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==Economics of development== {{main|Economics of vaccines}} One challenge in vaccine development is economic: Many of the diseases most demanding a vaccine, including [[HIV]], [[malaria]] and tuberculosis, exist principally in poor countries. Pharmaceutical firms and [[biotechnology]] companies have little incentive to develop vaccines for these diseases because there is little revenue potential. Even in more affluent countries, financial returns are usually minimal and the financial and other risks are great.<ref name="market_return">{{cite news | first=Jesse L. | last=Goodman | name-list-style = vanc | title=Statement by Jesse L. Goodman, M.D., M.P.H. Director Center for Biologics, Evaluation and Research Food and Drug Administration U.S. Department of Health and Human Services on US Influenza Vaccine Supply and Preparations for the Upcoming Influenza Season before Subcommittee on Oversight and Investigations Committee on Energy and Commerce United States House of Representatives | date=4 May 2005 | url=https://www.hhs.gov/asl/testify/t050504b.html | access-date=15 June 2008 | url-status=live | archive-url=https://web.archive.org/web/20080921163050/http://www.hhs.gov/asl/testify/t050504b.html | archive-date=21 September 2008 }}</ref> Most vaccine development to date has relied on "push" funding by government, universities and non-profit organizations.<ref>{{cite journal | vauthors = Olesen OF, Lonnroth A, Mulligan B | title = Human vaccine research in the European Union | journal = Vaccine | volume = 27 | issue = 5 | pages = 640β645 | date = January 2009 | pmid = 19059446 | doi = 10.1016/j.vaccine.2008.11.064 | pmc = 7115654 }}</ref> Many vaccines have been highly cost effective and beneficial for [[public health]].<ref>{{cite journal | vauthors = Jit M, Newall AT, Beutels P | title = Key issues for estimating the impact and cost-effectiveness of seasonal influenza vaccination strategies | journal = Human Vaccines & Immunotherapeutics | volume = 9 | issue = 4 | pages = 834β840 | date = April 2013 | pmid = 23357859 | pmc = 3903903 | doi = 10.4161/hv.23637 }}</ref> The number of vaccines actually administered has risen dramatically in recent decades.<ref>{{cite journal | vauthors = Newall AT, Reyes JF, Wood JG, McIntyre P, Menzies R, Beutels P | title = Economic evaluations of implemented vaccination programmes: key methodological challenges in retrospective analyses | journal = Vaccine | volume = 32 | issue = 7 | pages = 759β765 | date = February 2014 | pmid = 24295806 | doi = 10.1016/j.vaccine.2013.11.067 }}</ref> This increase, particularly in the number of different vaccines administered to children before entry into schools, may be due to government mandates and support, rather than economic incentive.<ref>{{Cite journal|last1=Roser|first1=Max|last2=Vanderslott|first2=Samantha|date=10 May 2013|title=Vaccination|url=https://ourworldindata.org/vaccination|journal=Our World in Data|access-date=3 May 2019|archive-date=1 September 2020|archive-url=https://web.archive.org/web/20200901093537/https://ourworldindata.org/vaccination|url-status=live}}</ref> ===Patents=== According to the [[World Health Organization]] (WHO), the biggest barrier to vaccine production in less developed countries has not been [[patent]]s, but the substantial financial, [[infrastructure]], and workforce requirements needed for market entry. Vaccines are complex mixtures of biological compounds, and unlike the case for [[prescription drug]]s, there are no true [[generic drug|generic vaccines]]. The vaccine produced by a new facility must undergo complete clinical testing for safety and efficacy by the manufacturer. For most vaccines, specific processes in technology are patented. These can be circumvented by alternative manufacturing methods, but this required R&D infrastructure and a suitably skilled workforce. In the case of a few relatively new vaccines, such as the [[human papillomavirus]] vaccine, the patents may impose an additional barrier.<ref>{{cite web|title=Increasing Access to Vaccines Through Technology Transfer and Local Production|publisher=[[World Health Organization]] (WHO)|date=2011|url=https://www.who.int/phi/publications/Increasing_Access_to_Vaccines_Through_Technology_Transfer.pdf|url-status=live|archive-url=https://web.archive.org/web/20151123091841/http://www.who.int/phi/publications/Increasing_Access_to_Vaccines_Through_Technology_Transfer.pdf|archive-date=23 November 2015}}</ref> When increased production of vaccines was urgently needed during the [[COVID-19 pandemic]] in 2021, the [[World Trade Organization]] and governments around the world evaluated whether to waive [[intellectual property]] rights and patents on [[COVID-19 vaccine]]s, which would "eliminate all potential barriers to the timely access of affordable COVID-19 medical products, including vaccines and medicines, and scale up the manufacturing and supply of essential medical products".<ref name="somos">{{cite news |author1=Christy Somos |title=Everything you need to know about the WTO's COVID-19 vaccine patent proposal |url=https://www.ctvnews.ca/health/coronavirus/everything-you-need-to-know-about-the-wto-s-covid-19-vaccine-patent-proposal-1.5418708 |access-date=23 May 2021 |work=CTV News |date=7 May 2021 |archive-date=23 May 2021 |archive-url=https://web.archive.org/web/20210523145416/https://www.ctvnews.ca/health/coronavirus/everything-you-need-to-know-about-the-wto-s-covid-19-vaccine-patent-proposal-1.5418708 |url-status=live }}</ref>
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