Vaccine damage

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In medical law, vaccination damage is an undesirable, negative consequence of vaccination . From a legal point of view, it is “the health and economic consequences of a health damage caused by the vaccination that goes beyond the usual extent of a vaccination reaction ; Vaccination damage is also present if a person was vaccinated with germs capable of multiplying and a person other than the vaccinated person was harmed. ” ( Section 2 No. 11 Infection Protection Act , valid since January 1, 2001).

Delimitations

On the day after a tetanus vaccination, swelling can occur in one of four cases - not vaccine damage, but the vaccination reaction

A distinction must be made between the vaccine damage and the desired vaccination reaction , which can appear in the form of slight reddening, pain or swelling at the injection site and is usually triggered by the immune reaction itself. These temporary local or general reactions are not notifiable. Vaccination complications are damage to health that goes beyond the usual extent of a vaccination reaction and must be reported to the health department by the doctor or alternative practitioner in accordance with IfSG § 6 Paragraph 1 No. 3 . This suspicion itself must report this suspicion in pseudonymized form to the competent state authority and the PEI in accordance with Section 11 (4) IfSG . They are listed as suspected vaccination complications.

Reactions after vaccination with weakened pathogens ( live vaccines ) (Austria, as of 2013)
frequency Art Live vaccine
very often to often Fever , malaise, headache , exanthema , diarrhea all, MMR , V , OPV
occasionally to rarely Parotitis , generalized lymphadenitis
very rarely Paresis , encephalitis , neuropathies OPV, MMR, yellow fever
Vaccination reactions after vaccination with dead vaccines (Austria, as of 2013)
frequency Art Dead vaccine
frequently Local reactions, malaise, fever (children> 38 ° C), headache all
Rare Joint discomfort, seizures HBV
very rare Collapse, (poly) neuropathy all

The extent of vaccination damage, on the other hand, can be very diverse and depends, among other things, on the type of vaccination, the vaccination history , the age of the patient and the type of vaccine .

Monitoring of vaccinations

Due to the health significance for those affected and the health system, vaccinations are subject to constant monitoring for vaccine damage ( pharmacovigilance ). In 2019, an overview of 138 prospective clinical studies on large numbers of children vaccinated against measles, mumps, rubella and chickenpox came to the conclusion that the risk of vaccine damage was low in relation to the risks of the vaccinated diseases (between 1 in 1150 for febrile seizures and 1 to 40,000 at ITP ).

Since 2001, doctors in Germany have had the "obligation to report suspected health damage beyond the usual extent of a vaccination reaction " anchored in the Infection Protection Act (IfSG) . Doctors are obliged to notify the health department if symptoms that occur after a vaccination could be causally related to the vaccination and go beyond a vaccination reaction. The actual frequency of vaccination side effects can only be determined with the help of actively recording pharmacovigilance systems or clinical studies geared to the respective vaccination complication . The Paul Ehrlich Institute (PEI), the Federal Institute for Vaccines and Biomedical Medicines, has made all reported vaccine side effects available for inspection in a database since May 2007 ("DB-ADR"). The Federal Institute for Drugs and Medical Devices and the PEI jointly publish a bulletin on drug safety several times a year with the latest results on vaccination complications. Scientific staff from the PEI assess a possible connection between vaccination and adverse drug reactions (ADRs) or the report of suspected cases according to WHO criteria.

The PEI registers between 3,000 and 4,000 suspected vaccination complications per year, around a third of which are serious. These are cases that are initially suspected of having a causal relationship with the vaccination - that means "not without further ado that a causal connection exists". The most commonly reported side effect is fever (5.66 percent), followed by erythema (2.95 percent) and headache (2.78 percent). The vast majority of the listed side effects were only reported once.

In 2016, 3,673 individual reports on suspected side effects / complications of vaccination were recorded, 1,080 of which were serious suspected cases after vaccinations; the number of ADRs was 12,180 in 2016. This is because a suspected case can contain several ADRs. The serious suspected cases included 15 deaths and 53 cases with permanent damage. In no single case of the deaths, a causal connection with the vaccinations could be established. Of the 53 cases with permanent damage, 24 had a possible, very likely or even an unquestionable association with vaccinations. Between 2005 and 2009, 169 of the 10,600 suspected cases reported were recognized as vaccine damage. The statutory health insurances bill over 40 million vaccinations per year.

A minority called vaccination opponents denies drug safety, suspects a conspiracy behind vaccinations, denies the existence of viruses or rejects the government vaccination recommendations out of religious conviction.

liability

Strict liability of the pharmaceutical entrepreneur (manufacturer)

Liability for damage to drugs is regulated in Sections 84 ff. Of the German Medicines Act (AMG). According to Section 84 AMG, the pharmaceutical company that has brought the medicinal product onto the market is liable to the injured person for the resulting damage if a person is killed as a result of its use or if the body or health of a person is not insignificantly injured. Medicines within the meaning of the AMG are also vaccines ( Section 4 (4), Section 2 (1) AMG).

Medical Liability

The doctor carrying out the vaccination is liable both from the treatment contract ( § 630a BGB) and from the offense ( § 823 BGB) for a careful procedure based on the state of medical science.

State compensation

Suffered by a person due to a delegated authority officially recommended and made in their area, statutory or legally arranged vaccination vaccine damage, and ye are in accordance with § 60 of the Infection Protection Act (IfSG) because of the health and economic consequences on application support services according to Federal Supply Act to . It is a self-sacrifice that compensates for individual damage caused by a measure that is otherwise generally useful to society (vaccination to protect against communicable diseases, Section 2 No. 9 IfSG). Because of the high interest of the state in vaccinations and measures of specific prophylaxis, § 61 IfSG contains a simplification of evidence in favor of the injured party. In order to recognize damage to health as a result of damage, the probability of the causal connection is sufficient .

Competition

In addition to the public law compensation claim, civil law liability claims continue to exist. However, claims based on the general idea of ​​self-sacrifice are generally subsidiary to claims for damages. Manufacturers and doctors are therefore not released from their liability by §§ 60 ff. IfSG. However, the injured party can no longer assert his civil liability claims, as these according to Section 63 (4) IfSG, Section 81a BVG are transferred to the state liable for compensation.

"Vaccine Court" in the USA

The Office of Special Masters of the US Court of Federal Claims , the so-called "Vaccine Court" accepts in the United States as part of a strict liability financial compensation of vaccine damage, provided a review of the request for compensation confirmed the alleged link between vaccination and damage. The US National Vaccine Injury Compensation Program (VICP) has existed since the 1980s.

In 2019, 653 people who claimed vaccine damage received a total of approximately $ 196 million in compensation under this program (an average of $ 259,000 per person). The compensation did not necessarily mean that the vaccination was causally related to the alleged damage - around 70% of the payments resulted from negotiated agreements. In these cases, the United States Department of Health and Human Services itself found no evidence of a causal link between vaccination and vaccination damage. On average, one person per year receives such a high compensation for a million vaccinations carried out.

Web links

Wiktionary: Vaccine damage  - explanations of meanings, word origins, synonyms, translations

Germany

Austria

Switzerland

Individual evidence

  1. ↑ a b B. Keller-Stanislawsk: vaccination complications and vaccination damage; from: Vaccination Compendium . Ed .: Heinz Spiess, Ulrich Heininger, Wolfgang Jilg. 8th edition. Georg Thieme Verlag, 2015, ISBN 978-3-13-498908-3 , p. 72 .
  2. ↑ a b c d Doris Oberle et al .: Vaccination Complications and Dealing with Suspected Cases . In: Federal Health Gazette . tape 62 , no. 4 , April 1, 2019, ISSN  1437-1588 , p. 450-461 , doi : 10.1007 / s00103-019-02913-1 .
  3. ↑ Ursula Wiedermann-Schmidt: Vaccination: When. Against what. Why . 1st edition. MANZ'sche Wien, Vienna 2016, ISBN 978-3-214-08089-1 , p. 194 .
  4. ↑ Ursula Wiedermann-Schmidt: Vaccination: When. Against what. Why . 1st edition. MANZ'sche Wien, Vienna 2016, ISBN 978-3-214-08089-1 , p. 196 .
  5. ↑ Carlo Di Pietrantonj et al .: Vaccines for measles, mumps, rubella, and varicella in children . In: The Cochrane Database of Systematic Reviews . tape 4 , April 20, 2020, p. CD004407 , doi : 10.1002 / 14651858.CD004407.pub4 , PMID 32309885 , PMC 7169657 (free full text).
  6. ↑ a b Database of reported suspected cases at the PEI
  7. ↑ Bulletin on drug safety. BfArM, accessed December 30, 2019 .
  8. ↑ Bulletin on drug safety. Paul Ehrlich Institute, accessed on December 30, 2019 .
  9. ↑ a b c Dr Thomas Schmitz, Sven Siebert: Plain text: Vaccination! - An educational book to protect our health . 1st edition. HarperCollins, 2019, ISBN 978-3-95967-884-1 , pp. 169-171 .
  10. ↑ Ralf Nowotny: Fact check: The reported cases of complications with vaccinations. In: mimikama . December 9, 2019, accessed January 12, 2020 .
  11. ↑ Bulletin on Drug Safety, Issue 1. PEI, March 2018, pp. 17-24 , accessed on December 30, 2019 .
  12. ↑ Edda Grabar: Sick after the vaccination. In: Der Tagesspiegel . November 3, 2014, accessed January 22, 2020 .
  13. ↑ cf. Angelika Hornig, Renate Klein, Anne Marcic et al .: National vaccination plan. Vaccination system in Germany - inventory and need for action Status January 1, 2012, p. 108 ff.
  14. ↑ BGHZ 45, 58 ff.
  15. ↑ BGH, NJW-RR 1994, 213
  16. ^ National Vaccine Injury Compensation Program. On: hrsa.gov ; Status: October 2018.
  17. ↑ a b Data & Statistics. (PDF) In: Health Resources and Services Administration. January 8, 2020, accessed on August 22, 2020 .