Corona Virus Vaccine - all you need to know

Corona virus vaccine all you need to know
We know our scientists much less than the Babas and Politicians. Indian media is more inclined towards highlighting Babas and politicians than the scientists. 

In this kind of crisis caused by Covid-19, it is likely that the scientists call a press conference but instead Baba Ramdev is doing that. 

Indian Council of Medical Research (ICMR) had their last press conference on 11th June 2020 when India had some 2.5 Lakh corona positive cases. In the last 30 days there was no press conference by ICMR and now India has around 8 lakh corona positive cases. 

It's not fault of the Babas that you do not know our scientists, it's fault of the Indian media and you yourself. Have you heard that Dr. Gagandeep Kang has resigned? 

No, you haven't, you probably do not know who Dr. Gagandeep Kang is. You can feel free to ask who Dr. Gagandeep Kang is and where from she has resigned. 

Here is a short introduction of Dr. Kang

Dr. Gagandeep Kang is the first ever Indian women scientist to be elected as a Fellow of the Royal Society (FRS), London. 

Dr. Kang is largely acclaimed for her critical role in the development of rotavirus vaccine. (Rotavirus is a virus which infects mostly the infants and young children. On infection, Rotavirus causes severe diarrhea and vomiting. India is the first country in Asia who indigenously developed the rotavirus vaccines Rotavac and Rotasiil in the year 2016).

Dr. Kang was the Executive Director of Translational Health Science and Technology Institute (THSTI) from which she has resigned having one more year of completion of her tenure.

THSTI is a Faridabad based public health research institute under the Ministry of Science and Technology's Department of Biotechnology. 

Now coming back to the point, a Committee was constituted in the month of April 2020 for development of indigenous Covid-19 drugs and vaccine and the committee was headed by Dr. Gagandeep Kang. 

Surprisingly enough, such a committee of importance has been dissolved by ICMR in May 2020, just after one month of forming the same. Nobody knows why the committee has been dissolved so suddenly. 

I hope, you are beginning to smell something foul now. Dr. Gagandeep Kang is also the Vice President of the Equitable Access Committee of Coalition for Epidemic Preparedness Innovations (CEPI). This CEPI is a global network of scientists and is based in Norway. Having formed in the year 2017, main objective of CEPI has been to control and stop future epidemics. 

According to this organization i.e. CEPI, it will take somewhere between 12-18 months to launch the vaccine of novel corona virus Covid-19 and the project will cost around 2 Arab Dollars. Many Countries and big companys have invested in this big project. 

Now, try to understand one thing, such a person of high stature as Dr. Gagandeep Kang has resigned from the post of Executive Director, THSTI and Indian media is completely silent on it. The reason for this silence is not understood at all. 

Indian Express contacted Dr. Kang and enquired about the reason for her resignation. Dr. Kang told that the disbanding of the committee by ICMR is not at all connected with her resignation and that she has resigned only on personal matters. 

Social media is flooded with all fake news about corona virus vaccine. Rise to this belief is caused especially after the Headline that India is about to launch Covid-19 vaccine on 15th August 2020. 

People are sharing this news like crazy believing that the vaccine for deadly corona virus has arrived. That, Corona virus has been defeated, lockdown is finished and masks will be thrown into dustbins. 

How this belief is originated? 

Director General, Indian Council of Medical Research (ICMR), Dr. Balram Vargava issued an official letter to it's associates which was leaked in the media. The letter hinted that the vaccine for corona virus will be launched on 15th August 2020 from the Red Fort, New Delhi. 

It is important to note that everyone want this vaccine and everyone will appreciate the launch of the vaccine. But we should not forget that there are certain scientific parameters and protocols for launching any biological vaccine. 

The letter of Dr. Vargava was addressed to the Principal Investigators of several hospitals and research centres who are connected with the trial process named as COVAXIN trial. 

Gist of the letter issued by Dr. Balram Vargava is as below :-

That, Indian Council of Medical Research has collaborated with Bharat Biotech International Limited to expedite the trial process of corona virus vaccine i.e. COVAXIN. This is going to be the first purely indigenous vaccine made by India. This project is of highest priority and is being monitored at the top most Government level. Strain from SARS COV-2 for the vaccine has been separated by ICMR and National Institute of Virology, Pune. In association with Bharat Biotech, the organization is working on pre-clinical and clinical trials of the Covid-19 vaccine. It is expected that having completed all trials the vaccine for Covid-19 will be launched by 15th August 2020. Bharat Biotech International Limited is working hard to achieve the goal but the final result will depend on the cooperation from all the involved organisations. You have been all selected to conduct the clinical trial of COVAXIN. In the interest of public health, you are strictly advised to accord faster approval of everything to start the trial process. Also ensure that, registration of all volunteers are completed by 7th July 2020. Please note that those who do not cooperate, matter will be viewed seriously. You are therefore advised to treat this project as top most priority and complete the timeline without any lapse. 

Readers are to note carefully that the above letter is by no means an advisory, instead it's provocative with indirect threats. As written in the letter, who at the top most level of Government is monitoring such an important scientific research? The Nation wants to know (Arnab Goswami). 

It's up to the readers to decide whether a letter addressed to the scientists should contain such a language of threats. 

The letter caused sufficient controversy which compelled ICMR to issue a clarification on 4th July 2020. In the clarification, ICMR stated that the strict language was used to reduce red-tapeism. Red-tapeism refers to excessive use of paperworks in order to start an official procedure. 

In that case, it is worthy to mention that ICMR didn't mention about red-tapeism in it's controversial letter. 

In a press release on 5th July 2020 by Ministry of Science and Technology it was mentioned that vaccines namely COVAXIN and ZyCov-D for which human trials has started can not be made ready before 2021. Surprisingly, this line has been removed citing some grammatical mistake. 

Indian Academy of Science, a Bengaluru based research Institute has strongly objected to the entire process. They have stated in a press release on 5th July 2020 that taking into cognizance of the letter issued by ICMR they welcome the development of vaccine for corona virus. But the idea of launching the vaccine by 15th August 2020 is unreasonable and impractical in itself. That the controversial letter of ICMR has given rise to impractical thoughts into the minds of the common Indian citizens. 

Obviously vaccine is required at the earliest but such kind of timeline in case of a scientific research was not seen earlier. It is possible to expedite paperworks but without compromising the scientific protocols it is an absolutely wrong idea to speed up natural scientific development process. 

This scientific process requires several weeks and months and if the scientific protocols are compromised in hurry it will surely create an adverse effect in coming years. 

Dr. Soumya Swaminathan, Chief Scientist of World Health Organization has said that currently 150 reseraches are in place throughout the world for development of vaccine for Covid-19 and at least one would become ready by 2021. 

Readers are requested to note what every experts are saying, they are saying that it will take some months if not years for the vaccine to be ready in all respects. 

But, nothing is impossible and everyone want the vaccine soon.

Dr. Anant Bhan an expert researcher on Bioethics, Global Health and Health policy has explained the process of development of vaccine in an exclusive interview with NDTV. Dr. Bhan was earlier the President of International Association of Bioethics. 

He said that as per vaccine science it takes a lot of time and trials prior to putting the vaccine in public domain. All interim steps and protocols are checked by specific committees prior to start of the clinical trial process.

All concerned Institutions or the clinical trial sites have Ethics Committees. These Ethics Committee check all records of pre-clinical trial, animal trials and only when they are convinced that the scientific protocols have been followed they approve the site for clinical trial.

They also check staffing pattern of the Institution, laboratory facilities and previous experience of the Institution in clinical trials. 

There are also other additional factors like on how many volunteers the trial will be conducted and how the volunteers will be educated about their rights. 

If the Ethics Committee identifies any risk then accordingly the risks will be minimized. But if you ask the Ethics Committee to complete all these tasks in 2 days or 7 days then it will create undue pressure. They can be asked for faster paperworks but can't be forced for faster scientific process. 

Dr. Anant Bhan has further explained that there are 3 stages of the clinical trial :-

Stage I : - stage I of the clinical trial is essentially a Safety Trial. This trial will look for risk factors to the volunteers who are being injected the vaccine. Whether there is any adverse effects or side effects as per specific dosage of the vaccine. Volunteers are kept in 24 hours surveillance for many days.
 
Stage II :- stage II of the clinical trial is for Immunogenicity. Immune response by the volunteers are checked after injecting the vaccine. Researchers will have to see whether antibodies are being developed by the vaccine. These antibodies will protect us from infection.

Stage III :- this final stage of the clinical trial will determine Efficacy of the vaccine. Is the vaccine is capable of providing protection when exposed to infection? This stage deals with thousands of participant. 

It is almost impossible to conduct these 3 stages of clinical trial in 45 days or even in 2 months. In the history of medical science no vaccine was ever launched in less than 1 year. Sometimes early efficacy can be seen but in the long run risk factors may show up when applied to more people with different medical history. 

Moreover, vaccines which are being developed throughout the world have very low success rate. We can not assume that because the pre-clinical trial was successful the vaccine is all ready for launch. 

It's a fundamental perception in science that scientists will have to be skeptical always. 

And last but not the least, the Supreme Court of India by it's ruling in a 2013 case halted more than 160 clinical trials. The Apex Court had to do this on widespread controversy on clinical trials which were then been conducted. 

All information concerning the clinical trial must be made transparent and clear to the participating candidates or the volunteers. Illiteracy of the volunteers can not be used as as undue advantage. The volunteers must be fully aware about the risk factors of the trial and they must know about their rights throughout the process. They are also entitled to leave the clinical trial anytime during the trial. 

Some important and other relevant information on Vaccine

After USA and Brazil, India is now at the 3rd position in terms of having most number of corona positive cases. 

A vaccine is somewhat like a pre-test examination before you appear in your final Board examination. That means, a vaccine necessarily prepares your body to fight with the particular virus or should we call  them Pathogens.

Pathogen are microorganisms like bacteria, virus, Protozoa, fungi etc. which causes disease to human body. 

When a pathogen attacks a human body, the immune system starts to work immediately. Our immune system has 3 main jobs :- 
  • Detecting the pathogen : the immune system detects the presence of a virus and it's characteristics
  • Removing the pathogen - the immune system fights with the intruder virus and tries to defeat it. This is done by our white blood cells (WBC) which generates antibodies to fight with the virus. During this stage symptoms like fever, cough etc. appears
  • Memorising the virus : our immune system memorises the virus and learns how to deal with this in future
A vaccine contains strains of the same virus of different states. Sometimes a vaccine is created with dead strain of a virus, sometimes with weaker strains of the virus and sometimes with various parts of the virus. 

So, a vaccine can be of different types having specific advantages and disadvantages.
  • Live Attenuated Vaccine :- this kind of vaccine is created by weakening the virus. Example vaccines are for small pox, chicken pox etc. This vaccine is highly effective but requires longer time to be prepared
  • Inactivated Vaccine :- this kind of Vaccine is created with dead strain of the particular virus. Example vaccines are for Flu, Polio and Rabies etc. This vaccine requires less time to be prepared but does not provide longer immunity. Dosage is to be repeated in phase manner. You can remember vaccine for polio which is to be repeated several times
  • Subunit Vaccine :- this vaccine is created with fragments of the specific virus. Vaccines for Hepatitis-B and HPU are example of Subunit Vaccines. (HPU stands for Human Papillomavirus which is a sexually transmitted disease)
Around the year 1700 there was no vaccine and the world child mortality rate (child below 5 years) was 40-50%. During that time 40-50% child used to die before  attaining the age of 5 years. And now the child mortality rate has come down to less than 1% in the developed countries. 

In average a vaccine requires 10 years to become ready for public use. Till now the fastest vaccine ever produced is for mumps (Parotitis) which took 4 years.

It is expected that the vaccine for Human Immunodeficiency Virus (HIV) will become ready by 2030 and if it happens than the total time required will be 50 years. 

But, the speed in which countries are working on corona virus, we can expect the vaccine in 12 to 18 months. 

Vaccine Development Process

Scientists first decide the type of vaccine that should be best for the specific virus. Then pre-clinical tests on live cells and animals are conducted in laboratory. After these the human tests or the clinical tests begin. 

Current status of development of vaccine for Covid-19

As per records of World Health Organization (WHO), 17 vaccines Covid-19 in 10 countries are ready for clinical test. China had already started the trial on it's military personnel in phase manner. 

USA is leading with 4 vaccines amongst which a company named Moderna-NIAID is at the top developing mRNA-1273. They have already completed the first 2 phases and planned to start the phase 3 of the clinical trial in the 1st week of July. However, the 3rd phase of the trial got delayed. Vaccine mRNA-1273 will be applied in 30000 candidates in the stage 3 of the trial. 

Germany based company BioNTech and Pfizer are jointly developing the vaccine BNT-162b1. They will also start the final trial with 30000 candidates.

Oxford University of United Kingdom is at the top as per many experts. It is reported that the vaccine developed by Oxford University provides stronger immunity than the rests. They have already started the final phase of the clinical trial in Brazil in the month of June 2020. By the end of August, Oxford University will have the final words. 

As already said, India is developing COVAXIN for which the clinical trial is yet to start. This is unrealistic that the entire process will be started and finished by 15th August 2020. 

Baba Ramdev has claimed in public domain that Patanjali has developed Coronil which is guaranteed to cure a Covid-19 positive patient in 7 days. The claim has created controversy and states like Maharashtra has banned Coronil for public use.

As per experts Coronil lacks scientific grounds. Patanjali has also failed to furnish necessary documents and reports in support of their claim. The AYUSH Ministry of Government of India has not yet approved Coronil which nullifies the claim made by Ramdev. 

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