A German politician long outspoken in his view that the H1N1 vaccine is potentially dangerous and a pharmaceutical-industry sales ploy has succeeded in persuading the Council of Europe’s Parliamentary Assembly to debate the matter, despite mounting evidence that serious adverse reactions to the vaccine have been few.

Dr. Wolfgang Wodarg, a Social Democrat and head of health at the Council of Europe, introduced in December a resolution stating that: “In order to promote their patented drugs and vaccines against flu, pharmaceutical companies have influenced scientists and official agencies, responsible for public health standards, to alarm governments worldwide. They have made them squander tight health care resources for inefficient vaccine strategies and needlessly exposed millions of healthy people to the risk of unknown side-effects of insufficiently tested vaccines.”

The Parliamentary Assembly will formally debate the topic of “false pandemics” on Jan. 28.

The World Health Organization, which Dr. Wodarg has frequently accused of collusion with pharmaceutical interests, issued a written statement Jan. 13 regarding the allegations under consideration: “Providing independent advice to Member States is a very important function of WHO. We take this work seriously and guard against the influence of any vested interests. We welcome any legitimate review process that can improve our work.”

In a news conference planned for Jan. 14, the WHO’s special advisor on pandemic influenza, Dr. Keiji Fukuda, will address the allegations in more detail.

The false-pandemic debate comes alongside the latest review of adverse vaccine reactions by the European Medicines Agency’s pharmacovigilance group, which, with 32.4 million Europeans now having received one of three centrally-authorized influenza A pandemic vaccines – Celvapan (Baxter), Focetria (Novartis) and Pandemrix (GlaxoSmithKline) -- has found little in the way of serious adverse reactions reported.

As of Jan. 3, the EMEA had logged 11,649 reports of adverse reactions to the three vaccines, an increase of 523 reports over the previous week, reflecting, the agency said, the increase in the number of people vaccinated. Most were non-serious administration-site or neurological reactions. However, the agency is monitoring closely reports of convulsions, pain in extremities, and influenza-like symptoms for Celvapan, and four cases of thrombocytopenia following vaccination with Focetria, two of which are believed to be unrelated to the vaccine.

For Pandemrix, the most widely administered of the three vaccines with an estimated 23.4 million Europeans vaccinated, adverse-reaction reports included six new cases of thrombocytopenia, three new cases of idiopathic thrombocytopenic purpura (ITP), and one case of autoimmune thrombocytopenia.

The EMEA received four new reports of Guillain-Barré syndrome after Pandemrix vaccination; however, the agency noted, the number of GBS cases reported remains lower than the background rate for the general population. Six new fatalities have been reported following Pandemix vaccination. Three of these patients had underlying cardiovascular and renal risk factors, one was a two-month-old child who died from H1N1 infection on the day of the vaccination, and two more cases remain inadequately documented and more information has been requested, the agency said.

The European death toll from pandemic influenza was 2,078 through January 8, according to the European Centre for Disease Prevention and Control. In its weekly pandemic flu report through Jan. 3, the ECDC reported low to medium influenza intensity throughout Europe, and stable activity or a decreasing trend, though it cautioned that holiday underreporting may have contributed to this picture.

Copyright (c) 2009 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

一位德国政治家长期以来一直对外宣称，我们应当关注甲型H1N1流感疫苗的潜在危害，并提防制药业所玩弄的一些销售伎俩，近日，他成功说服了欧洲理事会议会就此话题展开辩论，尽管现在有越来越多的证据表明，注射该疫苗通常极少出现严重的不良反应。

 

欧洲理事会卫生部门负责人、社会民主党人Wolfgang Wodarg博士在去年12月提出了一项决议案，该决议认为：“为了促进其抗流感专利药物和疫苗的销售，制药公司对负责制定公众健康标准的科学家和政府机构施加了影响，导致世界各国政府纷纷拉响警报。他们迫使政府将原本就极为紧缺的卫生资源浪费在低效的疫苗策略上，由于这些疫苗并未接受充分检验，并可能存在着未知的副作用，这就使得成百上千万的健康民众暴露于不必要的风险中。

 

欧洲理事会大会将于1月28日正式讨论“虚假的流感大流行”这一议题。

 

Wodarg博士经常指责世界卫生组织(WHO)涉嫌与制药业利益集团勾结，针对这一尚在审议中的指控，该组织在1月13日发表的书面声明中表示：“向会员国提供独立建议是WHO的一项非常重要的功能。我们会严肃对待这一职责并确保其不受任何既得利益集团的影响。我们愿意接受任何合法审查程序的监督，以便改进我们的工作。”

 

在预计于1月14日召开的新闻发布会上，WHO流感大流行特别顾问Keiji Fukuda博士将会就这一指控发表更为详尽的声明。

 

在欧洲药品管理局(EMEA)药物安全监察部门公布了对流感疫苗不良反应的最新评估后不久，便引发了这场针对流感虚假大流行的争论，当前有3,240万欧洲民众接种了至少1剂以下3种经EMEA批准的甲型流感疫苗——Celvapan(百特)、Focetria (诺华)和Pandemrix(葛兰素史克)。据报告，接种这些疫苗仅造成了极少的严重不良反应。

 

截止1月3日，EMEA共收到了11,649份关于这3种疫苗不良反应的报告，和上周的523份报告相比呈现上升趋势，据该机构称，这反映了疫苗接种人数的增多。大多数不良反应为非严重的给药部位反应或神经系统反应。然而，EMEA正在密切监测接种Celvapan后出现抽搐、四肢疼痛和流感样症状的报告以及接种Focetria后出现的4例血小板减少病例，其中2例被认为与疫苗无关。

 

在这3种疫苗中，应用最为普及的是Pandemrix，据估计，大约2,340万欧洲人接种了该疫苗，所报告的不良反应包括6例血小板减少新发病例和3例特发性血小板减少性紫癜(ITP)新发病例以及1例自身免疫性血小板减少病例。

 

EMEA还收到了4例吉兰-巴雷综合征(GBS)新发病例的报告；然而，该机构指出，所报告的GBS病例总数仍旧低于普通人群的基础发病率。还有6例Pandemix接种后新发死亡病例的报告。在这些病例中，3例具有潜在的心血管和肾病危险因素：1例为两个月龄婴儿，其在接种当日便死于H1N1流感；另2例目前记录在案的信息尚不完备，进一步的相关细节目前还在调查中，该机构称。

 

据欧洲疾病预防控制中心(ECDC)报告，截止1月8日，欧洲因大流行性流感而死亡的总人数大约为2,078人。在其1月3日公布的流感疫情周报中，EDEC称整个欧洲目前尚处于低至中等强度的流感流行中，目前疫情稳定并呈下降趋势，但该机构同时警告说，假日期间漏报可能导致了这种现象。

 

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