Mass vaccination of the population in connection with outbreaks related to virus epidemics has been carried out twice before. In 1976, over 45 million Americans – almost 25% of the population – received the swine flu vaccine against H1N1. When 25 deaths were reported to be associated with the vaccine the campaign was aborted. 362 cases of Guillain-Barré Syndrome (GBS) were reported to the American Institute of Public Health’s Center for Disease Control (CDC) (1). Neurological complications such as Guillain-Barré Syndrome (GBS) and Tranverse Myelitis (TM) are the most serious side effects of vaccination. GBS is caused by acute inflammatory demyelinating polyneuropathy with destruction of Schwann cells. Transverse myelitis (TM) is a similar process with segmental changes in the medulla. GBS was reported to have a 8.8- fold increase of the normal occurrence after the 1976 vaccination campaign – translating to more than 500 people that developed vaccine induced GBS.
It was estimated that in all some 55 deaths were associated the H1N1 vaccine. The federal government paid millions in compensation. The infleunza outbreak , which was thought to affect 50 to 60 million Americans, never developed as a dangerous epidemic. About 200 deaths were linked to swine flu according to the CDC (2).
In connection with the so-called H1N1 “swine flu pandemic ” in 2009, mass vaccination was initiated both in the USA and in Europe. Half of the Nordic population received a dose of the monovalent H1N1 flu vaccine Pandemrix, which was the vaccine used in most EU countries. The vaccine was offered to the entire population, but it was mainly health workers and school children through a school vaccination program where 80% of those under 18 were vaccinated. Two doses were purchased for the entire population but only one dose was given to approximately half the population (3,4.5).
In connection with this vaccination campaign, an increased incidence of narcolepsy was registered which was linked to this special vaccine. This risk was originally found in Finland (6), and then discovered in other European countries also in Norway (7). Narcolepsy is a chronic disorder of the central nervous system caused by the brain’s inability to regulate sleep-wake cycles and characterized by excessive daytime sleepiness (EDS) and abnormal manifestations of rapid eye movement (REM) sleep. An epidemiological study from Finland reported a 13-fold increased risk in children and adolescents aged 4-19 years.
Side effects of influenza vaccines are known to be underreported in clinical trials (8) and the VAERS reporting system [9,10]. In the 2009 HIN1 “Swine Flu” outbreak, there was a link between ASO3 adjuvanted A / H1N1 2009 pandemic vaccine (Pandemrix) and narcolepsy was identified in Scandinavian countries after an increasing association with the Pandremix vaccine and Narcolepsy was reported.
Pandemrix was produced by GlaxoSmithKline and was specially produced for the 2009 H1N1 flu pandemic. It was not used until 2009, and has not been used since. The development of narcolepsy was linked to a special adjuvant in the vaccine called ASO3. Adjuvants are so-called “excipients” added to vaccines to increase the body’s immune response beyond the response to the antigen.
2009-2010 H1N1 The flu outbreak was described as the first flu pandemic in 40 years but did not behave as expected. Estimates of the infected population were reduced in the UK from 30% to 10% – roughly the same as for seasonal flu – after it was found that people older than 50 had some immunity. Although the virus itself was new, the surface antigens had some similarities to those of the H1N1 virus that circulated up to the 1960s.
Epidemiologist and Pulmonologist Wolfgang Wodarg, then chair of the Council of Europe’s Health Committee, criticized the WHO and the pharmaceutical industry, claiming that the pandemic had been declared false (11)
On March 6, 2012, Charlotte Haug, then editor-in-chief of the Journal of the Norwegian Medical Association (Tidskriftet), writes an article with the following title: What did they know, and when did they know it? (12).
At least 35 children have been diagnosed with narcolepsy after receiving the swine flu vaccine in the autumn of 2009. What was the basis for recommending mass vaccination of the entire Norwegian population?
She asks the following questions: (i) What did the health authorities really know about how dangerous the new flu was, (i) how effective the vaccine was and (iii) what was the risk of side effects when the decision to vaccinate was made in October 2009? The National Institute of Public Health had then made available 51 status reports and 50 other reports on the pandemic which they sent to the Norwegian Directorate of Health and the Ministry of Health in the period 26.4. 2009 – 7.1. 2010.
As she writes …
“We have now gained better insight into this because the National Institute of Public Health has made available 51 status reports and 50 other reports on the pandemic that they sent to the Norwegian Directorate of Health and the Ministry of Health in the period 26.4. 2009 – 7.1. 2010. From these reports we can follow the development of knowledge about the pandemic from the time it originated in Mexico in April 2009 until tit was over in Norway in January 2010. Were we was faced with a potentially serious illness when the decision was made to unertake mass vaccination ?”
So what did the health authorities know, and when did they know?
“From 23.10. 2009 made the decision to recommend mass vaccination of the entire Norwegian population, they knew that we were facing a mild flu that was harmless to most people. The vaccine had not been clinically tested and the WHO’s own vaccine safety committee had expressed concern.”
It was further revealed that the WHO’s Global Advisory Committee on Vaccine Safety (GACVS) »discussed both the risk associated with Guillain-Barré syndrome and the importance of setting up active monitoring systems and clinical trials that could detect rare, serious side effects and possibly the mechanism. behind them. There was also considerable concern about what adjuvants in the flu vaccine would mean, and the committee emphasized that there were very limited data on safety, not least in children and pregnant women. The entire minutes of the meeting could be read on the WHO’s website.
20 years of critical analysis of the effectiveness and safety of influenza vaccines
In 2000, a separate thematic group was established in the Cochrane Collaboration to work with a critical source and meta-analysis of publications related to the prevention and treatment of influenza disease.
In 2009, when the second mass vaccination campaign against Influenza was launched, three comprehensive analyzes of evidence for the efficacy and safety of influenza vaccines in healthy adults, children and the elderly were carried out [13,14,15]. The conclusion of this work, which at the time had gathered nine years of work with evidence, was the following:
“The current annual registration of candidate flu vaccines is based on their ability to elicit a good antibody response. However, antibody responses are poor predictors of protection against influenza viruses. This is another example of the use of surrogate markers in biomedicine, where effects on clinically important outcomes remain unmeasured or untested from randomized trials: as clinical endpoints such as complications and death from influenza. For the flu, the underlying problem is that we do not understand what the goal is. What is the real threat, and what can we ever expect from the vaccines?
For conventional vaccine development, a massive worldwide machinery is needed to produce new vaccines every year to combat viral antigenic changes, and to address the rapidly transient antibody response. The vaccination selection and production programs are based on etiological assumptions that are neither explanatory nor predictive, as shown in the Cochrane reviews ».
Overall, the data sets that have so far been collected from studies conducted in the population have not been designed to be able to say anything about clinical benefit. The studies that show a serological response are not reflected in a real clinical effect. After years of critical review, it can not be seen that this will change with the inclusion of new studies, so much so as the security of data from the presentation of evidence (16).
- Nelson, K. E. Influenza Vaccine and Guillain-Barre Syndrome–Is There a Risk?”. American Journal of Epidemiology. 175 (11): 1129–1132.
- Richard Krause , The Swine Flu Episode and the Fog of Epidemics Emerg Infect Dis. 2006 Jan; 12(1): 40–43.
- Elling Ulvestad, Lars Slørdal. Jubileum til ettertanke. Utgave 9, 28. mai 2019 Tidsskr Nor Legeforen 2019. Publisert: 28. januar 2010. Tidsskr Nor Legeforen 2010;
- Preben Aavitsland. Jakten på det utenomjordiske Tidsskr Nor Legeforen Publisert:. 23.10.2014
- Elling Ulvestad, Elisabeth Swensen, Gunnar Skov Simonsen, Edvin Schei. Pandemien – bidrag til etterpåklokskap.
- Sarkanen T, Alakuijala A , Ilkka Julkunen I, Partinen M- Narcolepsy Associated with Pandemrix Vaccine. Curr Neurol Neurosci Rep 2018 Jun 1;18(7):43.
- Trogstad L, Bakken IJ, Gunnes N, Ghaderi S, Stoltenberg C, Magnus P, Håberg SE. Narcolepsy and hypersomnia in Norwegian children and young adults following the influenza A(H1N1)2009 pandemic. Vaccine (2017),
- Tom T Shimabukuro , Michael Nguyen , David Martin , Frank DeStefano Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS)Vaccine. 2015 Aug 26; 33(36): 4398–4405. Published online 2015 Jul 22. doi: 10.1016/j.vaccine.2015.07.035
- Frederick Varricchio F 1 , John Iskander, Frank Destefano, Robert Ball, Robert Pless, M Miles Braun, Robert T Chen. Understanding Vaccine Safety Information From the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J , 23 (4), 287-94 Apr 2004
- Surveillance for Safety After Immunization: Vaccine Adverse Events Reporting System (VAERS) United States. Morbidity and Mortality Weekly Report (MMWR). US Centres for Disease Control
- Jeremy Laurance. The swine flu backlash. Lancet, Volume 375, Issue 9712, Page 367, January 30, 2010.
- Charlotte Haug. Hva visste de og når visste de det. Tidsskr Nor Legeforen 2012;132: 50
- Jefferson T, Rivetti A, Di Pietrantonj C, Demicheli V. Vaccines for preventing influenza in healthy children. Cochrane Database of Systematic Reviews 2018, Issue 2. Art. No.: CD004879. DOI: 10.1002/14651858.CD004879.pub5.
- Demicheli V, Jefferson T, Ferroni E, Rivetti A, Di Pietrantonj C. Vaccines for preventing influenza in healthy adults. Cochrane Database of Systematic Reviews 2018, Issue 2. Art. No.: CD001269. DOI: 10.1002/14651858.CD001269.pub6.
- Demicheli V, Jefferson T, Di Pietrantonj C, Ferroni E, Thorning S, Thomas RE, Rivetti A. Vaccines for preventing influenza in the elderly. Cochrane Database of Systematic Reviews 2018, Issue 2. Art. No.: CD004876. DOI: 10.1002/14651858.CD004876.pub4.
- Influenza vaccination: policy versus evidence. Tom Jefferson, coordinator1 BMJ. 2006 Oct 28; 333(7574): 912–915.