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1.

Pre‑registration clinical trials of medicines and vaccines usually occur in 3 sequential phases: phase I trials usually assess safety and tolerability in a small group of less than 100 adults; phase II trials test safety, dosage and method of delivery in a larger group, usually of several hundred people; and, phase III trials aim to establish safety and efficacy usually in a large group of several hundred to several thousand people.

2.

The concept of a stringent regulatory authority was developed by the WHO Secretariat and the Global Fund to Fight AIDS, Tuberculosis and Malaria to guide medicine procurement decisions, and is now widely recognised by the international regulatory and procurement community as a regulatory authority that is:

  • a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency; or

  • an ICH observer, being the European Free Trade Association, as represented by Swissmedic, and Health Canada; or

  • a regulatory authority associated with an ICH member through a legally-binding, mutual recognition agreement, including Australia, Iceland, Liechtenstein and Norway.”

See: WHO Expert Committee on Specifications for Pharmaceutical Preparations Fifty-first report (Technical Report Series, No. 1003, 2017)

4.

https://www.newtral.es/vacunas-covid-criterios-reparto-ccaa/20210119/.

5.

https://www.cdc.gov/vaccines/programs/vtrcks/index.html.

6.

https://www.cdc.gov/vaccinesafety/concerns/concerns-history.html.

7.

https://www.cdc.gov/vaccinesafety/concerns/concerns-history.html.

12.

https://www.pandemicoversight.gov/.

13.

See, for example, Olson (2020[57]) on corporate lobbying and conflicts of interest during the COVID‑19 pandemic. Wouters et al. (2020[58]) provide background on lobbying by the bio-pharmaceutical industry, which includes vaccine manufacturers.

16.

An advisory body or expert group refers to any committee, board, commission, council, conference, taskforce, or similar group, or any subcommittee or other subgroup thereof that provides governments with advice, expertise or recommendations. They are made up of public and/or private‑sector members and/or representatives from civil society and may be put in place by the executive, legislative or judicial branches of government or government subdivisions.

18.

https://www.cdc.gov/vaccines/acip/meetings/index.html.

21.

For example: https://www.nature.com/articles/d41586-020-03219-y.

22.

For example: https://www.nature.com/articles/d41586-020-03441-8.

24.

https://www.efpia.eu/relationships-code/the-efpia-code/.

26.

https://www.cms.gov/openpayments/.

27.

The dispute between the EU and AstraZeneca on the timing and volume of vaccine deliveries is a case in point, though the eventual release of the heavily redacted contract resolved little of the conjecture surrounding the terms of the deal. The contract refers repeatedly to a requirement that AstraZeneca makes its “best reasonable effort” to manufacture and deliver vaccine doses according to the contract’s schedule, prompting speculation as to whether in its negotiations the EU may have traded away certainty for price.

29.

A recent report by the OECD on approaches to terrorist and violent extremist content (TVEC) in online content-sharing services shows that the majority of platforms ban such content to a certain extent, the majority do not have a definition of TVEC and only five companies produce reports about how they moderate and remove such content (OECD, 2020[60]).

30.

https://www.ft.com/content/3d24b654-187e-4270-b051-acfc350498d2.

31.

https://boe.es/boe/dias/2020/11/05/pdfs/BOE-A-2020-13663.pdf#BOEn.

33.

https://www.sst.dk/en/english/corona-eng/vaccination-against-COVID-19.

34.

https://www.goviralgame.com/.

35.

https://dcmsblog.uk/check-before‑you-share‑toolkit/.

36.

https://oecd-events.org/public-health-and-misinformation.

37.

https://oecd.ukgovernment.live/schedule.

38.

https://participez.lecese.fr/.

41.

By representative deliberative democratic processes it is meant processes that involve a group of randomly selected people, broadly representative of society, who are provided with the time and evidence to deliberate on a policy issue and propose collective, informed recommendations to public decision makers.

42.

https://www.parliament.scot/newsandmediacentre/116952.aspx.

46.

https://time.com/5936135/covid-race-data/

48.

https://www.sacbee.com/news/equity-lab/article249731623.html.

51.

https://sco-op.me/denmark-homeless-COVID-19-vaccination/.