About the tragedy in Gantsevichy district, when after the introduction of vaccination, the baby died, heard the whole of Belarus. But few people know how the Korean vaccine of Aumenta came to our country. The history of the efforts of the Ministry of health is very vague and therefore even more frightening.
The Ministry of health does not tire of repeating everywhere that tragedy with a two-month child happened after the use of two vaccines: Korean Aupindi and French Imovax Polio. Therefore the government, pending an investigation, suspended the use of these two vaccines.
Representatives of the Korean factory then arrived in Belarus, expressed regret and condolences to the family of the child, and incidentally assured that he will do everything possible for an objective investigation. But the French still keep a discreet silence and not even going to go to Belarus. There is nothing surprising, as the French probably can’t even grasp why they dragged this story. The fact that the Polio vaccine Imovax very well known not only the EU but also worldwide. She passed all the necessary tests and registration in the EU and in Belarus. In principle, there can be no question. It really is the vaccine, the safety of which is confirmed in the country of origin and in the EU and in Belarus.
The situation with the vaccine of Aumenta opposite. Statement of the Ministry of health that this drug has passed all the necessary tests – to put it mildly, not entirely untrue. In our opinion, for this alone Investigative Committee is investigating a criminal case on the death of a child, should have to involve officials of the Ministry of health responsible. But for some reason he is silent. Let’s hope after this article how it will react.
Experiment on Belarusian children
If you believe the information on the websites of a number of district hospitals in Belarus, the vaccine of Apenta has been actively used for our children from January 2017. The vaccine was not registered in Belarus and, accordingly, not passed in our country, any tests and inspections. The use of such vaccines is expressly prohibited by law “On medicines”, but it was actively used for more than two years.
“Diary” was sent to the Ministry of health request and asked directly: How unregistered in Belarus the vaccine was purchased and how it is applied in the Belarusian children?
The answer is not just surprised but literally shocked. We will show some quotes, which actually turns out that the Ministry of health turned to head the law “On medicines” and actually started in Belarus large-scale clinical trials of new Korean drug using Belarusian children as human biological material for these tests.
As pointed out by the Ministry of health, “in the majority of cases (more than 90% of all purchases) was purchased on the territory of the Republic of Belarus of the medicinal product”. However, the Law “On medicines” provides for the procedure of import of unregistered medicinal products.
“If you want to purchase unregistered drugs, these drugs have additional requirements. The drug should be registered in countries outside the ICH (international conference on harmonization of technical requirements for registration of pharmaceuticals for human). This list includes countries with a strong regulatory body for registration (EU, USA, Canada, Japan, Switzerland, South Korea, etc.)
The vaccine of Aumenta produced at the company LG Chem. Ltd., South Korea. The company has a certificate of conformity of production to requirements of good manufacturing practice. The vaccine of Aumenta prequalified with 10.02.2016 year and recommended for use by the world Health Organization. Prequalification of medicines by who are the procedure conducted by who to assess quality, safety and efficacy of medicinal products. It is a distinctive mark of world-class quality. The prequalification program of the who provides two-thirds of all infants of high-quality, safe, affordable vaccines. The vaccine of Aumenta also recommended and purchased international United Nations children’s Fund UNICEF.
The manufacturer of the vaccine of Aumenta performed the full scope of required clinical trials. During the development phase of the vaccine in clinical trials was included 489 children. According to international requirements do not require duplication performed on the territory of other countries clinical trials in the case that these tests are conducted in accordance with the requirements of good clinical practice. The plant implemented audit specialists,” – explained the Ministry of health. He also then wrote in its official press release, which is posted on the website.
Here, neither the approval or the outright noodles that the Ministry hangs on the ears of the inhabitants of the country to the public is not worried.
The law “On medicines” actually provides for importation and use in Ukraine of unregistered medicines. But these cases are strictly regulated by article 23. Of all these cases of mass importation of vaccines could only happen in two cases: for clinical (pre-clinical) testing and for elimination of consequences of emergency situations of natural and technogenic nature, epidemics. The remaining cases are private and may not apply to this vaccine.
“Ezhednevnik” has asked the health Ministry to clarify how case of import of unregistered medicines were used in the vaccine of Apenta, and if it still goes on emergency or outbreak of an epidemic, which urgently needed to resolve or explain when they happened in Belarus, as no one about them never heard of. The Ministry of health promised to respond, but three days later, suddenly refused to do, advising him to be content with what we have.
We did so, the more that information is more than enough. By and large the explanations of the Ministry of health here was not needed, just wanted to see how the officials will get out of a difficult situation.
Because in recent years in Belarus there were no emergencies or outbreaks, it can be assumed that the mass importation of vaccines of Aumenta could only be done for clinical trials. Otherwise customs would have just missed the shipment into the country, since GTK is also not stupid.
Therefore, the vaccine of Aumenta can be imported without registration only for clinical trials and nothing else. And here begins the scary part. Participation in clinical trials is entirely voluntary. Paid for it very large sums of money and other compensation provided, if something goes wrong. In clinical trials pharmaceutical companies spend millions, and even tens of millions of dollars. And then free the Korean company staged a test site of the Belarusian children. Or maybe not for free?
We still remember who our children performed various medical tests. But it was during the war and then in peacetime and with the permission of the authorities. Especially afraid of the words of the Ministry of health that in this way (without registration) on the Belarusian market gets about 10% of all medicines. But that’s not all.
A good scheme
Designing, testing and bringing to market a new drug is extremely expensive. Global pharmaceutical companies spend on it for 10-15 years and $ 800 million. At the same time, the wider the scope of application of the drug, the harder it is tested and the more funds are required. The five component vaccine of Aumenta, which insures children from five diseases – a case in point.
New drug is first tested on animals (two different types) and only then start clinical trials on humans, which include three phases.
The first phase of tests carried out on a small number of people, and, necessarily in healthy adult volunteers.
The second phase is testing a targeted group of people, that is those for whom the drug is intended. Here are already involved up to 300 volunteers who are under close medical surveillance.
The third phase – mass clinical trials, which in turn can include multiple stages, where the involvement of thousands of people.
Only after the third phase of clinical trials begins the process of registration of the medicine, confirming its efficacy and safety. However, if clinical trials had received some unfavorable data, the drug is unlikely to be registered. In addition, the registration authority may deem insufficient coverage of subjects and require additional testing. In General, the process is quite complex and lengthy, not guaranteeing a positive result that the drug will be approved for use. This is a major risk pharmaceutical companies hundreds of millions of dollars may be wasted.
We’re told about how tested and recorded new drug. The delegation of the Korean company, which visited Belarus last week, submitted to the Ministry of health of Belarus certificate of pharmaceutical product issued by the Korean national controller Ministry of Food and Drug Safety. As noted by the Ministry of health, the certificate No. 5115, dated 27 may 2014, confirmed that the vaccine of Aumenta passed all the necessary tests, so it is safe and effective. And, most importantly, has an official registration in South Korea, which is part of the International conference on harmonization of technical requirements for registration of pharmaceuticals for human (ICH). To ICH will return later to show the absurdity of the reference of the Ministry of health on the organization, and now will tell about the certificate.
Surprisingly, Koreans have provided their certificate only after the death of a Belarusian child, although I must do it before the delivery of the vaccine. But this is not the worst in the actions of the Ministry of health of Belarus and the Korean company.
If you go to Korean website PHARMA KOREA (http://epharmakorea.or.kr), which acts on behalf of the regulator – the Ministry of Food and Drug Safety and contains all the information not only was in South Korea medicines, but those that have been tested, and there you can see that Aumenta even in the country of origin is not registered. The vaccine is still in the section of scientific development, just at the stage of registration.
One would assume that it triggered the notorious human factor and someone put the wrong information in the registry, or we have something not well understood, but it is very unlikely.
The fact that in April 2015 a number of Korean information resources (Business Korea, The Korea Times and others) with reference to the company LG Chem announced that the company LG Life Sciences completed the third phase of clinical trials of a new vaccine of Aumenta.
If in April 2015 and have been completed clinical trials, the Korean regulatory authority Ministry of Food and Drug Safety could not issue a certificate of safety of the vaccine in 2014. May be a Korean company has invented a time machine and after completion of clinical trials is back in 2014?
The question is that the document then gave the Koreans? Unfortunately, the Ministry of health has not published the document. In our opinion, the Investigative Committee of Belarus should immediately withdraw and to work with him, after a series of examinations.
Based on data collected by us, there are two possible options: either provided a fake, or, more likely, given another document, which can not confirm the safety of the vaccine. This can be a certificate assigned to the Korean company rights of the producer of the vaccine or a quality management certificate or any other similar document, which the Koreans and the Ministry of health of Belarus want to cover their rears. The provision of such documents, e.g. certificates of quality management ISO 9001 is a certificate of conformance this Nostrum corrupt health Ministry officials about “the Diary” more than once wrote.
When in fact, nothing guarantees documents in Belarusian hospitals, including children’s, were delivered not certified and sometimes falsified medical equipment from a fake manufacturer. Including for these misdeeds, the heads of the Centre for examinations and tests in health service, and former Deputy Minister of health Igor lositsky. are now in the KGB detention center. Officials then sit, but the scheme seems to functioning to this day.
Belarus as a testing ground for new drugs
Information resources Korean there is another interesting point. If in April 2015 was completed the third phase of clinical trials before the end of 2015, the Korean company just had to register on the drug, but not received. This may mean that the tests were not entirely smooth and it took additional. This confirmed once again the information from specialized sites, where it is said that in August 2015 the third phase of clinical trials of the vaccine of Aumenta in the Philippines, as well as clinical trials in China. How reliable is this information we do not undertake to judge, but it hurts all the ugly going – one-to-one.
On the website of the relevant regulatory body in the US also indicates that there are clinical trials of vaccines Aumenta was launched 3 July 2017 and completed on 21 December 2017. Judging by the fact that the vaccine in the US is still not registered, it is possible to assume that there tests were not entirely successful. However, unlike Belarus, in all these countries, the tests were conducted solely on volunteers who were paid a lot of money and which were under the constant supervision of doctors. But the conduct of clinical trials in Belarus is nowhere any information. But the health Ministry does not tire of repeating about the safety of vaccines. Like, at the moment used 50 million doses in 43 countries and had no problems. But a reasonable question arises: If used as many doses without serious consequences, why the vaccine is still not registered in any country of the world? Even in the country she was not given the check, confirming the safety. What’s the problem?
In fact, the vaccine has problems. On the Internet on various forums and sites full of reviews mom on a very negative response to Aumento. That’s the only reason the Ministry of health does not want to ignore. Let us for example a few reviews (the style is retained).
I went to do 6 months vaccinated before 3 months doing tetraxis, 4 tetraxis and all was well, went to do 6, and tetranema was not paid, made aumenta. In the end, temperature is 38.0, no appetite. It is better to be refused!
the child is 3.5 months. yesterday was vaccinated “aumenta” (Korea), for almost a day temperature of 38.5 ((( antipyretic 6 hours is not enough, we have to alternate paracetamol and ibuprofen…
No want to scare anyone… we Have to opento it was 40.1! Did, after 3 hours the temperature began to rise and so we departed 3 days with the crazy, shouting and whims. The shot was just sick.
after the vaccine the child as a substitute. two days the temperature the baby is cranky and the night was hell(( I Will be refusing to write it on the trail significantly.
Yesterday came the second DTP. The first was an old vaccine reaction wasn’t, the second did this aumentou! Horrible! 2.5 hours of local reaction in form of swelling, indurations, redness and judging by the little-tenderness! Crying could not stop! Gave antihistamine +analgesic, weakness, confusion. In the end-fell asleep, but after a while the temperature rose to 40.8. Knocked long and dreary till the morning. The day passed, the swelling’s gone down on anti-allergic, fever more than 38 holding. Evil is not enough for experimentation on our children!
Great “noodles” on the ears
However, perhaps Aumenta – perfect vaccine, better in the world. We are not experts and will not make any claims. Only note that according to the Belarusian legislation, like the legislation of all developed countries, if the quality of the drug has not been confirmed, and the confirmation is the registration of such medicinal quality is considered to be substandard and dangerous.
In its comments, the Ministry of health indicated that when purchased unregistered in Belarus drug, it shall apply additional requirements. Supposedly, the tool must be “registered in the countries belonging to ICH (international conference on harmonization of technical requirements for registration of pharmaceuticals for human). This list includes countries with a strong regulatory body for registration (EU, USA, Canada, Japan, Switzerland, South Korea, etc.)”. For those who have never faced the industry, Mizdrava explanation sounds pretty convincing. But the suppliers of medicines, to which we turned for advice, laughed at it.
First, ICH is not included no country in the world. Within this organization there are no inter-country agreements and commitments, as there can be in principle mutual recognition of registration of medicines. It’s just a combination of the different organizations from several countries. From any country in the organization is a regulatory body which checks and the registration of the drug, and from some- just pharmacists Association. And Belarusian organizations in ICH no.
The purpose of the organization recognition of mutual registration, but only to develop common approaches to quality control of drugs. In other words, the representatives of the organisations meet, exchange experiences, give each other recommendations, and then leaving without any obligations to each other. What does ICH, especially if Aumenta generally not registered in any country of the world? Even if suddenly somehow found out that Aumenta still registered in South Korea (for example, it could have done without clinical trials), it absolutely does not change anything in this situation.
Most importantly, the law “On medicinal products” is not a word about ICH. Of course, nothing prevents the Ministry of health to provide additional requirements for unregistered medicines, but these requirements are not intended to replace the basic law and its requirements.
A similar situation exists with reference to the Ministry of health that the vaccine of Aumenta prequalified and recommended for use by the world Health Organization. Like, prequalification of medicines, the who is a sign of world-class quality, guaranteeing the quality, safety and efficacy of drugs.
In order to ensure that all this is true enough, again read the law “On medicines”, where there is no word on the prequalification by the who and that it allows the import of drugs without registration in Belarus. And it is possible to open Russian version of the who website and read all about the prequalification by the who. However, to save time readers will briefly tell you about it.
The prequalification program of the who created with the purpose of simplified admission of medicines in developing countries who do not have their structures, involved in quality assurance of medicines. This is the number of countries in Africa, South America, Asia. It’s all those countries where the unfavourable epidemiological situation, where there are problems with the provision of medicines and where people are dying by the thousands from various diseases. Who prequalification is a service exclusively for procurement agencies the who and the UN, e.g. UNICEF, UNFPA, so they can purchase drugs as part of its global programmes against diseases that pose a danger to the world and to countries where the situation with these diseases dysfunctional.
Initially, in 2001, the prequalification programme included medication only for the treatment of HIV/AIDS, tuberculosis and malaria. Then who also took up reproductive health and other problems in developing countries. By 2012, in the programme who prequalification of medicines who have already entered 316 medicines to major human diseases.
In contrast to the verification and registration of drugs in developed countries, who prequalification is conducted through a simplified procedure. The manufacturer is sufficient to provide: data on the purity of all ingredients used in production; data on the finished pharmaceutical product (such as information about stability); results of bioequivalence tests (clinical trials conducted in healthy adults volunteers). That is enough to provide data only about the first phase of clinical trials, it is not necessary neither the second nor the third phase, which is the most complex and costly. Moreover, who could even remove the requirement for reporting the first phase of clinical trials. In other words, the prequalification can pass generally without clinical trials. These are the global pharmaceutical companies to market new drugs. They are in the process of prequalification and run an experimental drug into mass use in developing countries, indeed, they are conducting a clinical ispytaniya saving millions. This is not just foreign media wrote. But in principle that’s fine, because even if in these countries there will be some adverse reactions to a new drug, they will still be in the hundreds or even thousands of times below a positive effect. In any case, for the population of these countries is not available other methods of obtaining drugs, except for global programs of the UN organizations through the who prequalification. At the same time, who openly said that the prequalification programme “does not seek to replace national regulatory authorities or national authorization systems for importation of medicines”.
Even if you just think about the words of the Ministry of health on “the sign of world-class quality”, the question arises by itself: what the EU, USA, Belarus, Russia and other developed country members who spend millions on checking and registration of medicines, when there is a “sign of world-class quality”? The answer is apparently simple, because they know the difference between their country and, for example, Nigeria, Congo or Somalia. Neither in the US nor in EU nor in Russia there are no requirements for registration of medicines to provide pre-qualification by who, but there is a requirement to provide a registration in the country of origin and with the obligatory passage of the three phases of clinical trials. Similar requirements exist in Belarus. When purchasing drugs or when their registration was never required to provide pre-qualification by who, as this document means nothing and guarantees nothing and is intended solely for the purchasing of UN organizations. But suddenly, in one moment, in relation to a particular vaccine approach to prequalification by the who in Belarus is changing dramatically. Why? Yes because you need to find at least some, even the most absurd and ridiculous justification for the use in Belarus of unregistered vaccines – conduct large clinical trials on his people. We wanted to find dokazatelstva that we are not right, as the open reality is really scary. But the more we dug, the more I learned, the worse it became.
The continuation of the investigation, read tomorrow in our next article.