The European Forum for Vaccine Vigilance (EFVV) – a coalition of European support groups and individuals concerned about vaccine safety and related issues – is calling on major international bodies to take immediate action to introduce mandatory surveillance of routine vaccinations.

ANH-Intl fully supports the EFVV in this matter, which ties into our Vaccine Choice campaign. We believe that it is impossible for individuals to make informed choices about whether or not to vaccinate in the absence of the type of evidence being demanded by EFVV: that is, comprehensive and rational scientific evidence of the safety and efficacy of vaccines. ANH-Intl Executive and Scientific Director, Dr Robert Verkerk, said of the EFVV campaign, “We hope this initiative helps to shine a clearer light on the often shaky scientific basis on which vaccination decisions are made, both by healthcare authorities and the population at large. In the absence of good-quality data, authorities must provide scientifically backed information for people who choose either to vaccinate or not vaccinate. Critical to this are dietary, lifestyle and herbal approaches that have been demonstrated to support the immune system.”

In a press release issued by EFVV (reproduced in full below), Dr Meryl Nass, a US microbiologist and board-certified internist, is quoted as saying, “We urgently need to establish surveillance systems that analyze diagnosis made at outpatient visits and hospitalisations for at least one year post-vaccinations so that statistically significant links can be identified and assessed for causality”.

The EFVV request was made to European Union (EU) Member States, the World Health Organization (WHO) and the EU Environmental Committee for Public Health and Food Safety (ENVI Committee) following safety concerns highlighted during EU Immunisation Week, April 23–30, 2011. Particularly worrying are potential links between vaccination and narcolepsy, the total lack of double-blind, placebo-controlled trials of vaccines and an overly lax adverse-event reporting scheme, whereby doctors are not obliged to notify authorities of side effects.

European patient groups are supporting the EFVV in its call for vaccine surveillance. Anna Watson of the Arnica Network for Natural Immunity in the UK explained that, “Patient groups around Europe, Arnica Network for Natural Immunity and The Informed Parent in the UK for example, have joined together in their concern over inadequate vaccine safety testing and surveillance of adverse drug reactions, and have called on the WHO to support a mandatory system that monitors possible side effects from vaccines.”

European patient groups call for mandatory vaccine surveillance systems

Safety concerns at the end of EU Immunisation Week (April 23-30, 2011) have prompted European patient groups to call for mandatory surveillance systems for routine vaccines. This would include training for GPs to recognize adverse vaccine reactions (ADRs), a campaign to boost public awareness of direct vaccine side effect reporting by patients and the immediate addition to the hospital patient admission procedure of questions on vaccine status, especially the administration of any recent vaccines.

The World Health Organisation (WHO) has supported European Immunisation Week as a chance to promote widespread vaccination. On 21st April however, the WHO's Global Advisory Committee on Vaccine Safety (GACVS) stated that further investigation is needed into possible links between narcolepsy and vaccination. In 2009–2010, in Finland and Sweden, the Pandemrix swine flu vaccine caused nine times as many narcolepsy cases as expected in children.  WHO noted that narcolepsy has never before been associated with vaccines.

EFVV, the European Forum for Vaccine Vigilance, is calling on EU member states, WHO and the EU Environmental Committee for Public Health and Food safety (ENVI) to mandate surveillance systems for vaccines. “We urgently need to establish surveillance systems that analyze diagnosis made at outpatient visits and hospitalizations for at least one year post-vaccinations so that statistically significant links can be identified and assessed for causality,” says Dr Meryl Nass, microbiologist.[1]

The gold standard of double-blind placebo testing (where the placebo is benign) is never applied to vaccines and there is never a control group in vaccine testing. Professor David Salisbury, Director of the UK Immunization program, has confirmed to EFVV spokeswoman Anna Watson that placebos in vaccine safety tests have always been other vaccines and that control groups were considered unethical in the case of vaccines.

“In the absence of double-blind trials, surveillance in the community is essential as vaccines may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women,” said Ms Watson. “Phase IV trials, known as Post-Marketing Surveillance Trials are vital, especially considering that Adverse Drug Reactions (ADRs) are the fifth leading cause of death in Europe,” she said.

Patients can now report ADRs directly in most European countries but most people are not aware of this. In theory, doctors and health professionals should be encouraged to complete ‘Yellow Cards’ for the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK or to follow equivalent procedures in their respective countries.  Vaccines are however considered ‘established medicines’, so doctors are not required to report side effects unless there is a prior association[2] or effects are life-threatening.  The result is that many potential side effects from vaccines remain unreported. “If no data is collected, it remains unknown whether vaccination increases the incidence of most diseases, particularly rare diseases. Additionally, GPs have very little training in spotting adverse drug reactions,” said Ms Watson.

Vaccine manufacturers have never been successfully challenged in civil action for damages arising from a vaccine-related injury or death, because legal aid is not available, so market forces are weak in this area. It is the view of the EFVV that the Vaccine Damage Payment Fund and its European equivalents, should be calling for Mandatory Active Vaccine Surveillance to fulfill the responsibility to vaccine safety.  Parents, patients and health professionals should be supported in vaccine safety initiatives.  As vaccine programmes continue to increase, so should our vigilance say the EFVV.

ENDS

T: Anna Watson UK   020 8541 1501  

E: [email protected] for European Forum Vaccine Vigilance central

Notes to Editor

EU Immunisation Week 23-30 April “Prevent, Protect, Immunize” http://eiw.euro.who.int/page/what-is-eiw 

Dr. Nass is a board-certified internist who has authored many publications, testified before Congress, and spoken before medical organizations regarding the problems of vaccinations and Gulf War syndrome. New Adverse Reactions from Vaccines – Surveillence needed by By Meryl Nass, M.D.

When there is no prior association, diseases occurring in temporal relationship to vaccination are generally felt to be coincidental. Therefore, they are not generally reported to voluntary reporting systems like the UK Medicines and Healthcare products Regulatory Agency (MRHA) or the U.S. Vaccine Adverse Event Reporting System (VAERS).

Other examples of vaccine problems:

2010 suspension of Fluvax in Australia and New Zealand that “caused two or three hospital admissions due to febrile convulsions for every hospital admission due to influenza prevented,” scientists wrote.

1999 suspension of Rotavirus vaccine that caused 22 times the expected incidence of intussusception as expected (United States).

Currently Gardasil results in an average of 6 times more reports of ADRs and hospitalizations to VAERS (Vaccine Adverse Event Reporting System ) than any other vaccine. 

The EFVV is a coalition of European support groups and individuals concerned about the safety of vaccines, the lack of information on and public awareness of vaccine adverse effects, the preservation of human health and respect for basic human rights.  The group was originally formed in 1998, conducted a six-year research project on the adverse effects of vaccines in Europe, completed in 2006, and organises a bi-annual award for ground-breaking and original independent research into the side effects of vaccines.  Delegates currently represent ten different countries: France, Spain, Great Britain, the Netherlands, Belgium, Germany, Italy, Luxembourg, Slovenia and Switzerland.