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În 2007 trei copii au murit în Vietnam din cauza vaccinului anti-hepatic Euvax B. În Bosnia vaccinul a generat diabolică la unii copii



The Association of Parents of Disabled Chidren from Bosnia and Herzegovina has filed criminal charges on January 18th, 2010, with a state prosecutor over the failure to investigate vaccine damage to children linked to vaccines financed by the GAVI. (the Global Alliance for Vaccines and Immunisation),

The charges maintain that state prosecutor Sead Kreštalica assisted members of the Federal Institute for Public Health in evading investigation for their role in the UNICEF’s GAVI vaccination programme against hepatitis b, which is believed to be responsible for the increase in the number of disabled children in Bosnia and Herzegovina since 2002.

The GAVI office, located inside the World Health Organization, launched a vaccination campaign against liver infectious disease among children that was financed with a $1.5 million grant from the Bill & Melinda Gates Foundation made to more than 20 governments.

In 2002, the epidemiology office of the Bosnian Federal Institute for Public Health put forward plans to vaccinate all newborn healthy babies against hepatitis b in first 24 hours of life within the framework of the GAVI vaccination campaign.

In 2002, only nine other countries in the world vaccinated all newborn healthy children against hepatitis b in first 24 hours of life: Bulgaria, Estonia, Latvia, Litthuania, Poland, Portugal, Rumunia, Turkey and Spain.

The hepatitis b virus does not spread as an epidemic and the virus is transmissing by needles, sexual contacts and human liquids.

UNICEF advisor was Dr Popov from Bulgaria, who appeared to have no experience in epidemiology, according to the former chief federal epidemiologist Prof. Zlatko Puvačić ( See „Express“ on 19. 06. 2002).

The GAVI vaccines seem to be connected with enourmous increase of disabled children in Bosnia and Herzegovina from 2002.

Disabled children who underwent an laboratory analysis were found to have unusually high amounts of of mercury in their hair nails and urine.

In Bosnia, newborn babies have been vaccinated only with BCG vaccine in the past 50 years and there have been no visible health problems due to the BCG vaccine.

The addition of the vaccine against hepatitis b was added to BCG in first 24 hours of life has resulted in babies receicing vaccines with two doses of mercury in the vaccine’s preservative, thiomersal. The increase in the mercury appears to have affected the capacity of babies to excrete mercury from their bodies and created basis for cumulative effect of mercury in their bodies.

Small babies have no capacity to produce a bile, which is main way of excretion of mercury from the body.

Also, small babies have limited capacity to produce glutation , which is the main detoxicant of the brain.

There is a correlation between a timing of the vaccines given in later months of life and the quantity of mercury found in childrens’ bodies and it shows cumulateve effect of mercury.

Children in Bosnia and Herzegovina have undergone a severe neurological deterioration. Some children lost the ability to walk, to sit down, to eat with a spoon, to talk: they have motoric and intellectual retardation and some of them have got encephalopathy, epilepsy and autism.

The Association has 117 registered cases, but according to other organizations who are concerned with children with special needs, it seems that there are more than 1100 child victims of GAVI vaccines.

Parents presented 41 requests for laboratory analysis, neurological , toxicological and genetics expertise to the Cantonal prosecution in Sarajevo but the request went answer.

The vaccine used, euvax b, until 2002 has been licenced in 30 countries : 1994-Bangladesh, Filipini, 1995-Argentina, Guatemala, Korea, Myanmar,1996-Equador,1997-Urugvay,1998-Tailand, Armenia, Azerbejdžan, Georgia, Iraq, 1999- Costa Ricca, Jamaica, Trinidad and Tobago, Kirgistan, Uzbekistan, 2000- Chile, Dominikan Republic, Peru, Pakistan, Turkey, Mauritania, Togo, 2001-Aruba ( Antili), Paragvay, Moldavia, Jordan i Gabon.

On 07. 08. 2001, Bosnia and Herzegovina became the first and, at that time, the only one country in Europe to licence this vaccine.

In 2002 the pharmaco- kinetic proprieties and duration of protective effect on healthy people of Euvax B were not known.

Parents in Bosna received no information on clinical studies on babies and no information in which countries, when and on which subjects, clinical tests has been conducted.

Parents also received no information on the vaccine’s pharmaceutical, chemical, biologicical, microbiological and virology or pharmaceutical toxicology.

Nevertheless, WHO in November 2000 declared this vaccine as accepetable for UN agencies .A producer of euvax b is LG from South Korea, better known as producer of TV and other electronic equipment. The distributer of euvax b is „Sanofi Aventis“.

WHO temporarily suspended the use of specific lots of the Euvax B vaccine in 2007 following evidence that it was linked to the deaths of infants in Viet Nam.

http://www.who.int/immunization_safety/aefi/investigations_EuvaxB_synopsis/en/print.html

Investigation of adverse events following Euvax B (hepatitis B) vaccination, May-July 2007

Synopsis and final outcome

From May to July 2007, WHO assisted the government of Viet Nam in the investigation of four serious adverse events (including three deaths) in infants following administration of Euvax B (hepatitis B) vaccine.

As a precautionary measure pending investigation of the reported cases, the Department of Immunization, Vaccines and Biologicals (IVB) at WHO recommended on 15 May the temporary suspension of the distribution and use of specific lots of Euvax B vaccine and provided guidance for parallel actions to be taken at country level.

Following investigation of the reported cases from Viet Nam and additional reports from other countries as well as vaccine quality testing and a review of the batch records and manufacturing and quality control process at the manufacturing site, no evidence of a quality problem with the vaccine was found.

Consequently, on 7 July 2007, WHO removed its recommendation for temporary suspension of specific lots of Euvax B vaccine and recommended that all lots of Euvax B under temporary suspension be released for use. At no time during the investigation was Euvax B vaccine removed from the WHO list of prequalified vaccines.

Background

Euvax B vaccine Euvax B is a recombinant DNA hepatitis B vaccine derived from hepatitis B surface antigen (HBsAg) produced by DNA recombinant technology in yeast cells (Saccharomyces cervisiae). HBsAg is absorbed onto aluminium salts as an adjuvant and preserved with thiomersal.

Other excipients are potassium phosphate monobasic, sodium phosphate dibasic and sodium chloride.

The vaccine is manufactured by LG Life Sciences, based in the Republic of Korea. The vaccine was prequalified by WHO in November 1996. As at May 2007, approximately 254 million doses had been distributed through UN agencies.

WHO response and initial recommendations

Following the reports of serious adverse events (including three deaths) in Viet Nam, and initiation of an investigation, WHO recommended, on 15 May 2007, the temporary suspension of the distribution and use of specific lots of Euvax B vaccine.

This action was taken as a precautionary measure pending the full investigation of the reported adverse events.

WHO recommended that, until further notice, there be no further distribution or use of specific Euvax B vaccine lots produced from the same final bulk as lots that had been supplied through the UN system to Viet Nam and were under investigation.

The recommendation was limited to specific bulks and corresponding final lots (further updated on 25 May 2007):

Bulk UVN05012 and related lots UVX05027, UVX05028 and UVX05029

Bulk UVN06004 and related lots UVX06005, UVX06006 and UVX06007

Bulk UVN05014 and related lots UVX05030, UVX05031, UVX05032, UVX05033 and UVX05034

At the time of suspension, there was no indication of a vaccine quality problem with specific lots of Euvax B, or with the vaccine in general.

WHO recommended that countries continue to provide hepatitis B vaccination, including the birth dose where applicable, using other lots of Euvax B not affected by the temporary suspension (and where already the case, other hepatitis B vaccines).

WHO and UNICEF urged countries not to suspend all use of Euvax B and/or use of other hepatitis B vaccines for the birth dose or other scheduled vaccination without careful risk-benefit considerations.

These considerations included a careful analysis of any potential risks of concern in the specific country and a thorough assessment of the potential negative impact on hepatitis B vaccine supply and acceptance in both the short- and long-term.

It was emphasized that the suspension of hepatitis B birth dose vaccination had major implications at it would mean that many infants would be at high risk for becoming hepatitis B carriers and at risk for premature death.

As a precautionary measure, the vaccine manufacturer, LG Life Sciences, and one of its international distributors, sanofi pasteur SA, also issued advice of a temporary suspension on the distribution and use of the same batches of the vaccine specified in the WHO recommendation.

Investigation of reported AEFI cases

Viet Nam

The three deaths and one other serious adverse event which followed vaccination of infants in April and May were investigated by the national authorities with support from WHO.

A detailed expert review of the clinical data and assessment of probable causes was carried out at the request of WHO.

The death of one infant (in Ho Chi Minh City) was determined to be unrelated to the vaccine.

This conclusion was based on autopsy findings of an acute myocardial infarction secondary to coronary artery thrombosis occurring in utero.

The clinical picture in the two other fatal cases (in Ha Tinh province ) was consistent with acute shock with several possible aetiologies.

Among the possible aetiologies, endotoxic or anaphylactoid shock were considered to be the most likely. (Anaphylaxis - or anaphylactic shock - a different clinical condition from anaphylactoid shock, is exceedingly rare in neonates and was not considered a likely aetiology in these cases).

However, no evidence was found to support or rule out programmatic error (such as contamination of the vaccine, or inadvertent administration of a wrong drug) that would explain these two possible aetiologies.

In the fourth case (in Thanh Hoa province), the cause of the AEFI was found to be most likely a pneumonia or sepsis/bacteraemia, with no definite conclusion to rule out or confirm a relationship to the administration of the vaccine.

Thus, one case was confirmed as a coincidental AEFI, while for the remaining three the information available did not confirm or rule out a possible link with the vaccine or vaccination.

Other countries

All reports of serious AEFI of which WHO was made aware were followed up and a vaccine quality problem ruled out.

Investigation of three serious AEFI cases which followed concurrent administration of Euvax B and other vaccines did not provide evidence of a link between the AEFIs and Euvax B vaccine.

Vaccine quality review and testing

Samples of the suspended vaccine lots, collected from the manufacturer and from Viet Nam, were tested for bacterial endotoxins, abnormal toxicity and pyrogen by a WHO-contracted laboratory.

Final test results showed that the lots complied with the quality specifications as recommended by WHO, the European Pharmacopeia and the Korean Pharmacopeia.

In conjunction with the Korea Food and Drug Administration (KFDA), a WHO team conducted a site visit to LG Life Sciences at the end of May to review the batch records and manufacturing and quality control process of the vaccine.

The report of this visit, and a subsequent review of this report by an ad hoc expert committee convened by WHO, provided consistent conclusions that there were no problems with regard to the quality, safety or potency of the Euvax B vaccine.

The KFDA also tested samples of the vaccine lots (from the suspended bulk batches) distributed and used in the immunization programme in the Republic of Korea. Results showed compliance with WHO quality standards.

Conclusions and final recommendations

The clinical, epidemiological and multiple vaccine quality investigations provided no evidence of a quality problem with specific lots of Euvax B, or with the vaccine in general.

Specifically, vaccine quality testing by the independent WHO-contracted laboratory showed the tested lots to be compliant with the quality specifications as recommended by WHO, the European Pharmacopeia and the Korean Pharmacopeia.

On the basis of the above findings, WHO removed, on 7 July 2007, its recommendation for the temporary suspension of specific lots of Euvax B vaccine.

Further, WHO recommended that all lots of Euvax B under temporary suspension be released for use.

National regulatory authorities and immunization programme managers were advised to take appropriate care, prior to releasing affected vaccine lots for use, to ensure that the relevant lots had been stored under recommended conditions while on hold.

At no time during the investigation was Euvax B vaccine removed from the WHO list of prequalified vaccines.

In this investigation, the possibility of a link with the vaccine or vaccination could not be confirmed or ruled out in three of the four serious AEFI cases.

As a result of background mortality due to other causes, deaths among neonates and infants reported following vaccination may be coincidental, in other words having only a temporal association with the vaccine(s) administered. Hence careful investigation of serious adverse events is critical.

Hepatitis B vaccination

Hepatitis B vaccine is highly effective in preventing hepatitis B virus infection. Failure to vaccinate infants increases the risk of chronic infection, that can lead in later life to liver disease (including cancer) and early death.

WHO and UNICEF recommend that all infants in all countries receive hepatitis B vaccine, with the first dose provided at birth in areas where mother-to-child hepatitis B virus transmission is significant.


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