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http://www.mw.ua/1000/1550/63026/

# 19 (698) 24 — 30 May 2008

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Unscheduled vaccination: GENIE SET FREE

Author: Olha SKRYPNYK

a teenager from the town of Kramatorsk, died several weeks before

finishing school. How can his parents ever be consoled? Will the

traditional " God-takes-the-best-to-the-heaven-earliest " help? Will it

help if they hear the officials from the Ministry of Health explain

that the unscheduled vaccination against measles and rubella in

Ukraine was meant to protect Europe from the measles epidemic, as

somebody somewhere at the top decided to eradicate this disease by

2010?!

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.

ly 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-ivsk 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.

Post-vaccination silence

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…

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