With W H O rapidly losing its credibility, the whole world is watching this vaccine development battle helplessly and with fear and anxiety.
by N.S.Venkataraman
It is known that it normally takes six to seven years to adequately test a new drug / vaccine by way of clinical trials and then place it in the market for the benefit of the patients.
As it is known , clinical trials have to be carried out in four phases, one phase after another, when hundreds of people would undergo clinical trial. Such people undergoing trial are expected to be those living in different climatic conditions with different food habits, various age groups, men and women as well as people suffering from ailments related to the new drug/vaccine in question. While this is so, it is a matter of high concern and it is also shocking that several pharmaceutical firms and research agencies claim that vaccine for COVID 19 would be available for treating patients in a few weeks from now, after their carrying out clinical trials for a few months and on people whose number would be much less than the stipulated level. This is a calculated risk.
In recent times, quite a number of drugs which duly underwent clinical trials and put into the market after approval by authorities, have been later on banned for use due to adverse effects noticed over a period of time. It is also known that several vaccines and drugs have side effects and what is suitable for one person have often proved to be unsuitable for another person. Some experts say that over use of drugs could be detrimental. Given such scenario, one tend to think whether launching a drug after inadequate clinical trials could be termed as an irresponsible act
While allopathic drugs and vaccines normally undergo clinical trials as per stipulated procedures, there are many traditional medicines in Ayurvedic, Unani , Siddha and other systems, which are also prescribed by a few doctors who practice in traditional medical treatment, for COVID 19 patients. With regard to such traditional medicines, complaints are often made that they have not been subjected to fool proof testing and clinical trials and many experts think that it would be unwise to use such traditional medicines in patients with COVID 19 ailment. Such traditional medicines are also advocated for use to treat COVID 19 patients by some governments.
Even as the drugs that have undergone extensive clinical trials are prescribed by medical doctors, it is often seen that there is difference in view with regard to diagnosis and prescriptions between different doctors , depending upon their level of expertise, experience . In such circumstances, it is often said that in the case of major ailments or surgeries , it is preferable to get the testing and advice from more than two doctors by the patient before undergoing the procedure.
All such scenario only indicate the absolute importance of carrying out extensive clinical trials before introducing the new vaccine in the market for treating COVID 19 patients. If vaccines without detailed clinical trials would be introduced, it would amount to playing with the life of innocent patients.
With such background in view, recent claims of several pharmaceutical firms and research agencies about the development of vaccine for treatment of COVID 19 is creating a sense of scare amongst “laymen”.
Russia granted regulatory approval to a COVID 19 vaccine in August, 2020 after less than two months of human testing , prompting some experts to question it’s safety and efficacy. Even when doubts persist, an article has been published in the Lancet Medical Journal, with preliminary results from phase 1 and phase 2 trials . This publication appears to be premature and give credibility to the claim of Russia about the new vaccine developed by it even before the completion of adequate clinical trials.
U S public health officials and Pfizer Inc. said that a vaccine could be ready for distribution as soon as late October,2020. Obviously, this could be done only without adequate test and trials, which could be an extremely counter productive exercise.
GAVI vaccine aims to procure Covax and deliver two billion doses of vaccines by the end of 2021 and some countries have secured their own supplies through bilateral deals.
Novo Nordisk, the Danish drug maker says that it’s research shows that GLP-1 drugs, which help patients keep blood sugar levels in check, could be a very meaningful therapy in helping people with diabetesto battle COVID 19.
So many other research agencies as well as China have claimed that COVID vaccine would be available very soon.
While such tall claims are being made, W H O says that none of candidates has exhibited clear signal of efficacy so far.
The current situation is that in their rush to out beat each other, several pharmaceutical firms, research agencies and a few countries are making tall and unsubstantiated claims on development of COVID vaccine , which is creating false sense of hope amongst people all over the world.
Is it that these pharmaceutical firms and research agencies want to continue the clinical trial even as the vaccine is made available in the market and want to prove or otherwise of its efficacy by trial and error method, when they would change the dosage or evolve new conditions for administering the vaccine etc.
If this would be their approach and attitude, then they may save time but lose lives.
With W H O rapidly losing its credibility, the whole world is watching this vaccine development battle helplessly and with fear and anxiety.
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