Swine flu vaccination

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Vaccination by injection into the upper arm muscle
Colored , electron microscopic picture of some influenza A / H1N1 viruses (source: CDC )

As swine flu vaccination is the vaccine against the (H1N1) 2009 influenza pandemic called (New flu). The vaccination is directed against the influenza A virus H1N1 of the "virus strain" A / California / 7/2009 (H1N1) . Since 2010, in the official nomenclature for Germany ( ICD-10-GM ), the disease detected has been classified under “J09 flu [..]” and “Influenza A / H1N1 pandemic 2009 [swine flu]” is coded. The virus has also been known as A (H1N1) pdm09 since October 2011 .

The pandemic vaccines described in this article may only be used in the context of the officially declared pandemic situation . In 2010, five such influenza vaccines were approved in the European Union .

It is usually used by injection into a muscle ( intramuscular injection ); MedImmune Influenza A (H1N1) 2009 , available in the USA, is dripped into the nose. The effect of these vaccines is based on stimulating the body's immune system to produce antibodies by giving them weakened or inactivated viruses or parts thereof , without causing disease.

Vaccine preparation 2009

The seasonal influenza vaccine planned for the 2009/2010 flu season was classified as not or only insufficiently effective against the swine flu pathogen after appropriate studies. However, it was still produced because in early summer 2009 it was not foreseeable whether the new pathogen would dominate the seasonal pathogens until the flu season. Therefore, with the "free" capacities still available, the development and production of vaccines adapted to the specific pathogen of swine flu took place.

vaccination

Vaccination campaign 2009/2010

Since the spread of the swine flu pathogen could no longer be stopped and an adapted vaccine could not be produced for the entire population in time, the WHO recommended in mid-July 2009 that all member countries give top priority to vaccinating the medical staff in order to be able to maintain the functionality of the health system . At the same time, it was left to the national authorities to give priority to vaccinating certain groups: children and adolescents who spread the virus quickly, people under 50 years of age who have a lower natural immunity to this virus, or special risk groups such as pregnant women and young children from six Months, the elderly or those with chronic respiratory diseases or who are very overweight. At the end of 2009, the Robert Koch Institute saw no evidence of an increased occurrence of serious adverse effects in the vaccinations that had taken place up to then.

Vaccines approved in the European Union

In 2010 five vaccines were approved across Europe:

Surname Manufacturer Brief description
Pandemrix GlaxoSmithKline made from fractions of viral envelopes from viruses bred in incubated hen's eggs (partial particle vaccine) with an enhancer
Focetria Novartis made from fractions of viral envelopes from viruses bred in incubated hen's eggs (partial particle vaccine) with an enhancer
Celvapan Baxter made from complete viral envelopes of viruses ( inactivated whole-particle vaccine ) grown in mammalian cells (Vero cells ) without potentiators
Arepanrix GlaxoSmithKline Made from fractions of the viral shells of viruses bred in incubated chicken eggs (partial particle vaccine) with active enhancer (no longer permitted)
Humenza Sanofi pasteur Made from fractions of the viral shells of viruses bred in incubated chicken eggs (partial particle vaccine) with active enhancer (no longer permitted)

Of these, Focetria, Pandemrix and Celvapan were recommended for use in the European Union (EU) by the European Medicines Agency from October 1, 2009 .

Arepanrix and Humenza, which were approved in the accelerated approval process, were not marketed in any EU country and the marketing approval has since been withdrawn by the respective companies for commercial reasons.

Admission process

European Union

The European Medicines Agency of the EU has provided various special authorization procedures for the approval of vaccines that are to be used to contain a pandemic .

This special approval process is intended to ensure that a flu vaccine can be approved more quickly. Typically this process takes 18 to 24 months in the EU.

The European Medicines Agency provides for the following three authorization procedures : mock-up authorization procedure (for example: procedure for imitation vaccines or model vaccine procedure), emergency authorization procedure (for example: emergency authorization procedure or accelerated authorization procedure) and modification of seasonal flu vaccines (for example: modification / Change in seasonal flu vaccines).

Model vaccine procedure

A model vaccine is a vaccine that was developed before a pandemic began. However, because the strain of virus that will cause the pandemic is not yet known at this time, companies cannot begin manufacturing a vaccine that contains the correct virus. To circumvent this problem, the model vaccine procedure ( mock-up procedure or 'core dossier' procedure ) allows manufacturers to obtain approval for a model vaccine or prototype vaccine before a pandemic. This procedure is only used for pandemic vaccines.

According to the criteria set by the European Medicines Agency, an effective model vaccine must induce protective antibody levels in at least 70% of those vaccinated.

Immune booster

see main article: Adjuvant (Pharmacology), Section: Adjuvants in Immunology

Most of the vaccines approved in the European Union contain so-called adjuvants (also called effect enhancers , boosters , immune enhancers ). The use of these pharmaceutical excipients in pandemic vaccines is justified by the strengthening of the immunological reaction , which makes it possible to reduce the amount of antigen required in a vaccination dose and which is intended to contribute to cross-immunity against an altered pandemic virus . The World Health Organization ( WHO) has spoken out in favor of the use of adjuvants, because they only require a fraction of the antigen dose and thus sufficient vaccine for a large number of people to be vaccinated can only be produced in a reasonable time.

So far, five vaccines have been approved in the USA , which come from the companies CSL , MedImmune , Novartis Vaccines , Sanofi-Pasteur and ID Biomedical Corporation of Quebec (GSK). They do not contain immune boosters. A total of 250 million vaccine doses of this type were ordered by the American government, of which about 41 million were distributed to the various states in early November.

In Europe, following major outbreaks of H5N1 bird flu , it was decided to proceed differently in the event of a pandemic than with the seasonal flu vaccination . This was based on the desire to be able to protect as many people as possible in the shortest possible time.

Five vaccines were approved in the European Union in 2010, four of which contained immune enhancers.

The Paul Ehrlich Institute (PEI), the German Federal Institute for Vaccines and Biomedical Medicines, considered the adjuvants to be useful. There are many years of experience in the use of flu vaccines that contain the adjuvant MF59 without serious side effects. The adjuvant AS03 , which contains the vaccine ordered by the federal states, is new, but has been clinically tested on many thousands of people. With the adjuvants, however, local reactions at the vaccination site as well as headaches and body aches will be more severe. Since no tests were carried out on pregnant women for ethical reasons , no specific data are available.

criticism

Some experts are critical of the use of vaccines with adjuvants. The Drugs Commission of the German Medical Association and the Standing Vaccination Commission recommended that groups for which there are insufficient data on safety should be offered a non-adjuvanted vaccine. In the USA, only vaccines against swine flu that are adjuvant-free are used. For example, the (very rare) neurological damage caused by attacks by the immune system on the spinal ganglia and peripheral nerves after vaccination ( Guillain-Barré syndrome ) is feared .

The German professional association of paediatricians (BVKJ) demanded that A / H1N1 vaccines that are free from adjuvants and the preservative thimerosal should also be developed for children .

The focus of the various messages contained in the adjuvant AS03 was squalene . The Paul Ehrlich Institute made it clear that there was no reason to fear squalene as a trigger of the so-called Gulf War Syndrome . In particular, it pointed out that the study on which these reports are based had not proven to be meaningful ( valid ). Antibodies to squalene would also occur naturally in the American population. According to a later meaningful study, the proportion of soldiers who complained about the so-called Gulf War Syndrome with such antibodies is not noticeably higher than in those without these complaints.

Preservatives

Vaccines are often supplied in multiple containers for mass vaccinations. They require as little cooling capacity as possible during transport and storage and can be produced more quickly than pre-filled syringes in the event of a pandemic, but must be preserved. Thimerosal is used for preservation . This mercury compound has not been used in vaccines for young children for several years. According to the European Medicines Agency, up to five percent of the population are allergic to the compound. However, only one in ten of this group develops clear symptoms.

Single vaccines

Pandemrix

Pandemrix antigen solution (purple lid) and adjuvant emulsion (yellow lid)

Pandemrix (manufacturer GlaxoSmithKline ) was developed on the basis of the avian influenza A virus H5N1 and approved by the European Medicines Agency . The vaccine is a split vaccine (partial particle vaccine) made on the basis of chicken eggs .

Before administration, two separately filled liquids are mixed in the vial to make the dispersion ready for injection . One part contains the antigen suspension, which contains 3.75 micrograms of virus particles per vaccine dose. This corresponds to a quarter of the amount of particles that is usually administered for vaccinations against seasonal flu per virus type. This also represents the lowest concentration of virus particles currently used in flu vaccines. Therefore, in order to increase the effectiveness of the primary vaccine, the other part consists of an emulsion which contains the adjuvant AS03 . The vaccine packaged in the multi-dose container also contains 5 µg / dose of thiomersal as a preservative. The use-by period is 24 hours.

In Germany, the Federal Ministry of Health and the federal states contractually agreed with GlaxoSmithKline at the end of 2007 to buy the new Pandemrix vaccine with the active enhancer AS03 in the event of an influenza pandemic. In the summer of 2009, the German federal states initially ordered 50 million cans of Pandemrix for around 700 million euros. This should allow 30 percent of the population to be vaccinated. Since fewer doses of the vaccine were required for various reasons (see readiness to vaccinate ), the federal states negotiated with the vaccine manufacturer at the beginning of 2010 to reduce the order. As a compromise, both parties agreed that only 70 percent of the cans ordered had to be removed. This saved 133 million euros. The 50 percent reduction in orders originally planned by the federal states was not approved by the manufacturer.

In Sweden , around 100 million euros were planned for a vaccination campaign for the approximately 9.2 million inhabitants.

According to the European Medicines Agency, the following side effects have been observed in more than ten percent of those vaccinated in clinical studies with the corresponding sample vaccine : headache; Fatigue; Pain, redness, swelling, or hardening at the injection site; Fever; Muscle and joint pain; if more than one percent: warmth, itching, or bruising at the injection site; increased sweating, chills, flu-like symptoms; Lymph node swelling on the neck, armpit or groin. The package insert for Pandemrix (available on the Internet) contains further information on these and other, infrequently expected side effects as well as instructions on how to behave.

In Sweden, on October 29, 2009, a first report on suspected adverse reactions following vaccination with Pandemrix was published. Noteworthy are the reports of allergic reactions in 37 patients, including 15 serious reactions. According to the Swedish authorities, four anaphylactic reactions were reported causally related to the vaccination. In no case did anaphylactic shock occur. It was not known how many doses were inoculated.

The Paul Ehrlich Institute regularly published "Information on suspected case reports of side effects and vaccination complications after the use of the swine flu (H1N1) vaccine Pandemrix approved in Germany". The last report was for ten weeks ended December 30, 2009 at 5:00 p.m. According to this, suspected cases of 1382 people were reported from Germany with an unspecified number of vaccinations. The report also included 5 suspected cases that occurred after vaccination with Celvapan. There were indications of an allergic reaction or hypersensitivity reaction in 134 people. An anaphylactic reaction was reported in 39 cases (including one report for Celvapan).

According to the European Medicines Agency dated December 4, 2009, the second dose of the Pandemrix vaccine often causes a fever in children under 3 years of age. Nevertheless, there was no reason to advise against the administration of the second vaccination dose, which is usual for this vaccination.

Narcolepsy

Some of the side effects recorded above have been diagnosed as narcolepsy . At the beginning of 2011, 161 cases of narcolepsy in connection with the Pandemrix vaccine had occurred out of 31 million doses of the vaccine administered worldwide, 70 percent of them in Sweden and Finland, but also seven cases in Germany, mainly in children aged 4 to 19 years .

In May 2012, the Paul Ehrlich Institute presented figures on reports of narcolepsy after vaccination in Germany. Between October 2010 and April 2012, 19 children and 10 adults were affected. Confirmed diagnoses were available in 13 children and 8 adults. Because of the risk of narcolepsy, the European Medicines Agency had already advised against the use of Pandemrix in people under the age of 20 in 2011. The vaccine is currently no longer used in Germany. In Switzerland, Pandemrix may not be given to pregnant women and children under six months. For people over 60 years of age, the use was approved on November 19, 2009, as there was evidence that the vaccine is also effective in this population group.

The swine flu virus resembles the body's own stimulant orexin in one area . It is believed that the immune system is attacking the orexin. Narcolepsy among children occurred more frequently in countries - including those further north - where swine flu had already broken out when the vaccinations were carried out. The previously suspected autoimmune reaction to orexin-producing cells in the brain has not yet been proven.

A study by the Stanford University School of Medicine in Palo Alto indicates that the antibodies in the Pandemrix vaccine are not directed against the orexin hormone itself, but against one of its receptors. In order for narcolepsy to develop, the blood-brain barrier must also be crossed. A secondary disease is a prerequisite for this. However, this does not necessarily have to coincide with the vaccination. The fact that narcolepsies only occurred after Pandemrix vaccinations is explained by the stronger immune response of Pandemrix. Pandemrix contains significantly higher concentrations of the nucleopeptide than other influenza vaccines. It remains unclear why only people with the HLA variant DQB1 * 06: 02 are affected by narcolepsy. The interpretation of the study leaves the possibility open that the natural immune response to the influenza virus can also trigger narcolepsy.

In Germany you can be entitled to care under the Infection Protection Act if you got vaccinated in 2009 and subsequently suffered from narcolepsy.

Focetria

Focetria (manufacturer Novartis ) is a partial particle vaccine made on the basis of chicken eggs and contains the adjuvant MF59 . The marketing authorization for Focetria was granted on May 2, 2007 by the European Commission in relation to the avian influenza A virus H5N1. In 2009 the preparation was switched to H1N1.

In clinical studies in (also older) adults, the following side effects occurred in 10 out of 100 cases or more often (“very common”) in connection with Focetria: pain, reactions at the injection site (redness, swelling, induration, bruising and pain), painful Muscles ( myalgia ), headache , sweating, exhaustion, general malaise and chills; 1 to 10 in 100 cases (“common”): bruise at the injection site, fever and nausea. Further, occasionally or rarely occurring side effects in adults, side effects in clinical studies in children and adolescents as well as further information can be found in the package insert available on the Internet.

Celvapan

Vaccination certificate with entry of the vaccination by Celvapan

Celvapan (manufacturer Baxter ) contains killed whole viruses (inactivated whole particle vaccine) without adjuvant. The viruses in Celvapan are grown in Vero cells - a cell line derived from green monkeys in 1962 . The process was developed because, given the H5N1 avian flu, it would be possible that chicken eggs would become scarce.

The German Federal Ministry of the Interior has ordered 200,000 cans of Celvapan.

The professional association of paediatricians published criticism of considerations to use Celvapan instead of Pandemrix for children and pregnant women, as no data were available.

In previous clinical studies with Celvapan (H5N1) in adults, including the elderly, the side effect of injection site pain was “very common” (more than 10 percent) and the only “common” side effect (1 to 10 percent): an ongoing one Nose and sore throat; Headache, dizziness, vertigo (motion sickness); excessive sweating, joint or muscle pain; Chills, tiredness (feeling tired), feeling unwell (feeling generally sick), fever; Hardened tissue, redness, swelling, or bruising at the injection site. Clinical studies (also on children) with the "Celvapan (H1N1)" against so-called "swine flu" confirm this expectation with regard to side effects. An updated list of side effects can be found in the package insert.

Celtura

Celtura (manufacturer: Novartis ) is a partial particle vaccine with adjuvant produced on the basis of cell cultures. Due to its production on a cell culture basis, this vaccine represents an alternative for those who are allergic to egg white and is approved in Germany and Switzerland. It contains 3.75 µg of antigen as an active ingredient and 0.125 ml of MF59 as an adjuvant per dose. It is offered in multiple ampoules and in pre-filled syringes with one dose each. Multiple containers contain thiomersal as a preservative .

Celtura is approved in Germany and Switzerland. In clinical studies with more than 1850 test persons, the tolerance and immunogenicity are proven. A single vaccination for 3- to 50-year-olds is sufficient for adequate protection against swine flu. The experience, which is limited according to the manufacturer, shows the following side effects frequently to very often: headache, sweating, joint and muscle pain, redness, swelling, hardening, bruising and pain at the injection site, fever, general feeling of illness, exhaustion and shivering. These reactions generally resolve within 1-2 days without treatment. No serious side effects have been observed in the clinical studies.

Panenza

Panenza (manufacturer: Sanofi Pasteur MSD ) is a partial particle vaccine made on the basis of chicken eggs and contains neither preservatives nor adjuvants. A split virus 15 µg / dose is used as the active ingredient. The vaccine has been approved for France.

In India, people who were directly involved in fighting the pandemic were vaccinated with this vaccine.

Panvax

Panvax (manufacturer: CSL Biotherapies ), also known under the name CSL H1N1 , is a partial particle vaccine produced on the basis of chicken eggs without adjuvants, which is available in multiple containers as well as in single doses. It contains the preservative thiomersal for distribution in multiple containers . A split virus 15 µg / dose is used as the active ingredient.

150,000 doses were ordered for Germany in order to vaccinate a third of pregnant women. The vaccine was available as pre-filled syringes (single doses) without thiomersal and formaldehyde in December 2009. The vaccination was only given to gynecologists.

MedImmune Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal

In the USA, a live vaccine from the manufacturer MedImmune that can be administered into the nose (intranasally) is available. With a special applicator , 0.1 ml of vaccine is applied to each nostril. The vaccine is intended for ages 2–9 years (two doses of vaccine about one month apart) and 10–49 years (one vaccine dose). The manufacturer's leaflet lists possible adverse effects of the vaccination that have been identified in clinical studies.

Vaccination readiness

While around 60 percent of the population in Sweden was vaccinated, willingness to vaccinate was low in Germany. Depending on the federal state, the average vaccination rate in the period from December 2009 to April 2010 for people over the age of 14 was between 3.8 percent in Bavaria and 14.4 percent in Saarland. A total of 16 percent of the medical staff were vaccinated.

Situation after the end of the pandemic

The pandemic was declared over in August 2010.

The vaccination program cost approximately € 1.3 billion in the UK and € 990 million in France. An average flu season costs € 87 million. Since the vaccination did not require two doses, as initially assumed, but only one and because of the low level of willingness to vaccinate, around 29 million vaccine doses remained unused in Germany. The health insurance companies only covered the costs for the doses that were actually inoculated, so the federal states suffered financial damage of 245 million euros. The vaccine expired at the end of 2011 and it could no longer be used. For this reason, the countries destroyed about 12.7 million vaccine doses on their own. Another 16 million cans that were stored centrally were burned.

At the beginning of 2010, Switzerland sold 750,000 cans of Celtura to Iran , and 150,000 more cans were given away free of charge. She also gave away around a tenth of her Pandemrix order to the WHO. 2.5 million vaccination doses had been used, 8.7 million vaccination doses worth 56 million Swiss francs had been destroyed by the end of 2011.

In the 2009/2010 season, 2,900 people died of an H1N1 infection in Europe, whereas an average of around 40,000 deaths is expected in a moderate flu season. It is believed that from April to December 2009 inclusive, H1N1 caused 123,000 to 203,000 deaths worldwide, of which 18,400 were found in laboratory tests.

No pandemic vaccines have been used since the end of the pandemic. Since 2010, the vaccination against seasonal flu also guarantees protection against A / California / 7/2009 (H1N1).

At the end of 2011, Transparency International demanded a comprehensive investigation of the processes surrounding the procurement of vaccines and the consequences of the pandemic warning for the federal, state and health insurance companies.

In Europe, vaccine procurement is to be better coordinated in the future. In addition, the possibility is to be created of assessing the pandemic threat independently of a WHO assessment. In the course of emergency regulations, freedom of travel could be restricted and the examination of travelers for symptoms of illness ordered.

Web links

Individual evidence

  1. ↑ New flu virus: Influenza A / H1N1. Federal Ministry of Health , Vienna, accessed on May 28, 2012 (at www.bmg.gv.at): "The new pandemic flu was caused by a previously unknown virus strain of subtype A / H1N1."
  2. ↑ K. Johansen, A. Nicoll, B. C. Ciancio, P. Kramarz: Pandemic influenza A (H1N1) 2009 vaccines in the European Union. In: Eurosurveillance , Volume 14, Issue 41. European Center for Disease Prevention and Control (ECDC), October 15, 2009, archived from the original ; accessed on November 10, 2009 (Date of submission: October 09, 2009).
  3. ↑ Chapter X Diseases of the Respiratory System (J00-J99): Influenza and Pneumonia (J09-J18). (No longer available online.) In: ICD-10-GM Version 2014. DIMDI German Institute for Medical Documentation and Information, archived from the original on May 9, 2015 ; Retrieved April 7, 2015 .
  4. ↑ Chapter XXII: Key numbers for special purposes (U00-U99): Other secondary key numbers for special purposes (U69-U69). (No longer available online.) In: ICD-10-GM Version 2014. DIMDI German Institute for Medical Documentation and Information, archived from the original on May 9, 2015 ; Retrieved April 7, 2015 .
  5. ↑ Chapter X Diseases of the Respiratory System (J00-J99): Influenza and Pneumonia (J09-J18). (No longer available online.) In: ICD-10-GM Version 2012. DIMDI German Institute for Medical Documentation and Information, archived from the original on May 31, 2012 ; Retrieved May 18, 2012 .
  6. ↑ Chapter XXII: Key numbers for special purposes (U00-U99): Other secondary key numbers for special purposes (U69-U69). (No longer available online.) In: ICD-10-GM Version 2012. DIMDI German Institute for Medical Documentation and Information, archived from the original on June 6, 2012 ; Retrieved May 18, 2012 .
  7. ^ Standardization of terminology of the pandemic A (H1N1) 2009 virus. (PDF) In: Weekly Epidemiological Record (WER), No. 43, 2011, 86, 469-480. World Health Organization (WHO), October 21, 2011, p. 480 , accessed on March 6, 2015 (English): “In order to minimize confusion and to differentiate the virus from the former seasonal A (H1N1) viruses circulating in humans before the influenza A (H1N1) 2009 pandemic, the advisers to the WHO technical consultation on the composition of influenza vaccines for the southern hemisphere 2012 season, after discussion on 26 September 2011, advise WHO to use the nomenclature below: A (H1N1) pdm09 "
  8. ↑ Michael Coston: WHO: Call It A (H1N1) pdm09. In: Avian Flu Diary. Michael P. Coston, October 21, 2011, accessed March 6, 2015 .
  9. ↑ a b c Medicines authorized during pandemic. EMA , accessed May 28, 2012 .
  10. ↑ Serum Cross-Reactive Antibody Response to a Novel Influenza A (H1N1) Virus after Vaccination with Seasonal Influenza Vaccine. In: Morbidity and Mortality Report Weekly. May 22, 2009
  11. ↑ a b Transcript of virtual press conference with Gregory Hartl, WHO Spokesperson for Global Alert and Response and Dr Marie-Paule Kieny, Director of the Initiative for Vaccine Research, World Health Organization 13 July 2009 . (PDF; 53 kB) WHO (English)
  12. ^ Message from the Standing Vaccination Commission (STIKO) at the Robert Koch Institute; Vaccination against the new influenza A (H1N1), reassessment of the data on November 24th, 2009 (PDF) RKI
  13. ↑ EMA: Vaccines: ( Memento of February 21, 2010 in the Internet Archive ) Three vaccines that have benefited from these procedures, and which will thus be available for use in the current H1N1 influenza pandemic, are: * Focetria, which was recommended on 24 September 2009 by the European Medicines Agency for an EU-wide marketing authorization. * Pandemrix, which was recommended on September 24, 2009 […]. * Celvapan, which was recommended on October 1, 2009 […]. (English)
  14. ↑ Arepanrix. EMA, accessed May 28, 2012 .
  15. ↑ Humenza. EMA, accessed May 28, 2012 .
  16. ↑ a b c European Medicines Agency: Authorization procedures ( Memento from January 13, 2010 in the Internet Archive ): These procedures, managed by the European Medicines Agency, allow an influenza vaccine to be authorized more quickly than the 18 to 24 months usually required for the authorization of a medicine in the EU.
  17. ↑ a b c d European Medicines Agency: Authorization procedures: The mock-up authorization procedure ( Memento of January 13, 2010 in the Internet Archive ): A mock-up vaccine is a type of flu vaccine that is developed well before a pandemic has started . Because the strain of flu virus that will cause a future pandemic is not known, pharmaceutical companies cannot start to prepare a vaccine containing the correct flu virus until a pandemic has started. To get around this problem, the mock-up procedure (also known as the 'core dossier' procedure) allows vaccine manufacturers to gain an authorization for a prototype pandemic vaccine in advance of a pandemic. This approach is unique to pandemic vaccines.
  18. ↑ a b Opinion of the drug commission of the German medical profession on vaccination against the new influenza A (H1N1) . (PDF; 169 kB) Drugs Commission of the German Medical Association (Technical Committee of the German Medical Association), September 10, 2009, p. 5 (10 p., “This statement is based on the state of knowledge from 09.09.2009.”, “70%” and “Cross immunity ")
  19. ^ European Medicines Agency: Authorization procedures: The mock-up authorization procedure ( Memento of January 13, 2010 in the Internet Archive ); In particular, the mock-up vaccine must show that it brings about an appropriate level of protection: according to criteria laid down by the Agency, at least 70% of the people in which the vaccine is studied must develop protective levels of antibodies for the vaccine to be approvable.
  20. ^ A b Erich Lederer: Influenza vaccination: dance around the adjuvant. In: doccheck.com. October 16, 2009, accessed May 30, 2012 .
  21. ^ A b "Glaxo wins US approval for swine flu vaccine" , Reuters, November 10, 2009
  22. ↑ FDA 2009 H1N1 (Swine) Flu Page. FDA, accessed May 30, 2012 .
  23. ↑ a b c Vaccination against swine flu: Everything under control (II): incorrect assessments, releases from liability and a lot of money. In: Arznei-Telegramm , September 25, 2009, arznei-telegramm.de ( Memento of November 22, 2009 in the Internet Archive ) (PDF; 24 kB)
  24. ↑ Frustration in the US: Currently not enough swine flu vaccine doses. In: Doctors newspaper , October 23, 2009 ( online )
  25. ^ Margaret A. Hamburg: Letter from the Commissioner to Nation's Healthcare Professionals on H1N1 Vaccine. FDA, November 10, 2009, accessed May 30, 2012 .
  26. ↑ a b c Statement from the Paul Ehrlich Institute on vaccines against pandemic H1N1 influenza (swine flu): Joint press briefing by the Paul Ehrlich Institute and the Robert Koch Institute on August 6, 2009 in Berlin. (No longer available online.) Paul Ehrlich Institute , archived from the original on March 5, 2010 ; Retrieved May 30, 2012 .
  27. ^ A b Eva Richter-Kuhlmann, Nicola Siegmund-Schultze: Pandemic Vaccines: "Security is guaranteed" . In: Deutsches Ärzteblatt , 2009; 106 (33): A-1610 ( online )
  28. ↑ FAQs from the Robert Koch Institute on vaccination against seasonal and pandemic influenza. RKI, archived from the original on August 30, 2009 ; Retrieved May 30, 2012 .
  29. ↑ Swine flu vaccines are tested to an appropriate standard. (No longer available online.) PEI, May 2009, archived from the original on December 28, 2009 ; accessed on June 8, 2019 .
  30. ↑ Questions and answers on vaccines against the 2009 pandemic (H1N1) virus (swine flu). PEI, archived from the original on March 17, 2010 ; Retrieved May 30, 2012 .
  31. ↑ kinderaerzte-im-netz.de
  32. ↑ Opinion on the risks that are discussed in connection with squalene: Squalene or squalene antibodies as the alleged trigger for the "Gulf war syndrome". (No longer available online.) Paul Ehrlich Institute, November 12, 2008, archived from the original on March 16, 2010 ; Retrieved May 30, 2012 .
  33. ↑ impfakademie.de ( Memento of the original from March 7, 2016 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. @1@ 2Template: Webachiv / IABot / www.impfakademie.de
  34. ↑ rme / aerzteblatt.de: Other vaccines against swine flu. In: aerzteblatt.de . October 8, 2009, accessed February 2, 2015 .
  35. ↑ a b package insert. (PDF; 382 kB) In: Summary of the product characteristics. EMA, pp. 37–45 , accessed on May 30, 2012 (last update: February 27, 2012).
  36. ↑ Philip Bethge, Andrea Brandt, Michael Fröhlingsdorf, Veronika Hackenbroch: Medicine: The plague of the young. In: Spiegel Online . November 9, 2009, accessed February 2, 2015 .
  37. ↑ Countries order 50 million vaccine doses to protect against swine flu. In: Doctors newspaper online. July 24, 2009, accessed May 30, 2012 .
  38. ↑ Swine flu vaccination: federal states save 133 million euros. In: Doctors newspaper online. January 12, 2010, accessed May 30, 2012 .
  39. ↑ Swine flu: Sweden is preparing mass vaccination. In: Doctors newspaper, 25 August 2009 ( online )
  40. ↑ Summary of Product Characteristics. (PDF) In: Pandemrix: Latest preliminary information (Status: October 27, 2015). European Medicines Agency, pp. 5-7 , accessed June 8, 2019 .
  41. ↑ Medical Products Agency - Sweden: Summary of adverse drug reaction reports in Sweden with Pandemrix ( online )
  42. ↑ First experiences with vaccination in Sweden (October 2009). (No longer available online.) PEI, archived from the original on March 5, 2010 ; Retrieved May 30, 2012 .
  43. ↑ a b Information on suspected case reports of side effects and vaccination complications after using the swine flu (H1N1) vaccine approved in Germany. (PDF) (No longer available online.) PEI, January 19, 2010, archived from the original on June 8, 2019 ; accessed on June 8, 2019 . Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. @1@ 2Template: Webachiv / IABot / www.pei.de
  44. ↑ European Medicines Agency advises of risk of fever in young children following vaccination with Pandemrix ( Memento of May 25, 2010 in the Internet Archive ) on ema.europa.eu (PDF) EMEA Press release, London, December 4, 2009
  45. ↑ rme / aerzteblatt.de: H1N1 vaccination in children: fever after the second Pandemrix dose. In: aerzteblatt.de . December 4, 2009, accessed February 2, 2015 .
  46. ↑ What is the truth about narcolepsy from H1N1 vaccination? In: Doctors newspaper online. February 2, 2011, accessed May 30, 2012 .
  47. ↑ Sven Stockrahm: Swine flu vaccine could increase the risk of narcolepsy . In: time online . February 2, 2011.
  48. ↑ Nina Weber: Swine flu vaccine apparently promotes sleep disorders . March 29, 2012: "People with a certain gene variant get sick more often - and this is very common in Northern Europe."
  49. ↑ Finland: Narcolepsy due to Pandemrix "likely". In: Ärzteblatt. February 1, 2011, accessed on May 30, 2012 (working group describes a connection between Pandemrix and narcolepsy cases as probable, but also suspects previously unknown co-factors).
  50. ↑ a b Narcolepsy after swine flu vaccination. In: Doctors newspaper online. May 1, 2012, accessed May 30, 2012 .
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