National Health Emergency

Observing news of the fake vaccine is increasingly worrying. The number of health facilities which use unofficial suppliers is getting bigger. It increases from 28 to 37, mostly hospitals and clinics (Kompas, 2/7/2016). However, the Drug and Food Monitoring Agency (BPOM) quickly concludes that there has not been hazardous materials in the fake vaccine.

The impression which will be conveyed seems as if the fake vaccine cases are only about crimes conducted by the counterfeiters and their chains. The National Police's Criminal Investigation Department (Bareskrim) has got a task which is not effortless, like searching for a needle in a haystack. Moreover, the intelligent agency has not considered the case as a national problem.

The slow rate to uncover the case gives time to the counterfeiters with their chains to remove evidence, one of them is by throwing them into the rivers. Non-technical difficulties will be found if regional leaders jump in by declaring their areas are free from fake vaccines. Meanwhile, the community and parents are faced with uncertainty, fears about immunization on their children under five years old who will and who have already received vaccination.

The perpetrators of this forgery, ranging from producers, dealers and vaccinators, must be from educated groups who are literate with regulations related to health. Shamefully, however, in order to get additional incomes, they sacrifice the future of the sons and daughters of the Indonesian nation.

Vaccines and vaccination

The main objective of vaccination, particularly on children under five, is an act to prevent against strategic diseases so that it can reduce the number of morbidity and mortality as well as to prepare a generation which is healthy, productive. Therefore, vaccination is also a state investment to set up human resources which are strong, healthy and productive.

There are 14 types of vaccines given from the age of one day to 18 years. Five mandatory vaccines are BCG, Hepatitis B, Polio, DTP, and measles, while other vaccines are simply recommendation. So far, the vaccination on children under five is carried out under a "closed" network. The process of production, distribution up to the names of the babies being vaccinated are all recorded. It is a bit confusing to see that the fake vaccines are able to "penetrate" the closed network for more than 10 years.

It is natural that people become skeptical on how to handle this case. Statements from the authorities are confusing. In reality, with a span of 10 years, this modus has already been rooted, and an argument that this case is close to the above-mentioned educated groups is acceptable. Because, it is impossible for the practice to persist for so long if there is no agreement between the counterfeiters and other related series.

As a vaccine researcher, I have felt the tightness of the standard of procedure (SOP), from preparing a germ for the vaccine seed to the type of testing in pre-clinical level, including its waste disposal.

The World Health Organization (WHO) as a world health institution has set the SOP for production of vaccines and testing through technical report series (TRS). One type of vaccine can consist of tens of TRS which must be adhered since the principle of vaccination is to inject "scalable germs or pathogens" into the body so that antibody which is formed can prevent diseases from infecting someone's body. For one vaccine, it takes six years until it can be used.

Fake vaccines

Actually, fake vaccines can have a lot of meanings. An original vaccine but its document is false, or a vaccine with different content, but with packaging and brands similar to the original one with its document. Apparently, the fake vaccines currently in circulation have the false contents, but their packaging, brand and labels are similar to the original vaccines. They are certainly without any documents. Existing indication shows there is no document at all at the time of transaction with the recipients. If this happens, it means the forgers and the recipients already know each other.

Several vaccine producers will keep secret the specification of their packaging and labels. The objective is to avoid misuse of the products, including counterfeiting. Thus, whether the packaging and labels are genuine or false, those who know them are only the producers. It is something which is not appropriate if the community is involved in overseeing the forgery of the vaccines. If necessary, the original producers should immediately replace the packaging and labels of the vaccines being counterfeited.

A vaccine usually has three kinds of content, namely bacteria, solvents and adjuvant (a chemical added to vaccines to stimulate the formation of body's immunity), which then is blended in a vaccine formula. After the test results of each content of the vaccine are safe, it is followed by testing the formula, namely the test on its toxicity, on its potential, formula challenge test, up the clinical test. This process will be monitored by an authorized state institution.

A toxicity test of a formula is carried out to check the presence of toxins and contaminants of the formula in experimental animals. Parameters to be passed consist of about 150 kinds. Starting from the weight, blood description, liver function, heart, kidney, shedding contamination, disturbance on all organs of the body ranging from brain network to the gland contained in testes (male) and ovaries (female).

Of course, a question will arise if the testing on fake vaccines is carried out very fast and concluded that the fake vaccines are not dangerous. What is the main objective of testing the fake vaccines? Is it just to seek for a differentiator as evidence, or is there any purpose to find out the impact of the toddlers under five who have been vaccinated? If only the testing seems to be just the way it is due to the shortage of facilities, all potentials owned by this nation can be utilized to help, or involve the world institutions to help test the fake vaccines.

Germ contamination on fake vaccines

It is very irresponsible if the fake vaccines are concluded to be harmless without going through measured testing. Statements like this can cause worries among the society because -- if it is only water being injected -- its sterility is not guaranteed. Moreover, those injected with the vaccines are toddlers under five whose growth and metabolism have not developed well. Aside from that, the syringes (for injecting vaccines) being used have to be standardized because the needles will rip the peripheral vascular of the toddlers, which can be fatal due to the rudimentary clotting system of the toddlers.

Contamination of germs that cannot be identified does not mean the fake vaccines are free from contamination. Hopefully, because of the inadequate comprehension and testing equipment which lead to the simplification of the problem, this should have become a mutual concern. Contamination of germs can happen because of being not sterile so that it becomes an effect or "deliberately included".

This is a national problem which is not simple, especially for the future of the next generation. Many literatures describe the relationship of an microorganism infection with a disease which is unpredictable, such as the growth of stunted bodies. The number of stunting cases in Indonesia is included in the top five in the world. Does this stunting case cause Indonesia to be not able to be a football champion?

The relationship between a germ and a case of the chronic decrease of the body defense system can lead to cases of autism, mental disorder and some other conditions which could occur in the future. Nobody knows, except the overall content of the fake vaccines is observed into pieces. The dynamics of bacteria can be natural, or designed in accordance with the intention of the makers, through the change of potential pathogens from small titer until it magnifies in line with the age of the infestation.

Therefore, the fake vaccines do not only reflect the existence of economic crime cases, but it also shows how fragile the moral of a part of this nation; simply to search for money, they are willing to endanger the future of the nation, especially when it is done by groups of educated people.

Several years ago, still in the span of the fake vaccine distribution, Indonesia was shocked by an outbreak of diphtheria in children and even adults, which were believed to have allegedly caused by the empty antibodies against diphtheria toxin. The cases which used to appear on toddlers under five can be traced back, possibly there is its link.

The policy on the impact which may arise on toddlers under five who have been immunized with fake vaccines is not adequately just at the level of task force. It should not be at the sector level or ministry as well, but must be completed at the state level.

Indonesia is in a "National Health Emergency". Its consideration is that the network of the fake vaccines has been formed for a very long time and is neat so that the unit which handles it involves cross-sector levels because it has dealt with the public health and resilience of the country. The case of fake vaccines is similar to the drug and children sex crimes, and can even be more than that given the fact that the fake vaccines could result in masses and endanger environment. All the efforts have to be deployed to rescue the future of Indonesia. This term does not have its reference, but an analogy with the outbreak of diseases in Indonesia.

Additionally, all stock of vaccines, both the original and fake ones which have not yet been identified, may also need to be immediately withdrawn from all health facilities. Later, the government through the Ministry of Health and BPOM, producers whose vaccines are falsified and the police sort the withdrawn vaccines, and later the fake vaccines are destroyed in the presence of the Indonesian community. The aim of this withdrawal to make the community feel at ease that the government seriously deals with the cases of fake vaccines, and there will be no more suspicion that the vaccines to be used next are fake. This action is needed to break the chain of the fake vaccines.

The government will later need to focus on tests on the contamination of microorganism to set further steps. We should also not to be in a hurry to do revaccination on toddlers under five as their condition and titer antibodies during the revaccination are not a simple issue.

by CA Nidom

source Kompas, Friday, July 15, 2016