Friday 27-Mar-2015

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    Prof B. M. Hegde

    There is a novel way of testing new vaccines in an emergency pandemic, we are told, by bypassing the regular mandatory human testing. I wonder if the WHO has permitted this to be done by the drug companies! The new European procedure, which was established by the Commission and implemented by the EMEA, allows manufacturers to gain an authorisation for a ‘mock-up’ vaccine before a pandemic has occurred. EMEA explains, in a question answer document, thus: (

    “A mock-up pandemic influenza vaccine is a vaccine that mimics the future pandemic influenza vaccine in terms of its composition and manufacturing method. However, because the virus strain causing the pandemic is not known, the mock-up vaccine contains another flu strain instead. This is a strain that is not circulating in humans, and to which humans have not been exposed in the past. This enables the company to test its vaccine in preparation for any flu pandemic that may occur in the future, by carrying out studies with the mock-up vaccine that predict how people will react to the vaccine when the strain causing a pandemic is included.”

    I am a bit concerned, may be the wiser ones amongst us would allay my fears, about a couple of things here. The “mock-up” uses a new strain of ‘Flu vaccine. Does this mean that we have stockpiled many unknown but, potentially dangerous, ‘Flu strains in our laboratories? Is this a normal practice? If the virus has not been exposed to humans thus far, how are we sure that the few individuals that we expose to this new strain are not being made guinea pigs?

    Even assuming that all the above are fine, when the pandemic hits in future the virus strain would again be a new one like the mock up virus and its reactions could be as unpredictable as that of the mock up virus. Each virus would produce its own individual way of attacking humans. How then are we sure that the mock up bypass is of any guidance? Reminds me of bypassing the coronary epicardial arteries in chronic angina where the culprit is the reduced coronary reserve in the millions of perforating muscular vessels inside the myocardium. Are all bypasses in medicine basically money spinners? This bypassing will give permission to manufacturers to get new vaccines as and when they think fit using whichever strain they think is needed. To me it looks as if we have put the cart before the horse. Long before the pandemic has arrived efforts to make vaccines have begun; rather vaccine manufacturing seems to be our primary concern in a pandemic.

    I strongly feel the whole science of vaccination needs a re-look in view of the fact that only one viral disease, small-pox, has been successfully eradicated so far by human effort. Every other vaccine could be explained as only a partial success in so far as the virus has only to mutate to bounce back with greater vigour. The vaccine will, of course, be useless in that scenario. Edward Jenner used cow pox virus on James Phipps. Cow pox virus is genetically different from small pox virus. It was T. Z. Holwell, FRCP (London), FRS, who studied the protective power of the Indian Ayurvedic vaccination system prospectively for twenty years in The Bengall in the eighteenth century to suggest universal vaccination that has eradicated small pox for ever. (1) Hopefully, all laboratories will have destroyed their stock of that deadly small pox virus.

    Holwell in his paper to the President and Fellows of the London Royal College in 1767 AD did write that the Indian vaccination was not only effective but done with great care and sophistication. Holwell even noted that the vaccination system existed for “times out of mind” in India, and has been effective for hundreds of years, which he strongly recommended for universal use! I think that his original papers are preserved in the library archives in Regents Park. Recently Douglas C Wallace, a noted US geneticist, who has discovered some extra nuclear mitochondrial DNAs (mtDNA) that are more useful for drug testing and disease prevention in contrast to our conventional Mendalian genetics where only nuclear DNAs are taken into consideration. (2)

    Using his MITCHIP he has been able to find that Asian herbal medicines are not only effective against many diseases including some infections like malaria that he had tested, but has also shown that the western pharmacology of chemical compounds for a target might even damage the cell in the bargain. Could this be the bane of all our problems with the deadly adverse drug reactions? We might have to take a leaf out of Wallace’s work to think of a new science of vaccination.

    Another point that worries me is the possibility of multiple vaccinations confusing the human immune system. Children get nearly 20 vaccinations in infancy and many more after that. To cap it, now we have the “mock-up” vaccines also getting ready! Real immunity comes from real disease only. Vaccines create a mild form of the disease and we do not know how effective that mild (forme frustae) disease would be in producing anti-bodies. Lately frequent tetanus toxoid injections have been shown to be useless if not dangerous. One could easily understand the anxiety and enthusiasm to produce vaccines. The latter is the best business as the whole world becomes vaccine customers for the business. My worry is: could the recent spurt in auto-immune diseases have anything to do with this preventive strategy of modern medicine? I could be wrong but, just in case someone has an answer!!

    One lead here seems apt. African Americans have the highest incidence of autoimmune diseases compared the Caucasians, while Africans in Africa have very low incidence of autoimmunity. While there could be many imponderables, but one that might connect the two is that Africans have many kinds of germs that their immune system has to fight against for survival. Their nearly 150 odd genes that oversee the immune system are busily engaged. While African Americans live in a relatively germ free sterile environment in the US compared to Africa. May be the genes have no work to do. Could they become naughty and produce anti-bodies against their own body cells? (Horror auto-toxicus of Paul Ehrlich?)


    1)Hegde BM. Vaccination system in India. 1998; 46: 472-473.

    2)Wallace DC. Mitochondrial Chi. Genetics 2008; 179: 727-735.