2009 swine flu pandemic vaccine

Protection against the H1N1/09 virus August 2026 vanc 6 The 2009 swine flu pandemic vaccines were influenza vaccines developed to protect against the pandemic H1N1/09 virus. These vaccines either contained inactivated (killed) influenza virus, or weakened live virus that could not cause influenza. The killed virus was injected, while the live virus was given as a nasal spray. Both these types of vaccine were produced by growing the virus in chicken eggs. Around three billion doses were produced, with delivery in November 2009.https://www.google.com/hostednews/afp/article/ALeqM5i3dF4UiVwrFyMFiCvWCF_-cX9i2Q Agence France-Presse WHO cuts swine flu vaccine production estimate 24 September 2009 25 November 2009 6 February 2010 https://web.archive.org/web/20100206024858/http://www.google.com/hostednews/afp/article/ALeqM5i3dF4UiVwrFyMFiCvWCF_-cX9i2Q dead https://www.who.int/entity/mediacentre/pandemic_h1n1_presstranscript_2009_09_24.pdf Transcript of virtual press conference with Gregory Hartl, Spokesperson for H1N1, and Dr Marie-Paule Kieny, WHO Director of the Initiative for Vaccine Research, World Health Organization 24 September 2009 World Health Organization 13 August 2010 https://web.archive.org/web/20100828000117/http://www.who.int/entity/mediacentre/pandemic_h1n1_presstranscript_2009_09_24.pdf 28 August 2010 liveJune 2017 In studies, the vaccines appeared both effective and safe, Wu J, Xu F, Lu L, Lu M, Miao L, Gao T, Ji W, Suo L, Liu D, Ma R, Yu R, Zhangzhu J, Liu W, Zeng Y, Li X, Zhang X, Pang X, Deng Y Safety and effectiveness of a 2009 H1N1 vaccine in Beijing The New England Journal of Medicine 363 25 2416–2423 December 2010 21158658 10.1056/NEJMoa1006736 205092379 free Safety of influenza A (H1N1) 2009 monovalent vaccines - United States, October 1-November 24, 2009 MMWR. Morbidity and Mortality Weekly Report 58 48 1351–1356 December 2009 20010511 https://www.cdc.gov/mmwr/pdf/wk/mm5848.pdf 8 September 2017 live https://web.archive.org/web/20170625012522/https://www.cdc.gov/mmwr/PDF/wk/mm5848.pdf 25 June 2017 Centers for Disease Control and Prevention (CDC) Van der Vliet D, Pepin S, Lambert M, Fauchoux N, Donazzolo Y, Dupuy M, Dakowski C, Denis M Similar immunogenicity of the A/H1N1 2009 pandemic influenza strain when used as a monovalent or a trivalent vaccine Human Vaccines 6 10 823–828 October 2010 20935517 10.4161/hv.6.10.13600 20297275 free Simpson CR, Ritchie LD, Robertson C, Sheikh A, McMenamin J Effectiveness of H1N1 vaccine for the prevention of pandemic influenza in Scotland, UK: a retrospective observational cohort study The Lancet. Infectious Diseases 12 9 696–702 September 2012 22738894 10.1016/S1473-3099(12)70133-0 19702558 Valenciano M, Kissling E, Cohen JM, Oroszi B, Barret AS, Rizzo C, Nunes B, Pitigoi D, Larrauri Cámara A, Mosnier A, Horvath JK, O'Donnell J, Bella A, Guiomar R, Lupulescu E, Savulescu C, Ciancio BC, Kramarz P, Moren A Estimates of pandemic influenza vaccine effectiveness in Europe, 2009-2010: results of Influenza Monitoring Vaccine Effectiveness in Europe (I-MOVE) multicentre case-control study PLOS Medicine 8 1 e1000388 January 2011 21379316 3019108 10.1371/journal.pmed.1000388 Simonsen L free http://www.nih.gov/news/health/dec2010/niaid-13.htm 2009 H1N1 vaccine safe and induces robust immune response in people with asthma National Institutes of Health (NIH) 13 December 2010 29 January 2011 https://web.archive.org/web/20110104050001/http://www.nih.gov/news/health/dec2010/niaid-13.htm 4 January 2011 dead Busse WW, Peters SP, Fenton MJ, Mitchell H, Bleecker ER, Castro M, Wenzel S, Erzurum SC, Fitzpatrick AM, Teague WG, Jarjour N, Moore WC, Sumino K, Simeone S, Ratanamaneechat S, Penugonda M, Gaston B, Ross TM, Sigelman S, Schiepan JR, Zaccaro DJ, Crevar CJ, Carter DM, Togias A Vaccination of patients with mild and severe asthma with a 2009 pandemic H1N1 influenza virus vaccine The Journal of Allergy and Clinical Immunology 127 1 130–137, 137.137–3 January 2011 21145578 3017653 10.1016/j.jaci.2010.11.014 Liang XF, Li L, Liu DW, Li KL, Wu WD, Zhu BP, Wang HQ, Luo HM, Cao LS, Zheng JS, Yin DP, Cao L, Wu BB, Bao HH, Xu DS, Yang WZ, Wang Y Safety of influenza A (H1N1) vaccine in postmarketing surveillance in China The New England Journal of Medicine 364 7 638–647 February 2011 21288090 10.1056/NEJMoa1008553 23923166 free providing a strong protective immune response and having a similar safety profile to the usual seasonal influenza vaccine. Review Shows Safety of H1N1 Vaccine, Officials Say https://www.nytimes.com/2009/12/05/health/05flu.html Grady D The New York Times 5 December 2009 No substantial differences between H1N1 and seasonal influenza vaccines were noted in the proportion or types of serious adverse events reported. 23 December 2010 6 September 2015 https://web.archive.org/web/20150906041704/http://www.nytimes.com/2009/12/05/health/05flu.html live Vajo Z, Tamas F, Sinka L, Jankovics I Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with the seasonal influenza vaccine for the 2009-10 influenza season: a multicentre, randomised controlled trial. Lancet 375 9708 49–55 Jan 2010 20018367 10.1016/S0140-6736(09)62039-0 free However, about 30% of people already had some immunity to the virus, with the vaccine conferring greatest benefit on young people, since many older people are already immune through exposure to similar viruses in the past. The vaccine also provided some cross-protection against the 1918 flu pandemic strain.Swine flu shot protects against 1918 flu: study https://www.reuters.com/article/idUSTRE65E65S20100616 Reuters 16 June 2010 Fox M 17 June 2010 https://web.archive.org/web/20100618085652/https://www.reuters.com/article/idUSTRE65E65S20100616 18 June 2010 live Early results (pre-25 December 2009) from an observational cohort of 248,000 individuals in Scotland showed the vaccine to be effective at preventing H1N1 influenza (95.0% effectiveness [95% confidence intervals 76.0–100.0%]) and influenza-related hospital admissions (64.7% [95% confidence intervals 12.0–85.8%]). Simpson CR, Ritchie LD, Robertson C, Sheikh A, McMenamin J Vaccine effectiveness in pandemic influenza - primary care reporting (VIPER): an observational study to assess the effectiveness of the pandemic influenza A (H1N1)v vaccine Health Technology Assessment 14 34 313–346 July 2010 20630126 10.3310/hta14340-05 free Developing, testing, and manufacturing sufficient quantities of a vaccine is a process that takes many months. According to Keiji Fukuda of the World Health Organization, "There's much greater vaccine capacity than there was a few years ago, but there is not enough vaccine capacity to instantly make vaccines for the entire world's population for influenza."http://www.financialexpress.com/printer/news/455987/ Preparing for the worst The Financial Express 8 May 2009 6 December 2009 27 March 2020 https://web.archive.org/web/20200327014231/http://www.financialexpress.com/printer/news/455987/ live The nasal mist version of the vaccine started shipping on 1 October 2009.First round of swine flu vaccine shipped to Texas, other states http://www.dallasnews.com/sharedcontent/dws/dn/latestnews/stories/100109dnmetswinevaccine.1d4b92c27.html The Dallas Morning News https://web.archive.org/web/20091004161629/http://www.dallasnews.com/sharedcontent/dws/dn/latestnews/stories/100109dnmetswinevaccine.1d4b92c27.html 4 October 2009 live 1 October 2009 1 October 2009June 2017 Types Two types of influenza vaccines were available: TIV (flu shot (injection) of trivalent (three strains; usually A/H1N1, A/H3N2, and B) inactivated (killed) vaccine) or LAIV (nasal spray (mist) of live attenuated influenza vaccine.) TIV works by putting into the bloodstream those parts of three strains of flu virus that the body uses to create antibodies; while LAIV works by inoculating the body with those same three strains, but in a modified form that cannot cause illness. LAIV is not recommended for individuals under age 2 or over age 49,Summary of Recommendations for Adult Immunization http://www.immunize.org/catg.d/p2011.pdf Immunization Action Coalition September 2009 6 December 2009 26 June 2010 https://web.archive.org/web/20100626054148/http://www.immunize.org/catg.d/p2011.pdf live but might be comparatively more effective among children over age two.The Nasal-Spray Flu Vaccine (Live Attenuated Influenza Vaccine [LAIV]) https://www.cdc.gov/flu/about/qa/nasalspray.htm Centers for Disease Control and Prevention (CDC) 20 October 2009 6 December 2009 https://web.archive.org/web/20091126010356/http://cdc.gov/flu/about/qa/nasalspray.htm 26 November 2009 dead Manufacturing methods For the inactivated vaccines, the virus is grown by injecting it, along with some antibiotics, into fertilized chicken eggs. About one to two eggs are needed to make each dose of vaccine. http://www.gsk.com/press_archive/press2005/flu_backgrounder.pdf Egg-based vs. cell-based influenza vaccine production GlaxoSmithKline 2005 https://web.archive.org/web/20081206034009/http://www.gsk.com/press_archive/press2005/flu_backgrounder.pdf 6 December 2008 The virus replicates within the allantois of the embryo, which is the equivalent of the placenta in mammals. The fluid in this structure is removed and the virus purified from this fluid by methods such as filtration or centrifugation. The purified viruses are then inactivated ("killed") with a small amount of a disinfectant. The inactivated virus is treated with detergent to break up the virus into particles, and the broken capsule segments and released proteins are concentrated by centrifugation. The final preparation is suspended in sterile phosphate buffered saline ready for injection. https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181950.htm Influenza A (H1N1) 2009 Monovalent https://web.archive.org/web/20190423144049/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181950.htm 23 April 2019 U.S. Food and Drug Administration (FDA) This vaccine mainly contains the killed virus but might also contain tiny amounts of egg protein and the antibiotics, disinfectant and detergent used in the manufacturing process. In multi-dose versions of the vaccine, the preservative thimerosal is added to prevent growth of bacteria. In some versions of the vaccine used in Europe and Canada, such as Arepanrix and Fluad, an adjuvant is also added, this contains squalene, vitamin E and an emulsifier called polysorbate 80. http://www.wrha.mb.ca/professionals/influenza/files/orientation/Orientation_4-A.pdf Pandemic H1N1 (pH1N1) Influenza Vaccine Quick Reference Guide Winnipeg Regional Health Authority 2009 https://web.archive.org/web/20101011082256/http://www.wrha.mb.ca/professionals/influenza/files/orientation/Orientation_4-A.pdf 11 October 2010 To make the live vaccine, the virus is first adapted to grow at 25 °C °F and then grown at this temperature until it loses the ability to cause illness in humans, which requires the virus to grow at normal human body temperature of 37 °C °F. Multiple mutations are needed for the virus to grow at cold temperatures, so this process is effectively irreversible and once the virus has lost virulence (become "attenuated"), it will not regain the ability to infect people. Murphy BR, Coelingh K Principles underlying the development and use of live attenuated cold-adapted influenza A and B virus vaccines Viral Immunology 15 2 295–323 2002 12081014 10.1089/08828240260066242 https://zenodo.org/record/1235209 16 October 2019 live https://web.archive.org/web/20201122082210/https://zenodo.org/record/1235209 22 November 2020 The attenuated virus is then grown in chicken eggs as before. The virus-containing fluid is harvested and the virus purified by filtration; this step also removes any contaminating bacteria. The filtered preparation is then diluted into a solution that stabilizes the virus. This solution contains monosodium glutamate, potassium phosphate, gelatin, the antibiotic gentamicin, and sugar. https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181970.htm Influenza A (H1N1) 2009 Monovalent Vaccine (MedImmune LLC)] https://web.archive.org/web/20190423064704/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181970.htm 23 April 2019 U.S. Food and Drug Administration (FDA) A different method of producing influenza virus was used to produce the Novartis vaccine Optaflu. In this vaccine the virus is grown in cell culture instead of in eggs. https://www.ema.europa.eu/en/documents/overview/optaflu-epar-summary-public_en.pdf Optaflu Vaccine European Medicines Agency October 2015 This method is faster than the classic egg-based system and produces a purer final product. There are no traces of egg proteins in the final product, so it is safe for people with egg allergies. http://www.novartisvaccines.com/downloads/diseases-products/flu-cell-culture-fact-sheet.pdf Flu Cell Culture Manufacturing and the Novartis Proprietary Cell Line https://web.archive.org/web/20091122181447/http://www.novartisvaccines.com/downloads/diseases-products/flu-cell-culture-fact-sheet.pdf 22 November 2009 Novartis June 2009 Doroshenko A, Halperin SA Trivalent MDCK cell culture-derived influenza vaccine Optaflu (Novartis Vaccines) Expert Review of Vaccines 8 6 679–688 June 2009 19485748 10.1586/erv.09.31 207223652 Previous seasonal vaccine production Prior to the H1N1/09 outbreak, WHO recommended that vaccines for the Northern Hemisphere's 2009–2010 flu season contain an A(H1N1)-like virus, and stocks were made available.https://www.who.int/csr/disease/influenza/vaccine_north2009_10/en/index1.html 12 February 2009: Information meeting (Morning) World Health Organization dead https://web.archive.org/web/20090607164742/http://www.who.int/csr/disease/influenza/vaccine_north2009_10/en/index1.html 7 June 2009 https://www.who.int/csr/disease/influenza/recommendations2009_10north/en/index.html WHO: Recommended composition of influenza virus vaccines for use in the 2009–2010 northern hemisphere influenza season World Health Organization dead https://web.archive.org/web/20090612022524/http://www.who.int/csr/disease/influenza/recommendations2009_10north/en/index.html 12 June 2009 https://www.who.int/csr/disease/influenza/200902_recommendation.pdf World Health Organization (WHO) Recommended composition of influenza virus vaccines for use in the 2009–2010 influenza season https://web.archive.org/web/20090607164118/http://www.who.int/csr/disease/influenza/200902_recommendation.pdf 7 June 2009 However, the strain of H1N1 in the seasonal flu vaccine was different from the pandemic strain H1N1/09 and offered no immunity against it. Effectiveness of 2008-09 trivalent influenza vaccine against 2009 pandemic influenza A (H1N1) - United States, May-June 2009 MMWR. Morbidity and Mortality Weekly Report 58 44 1241–1245 November 2009 19910912 https://www.cdc.gov/mmwr/pdf/wk/mm5844.pdf 13 February 2011 live https://web.archive.org/web/20110205235203/http://www.cdc.gov/mmwr/PDF/wk/mm5844.pdf 5 February 2011 Centers for Disease Control and Prevention (CDC) The US Centers for Disease Control and Prevention (CDC) characterized over 80 new H1N1 viruses that may be used in a vaccine. https://www.cdc.gov/flu/weekly/weeklyarchives2008-2009/weekly21.htm 2008–2009 Influenza Season Week 21 ending 30 May 2009 https://web.archive.org/web/20170618222946/https://www.cdc.gov/flu/weekly/weeklyarchives2008-2009/weekly21.htm 18 June 2017 Centers for Disease Control and Prevention 30 May 2009 Production questions and decisions Questions There was concern in mid-2009 that, should a second, deadlier wave of this new H1N1 strain appear during the northern autumn of 2009, producing pandemic vaccines ahead of time could turn out to be a serious waste of resources as the vaccine might not be effective against it, and there would also be a shortage of seasonal flu vaccine available if production facilities were switched to the new vaccine. Seasonal flu vaccine was being made as of May 2009. Although vaccine makers would be ready to switch to making a swine flu vaccine, many questions remained unanswered, including: "Should we really make a swine flu vaccine? Should we base a vaccine on the current virus, since flu viruses change rapidly? Vaccine against the current virus might be far less effective against a changed virus – should we wait to see if the virus changes? If vaccine production doesn't start soon, swine flu vaccine won't be ready when it's needed."http://www.webmd.com/cold-and-flu/news/20090526/cdc-preparing-for-swine-flu-surge-in-fall CDC prepares for swine flu surge in fall WebMD 26 May 2009 DeNoon DJ Here are the questions that must be answered: • Should we really make a swine flu vaccine? • Should we base a vaccine on the current virus? Flu viruses change rapidly. Vaccine against the current virus might be far less effective against a changed virus. • Should we wait to see if the virus changes? If vaccine production doesn't start soon, swine flu vaccine won't be ready when it's needed. 25 November 2009 https://web.archive.org/web/20091127231542/http://www.webmd.com/cold-and-flu/news/20090526/cdc-preparing-for-swine-flu-surge-in-fall 27 November 2009 live The costs of producing a vaccine also became an issue, with some U.S. lawmakers questioning whether a new vaccine was worth the unknown benefits. Representatives Phil Gingrey and Paul Broun, for instance, were not convinced that the U.S. should spend up to US$2 billion to produce one, with Gingrey stating "We can't let all of our spending and our reaction be media-driven in responding to a panic so that we don't get Katrina-ed. ... It's important because what we are talking about as we discuss the appropriateness of spending $2 billion to produce a vaccine that may never be used – that is a very important decision that our country has to make."https://www.politico.com/story/2009/05/gop-docs-question-virus-vaccine-022205 Republican doctors question virus vaccine Politico 7 May 2009 We can't let all of our spending and our reaction be media-driven in responding to a panic so that we don't get Katrina-ed. ... It's important because what we are talking about as we discuss the appropriateness of spending $2 billion to produce a vaccine that may never be used – that is a very important decision that our country has to make. 25 November 2009 7 July 2009 https://web.archive.org/web/20090707165616/http://www.politico.com/news/stories/0509/22205.html live In fact, a Fairleigh Dickinson University PublicMind poll found in October 2009 that a majority (62%) of New Jerseyans were not planning on getting the vaccine at all. http://publicmind.fdu.edu/h1n1/release.pdf New Jerseyans Not Worried About H1N1 8 October 2009 Fairleigh Dickinson University PublicMind Poll 15 December 2010 12 March 2012 https://web.archive.org/web/20120312170728/http://publicmind.fdu.edu/h1n1/release.pdf live Before the pandemic was declared, the WHO said that if a pandemic was declared it would attempt to make sure that a substantial amount of vaccine was available for the benefit of developing countries. Vaccine makers and countries with standing orders, such as the U.S. and a number of European countries, would be asked, according to WHO officials, "to share with developing countries from the moment the first batches are ready if an H1N1 vaccine is made" for a pandemic strain.https://www.google.com/hostednews/canadianpress/article/ALeqM5iDCW8up896awdNRubgB9LXBs0WcQ Developing countries should share first batches of swine flu vaccine: WHO The Canadian Press 6 May 2009 25 November 2009 June 2024 medic yesmedic The global body stated that it wanted companies to donate at least 10% of their production or offer reduced prices for poor countries that could otherwise be left without vaccines if there is a sudden surge in demand.https://www.google.com/hostednews/ap/article/ALeqM5gzz357patY4-QaJFvo9O95zMM_EQD989H17O1 https://web.archive.org/web/20090607164227/http://www.google.com/hostednews/ap/article/ALeqM5gzz357patY4-QaJFvo9O95zMM_EQD989H17O1 dead 7 June 2009 WHO seeks swine flu vaccine help for poor nations Associated Press Geneva 19 May 2009 25 November 2009 Production timelines After a meeting with the WHO on 14 May 2009, pharmaceutical companies said they were ready to begin making a swine flu vaccine. According to news reports, the WHO's experts would present recommendations to WHO Director-General Margaret Chan, who was expected to issue advice to vaccine manufacturers and the Sixty-second World Health Assembly.https://www.who.int/mediacentre/events/2009/wha62/en/index.html https://web.archive.org/web/20090502184758/http://www.who.int/mediacentre/events/2009/wha62/en/index.html dead 2 May 2009 WHO – Sixty-second World Health Assemblyhttps://www.who.int/mediacentre/news/releases/2009/vaccine_manufacturers_meeting_20090519/en/index.html UN, WHO heads meet vaccine manufacturers World Health Organization 19 May 2009 1 November 2009 https://web.archive.org/web/20091110033701/http://www.who.int/mediacentre/news/releases/2009/vaccine_manufacturers_meeting_20090519/en/index.html 10 November 2009 deadhttp://www.thejakartapost.com/news/2009/05/14/who-meets-production-swine-flu-vaccine.html WHO meets on production of swine flu vaccine Associated Press 14 May 2009 6 December 2009 dead https://web.archive.org/web/20090817181256/http://www.thejakartapost.com/news/2009/05/14/who-meets-production-swine-flu-vaccine.html 17 August 2009 WHO's Keiji Fukuda told reporters "These are enormously complicated questions, and they are not something that anyone can make in a single meeting." Most flu vaccine companies can not make both seasonal flu vaccine and pandemic flu vaccine at the same time. Production takes months and it is impossible to switch halfway through if health officials make a mistake. If the swine flu mutates, scientists aren't sure how effective a vaccine made now from the current strain will remain. Rather than wait on the WHO decision, however, some countries in Europe have decided to go ahead with early vaccine orders.https://www.bloomberg.com/apps/news?pid=20601102&sid=a_2jDXJCigho&refer=uk Bloomberg News 15 May 2009 Glaxo to make flu vaccine, gets U.K., France orders (update2) 25 November 2009 7 June 2009 https://web.archive.org/web/20090607164315/http://www.bloomberg.com/apps/news?pid=20601102&sid=a_2jDXJCigho&refer=uk live On 20 May 2009, AP reported: "Manufacturers won't be able to start making the [swine flu] vaccine until mid-July at the earliest, weeks later than previous predictions, according to an expert panel convened by WHO. It will then take months to produce the vaccine in large quantities. The swine flu virus is not growing very fast in laboratories, making it difficult for scientists to get the key ingredient they need for a vaccine, the 'seed stock' from the virus [...] In any case, mass producing a pandemic vaccine would be a gamble, as it would take away manufacturing capacity for the seasonal flu vaccine for the flu that kills up to 500,000 people each year. Some experts have wondered whether the world really needs a vaccine for an illness that so far appears mild."https://www.usatoday.com/news/health/2009-05-19-who-swine-flu_N.htm WHO seeks swine flu vaccine help for poor nations USA Today Associated Press 20 May 2009 13 February 2011 28 June 2011 https://web.archive.org/web/20110628190905/http://www.usatoday.com/news/health/2009-05-19-who-swine-flu_N.htm live Another option proposed by the CDC was an "earlier rollout of seasonal vaccine," according to the CDC's Daniel Jernigan. He said the CDC would work with vaccine manufacturers and experts to see if that would be possible and desirable. Flu vaccination usually starts in September in the United States and peaks in November. Some vaccine experts agree it would be better to launch a second round of vaccinations against the new H1N1 strain instead of trying to add it to the seasonal flu vaccine or replacing one of its three components with the new H1N1 virus.https://www.reuters.com/article/idUSN20521380 U.S. officials consider bumping up flu shot season Reuters 20 May 2009 Fox M 13 February 2011 https://web.archive.org/web/20110203004640/https://www.reuters.com/article/2009/05/20/idUSN20521380 3 February 2011 live The Australian company CSL said that they were developing a vaccine for the swine flu and predicted that a suitable vaccine would be ready by August.CSL gets US government order for H1N1 antigen http://www.theaustralian.news.com.au/business/story/0,28124,25555144-5017996,00.html 29 May 2009 The Australian Dow Jones Newswires Harrison A 25 November 2009 https://web.archive.org/web/20090607164216/http://www.theaustralian.news.com.au/business/story/0,28124,25555144-5017996,00.html 7 June 2009 dead However, John Sterling, Editor in Chief of Genetic Engineering & Biotechnology News, said on 2 June, "It can take five or six months to come up with an entirely novel influenza vaccine. There is a great deal of hope that biotech and pharma companies might be able to have something ready sooner."https://www.sciencedaily.com/releases/2009/06/090602161944.htm Efforts to quickly develop swine flu vaccine ScienceDaily 4 June 2009 25 November 2009 31 July 2009 https://web.archive.org/web/20090731122329/http://www.sciencedaily.com/releases/2009/06/090602161944.htm live 2009 09, a vaccine for H1N1/09 was expected to be available starting in November 2009, with production of three billion doses per year. It was expected that two doses would be needed to provide sufficient protection, but tests indicated that one dose would be sufficient for adults. Plennevaux E, Sheldon E, Blatter M, Reeves-Hoché MK, Denis M Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials Lancet 375 9708 41–48 January 2010 20018365 10.1016/S0140-6736(09)62026-2 Data are needed from large clinical trials of paediatric, adult, and elderly people to find the appropriate antigen dose and vaccination schedule for the 2009 pandemic influenza A H1N1. We therefore report preliminary safety and immunogenicity results after one injection of a licensed monovalent pandemic H1N1 vaccine in the USA. 1339706 2009 09 28, GlaxoSmithKline produced a vaccine made by growing the virus in hens' eggs, then breaking and deactivating the virus,http://www.gsk.com/media/flu/GSK-Flu-Vaccine-Production-Process.pdf Flu vaccine development process GlaxoSmithKline 2 November 2009 https://web.archive.org/web/20091007154040/http://www.gsk.com/media/flu/GSK-Flu-Vaccine-Production-Process.pdf 7 October 2009 deadhttp://www.gsk.com/media/flu/tissue_backgrounder.pdf Egg vs cell-based vaccine production GlaxoSmithKline 2 November 2009 https://web.archive.org/web/20091007015121/http://www.gsk.com/media/flu/tissue_backgrounder.pdf 7 October 2009 dead and Baxter International produced a vaccine made in cell culture, suitable for those who have an egg allergy. The vaccines have been approved for use in the European Union.http://www.emea.europa.eu/humandocs/Humans/EPAR/pandemrix/pandemrix.htm Pandemrix European Public Assessment Report European Medicines Agency 1 November 2009 dead https://web.archive.org/web/20091015042718/http://www.emea.europa.eu/humandocs/Humans/EPAR/pandemrix/pandemrix.htm 15 October 2009 http://www.emea.europa.eu/humandocs/Humans/EPAR/focetria/focetria.htm Focetria European Public Assessment Report European Medicines Agency 1 November 2009 dead https://web.archive.org/web/20091008130725/http://www.emea.europa.eu/humandocs/Humans/EPAR/focetria/focetria.htm 8 October 2009 http://www.emea.europa.eu/pdfs/general/direct/pr/60258209en.pdf European Medicines Agency recommends authorisation of two vaccines for influenza pandemic (H1N1) 2009 European Medicines Agency 1 November 2009 https://web.archive.org/web/20091007102458/http://www.emea.europa.eu/pdfs/general/direct/pr/60258209en.pdf 7 October 2009 deadhttp://www.emea.europa.eu/humandocs/Humans/EPAR/celvapan/celvapan.htm Celvapan European Public Assessment Report European Medicines Agency 1 November 2009 dead https://web.archive.org/web/20090718040645/http://www.emea.europa.eu/humandocs/Humans/EPAR/celvapan/celvapan.htm 18 July 2009 http://www.emea.europa.eu/humandocs/PDFs/EPAR/celvapan/62290809en.pdf European Medicines Agency recommends authorisation of additional vaccine for influenza pandemic (H1N1) 2009 European Medicines Agency 1 November 2009 https://web.archive.org/web/20091007233317/http://www.emea.europa.eu/humandocs/PDFs/EPAR/celvapan/62290809en.pdf 7 October 2009 deadhttp://www.pr-inside.com/baxter-receives-emea-positive-opinion-for-r1509826.htm Baxter Receives EMEA Positive Opinion for Celvapan H1N1 Pandemic Influenza Vaccine Baxter International 2 October 2009 2 November 2009 dead https://web.archive.org/web/20110715111332/http://www.pr-inside.com/baxter-receives-emea-positive-opinion-for-r1509826.htm 15 July 2011 http://www.baxter.com/press_room/press_releases/2009/10_07_09-celvapan.html Baxter Receives European Commission Approval for Celvapan H1N1 Pandemic Influenza Vaccine Baxter International 7 October 2009 2 November 2009 https://web.archive.org/web/20100220111220/http://www.baxter.com/press_room/press_releases/2009/10_07_09-celvapan.html 20 February 2010 dead Testing Initial Phase I human testing began with Novartis' MF59 candidate in July 2009,NCT00943358 Safety and Immunogenicity of A/H1N1v Vaccines in Healthy Adults http://www.clinicaltrials.gov/ct2/show/NCT00943358?term=H1N1&rank=8 Safety and Immunogenicity of A/H1N1v Vaccines in Healthy Adults 28 May 2017 15 June 2011 https://web.archive.org/web/20110615081234/http://www.clinicaltrials.gov/ct2/show/NCT00943358?term=H1N1&rank=8 live at which time phase II trials of CSL's candidate CSL425 vaccine were planned to start in August 2009, but had not begun recruiting.NCT00940108 A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children https://www.clinicaltrials.gov/ct2/show/NCT00940108 A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children 6 April 2023 20 April 2021 https://web.archive.org/web/20210420201337/https://www.clinicaltrials.gov/ct2/show/NCT00940108 live Sanofi Pasteur's candidate inactivated H1N1 had several phase II trials planned 2009 07 21 on, but had not begun recruiting.NCT00944073 Peds Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels https://clinicaltrials.gov/ct2/show/NCT00944073 Peds Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels 6 April 2023 9 April 2021 https://web.archive.org/web/20210409012330/https://clinicaltrials.gov/ct2/show/NCT00944073 live News coverage conflicted with this information, as Australian trials of the CSL candidate were announced as having started on 21 July, http://www.telegraph.co.uk/health/swine-flu/5888388/Worlds-first-human-swine-flu-vaccine-trials-begin.html World's first human swine flu vaccine trials begin London The Daily Telegraph 23 July 2009 https://web.archive.org/web/20090724013654/http://www.telegraph.co.uk/health/swine-flu/5888388/Worlds-first-human-swine-flu-vaccine-trials-begin.html 24 July 2009 and the Chinese government announced the start of trials of the Hualan Biological Engineering candidate. https://www.google.com/hostednews/afp/article/ALeqM5hlbONP2BvuMfNe4585LP6NmG6iAg Chinese firm begins swine flu vaccine trial: state media https://web.archive.org/web/20101209134210/http://www.google.com/hostednews/afp/article/ALeqM5hlbONP2BvuMfNe4585LP6NmG6iAg 9 December 2010 Beijing Agence France-Presse 22 July 2009 In July 2009, Omninvest in Hungary, in a randomized-controlled trial, began testing Fluval P, a whole virion, aluminum adjuvanted pandemic influenza H1N1 vaccine, which was found to be safe and effective, when administered alone, or together with the seasonal influenza vaccine. Vajo Z, Tamas F, Sinka L, Jankovics I Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with the seasonal influenza vaccine for the 2009-10 influenza season: a multicentre, randomised controlled trial. Lancet 375 9708 49–55 Jan 2010 20018367 10.1016/S0140-6736(09)62039-0 free Pandemrix, made by GlaxoSmithKline (GSK), and Focetria, made by Novartis were approved by the European Medicines Agency on 25 September 2009, and Celvapan, made by Baxter was approved the following week. https://www.bbc.co.uk/blogs/thereporters/ferguswalsh/2009/09/swine_flu_vaccines_get_first_uk_trial.html Swine flu vaccines get first UK trial 28 September 2009 https://web.archive.org/web/20091003083254/http://www.bbc.co.uk/blogs/thereporters/ferguswalsh/2009/09/swine_flu_vaccines_get_first_uk_trial.html 3 October 2009 BBC News The first comparative clinical study of both vaccines started on children in the United Kingdom on 25 September 2009.November 2009 GSK announced results from clinical trials assessing the use of Pandemrix in children, adults, and the elderly.http://us.gsk.com/html/media-news/pressreleases/2009/2009_pressrelease_10119.htm Pandemic 2009 Influenza Update: Pandemrix data in an elderly population GlaxoSmithKline 27 October 2009 2 November 2009 dead https://web.archive.org/web/20110711132945/http://us.gsk.com/html/media-news/pressreleases/2009/2009_pressrelease_10119.htm 11 July 2011 http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10111.htm Pandemic (H1N1) 2009 Influenza Update: Results from second clinical trial of GSK's H1N1 adjuvanted vaccine confirm immune response and tolerability GlaxoSmithKline 16 October 2009 7 November 2009 https://web.archive.org/web/20091031103005/http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10111.htm 31 October 2009 deadhttp://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10116.htm Pandemic (H1N1) 2009 Influenza Update: Experience of GSK's H1N1 adjuvanted vaccine, Pandemrix, and preliminary paediatric results GlaxoSmithKline 23 October 2009 7 November 2009 https://web.archive.org/web/20091029160027/http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10116.htm 29 October 2009 deadhttp://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10133.htm Pandemic 2009 Influenza Update: Pandemrix data in children and adolescents from 3 to 17 years of age GlaxoSmithKline 23 November 2009 13 February 2011 dead https://web.archive.org/web/20101227022559/http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10133.htm 27 December 2010 A 2009 trial examined the safety and efficacy of two different doses of the split-virus vaccine, and was published in The New England Journal of Medicine. Greenberg ME, Lai MH, Hartel GF, Wichems CH, Gittleson C, Bennet J, Dawson G, Hu W, Leggio C, Washington D, Basser RL Response to a monovalent 2009 influenza A (H1N1) vaccine The New England Journal of Medicine 361 25 2405–2413 December 2009 19745216 10.1056/NEJMoa0907413 39944161 free The vaccine used in the trial was prepared by CSL Biotherapies in chicken eggs, in the same way as the seasonal vaccine. A robust immune response was produced in over 90% of patients after a single dose of either 15 or 30 μg of antigen. This study suggested that the current recommendation for two doses of vaccine are overkill and that a single dose is quite sufficient. Arepanrix, an AS03-Adjuvanted H1N1 Pandemic Influenza Vaccine similar to Pandemrix and also made by GSK, was authorized by Canada's Minister of Health on 21 October 2009.http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2009_arepanrix_h1n1_132070-eng.php Notice of Decision for Arepanrix H1N1 21 October 2009 22 October 2009 https://web.archive.org/web/20091025160004/http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/phase1-decision/drug-med/nd_ad_2009_arepanrix_h1n1_132070-eng.php 25 October 2009 deadhttp://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodpharma/legislation/interimorders-arretesurgence/prodinfo-vaccin-eng.pdf Product Information Leaflet Arepanrix H1N1 AS03-Adjuvanted H1N1 Pandemic Influenza Vaccine 21 October 2009 22 October 2009 11 January 2013 https://web.archive.org/web/20130111155651/http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodpharma/legislation/interimorders-arretesurgence/prodinfo-vaccin-eng.pdf live http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodpharma/legislation/interimorders-arretesurgence/faq-vaccin-eng.pdf Questions and Answers on Influenza A (H1N1) 2009 Pandemic Vaccine Arepanrix H1N1 21 October 2009 7 November 2009 11 January 2013 https://web.archive.org/web/20130111155649/http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodpharma/legislation/interimorders-arretesurgence/faq-vaccin-eng.pdf live Adverse events A review by the U.S. National Institutes of Health (NIH) concluded that the 2009 H1N1 ("swine flu") vaccine has a safety profile similar to that of seasonal vaccine. In an initial clinical trial in Australia, non-serious adverse events were reported by about half of the 240 people vaccinated, with these events including tenderness and pain at the site of injection, headache, malaise, and muscle pain. Two people had more severe events, with a much longer spell of nausea, muscle pain and malaise that lasted several days. The authors stated that the frequency and severity of these adverse events were similar to those normally seen with seasonal influenza vaccines. A second trial involved 2,200 people ranging from 3 to 77 years of age. Zhu FC, Wang H, Fang HH, Yang JG, Lin XJ, Liang XF, Zhang XF, Pan HX, Meng FY, Hu YM, Liu WD, Li CG, Li W, Zhang X, Hu JM, Peng WB, Yang BP, Xi P, Wang HQ, Zheng JS A novel influenza A (H1N1) vaccine in various age groups The New England Journal of Medicine 361 25 2414–2423 December 2009 19846844 10.1056/NEJMoa0908535 16259245 free In this study no patients reported serious adverse events, with the most commonly observed events being pain at the injection site and fever, which occurred in 10–25% of people. Although this trial followed up patients individually, the Government has been criticized for relying on voluntary reporting for post-vaccination evaluation in other circumstances, since this is "unlikely to accurately measure the percentage of people who get adverse effect".H1N1 immunisation: Too much, too soon? Collignon P Aust Prescr 30–31 33 2 April 2010 0312-8008 10.18773/austprescr.2010.011 free 1885/261118 free 2009 11 19, the World Health Organization (WHO) said that 65 million doses of vaccine had been administered and that it had a similar safety profile to the seasonal flu vaccine, with no significant differences in the adverse events produced by the different types of vaccine. https://www.who.int/mediacentre/vpc_transcript_19_november_09_kieny.pdf Transcript of virtual press conference with Dr Marie-Paule Kieny, Director, Initiative for Vaccine Research https://web.archive.org/web/20160303183139/http://www.who.int/mediacentre/vpc_transcript_19_november_09_kieny.pdf 3 March 2016 World Health Organization 19 November 2009 There has been one report of an adverse event per 10,000 doses of vaccine, with only five percent of these adverse events being serious, an overall rate of serious events of one in 200,000 doses. In Canada, after 6.6 million doses of vaccine had been distributed between 21 October and 7 November, there were reports of mild adverse events in 598 people vaccinated including: nausea, dizziness, headache, fever, vomiting, and swelling or soreness at the injection site. There were reports of tingling lips or tongue, difficulty breathing, hives, and skin rashes. Thirty six people had serious adverse events, including anaphylaxis and febrile convulsions. The rate of serious adverse events is one in 200,000 doses distributed, which according to Canada's chief public health officer, is less than expected for the seasonal flu vaccine. GlaxoSmithKline recalled a batch of vaccine in Canada after it appeared to cause higher rates of adverse events than other batches. In the US, 46 million doses had been distributed 2009 11 20 on, and 3182 adverse events were reported. The CDC stated that the "vast majority" were mild, with about one serious adverse event in 260,000 doses. http://vaers.hhs.gov/resources/2009H1N1Summary_Nov25.pdf Summary of 2009 Monovalent H1N1 Influenza Vaccine Data Vaccine Adverse Event Reporting System https://web.archive.org/web/20091229005305/http://vaers.hhs.gov/resources/2009H1N1Summary_Nov25.pdf 29 December 2009 Centers for Disease Control and Prevention 20 November 2009 In Japan, around 15 million people had been vaccinated by 31 December 2009. 1,900 cases of side effects and 104 cases of death were reported from medical institutions. The health ministry announced that it will conduct epidemiologic investigation. http://search.japantimes.co.jp/cgi-bin/nn20091231a7.html H1N1 vaccine death probe set https://web.archive.org/web/20111006170702/http://search.japantimes.co.jp/cgi-bin/nn20091231a7.html 6 October 2011 The Japan Times 31 December 2009 In France, around five million people had been vaccinated by 30 December 2009. 2,657 cases of side effects, eight cases of intrauterine death and five cases of miscarriages were reported after vaccination by afssaps. http://www.santelog.com/modules/connaissances/actualite-sante-signalements-sur-vaccins-h1n1-8-cas-de-mort-intra-utérine-depuis-le-début-_2431.htm Signalements sur vaccins H1N1 : 8 cas de mort intra-utérine Reports on H1N1 vaccines: 8 cases of intrauterine death 12 January 2009 fr Actu Santé 12 January 2010 https://web.archive.org/web/20100920034449/http://www.santelog.com/modules/connaissances/actualite-sante-signalements-sur-vaccins-h1n1-8-cas-de-mort-intra-ut%C3%A9rine-depuis-le-d%C3%A9but-_2431.htm 20 September 2010 dead Rare potential adverse events are temporary bleeding disorders and Guillain–Barré syndrome (GBS), a serious condition involving the peripheral nervous system, from which most patients recover fully within a few months to a year. Some studies have indicated that influenza-like illness is itself associated with an increased risk of GBS, suggesting that vaccination might indirectly protect against the disorder by protecting against flu. According to Marie-Paule Kieny of WHO assessing the side-effects of large-scale influenza vaccination is complicated by the fact that in any large population a few people will become ill and die at any time. For example, in any six-week period in the UK six sudden deaths from unknown causes and 22 cases of Guillain–Barré syndrome would be expected, so if everyone in the UK were vaccinated, this background rate of illness and death would continue as normal and some people would die simply by chance soon after the vaccination. Black S, Eskola J, Siegrist CA, Halsey N, MacDonald N, Law B, Miller E, Andrews N, Stowe J, Salmon D, Vannice K, Izurieta HS, Akhtar A, Gold M, Oselka G, Zuber P, Pfeifer D, Vellozzi C Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccines Lancet 374 9707 2115–2122 December 2009 19880172 2861912 10.1016/S0140-6736(09)61877-8 Some scientists have reported concerns about the longer-term effects of the vaccine. For instance, Sucharit Bhakdi, professor of medical microbiology at the Johannes Gutenberg University of Mainz in Germany, wrote in the journal, Medical Microbiology and Immunology, of the possibility that immune stimulation by vaccines or any other cause might worsen pre-existing heart disease. Bhakdi S, Lackner K, Doerr HW Possible hidden hazards of mass vaccination against new influenza A/H1N1: have the cardiovascular risks been adequately weighed? Medical Microbiology and Immunology 198 4 205–209 November 2009 19851782 10.1007/s00430-009-0130-9 free Chris Shaw, a neuroscientist at the University of British Columbia, expressed concern that serious side-effects may not appear immediately; he said it took five to ten years to see most of the Gulf War syndrome outcomes. The CDC states that most studies on modern influenza vaccines have seen no link with GBS, Preliminary results: surveillance for Guillain-Barré syndrome after receipt of influenza A (H1N1) 2009 monovalent vaccine - United States, 2009-2010 MMWR. Morbidity and Mortality Weekly Report 59 21 657–661 June 2010 20520590 https://www.cdc.gov/mmwr/pdf/wk/mm5921.pdf 13 February 2011 live https://web.archive.org/web/20110629132337/http://www.cdc.gov/mmwr/pdf/wk/mm5921.pdf 29 June 2011 Centers for Disease Control and Prevention (CDC) Haber P, Sejvar J, Mikaeloff Y, DeStefano F Vaccines and Guillain-Barré syndrome Drug Safety 32 4 309–323 2009 19388722 10.2165/00002018-200932040-00005 33670594 Kaplan JE, Katona P, Hurwitz ES, Schonberger LB Guillain-Barré syndrome in the United States, 1979-1980 and 1980-1981. Lack of an association with influenza vaccination JAMA 248 6 698–700 August 1982 7097920 10.1001/jama.248.6.698 Although one review gives an incidence of about one case per million vaccinations, Vellozzi C, Burwen DR, Dobardzic A, Ball R, Walton K, Haber P Safety of trivalent inactivated influenza vaccines in adults: background for pandemic influenza vaccine safety monitoring Vaccine 27 15 2114–2120 March 2009 19356614 10.1016/j.vaccine.2009.01.125 https://zenodo.org/record/1259425 2 June 2020 live https://web.archive.org/web/20200801190854/https://zenodo.org/record/1259425 1 August 2020 a large study in China, reported in The New England Journal of Medicine covering close to 100 million doses of H1N1 flu vaccine found only eleven cases of Guillain–Barré syndrome, actually lower than the normal rate of the disease in China, and no other notable side effects. Pregnant women and children A 2009 review of the use of influenza vaccines in pregnant women stated that influenza infections posed a major risk during pregnancy and that multiple studies had shown that the inactivated vaccine was safe in pregnant women, concluding that this vaccine "can be safely and effectively administered during any trimester of pregnancy" and that high levels of immunization would avert "a significant number of deaths". Tamma PD, Ault KA, del Rio C, Steinhoff MC, Halsey NA, Omer SB Safety of influenza vaccination during pregnancy American Journal of Obstetrics and Gynecology 201 6 547–552 December 2009 19850275 10.1016/j.ajog.2009.09.034 A 2004 review of the safety of influenza vaccines in children stated that the live vaccine had been shown to be safe but that it might trigger wheezing in some children with asthma; less data for the trivalent inactivated vaccine was available, but no serious symptoms had been seen in clinical trials. Jacobson RM An update on childhood and adolescent vaccines Mayo Clinic Proceedings 84 5 457–9; quiz 460 May 2009 19411442 2676128 10.4065/84.5.457 Squalene Newsweek states that "wild rumours" about the swine flu vaccine are being spread through e-mails, it writes that "The claims are nearly pure bunk, with only trace amounts of fact."http://www.newsweek.com/id/218513 FactCheck: Swine Flu Vaccine Fears Greatly Exaggerated newsweek.com 19 October 2009 26 November 2009 27 March 2010 https://web.archive.org/web/20100327235112/http://www.newsweek.com/id/218513 live These rumours generally make unfounded claims that the vaccine is dangerous and they may also promote conspiracy theories. For example, Newsweek states that some chain e-mails make false claims about squalene (shark liver oil) in vaccines. The New York Times also notes that anti-vaccine groups have spread "dire warnings" about formulations of the vaccine that contain squalene as an adjuvant. McNeil Jr DG Donald Gerard McNeil Jr. https://www.nytimes.com/2009/09/28/health/policy/28vaccine.html Don't Blame Flu Shots for All Ills, Officials Say The New York Times 27 September 2009 26 November 2009 https://web.archive.org/web/20110430004505/http://www.nytimes.com/2009/09/28/health/policy/28vaccine.html 30 April 2011 live An adjuvant is a substance that boosts the body's immune response, thereby stretching the supply of the vaccine and helping immunize elderly people with a weak immune system. Smith J http://www.healthzone.ca/health/newsfeatures/swineflu/article/728601--batch-of-h1n1-vaccine-recalled-for-severe-reactions Batch of H1N1 vaccine recalled for severe reactions https://web.archive.org/web/20130112060324/http://www.healthzone.ca/health/newsfeatures/swineflu/article/728601--batch-of-h1n1-vaccine-recalled-for-severe-reactions 12 January 2013 Toronto Star 20 November 2009 Squalene is a normal part of the human body, made in the liver and circulating in the blood, and is also found in many foods, such as eggs and olive oil. https://www.fda.gov/ohrms/DOCKETS/dockets/80n0208/80n-0208-c000037-15-01-vol151.pdf The Facts on Squalene https://web.archive.org/web/20170531075404/https://www.fda.gov/ohrms/dockets/dockets/80n0208/80n-0208-c000037-15-01-vol151.pdf 31 May 2017 U.S. Food and Drug Administration (FDA) None of the formulations of vaccine used in the US contain squalene, or any other adjuvant. http://www.flu.gov/myths/index.html Misconceptions about Seasonal Influenza and Influenza Vaccines https://web.archive.org/web/20120104072435/http://flu.gov/myths/index.html 4 January 2012 United States Department of Health and Human Services However, some European and Canadian formulations do contain 25 μg of squalene per dose, which is roughly the amount found in a drop of olive oil. http://www.food-info.net/uk/products/olive/olive06.htm Health Effects of the Minor Components of Olive Oil https://web.archive.org/web/20210507191233/http://www.food-info.net/uk/products/olive/olive06.htm 7 May 2021 Food-Info Wageningen University Some animal experiments have suggested that squalene might be linked to autoimmune disorders. Roslin A https://www.straight.com/article-270843/vancouver/whats-your-vaccine What's in your H1N1 flu vaccine? https://web.archive.org/web/20191008014236/https://www.straight.com/article-270843/vancouver/whats-your-vaccine 8 October 2019 Straight.com Vancouver 19 November 2009 Kuroda Y, Nacionales DC, Akaogi J, Reeves WH, Satoh M Autoimmunity induced by adjuvant hydrocarbon oil components of vaccine Biomedicine & Pharmacotherapy 58 5 325–337 June 2004 15194169 10.1016/j.biopha.2004.04.009 although others suggest squalene might protect people against cancer. Smith TJ Squalene: potential chemopreventive agent Expert Opinion on Investigational Drugs 9 8 1841–1848 August 2000 11060781 10.1517/13543784.9.8.1841 2740933 Owen RW, Haubner R, Würtele G, Hull E, Spiegelhalder B, Bartsch H Olives and olive oil in cancer prevention European Journal of Cancer Prevention 13 4 319–326 August 2004 15554560 10.1097/01.cej.0000130221.19480.7e Squalene-based adjuvants have been used in European influenza vaccines since 1997, with about 22 million doses administered over the past twelve years.https://www.who.int/vaccine_safety/topics/adjuvants/squalene/questions_and_answers/en/index.html https://web.archive.org/web/20061023162835/http://www.who.int/vaccine_safety/topics/adjuvants/squalene/questions_and_answers/en/index.html dead 23 October 2006 WHO - Squalene-based adjuvants in vaccines The WHO states that no severe side effects have been associated with these vaccines, although they can produce mild inflammation at the site of injection. The safety of squalene-containing influenza vaccines have also been tested in two separate clinical trials, one with healthy non-elderly people, Frey S, Poland G, Percell S, Podda A Comparison of the safety, tolerability, and immunogenicity of a MF59-adjuvanted influenza vaccine and a non-adjuvanted influenza vaccine in non-elderly adults Vaccine 21 27–30 4234–4237 October 2003 14505903 10.1016/S0264-410X(03)00456-0 and one with elderly people, De Donato S, Granoff D, Minutello M, Lecchi G, Faccini M, Agnello M, Senatore F, Verweij P, Fritzell B, Podda A Safety and immunogenicity of MF59-adjuvanted influenza vaccine in the elderly Vaccine 17 23–24 3094–3101 August 1999 10462245 10.1016/S0264-410X(99)00138-3 in both trials the vaccine was safe and well tolerated, with only weak side-effects, such as mild pain at the injection site. A 2009 meta-analysis brought together data from 64 clinical trials of influenza vaccines with the squalene-containing adjuvant MF59 and compared them to the effects of vaccines with no adjuvant. The analysis reported that the adjuvanted vaccines were associated with slightly lower risks of chronic diseases, but that neither type of vaccines altered the normal rate of autoimmune diseases; the authors concluded that their data "supports the good safety profile associated with MF59-adjuvanted influenza vaccines and suggests there may be a clinical benefit over non-MF59-containing vaccines". Pellegrini M, Nicolay U, Lindert K, Groth N, Della Cioppa G MF59-adjuvanted versus non-adjuvanted influenza vaccines: integrated analysis from a large safety database Vaccine 27 49 6959–6965 November 2009 19751689 10.1016/j.vaccine.2009.08.101 A 2004 review of the effects of adjuvants on mice and humans concluded that "despite numerous case reports on vaccination induced autoimmunity, most epidemiological studies failed to confirm the association and the risk appears to be extremely low or non-existent", although the authors noted that the possibility that adjuvants might cause damaging immune reactions in a few susceptible people has not been completely ruled out. Kuroda Y, Nacionales DC, Akaogi J, Reeves WH, Satoh M Autoimmunity induced by adjuvant hydrocarbon oil components of vaccine Biomedicine & Pharmacotherapy 58 5 325–337 June 2004 15194169 10.1016/j.biopha.2004.04.009 http://qbit.cc/blog/wp-content/uploads/2009/09/oil-adjuvant-induced-autoimmunity-Kuroda-et-al.pdf 25 November 2009 dead https://web.archive.org/web/20110706215648/http://qbit.cc/blog/wp-content/uploads/2009/09/oil-adjuvant-induced-autoimmunity-Kuroda-et-al.pdf 6 July 2011 A 2009 review of oil-based adjuvants in influenza vaccines stated that this type of adjuvant "neither stimulates antibodies against squalene oil naturally produced by the humans body nor enhances titers of preexisting antibodies to squalene" and that these formulations did not raise any safety concerns. Vogel FR, Caillet C, Kusters IC, Haensler J Emulsion-based adjuvants for influenza vaccines Expert Review of Vaccines 8 4 483–492 April 2009 19348563 10.1586/erv.09.5 207223690 A paper published in 2000 suggested that squalene might have caused of Gulf War syndrome by producing anti-squalene antibodies, Asa PB, Cao Y, Garry RF Antibodies to squalene in Gulf War syndrome Experimental and Molecular Pathology 68 1 55–64 February 2000 10640454 10.1006/exmp.1999.2295 although other scientists stated that it was uncertain if the methods used were actually capable of detecting these antibodies. Alving CR, Grabenstein JD Re: Antibodies to squalene in Gulf War Syndrome Experimental and Molecular Pathology 68 3 196–198 June 2000 10816387 10.1006/exmp.2000.2314 https://zenodo.org/record/1229598 19 April 2019 live https://web.archive.org/web/20201122193522/https://zenodo.org/record/1229598 22 November 2020 A 2009 U.S. Department of Defense study comparing healthy Navy personnel to those suffering from Gulf War syndrome was published in the journal Vaccine, this used a validated test for these antibodies and found no link between the presence of the antibodies and illness, with about half of both groups having these antibodies and no correlation between symptoms and antibodies. Phillips CJ, Matyas GR, Hansen CJ, Alving CR, Smith TC, Ryan MA Antibodies to squalene in US Navy Persian Gulf War veterans with chronic multisymptom illness Vaccine 27 29 3921–3926 June 2009 19379786 10.1016/j.vaccine.2009.03.091 Furthermore, none of the vaccines given to US troops during the Gulf war actually contained any squalene adjuvants. http://www.who.int/vaccine_safety/topics/adjuvants/squalene/Jun_2006/en/index.html https://web.archive.org/web/20070111074029/http://www.who.int/vaccine_safety/topics/adjuvants/squalene/Jun_2006/en/index.html 11 January 2007 Safety of squalene World Health Organization WHO Weekly Epidemiological Record 14 July 2006 http://www.gao.gov/archive/1999/ns99005.pdf Gulf War illnesses: questions about the presence of squalene antibodies in veterans can be resolved https://web.archive.org/web/20210227012900/https://www.gao.gov/archive/1999/ns99005.pdf 27 February 2021 Government Accountability Office (GAO) 29 March 1999 Thiomersal Multi-dose versions of the vaccine contain the preservative thiomersal (also known as thimerosal), a mercury compound that prevents contamination when the vial is used repeatedly.Institute for Vaccine Safety 21 October 2009 http://vaccinesafety.edu/thi-table-10-0928.pdf Thimerosal content in some US licensed vaccines 27 October 2009 dead https://web.archive.org/web/20110720105944/http://vaccinesafety.edu/thi-table-10-0928.pdf 20 July 2011 Single-dose versions and the live vaccine do not contain this preservative. In the U.S., one dose from a multi-dose vial contains approximately 25 micrograms of mercury, a bit less than a typical tuna fish sandwich.As flu vaccine arrives for the season, some questions and answers Parker-Pope T The New York Times 9 October 2009 27 October 2009 https://www.nytimes.com/2009/10/10/health/10primer.html https://web.archive.org/web/20130414081838/http://www.nytimes.com/2009/10/10/health/10primer.html 14 April 2013 live Pichichero ME, Cernichiari E, Lopreiato J, Treanor J Mercury concentrations and metabolism in infants receiving vaccines containing thiomersal: a descriptive study Lancet 360 9347 1737–1741 November 2002 12480426 10.1016/S0140-6736(02)11682-5 44806603 (The comparison of the injected and ingested quantities is for reference only, since the rate of absorption of ingested elemental mercury into the bloodstream is less than 0.01%. Park JD, Zheng W Human exposure and health effects of inorganic and elemental mercury Journal of Preventive Medicine and Public Health = Yebang Uihakhoe Chi 45 6 344–352 November 2012 23230464 3514464 10.3961/jpmph.2012.45.6.344 ) In Canada, different variants contain five and 50 micrograms of thimerosal per dose.http://www.phac-aspc.gc.ca/alert-alerte/h1n1/faq_rg_h1n1-eng.php Frequently asked questions – H1N1 flu virus 29 September 2009 27 October 2009 Public Health Agency of Canada https://web.archive.org/web/20091023121308/http://www.phac-aspc.gc.ca/alert-alerte/h1n1/faq_rg_h1n1-eng.php 23 October 2009 live The use of thiomersal has been controversial, with claims that it can cause autism and other developmental disorders. Burton D Mercury in medicine report Congressional Record May 2003 E1011–30 149 http://frwebgate.access.gpo.gov/cgi-bin/getpage.cgi?dbname=2003_record&position=all&page=E1011 25 November 2009 10 December 2021 https://web.archive.org/web/20211210171009/https://www.govinfo.gov/content/pkg/CREC-2003-05-21/pdf/CREC-2003-05-21-pt1-PgE1011-3.pdf live The U.S. Institute of Medicine examined these claims and concluded in 2004 that the evidence did not support any link between vaccines and autism. Board on Health Promotion and Disease Prevention (HPDP) Immunization Safety Review: Vaccines and Autism May 2004 Institute of Medicine (IOM). National Academies Press. 978-0-309-09237-1 http://books.nap.edu/openbook.php?record_id=10997 https://web.archive.org/web/20150402133034/http://books.nap.edu/openbook.php?record_id=10997 2 April 2015 Other reviews came to similar conclusions, with a 2006 review in the Canadian Journal of Neurological Sciences stating that there is no convincing evidence to support the claim that thimerosal has a causal role in autism, Doja A, Roberts W Immunizations and autism: a review of the literature The Canadian Journal of Neurological Sciences. Le Journal Canadien des Sciences Neurologiques 33 4 341–346 November 2006 17168158 10.1017/s031716710000528x free and a 2009 review in the journal Clinical Infectious Diseases stating that claims that mercury can cause autism are "biologically implausible". Gerber JS, Offit PA Vaccines and autism: a tale of shifting hypotheses Clinical Infectious Diseases 48 4 456–461 February 2009 19128068 2908388 10.1086/596476 cite press release Vaccines and Autism: Many Hypotheses, But No Correlation Infectious Diseases Society of America 2009-01-30 12 August 2011 http://www.idsociety.org/Content.aspx?id=13336 https://web.archive.org/web/20110812162028/http://www.idsociety.org/Content.aspx?id=13336 The U.K. National Health Service stated in 2003 that "There is no evidence of long-term adverse effects due to the exposure levels of thiomersal in vaccines." http://www.immunisation.nhs.uk/Publications/thiomersalfsht.pdf Thiomersal and vaccines Department of Health Publications, National Health Service, UK 2003 https://web.archive.org/web/20091119062742/http://www.immunisation.nhs.uk/publications/thiomersalfsht.pdf 19 November 2009 The World Health Organization concluded that there is "no evidence of toxicity in infants, children or adults exposed to thiomersal in vaccines".Thiomersal and vaccines Global Advisory Committee on Vaccine Safety World Health Organization https://www.who.int/vaccine_safety/topics/thiomersal/en/index.html 14 July 2006 31 October 2009 https://web.archive.org/web/20091106092438/http://www.who.int/vaccine_safety/topics/thiomersal/en/index.html 6 November 2009 dead In 2008 a review noted that even though thiomersal was removed from all US childhood vaccines in 2001, this has not changed the number of autism diagnoses, which are still increasing. Fombonne E Thimerosal disappears but autism remains Archives of General Psychiatry 65 1 15–16 January 2008 18180423 10.1001/archgenpsychiatry.2007.2 http://www.co.ottawa.mi.us/HealthComm/Health/pdf/AGP_Thimerosal_Disappears_Autism_Remains.pdf 4 December 2009 dead https://web.archive.org/web/20100107163858/http://www.co.ottawa.mi.us/HealthComm/Health/pdf/AGP_Thimerosal_Disappears_Autism_Remains.pdf 7 January 2010 Dystonia According to the CDC, there is no evidence either for or against dystonia being caused by the vaccinations. Dystonia is extremely rare. Due to the very low numbers of cases, dystonia is poorly understood. There were only five cases noted that might have been associated with influenza vaccinations over a span of eighteen years. http://www.wusa9.com/news/health/story.aspx?storyid=92392&catid=28 Doctors Back Woman's Claim of Adverse Reaction To Seasonal Flu Vaccine https://web.archive.org/web/20160303231849/http://www.wusa9.com/news/health/story.aspx?storyid=92392&catid=28 3 March 2016 Chinn S 9News NOW 15 October 2009 In one discredited case, a woman wrongly blamed difficulties with movement and speech on a seasonal influenza vaccination. http://loudountimes.com/blogs/loudoun-lowdown/2009-10-13/loudoun-lowdown-nicholas-graham-flu-shot-desiree/ The Flu, & a 'Shot to the System' https://web.archive.org/web/20091221011520/http://loudountimes.com/blogs/loudoun-lowdown/2009-10-13/loudoun-lowdown-nicholas-graham-flu-shot-desiree/ 21 December 2009 Graham N Loudoun Times-Mirror 13 October 2009 Zadrozny Brandy 2023-08-04 The 'Flu Shot Cheerleader' is back – with a warning about the anti-vaccine movement https://www.nbcnews.com/news/us-news/desiree-jennings-flu-shot-anti-vaccine-media-rcna97724# 2024-09-04 NBC News en The Dystonia Medical Research Foundation stated that it is unlikely that the symptoms in this case were actually dystonia and stated that there has "never been a validated case of dystonia resulting from a flu shot".http://www.dystonia-foundation.org/pages/dystonia___flu_vaccine/569.php Dystonia & Flu Vaccine in the Media Dystonia Medical Research Foundation 2009 2 December 2009 https://web.archive.org/web/20091119030939/http://www.dystonia-foundation.org/pages/dystonia___flu_vaccine/569.php 19 November 2009 dead A vaccine court special master concluded that the woman's symptoms weren't from the vaccine. Additionally, the woman later said that Jenny McCarthy's anti-vaccine group Generation Rescue had "commandeered my injury to turn it into a poster story for their cause against vaccines." Zadrozny B Brandy Zadrozny Transcript for Tiffany Dover Is Dead: The Playbook https://www.nbcnews.com/podcast/truthers/transcript-playbook-n1295336 11 May 2022 NBC News 11 May 2022 en 11 May 2022 https://web.archive.org/web/20220511185526/https://www.nbcnews.com/podcast/truthers/transcript-playbook-n1295336 live Children vaccine recall On 15 December 2009, one of the five manufacturers supplying the H1N1 vaccine to the United States recalled thousands of doses because they were not as potent as expected. The French manufacturer Sanofi Pasteur voluntarily recalled about 800,000 doses of vaccine meant for children between the ages of six months and 35 months. The company and the Centers for Disease Control and Prevention (CDC) emphasized that the recall was not prompted by safety concerns, and that even though the vaccine is not quite as potent as it is supposed to be, children who received it do not need to be immunized again. The CDC emphasized that there is no danger for any child who received the recalled vaccine. When asked what parents should do, CDC spokesman Tom Skinner said, "absolutely nothing." He said if children receive this vaccine, they will be fine.http://www.cnn.com/2009/HEALTH/12/15/flu.vaccine.recall/index.html 800,000 H1N1 vaccine doses for young children recalled; safety not a concern 16 September 2009 Falco M 15 December 2009 CNN 16 December 2009 https://web.archive.org/web/20091216143440/http://www.cnn.com/2009/HEALTH/12/15/flu.vaccine.recall/index.html live https://www.nytimes.com/2009/12/16/health/16flu.html Infants' Swine Flu Vaccine Is Recalled as Less Potent The New York Times McNeil Jr DG Donald Gerard McNeil Jr. 15 December 2009 17 December 2009 1 December 2017 https://web.archive.org/web/20171201134616/http://www.nytimes.com/2009/12/16/health/16flu.html live Narcolepsy in Finland and Sweden Pandemrix In 2010, The Swedish Medical Products Agency (MPA) and The Finnish National Institute for Health and Welfare (THL) received reports from Swedish and Finnish health care professionals regarding narcolepsy as suspected adverse reaction following Pandemrix flu vaccination. The reports concern children aged 12–16 years where symptoms compatible with narcolepsy, diagnosed after thorough medical investigation, have occurred one to two months after vaccination.August 2022 THL concluded in February 2011 that there is a clear connection between the Pandemrix vaccination campaign of 2009 and 2010 and narcolepsy epidemic in Finland: there was a nine times higher probability to get narcolepsy with vaccination than without it.http://www.mtv3.fi/uutiset/kotimaa.shtml/2011/02/1265779/thl-pandemrixilla-ja-narkolepsialla-on-selva-yhteys THL: Pandemrixilla ja narkolepsialla on selvä yhteys 29 September 2012 2 April 2012 https://web.archive.org/web/20120402161450/http://www.mtv3.fi/uutiset/kotimaa.shtml/2011/02/1265779/thl-pandemrixilla-ja-narkolepsialla-on-selva-yhteys livehttp://www.thl.fi/en_US/web/en/pressrelease?id=24103 Terveyden ja hyvinvoinnin laitos - THL 29 September 2012 https://web.archive.org/web/20120905230223/http://www.thl.fi/en_US/web/en/pressrelease?id=24103 5 September 2012 dead At the end of March 2011, an MPA press release stated: "Results from a Swedish registry based cohort study indicate a 4-fold increased risk of narcolepsy in children and adolescents below the age of 20 vaccinated with Pandemrix, compared to children of the same age that were not vaccinated."http://www.lakemedelsverket.se/english/All-news/NYHETER-2011/A-Swedish-registry-based-cohort-study-provides-strengthened-evidence-of-an-association-between-vaccination-with-Pandemrix-and-narcolepsy-in-children-and-adolescents-/ A Swedish registry based cohort study provides strengthened evidence of an association between vaccination with Pandemrix and narcolepsy in children and adolescents Medical Products Agency Sweden 29 September 2012 11 September 2019 https://web.archive.org/web/20190911170137/https://lakemedelsverket.se/english/All-news/NYHETER-2011/A-Swedish-registry-based-cohort-study-provides-strengthened-evidence-of-an-association-between-vaccination-with-Pandemrix-and-narcolepsy-in-children-and-adolescents-/ live The same study found no increased risk in adults who were vaccinated with Pandemrix.August 2022 Availability Centers for Disease Control and Prevention thumb|right|250px|2,500 people line up in a mall in Texas City, Texas to receive the H1N1 vaccine from the Galveston County Health Department on 30 October 2009. The American Centers for Disease Control and Prevention issued the following recommendations on who should be vaccinated (order is not in priority):CDC H1N1Flu Centers for Disease Control and Prevention 6 November 2009 15 October 2009 https://www.cdc.gov/h1n1flu/vaccination/acip.htm https://web.archive.org/web/20091106014045/http://www.cdc.gov/h1n1flu/vaccination/acip.htm 6 November 2009 livehttps://www.cdc.gov/media/pressrel/2009/r090729b.htm CDC Advisors Make Recommendations for Use of Vaccine Against Novel H1N1 Centers for Disease Control and Prevention (CDC) 29 July 2009 6 November 2009 https://web.archive.org/web/20091103193947/http://www.cdc.gov/media/pressrel/2009/r090729b.htm 3 November 2009 live Use of influenza A (H1N1) 2009 monovalent vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009 MMWR. Recommendations and Reports 58 RR-10 1–8 August 2009 19713882 https://www.cdc.gov/mmwr/PDF/rr/rr5810.pdf 6 December 2009 live https://web.archive.org/web/20091007200207/http://www.cdc.gov/mmwr/pdf/rr/rr5810.pdf 7 October 2009 Centers for Disease Control and Prevention (CDC) National Center For Immunization And Respiratory Diseases C Update on influenza A (H1N1) 2009 monovalent vaccines MMWR. Morbidity and Mortality Weekly Report 58 39 1100–1101 October 2009 19816398 https://www.cdc.gov/mmwr/pdf/wk/mm5839.pdf 13 February 2011 live https://web.archive.org/web/20110629132344/http://www.cdc.gov/mmwr/pdf/wk/mm5839.pdf 29 June 2011 Centers for Disease Control and Prevention (CDC) Pregnant women, because they are at higher risk of complications and can potentially provide protection to infants who cannot be vaccinated; Household contacts and caregivers for children younger than 6 months of age, because younger infants are at higher risk of influenza-related complications and cannot be vaccinated. Vaccination of those in close contact with infants younger than 6 months old might help protect infants by "cocooning" them from the virus; Healthcare and emergency medical services personnel, because infections among healthcare workers have been reported and this can be a potential source of infection for vulnerable patients. Also, increased absenteeism in this population could reduce healthcare system capacity; All people from 6 months through 24 years of age: Children from 6 months through 18 years of age, because cases of 2009 H1N1 influenza have been seen in children who are in close contact with each other in school and day care settings, which increases the likelihood of disease spread, and Young adults 19 through 24 years of age, because many cases of 2009 H1N1 influenza have been seen in these healthy young adults and they often live, work, and study in close proximity, and they are a frequently mobile population; and, Persons aged 25 through 64 years who have health conditions associated with higher risk of medical complications from influenza. Once the demand for these groups has been met at a local level, everyone from the ages of 25 through 64 years should be vaccinated too. In addition, the CDC recommends:Children through 9 years of age should get two doses of vaccine, about a month apart. Older children and adults need only one dose.https://www.cdc.gov/vaccines/pubs/vis/downloads/vis-inact-h1n1.pdf Vaccine Information Statement 2009 H1N1 Inactivated Influenza Vaccine 10/2/09 Centers for Disease Control and Prevention (CDC) 2 December 2009 2 December 2009 https://web.archive.org/web/20091126140406/http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-inact-h1n1.pdf 26 November 2009 deadhttps://www.cdc.gov/vaccines/pubs/vis/downloads/vis-laiv-h1n1.pdf Vaccine Information Statement 2009 H1N1 LAIV 10/2/09 Centers for Disease Control and Prevention (CDC) 2 December 2009 2 December 2009 https://web.archive.org/web/20091126140329/http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-laiv-h1n1.pdf 26 November 2009 dead National Health Service The UK's National Health Service policy is to provide vaccine in this order of priority:Swine flu – Vaccine National Health Service http://www.nhs.uk/conditions/pandemic-flu/pages/vaccine.aspx 6 November 2009 4 November 2009 https://web.archive.org/web/20091110062517/http://www.nhs.uk/conditions/pandemic-flu/pages/vaccine.aspx 10 November 2009 live People aged between six months and 65 years with: chronic lung disease; chronic heart disease; chronic kidney disease; chronic liver disease; chronic neurological disease; diabetes; or suppressed immune system, whether due to disease or treatment. All pregnant women. People who live with someone whose immune system is compromised (for example, people with cancer or HIV/AIDS). People aged 65 and over in the seasonal flu vaccine at-risk groups. This excludes the large majority of individuals aged six months to 24 years, a group for which the CDC recommends vaccination. The NHS notes that: Healthy people over 65 years of age seem to have some natural immunity. Children, while disproportionately affected, tend to make full recoveries. The vaccine is ineffective in young infants. The United Kingdom began its administration program 21 October 2009. UK Soldiers serving in Afghanistan will also be offered vaccination. Triggle N Swine flu jabs starting next week BBC News 15 October 2009 https://news.bbc.co.uk/1/hi/health/8309217.stm 26 October 2009 https://web.archive.org/web/20091018103038/http://news.bbc.co.uk/1/hi/health/8309217.stm 18 October 2009 live Q&A: Swine flu vaccination BBC News 15 October 2009 https://news.bbc.co.uk/2/hi/health/8200504.stm 26 October 2009 10 December 2021 https://web.archive.org/web/20211210171014/http://news.bbc.co.uk/2/hi/health/8200504.stm live By April 2010, it was apparent that most of the vaccine was not needed. The US government had bought 229 million doses of H1N1 vaccines of which 91 million doses were used; of the surplus, 5 million doses were stored in bulk, 15 million doses were sent to developing countries and 71 million doses were destroyed.http://www.aolnews.com/health/article/once-hard-to-get-h1n1-vaccines-now-getting-dumped/19422863 Drummond K Once Scarce, H1N1 Vaccines Now Getting Dumped 2 April 2010 2 April 2010 https://web.archive.org/web/20100402224921/http://www.aolnews.com/health/article/once-hard-to-get-h1n1-vaccines-now-getting-dumped/19422863 2 April 2010 dead The World Health Organization is planning to examine if it overreacted to the H1N1 outbreak. Political issues thumb|250px|US President Barack Obama receives the vaccine on 20 December 2009 General political issues, not restricted to the 2009 outbreak, arose regarding the distribution of vaccine. In many countries supplies are controlled by national or local governments, and the question of how the vaccine will be allocated should there be an insufficient supply for everyone is critical, and will likely depend on the patterns of any pandemic, and the age groups most at risk for serious complications, including death. In the case of a lethal pandemic people will be demanding access to the vaccine and the major problem will be making it available to those who need it. Annas GJ Blinded by bioterrorism: public health and liberty in the 21st century Health Matrix 13 1 33–70 2003 14569657 While it has been suggested that compulsory vaccination may be needed to control a pandemic, many countries do not have a legal framework that would allow this. The only populations easily compelled to accept vaccination are military personnel (who can be given routine vaccinations as part of their service obligations), health care personnel (who can be required to be vaccinated to protect patients), Maltezou HC, Dounias G, Rapisarda V, Ledda C Vaccination policies for healthcare personnel: Current challenges and future perspectives Vaccine 11 100172 August 2022 35719325 9190304 10.1016/j.jvacx.2022.100172 and school children, who (under United States constitutional law) could be required to be vaccinated as a condition of attending school. Mariner WK, Annas GJ, Parmet WE Wendy E. Parmet 2 May 2009 Pandemic Preparedness: A Return to the Rule of Law http://www.earlemacklaw.drexel.edu/law/lawreview/v1n2/mariner.pdf dead Drexel Law Review 1 2 341–82 1399066 https://web.archive.org/web/20110719185656/http://www.earlemacklaw.drexel.edu/law/lawreview/v1n2/mariner.pdf 19 July 2011 5 February 2011 See also 2009 swine flu pandemic COVID-19 vaccine Immunologic adjuvant References 30em External links "2009 H1N1 Vaccine Doses Allocated, Ordered, and Shipped by Project Area" (CDC) Abelin A, Colegate T, Gardner S, Hehme N, Palache A Lessons from pandemic influenza A(H1N1): the research-based vaccine industry's perspective Vaccine 29 6 1135–1138 February 2011 21115061 10.1016/j.vaccine.2010.11.042 free Vaccines for pandemic (H1N1) 2009. World Health Organization (WHO). Vaccine against 2009 H1N1 Influenza Virus. Centers for Disease Control and Prevention (CDC). 2009 influenza A (H1N1) pandemic. European Centre for Disease Prevention and Control (ECDC). Summaries of the pandemic. European Centre for Disease Prevention and Control (ECDC). vaccine Category:Influenza vaccines