Compulsory, but not forced, vaccination
The tragic accident in Kramatorsk scared the young people who agreed to get inoculated, their parents and rank-and-file medics involved in this dubious project of saving Europe from viruses. It was intensely covered by the media and caught the attention of the President, who summoned the Minister of Health to order a thorough inquiry into the case.
While people in Donetsk Oblast are mourning and worrying, senior officials of the sanitary-and-epidemiologic service at the Ukrainian Ministry of Health, WHO and UNICEF representatives have called numerous press briefings to reassure the public that everything is going as planned and the only reason 14 schoolchildren were hospitalized in Donetsk Oblast is that doctors there are overcautious. Some time later the number grew to 68 boys and girls who felt sick after inoculation. In the evening, Minister V.Kniazevych announced at last that the unscheduled vaccination was suspended.
Too late, alas! Experts believe the latest events will undermine the minister’s plans to reorganize the public health system. Time and trust have been lost, together with the chances of gaining support. Frankly speaking, top officials of the ministry of Health had every opportunity to come off clear, since the decision to have mass vaccination had been made long before V.Kniazevych was appointed minister. According to the original plan, the campaign was to be launched in November 2007, but something did not work then and the launch was postponed for six months. In the meantime, medical researchers and NGOs managed to raise public awareness of the problem, pointing to bottlenecks in the campaign. However, their disturbing conclusions did not seem to interest anyone in the ministry. On February 23, 2008, in his exclusive interview to ZN, Minister Kniazevych said he “revoked the decision on the compulsory character of vaccination. And it is critical that the vaccine be officially registered in Ukraine.” Nevertheless, three days later – on February 27 – the Cabinet of Ministers signed a relevant resolution, which the sanitary-and-epidemiologic service rushed to implement. The service had always been the greatest enthusiast of and lobbyist for the campaign of mass vaccination against measles and rubella with the Indian-made vaccine.
According to competent sources in the Ministry of Health, the concerned international organizations insisted on the maximum possible number of vaccinations: they knew in advance how many young people aged 15 to 29 live in a certain city, town or district. Ukrainian public servants, who are duty-bound to expedite national interests, agreed, yielding to their argumentation or, rather, surrendering us and our children. There is enough evidence of the above. You may ask: “Enough for what or whom?” It is enough for us, Ukrainians who realize that rhetoric about protecting the population from epidemic, inflation or independent school tests always disguises somebody’s personal motives. Unfortunately, this evidence is not enough for the competent authorities obligated by law to guarantee national security and promote Ukrainians’ rights. State officials must be of the opinion that 9 million doses of live (sic!) vaccine against measles and rubella pose neither actual nor potential threat to 46 million people in Ukraine. Even if the mass vaccination is called off after all, where and how can this viral invasion be neutralized? Will the country of origin take the vaccine back? Will WHO and UNICEF, which brought this Trojan horse to Ukraine, help us get rid of it?
Under the current political circumstances, not only do outsiders foist the behavioural rules and patterns of the third world countries on our children, but they also try to affect their health. According to researchers, the vaccine, which is cultivated from the cells of a hostile – Asian – genotype, is harmful to Europeans. But for the Kramatorsk teenager’s tragic death, high-ranking officials would have never paid attention to what is going on in the country. Today, at last, various public agencies have started looking into the matter: commissions are being set, dozens of meetings are being held to find the way out. Yet so far they have failed to give a clear answer as to how such a huge batch of vaccine got to Ukraine. Mind you, these are not medicines but potentially hazardous immunobiological preparations that should be toughly controlled by specialized services.
Was mass vaccination justified?
It is important to find out who initiated the mass vaccination. Officials in the Ministry of Health avoid answering this question referring to the WHO and Ukraine’s mutual understanding in this regard. At one of the briefings when the pause following the question grew embarrassingly long, N.Prodanchuk, First Deputy Minister of Health, admitted: “Ukraine asked for help.”
He told the truth. The ministry archives should be still keeping the UNICEF representative’s letters of appreciation, addressed to S.Berezhnov and reading that the Ukrainian Party thankfully accepted all recommendations of that international organization; so, pursuant to the previous agreement, mass vaccination was to be launched on November 19, 2007.”
We do not know if N.Prodanchuk received a similar letter of appreciation – he is a new man in the ministry – but his deputy L. Mukharska has been in office for quite a while; thus, she has the whole picture of the mass vaccination. Since last summer, L.Mukharska has been persuading decision makers and the general public, on numerous occasions, that in 2006 Ukraine went through a major measles epidemic resulting in 45 thousand cases of disease and 5 deaths. The only way out is mass vaccination against measles. You may ask: “What does anti-rubella vaccine have to do with it?” According to L.Mukharska, it is difficult to organize two campaigns and much more convenient to inoculate people only once with a two-component vaccine.
Infectiologists, including Academician Zhanna Vozianova, believe in an alternative approach. First, male teenagers should be vaccinated against epidemic parotiditis, which outbreaks now and then in the armed forces and can be complicated with infertility. Second, national monitoring data show that “almost 85% of the Ukrainian population, both urban and rural, is seropositive to measles. Only 15% needs vaccine correction.” That means that the overwhelming majority of people have developed immunity as the result of either planned vaccination in their childhood or previous infection with measles. Put differently, there is no need for mass vaccination.
The data on the number of infected and diseased during the measles epidemic of 2006 cited by the sanitary-and-epidemiologic service can be challenged. Official messages the Ministry of Health sent out at that time are different: “The press service of the Ministry of Health hereby officially notifies that no measles epidemic is observed in Ukraine, particularly in Kyiv. According to the WHO criteria, an epidemic is a situation whereby the prevalence level of a certain infection exceeds 1% of the total population in a given region.”
Who counted dozens of thousands of infected people so accurately? Why do different sources quote a different mortality figure – from four to six persons? It was a hard task for ministry officials to make a U-turn from denying the measles outbreak point blank to admitting the epidemic. Hence the numbers: 45 thousand is very close to the WHO standards (1% of the population is 46 thousand) and, at the same time, it allows the ministry to save face.
Top managers of the sanitary-and-epidemiologic service love to demonstrate multicoloured graphs, charts and diagrams so as to make Ukrainians ashamed, if not frightened: it is from the capital city of Kyiv that the ominous arrows of the measles epidemic reached out to Europe, Asia and far-away America.
According to N.Prodanchuk, “we are not 95% protected today, thus the population cannot be considered safe, according to epidemiologic indicators. Our situation is not unique: the circumstances in Japan are even worse. The conclusion is obvious – vaccination is necessary not only from the standpoint of an individual but also for the sake of protecting the entire population of Ukraine, of Europe.”
Why did the Ukrainian sanitary-and-epidemiologic service decide that Ukraine was the only country in Europe that failed to overcome the measles epidemic? Zhanna Vozianova, an unimpeachable authority in infectiology, maintains “it is impossible to totally eradicate measles, at least now. When the discussion about eliminating poliomyelitis and other infectious diseases was underway, measles was also included in the list. Yet some time later, experts realized it was premature. The best they could do at that juncture was to control measles. Ukraine introduced planned vaccination against measles but its effectiveness was never analyzed. We know nothing about the level of immunity developed after each inoculation. We should start with this.”
Europe has measles, Ukraine has mass vaccination
Consistent with Zhanna Vozianova’s opinion are the WHO data on the measles outbreaks in Romania, Italy, the UK, Germany and other European countries. Careful analysis of Ukrainian statistics reveals high measles prevalence in the capital city and border oblasts of Ukraine: Sumy, Kharkiv and Trans-Carpathian. So it is an even chance that measles was brought to Ukraine, rather than exported from it. For instance, in Denmark and Switzerland the virus of B3 genotype was registered, in Romania it was D4, while in Ukraine and Spain it was D6. Probably, ministry officials did not notice the difference. In the course of discussion between high-ranking representatives of the sanitary-and-epidemiologic service and academics, a professor of immunology asked what genotype of measles virus was used in the Indian vaccine. The deputy chief sanitary doctor of Ukraine looked at the director of the Centre for Immunobiological Preparations, and the two of them smiled: “Measles is not the flu, it has only one virus!” No wonder such “competent” officials easily approved the procurement of the two-component MR vaccine whereas the immunologists consider it a big mistake.
“Unnecessary immunization leads to higher allergy rates,” argues Professor Kateryna Harkava. “It is wrong to think that allergies have only external manifestations, like rash or reddening. One should bear in mind anaphylactic shock that can be lethal. Before launching mass vaccination of the adult population, medical scholars and practitioners should study the vaccination calendar carefully. In the first year of life a child gets 17 vaccines! The next six months are also stressful – another four compulsory vaccines. Can such a severe attack on the human immune system ensure its effective functioning?
“Since the vaccine is of Indian make, we are dealing with the Asian, rather than the European, population. It means the presence of antigens unknown to us Ukrainians. It can lead to such allergic reactions and conditions that we can hardly imagine. We know that 85% of young people have antibodies to the measles virus, and 89% of women of reproductive age have antibodies to the rubella virus. What was the rationale for the decision to mass vaccine young people?”
Many would like to learn about it. Most experts are doubtful about the Indian vaccine’s quality, especially in view of the manufacturer’s information on serious complications. The manufacturer lists more complications than the officials of the Ministry of Health would declare during the public education campaigns. The sanitary-and-epidemiologic service would mention rising body temperature and edema at the place of injunction, whereas the manufacturer also refers to thrombocytopenia (one case per 30 thousand inoculations), encephalitis and anaphylactic shock (one case per million inoculations). Our health authorities must think the manufacturer calumniates itself as, according to H.Moiseyeva, Director of the Centre for Immunobiological Preparations, they had no complaints about the Indian vaccine: “Forty million doses of this vaccine were used in the world for mass immunization. We have the data on post-vaccine reactions from all over the world, as well as the results of mass vaccination in Iran, where even pregnant women were subject to it. We analyzed the WHO data in the Indian vaccine dossier: not a single case of complications has ever been registered as yet.”
In fact, the Indian vaccine was used in a limited number of countries: Albania, Romania, Kyrgyzstan, Moldova, Tajikistan, Azerbaijan and Iran. Russia uses an anti-measles vaccine of its own make, declining humanitarian aid of this kind. In the UK and Switzerland, measles outbreaks have not subsided since 2006, but their governments are in no hurry to mass immunize with the Indian vaccine. Notably, WHO does not insist on it. Health authorities in Austria, Germany and Norway decided to control the vaccination process in schools with a mandatory check of each (sic!) child’s immunity status. In Ukraine the vaccination is compulsory for every person in the age bracket of 15 to 29 years, including those who have had measles, although every medical student will know that in this case people develop life-long immunity. The vaccine, on the other hand, produces immunity for no longer than several years, in the best case scenario; in the worst case, it fails to do so. That is exactly what happened with a lot of boys and girls in 2006. According to the sanitary-and-epidemiologic service reports, the planned vaccinations were successful. Today, however, L.Mukharska clarifies that “we used low-immunogenic vaccines then; they came to Ukraine as part of humanitarian aid and were not subject to state registration.” Who can guarantee that the quality of this vaccine, also supplied within the humanitarian aid programmes, is better?
A false start or a tactical move?
One of the most worrying things is that the anti-rubella vaccine is particularly hazardous for pregnant women: European manufacturers warn against conception within at least three months after inoculation. For some reason, the instruction to the Indian vaccine shortens this time period to two months, and some of the Ukrainian translations reduce it even more – to 28 days. Similar inconsistency is observed when it comes to potential complications related to arthritis and arthralgia: some papers cite the statistics of 20%, others just mention “sporadic cases.”
In March, during consultations with the academic community, the chief sanitary doctor of Ukraine promised in public: “I will not allow the import of preparations with potential complications in 20% of arthritis! My first instruction is to get the vaccine registered in the order established for all other immunobiological preparations. There are several manufacturers of this vaccine – they should also be registered in Ukraine, and those people who do not want to be inoculated with the Indian vaccine offered by WHO will have a choice. The consequences and complications of vaccination are not so serious as often said. Even sushi can cause anaphylactic shock but no one will think of threatening you with it. The government decided that the campaign will take the entire year. We had difficult negotiations with WHO and UNICEF. They could not understand why there were no problems with vaccination in Moldova, Azerbaijan and Turkmenistan. I told them the Ukrainian society is demonstrating a high level of freedom. We cannot resort to the totalitarian methods of the past – 30 years ago we would have done it in a month.”
It is unclear how the currently used methods differ from the totalitarian ones. Official launch was scheduled for May 26, 2008 but as early as on May 5 the mass vaccination started in Donetsk Oblast. Luhansk and Poltave oblasts followed suit. Representatives of the sanitary-and-epidemiologic service in Ivano-Frankivsk Oblast claimed on a national TV channel that not a single school leaver would get a health certificate (required for applying to college or university) without undergoing vaccination. The Crimean sanitary-and-epidemiologic authorities assured the public that the vaccine they were using was of Italian make.
Kharkiv medics refused to launch the vaccination prior to the officially set date. Now Donetsk health authorities will have to explain why they injected children with the unregistered vaccine three weeks before the approved date. The prosecutor’s office will not take oral instructions for a valid reason.
It seems that the campaign organizers were interested in the early launch: the timing was most opportune due to long holidays. Had it not been for the tragic case in Kramatorsk, nobody would have noticed it.
“Nobody” here refers to the state officials in charge of public health, security and human rights, as well as political leaders totally ignorant of the experiment that began in Ukraine. The Supreme Rada kept silent, in particular its committees specializing in public health, family and legal matters. The “shadow” government kept silent. So did the politicians who demanded, a couple of weeks earlier, that the independent examinations for school leavers be abolished, qualifying them as an experiment with children: what if a child feels unwell on the examination day but is made to write it all the same? The boy from Kramatorsk survived the exam; he would have entered a technical university in the autumn. What he did not survive was vaccination. Why do the politicians who claim they stand for the “small” Ukrainians’ interests say nothing now? How could the inoculated schoolchildren perform successfully at the exam if some of them had a fever of up to 39°? Kramatorsk mourned and buried 17-year-old Anton, but the authorities never responded to its grief. Ten days later, the NSCD Secretary made a passionate speech laying the blame on the incumbent government. She, of all people, should know how long it takes to prepare and adopt documents in the Cabinet of Ministers – she used to be the Minister of Health about a decade ago. Today it is no secret that the decision to mass vaccinate was made by the previous government on the initiative of the then minister of health and chief sanitary doctor.
The discussion to mass vaccinate has been underway for almost a year. Everyone seems to have learnt by now that the two-component MR vaccine is not used for planned immunization anywhere in the world. Only third world countries use it for unscheduled/emergency vaccination within a humanitarian aid framework. Is it credible that proper monitoring covers all inoculated persons in remote areas? Should one trust the data provided by health authorities of countries whose medicine is in an even poorer state than ours?
Why don’t the law enforcement bodies investigate the violation of Ukrainian legislation by the Ministry of Health? First, the vaccination calendar provides for two planned anti-measles inoculations in early childhood, while the unscheduled vaccination of adults is not envisioned by national laws and regulations. Second, only officially registered vaccines can be used for immunization. Third, illegal medico-biological and other experiments with people are penalized with fines, imprisonment and disqualification. Those interested in details will find them in the Law of Ukraine “On Protection of the Population from Infectious Diseases” (2000) and Article 142 of the Criminal Code of Ukraine.
So who will be held accountable for the premature start of the vaccination campaign, for the hospitalization of a hundred children and the teenage boy’s death? Answering this question at the press briefing, N.Prodanchuk said: “The government, of course!” The journalists had to ask for clarification: “Which one – Tymoshenko’s or Yanukovych’s?” The First Deputy Minister replied: “Tymoshenko’s because the decision was signed in February. First of all, the Minister of Health should be brought to account.”
N.Prodanchuk emphasized several times that he had held his position for only four months as if forgetting that Minister V.Kniazevych was also appointed four months ago. It was not him but his predecessor, ex-Minister V.Haydayev and former Deputy Minister S.Barazhnov whom WHO addressed and convinced to carry out the unscheduled vaccination. Researchers from the Academy of Medical Sciences of Ukraine also wrote to them cautioning against hasty imprudent steps but their arguments proved less convincing.
As a result, the Indian manufacturer got an extremely profitable order. Some people would argue, though, that the order was for eight, rather than nine, million doses and that UNICEF paid for everything: USD 5 million for the vaccine and USD 300 thousand for the public education campaign.
The most important thing is that none of the healthcare officials can answer the question: was the Indian vaccine registered in Ukraine or not? N. Prodanchuk said that the vaccine was registered on April 18th. However, the State Drug Service is insisting that the Indian vaccine was not registered in Ukraine. Who should we believe? According to the official statements of the sanitary-and-epidemiologic service made in February, March and April, we can conclude that the Indian vaccine wasn’t registered and won’t be. “Our legislation stipulates a possibility of using unregistered drugs under certain conditions,” said L. Mukhtarskaya. “It was planned that the vaccine would be imported according to a so-called one-time permission.”
In Europe, health services do not trust the words of producers of drugs and conduct their own clinical trials with the help of volunteers. This takes time and costs a lot, but helps to select the best drugs to avoid tragedies. N. Prodanchuk also promised to conduct such research, but now, officials insist that certification of WHO is enough for Ukraine.
“Why not?” says Vyacheslav Kostyliov, the president of public organization Civil Rights Protection League. “It is not a secret that WHO carries out its activities thanks to the support of pharmaceutical firms. UNICEF is the biggest customer of pharmaceutical firms that produce vaccines. UNICEF purchases and controls the quality of vaccines by itself.”
Despite all efforts, journalists couldn’t find the answer to the questions: who is going to be responsible for the death of the boy from Kramatorsk and who is going to pay compensation to his family? Some time earlier, Health Ministry officials stated that the producer of the vaccine would be responsible. However, lawyers qualify this statement of the Health Ministry officials as a deliberate deception since the producer of the vaccine didn’t conclude any contracts with Ukraine – the producer of the vaccine had a contract with UNICEF, which, in its turn, was executing the order of WHO. Can our state claim WHO? No, it is not possible even in theory because the Indian vaccine was provided by WHO as humanitarian aid and was accompanied with WHO’s certificate of quality. Acknowledgment of the fact that the death of the boy was caused by the vaccine will undermine the authority of WHO and will provoke distrust to its system of certification and to the idea of “elimination of measles in Europe by 2010.”
In order to talk about somebody’s responsibility it is first necessary to prove that the death was actually caused by the vaccine. I think that there is no chance of doing this and the Kramatorsk case is vivid proof of this. It is not clear what exactly the commission will examine for the entire month, considering that the boy has already been buried. The diagnosis has been changed three times now, and even though the final results are expected in a month, Chief Sanitary Inspector N. Prodanchuk has already announced that the death of the school-boy is not connected with the vaccination.
Interestingly in India, after four little children died in Tamil-Nadu state during the recent scheduled vaccination against measles, the government immediately banned using the vaccine of national origin and stopped carrying out a national anti-measles immunization program.
Nevertheless, in Ukraine, healthcare officials are not taking the idea of stopping the mass vaccination into consideration: despite the order of the Minister of Health, Kyiv students are being taken to medical centers for vaccination starting Monday…