Editing Vaccine (section)

==Licensing==
{{see also|Vaccine trial}}
A vaccine ''licensure'' occurs after the successful conclusion of the development cycle and further the clinical trials and other programs involved through [[Phases of clinical research|Phases]]{{spaces}}I–III demonstrating safety, immunoactivity, immunogenetic safety at a given specific dose, proven effectiveness in preventing infection for target populations, and enduring preventive effect (time endurance or need for revaccination must be estimated).<ref name="who-vacc">{{cite web|date=1 April 2014|title=Principles and considerations for adding a vaccine to a national immunization programme|url=https://apps.who.int/iris/bitstream/handle/10665/111548/9789241506892_eng.pdf|url-status=live|archive-url=https://web.archive.org/web/20200929164919/https://apps.who.int/iris/bitstream/handle/10665/111548/9789241506892_eng.pdf|archive-date=29 September 2020|access-date=17 August 2020|publisher=[[World Health Organization]] (WHO)}}</ref> Because preventive vaccines are predominantly evaluated in healthy population cohorts and distributed among the general population, a high standard of safety is required.<ref>{{cite journal |last1=Bok |first1=Karin |last2=Sitar |first2=Sandra |last3=Graham |first3=Barney S. |author4-link=John R. Mascola |last4=Mascola |first4=John R. |title=Accelerated COVID-19 vaccine development: milestones, lessons, and prospects |journal=Immunity |date=August 2021 |volume=54 |issue=8 |pages=1636–1651 |doi=10.1016/j.immuni.2021.07.017|pmid=34348117 |pmc=8328682 }}</ref> As part of a multinational licensing of a vaccine, the World Health Organization ''Expert Committee on Biological Standardization'' developed guidelines of international standards for manufacturing and [[quality control]] of vaccines, a process intended as a platform for national regulatory agencies to apply for their own licensing process.<ref name="who-vacc" /> Vaccine manufacturers do not receive licensing until a complete clinical cycle of development and trials proves the vaccine is safe and has long-term effectiveness, following scientific review by a multinational or national regulatory organization, such as the [[European Medicines Agency]] (EMA) or the US [[Food and Drug Administration]] (FDA).<ref name="wijnans">{{cite journal|last1=Wijnans|first1=Leonoor|last2=Voordouw|first2=Bettie|date=11 December 2015|title=A review of the changes to the licensing of influenza vaccines in Europe|journal=Influenza and Other Respiratory Viruses|volume=10|issue=1|pages=2–8|doi=10.1111/irv.12351|issn=1750-2640|pmc=4687503|pmid=26439108}}</ref><ref name="chop">{{cite web|last=Offit|first=Paul A.|year=2020|title=Making vaccines: Licensure, recommendations and requirements|url=https://www.chop.edu/centers-programs/vaccine-education-center/making-vaccines/licensure-recommendations-and-requirements|url-status=live|archive-url=https://web.archive.org/web/20200908060918/https://www.chop.edu/centers-programs/vaccine-education-center/making-vaccines/licensure-recommendations-and-requirements|archive-date=8 September 2020|access-date=20 August 2020|publisher=Children's Hospital of Philadelphia}}</ref>

Upon [[Developing country|developing countries]] adopting WHO guidelines for vaccine development and licensure, each country has its own responsibility to issue a national licensure, and to manage, deploy, and monitor the vaccine throughout its use in each nation.<ref name="who-vacc" /> Building trust and acceptance of a licensed vaccine among the public is a task of communication by governments and healthcare personnel to ensure a vaccination campaign proceeds smoothly, saves lives, and enables economic recovery.<ref name="toner">{{cite report|url=https://www.centerforhealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2020/200819-vaccine-allocation.pdf|title=Interim Framework for COVID-19 Vaccine Allocation and Distribution in the United States|publisher=Johns Hopkins Center for Health Security|access-date=24 August 2020|archive-url=https://web.archive.org/web/20200822093641/https://www.centerforhealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2020/200819-vaccine-allocation.pdf|archive-date=22 August 2020|vauthors=Toner E, Barnill A, Krubiner C, Bernstein J, Privor-Dumm L, Watson M, Martin E, Potter C, Hosangadi D, Connell N, Watson C, Schoch-Spana M, Veenema TG, Meyer D, Biddison EL, Regenberg A, Inglesby T, Cicero A|display-authors=6|publication-place=Baltimore, MD|year=2020|url-status=live}}</ref><ref>{{cite journal|last1=Dooling|first1=Kathleen|last2=Marin|first2=Mona|last3=Wallace|first3=Megan|last4=McClung|first4=Nancy|last5=Chamberland|first5=Mary|last6=Lee|first6=Grace M.|last7=Talbot|first7=H. Keipp|last8=Romero|first8=José R.|last9=Bell|first9=Beth P.|last10=Oliver|first10=Sara E.|display-authors=6|date=December 2020|title=The Advisory Committee on Immunization Practices' Updated Interim Recommendation for Allocation of COVID-19 Vaccine – United States, December 2020|journal=MMWR. Morbidity and Mortality Weekly Report|volume=69|issue=5152|pages=1657–1660|doi=10.15585/mmwr.mm695152e2|pmid=33382671|pmc=9191902 |doi-access=free|name-list-style=vanc}}</ref> When a vaccine is licensed, it will initially be in limited supply due to variable manufacturing, distribution, and logistical factors, requiring an allocation plan for the limited supply and which population segments should be prioritized to first receive the vaccine.<ref name="toner" />

===World Health Organization===
Vaccines developed for multinational distribution via the [[UNICEF|United Nations Children's Fund (UNICEF)]] require pre-qualification by the WHO to ensure [[international standard]]s of quality, safety, immunogenicity, and efficacy for adoption by numerous countries.<ref name="who-vacc" />

The process requires manufacturing consistency at WHO-contracted laboratories following [[Good Manufacturing Practice]] (GMP).<ref name="who-vacc" /> When UN agencies are involved in vaccine licensure, individual nations collaborate by 1) issuing marketing authorization and a national license for the vaccine, its manufacturers, and distribution partners; and 2) conducting [[postmarketing surveillance]], including records for adverse events after the vaccination program. The WHO works with national agencies to monitor inspections of manufacturing facilities and distributors for compliance with GMP and regulatory oversight.<ref name="who-vacc" />

Some countries choose to buy vaccines licensed by reputable national organizations, such as EMA, FDA, or national agencies in other affluent countries, but such purchases typically are more expensive and may not have distribution resources suitable to local conditions in developing countries.<ref name="who-vacc" />

===European Union===
In the European Union (EU), vaccines for pandemic pathogens, such as [[seasonal influenza]], are licensed EU-wide where all the [[Member state of the European Union|member states]] comply ("centralized"), are licensed for only some member states ("decentralized"), or are licensed on an individual national level.<ref name="wijnans" /> Generally, all EU states follow regulatory guidance and clinical programs defined by the European [[Committee for Medicinal Products for Human Use]] (CHMP), a scientific panel of the [[European Medicines Agency]] (EMA) responsible for vaccine licensure.<ref name="wijnans" /> The CHMP is supported by several expert groups who assess and monitor the progress of a vaccine before and after licensure and distribution.<ref name="wijnans" />

===United States===
Under the FDA, the process of establishing evidence for vaccine clinical safety and efficacy is the same as for [[Drug approval|the approval process for prescription drugs]].<ref name="fda-vacc">{{cite web|date=30 January 2020|title=Vaccine product approval process|url=https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-product-approval-process|archive-url=https://web.archive.org/web/20200927144627/https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-product-approval-process|archive-date=27 September 2020|access-date=17 August 2020|publisher=U.S. [[Food and Drug Administration]] (FDA)}}</ref> If successful through the stages of clinical development, the vaccine licensing process is followed by a [[Biologics License Application]] which must provide a scientific review team (from diverse disciplines, such as physicians, statisticians, microbiologists, chemists) and comprehensive documentation for the vaccine candidate having efficacy and safety throughout its development. Also during this stage, the proposed manufacturing facility is examined by expert reviewers for GMP compliance, and the label must have a compliant description to enable health care providers' definition of vaccine-specific use, including its possible risks, to communicate and deliver the vaccine to the public.<ref name="fda-vacc" /> After licensure, monitoring of the vaccine and its production, including periodic inspections for GMP compliance, continue as long as the manufacturer retains its license, which may include additional submissions to the FDA of tests for potency, safety, and purity for each vaccine manufacturing step.<ref name="fda-vacc" />

===India===
In India, the [[Drugs Controller General of India|Drugs Controller General]], the head of department of the [[Central Drugs Standard Control Organization]], India's national regulatory body for cosmetics, pharmaceuticals and medical devices, is responsible for the approval of licences for specified categories of drugs such as vaccines and other medicinal items, such as blood or blood products, IV fluids, and sera.<ref>{{cite web |url=https://cdsco.gov.in/opencms/opencms/en/Home/ |title=home |publisher=Cdsco.gov.in |date=15 April 2021 |access-date=10 January 2022 |archive-date=4 January 2022 |archive-url=https://web.archive.org/web/20220104201219/https://cdsco.gov.in/opencms/opencms/en/Home/ |url-status=live }}</ref>

===Postmarketing surveillance===
Until a vaccine is in use amongst the general population, all potential [[Vaccine adverse event|adverse events]] from the vaccine may not be known, requiring manufacturers to conduct [[Phase IV trial|Phase{{spaces}}IV]] studies for [[postmarketing surveillance]] of the vaccine while it is used widely in the public.<ref name="who-vacc" /><ref name="fda-vacc" /> The WHO works with UN member states to implement post-licensing surveillance.<ref name="who-vacc" /> The FDA relies on a [[Vaccine Adverse Event Reporting System]] to monitor safety concerns about a vaccine throughout its use in the American public.<ref name="fda-vacc" />