also pointed out that baby aspirins are often given to children when they are vaccinated to suppress side effects such as a fever or a pain in the arm.

Kang told The Wire that the two or three cases of neurological problems after the Oxford-AstraZeneca vaccine are a different matter. However, she added there have only been two or three such cases out of the thousands of people who were part of the trials. Therefore, you cannot say they are because of the vaccine. She added it would be a different matter if many more cases emerge when the vaccine is administered for regular use. That is not the case at the moment.

Kang also said she disagreed with Professor T. Jacob John’s view that the Special Expert Committee has bent over backwards to accept the Oxford vaccine data. She does not believe Oxford has been shown special favours.

In The Wire interview Kang was also questioned the way both COVID-19 vaccines have been cleared in India. She said: “We have got a real communication problem. We need to do a lot more to convince people we have done the right thing. The pandemic no doubt creates urgency but if we are to use vaccines we need to build trust.”

Asked whether the DCGI, when he cleared the vaccines, should have followed the practice of the MHRA in Britain and the FDA in America and answered questions Kang said: “All government authorities should be more available to answer questions”. She added that “the more open and transparent we are will make all the difference in building trust.”

Finally, asked whether the names of members of the Subject Expert Committee and the National Expert Group on COVID-19 should be made public, Kang said: “I can’t think of reasons why their names are not in public”. She added one possible reason could be to protect them from pressure and questioning. When it was pointed out that experts should be willing to be questioned and to defend their decisions, Kang said she hoped, “One day questions would be welcome.”

Those of you who want to take the time to listen to the actual interview, can click on the link below to see and hear the interview in the youtube.

https://www.youtube.com/watch?v=YCm68olXnAk&ab_channel=TheWire

I will share the steps of an ideal vaccine trial in my next blog. This may give you an idea of the stages through which a vaccine is carried through before it is made available for the public. In 1980-1988 I was part of a team that carried out phase 3 trials of injectable polio vaccine.

Some of you may be interested in getting a copy of my book COVID-19. The eBook is availablle in the following links.

Global eBook in US $ http://tiny.cc/gb01tz

Indian eBook in http://tiny.cc/bb01tz

Rajaratnam Abel

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Happy New Year 2021

I just did not want to miss this opportunity of wishing you all a very happy new year in 2021.

Everyone would like to forget 2020 and hope for the best in the coming year.

I had hoped to send each one of you updated ebooks during the holiday season. Covid death within the family upset all my plans. What I missed, I will catch up during the new year.

Only God can give us that rich blessing we all desire. It is my sincere prayer that God would richly bless each one of you during the coming year.

Expect new blogs during the coming months. I will share the forthcoming books during the coming year.

Hope to keep in touch during the coming year.

Rajaratnam Abel

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