Making a COVID-19 vaccine that works for everyone: ensuring equity and inclusivity in clinical trials

References

• Blane D, Social determinants of health–socioeconomic status, social class, and ethnicity. Am J Public Health 1995;85:903–6.
   PubMed Web of Science ®Google Scholar
• Deaths involving COVID-19 by local area and socioeconomic deprivation - office for National Statistics [Internet]. [cited 2020 Dec 23]. Available from: https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/bulletins/deathsinvolvingcovid19bylocalareasanddeprivation/deathsoccurringbetween1marchand31july2020
   Google Scholar
• Raisi-Estabragh Z, McCracken C, Bethell MS, et al. Greater risk of severe COVID-19 in Black, Asian and minority ethnic populations is not explained by cardiometabolic, socioeconomic or behavioural factors, or by 25(OH)-vitamin D status: study of 1326 cases from the UK Biobank. J Public Health (Bangkok). 2020 Aug 18;42:451–460.
   PubMed Web of Science ®Google Scholar
• Gurven MD, Lieberman DE. WEIRD bodies: mismatch, medicine and missing diversity. Evol Human Behav. 2020;41:330–340.
   Web of Science ®Google Scholar
• Nkengasong JN, Ndembi N, Tshangela A, et al. COVID-19 vaccines: how to ensure Africa has access. Nature. 2020;586:197–199.
   PubMed Web of Science ®Google Scholar
• Forster AS, Rockliffe L, Chorley AJ, et al. Ethnicity-specific factors influencing childhood immunisation decisions among Black and Asian Minority Ethnic groups in the UK: a systematic review of qualitative research. J Epidemiol Community Health. 2017 Jun 1;71:544–549 [cited 2020 Dec 31].
   PubMed Web of Science ®Google Scholar
• Walsh EE, Frenck RW, Falsey AR, et al. Safety and immunogenicity of two RNA-based Covid-19 vaccine candidates. N Engl J Med. 2020 Oct 14;397(10269):99-111.
   Web of Science ®Google Scholar
• Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020 Dec 10;383:2603–2615.
   PubMed Web of Science ®Google Scholar
• Voysey M, Clemens SAC, Madhi SA, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2020 Dec 8. [cited 2020 Dec 23]. Available from: http://www.ncbi.nlm.nih.gov/pubmed/33306989.
   Google Scholar
• Anderson EJ, Rouphael NG, Widge AT, et al. Safety and immunogenicity of SARS-CoV-2 mRNA-1273 vaccine in older adults. N Engl J Med. 2020 Sep 29;383:2427–2438.
   PubMed Web of Science ®Google Scholar
• Jackson LA, Anderson EJ, Rouphael NG, et al. An mRNA vaccine against SARS-CoV-2 — preliminary report. N Engl J Med. 2020 Nov 12;383:1920–1931.
   PubMed Web of Science ®Google Scholar
• Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2020 Dec 30:NEJMoa2035389. [cited 2021 Jan 2]. Available from: http://www.nejm.org/doi/10.1056/NEJMoa2035389.
   Web of Science ®Google Scholar
• El-Sadr WM, Justman J. Africa in the path of COVID-19. N Engl J Med. 2020 Jul 16 [cited 2020 Dec 31];383:e11.
   PubMed Web of Science ®Google Scholar
• Baqui P, Bica I, Marra V, et al. Ethnic and regional variations in hospital mortality from COVID-19 in Brazil: a cross-sectional observational study. Lancet Glob Heal. 2020 Aug 1;8:e1018–26.
   PubMed Web of Science ®Google Scholar
• McEwen BS. Neurobiological and systemic effects of chronic stress. Chronic Stress. SAGE Publications Inc.; 2017; 1:247054701769232.
   Google Scholar
• Deedwania P. Diabetes, cardiovascular disease, and ethnicity. J Am Coll Cardiol. 2013;61:1787–1789.
   Web of Science ®Google Scholar
• Scientific Evidence for Conditions that Increase Risk of Severe Illness. COVID-19. CDC. [Internet]. [cited 2020 Dec 31]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/evidence-table.html
   Google Scholar
• Cao Y, Li L, Feng Z, et al. Comparative genetic analysis of the novel coronavirus (2019-nCoV/SARS-CoV-2) receptor ACE2 in different populations. Cell Discov. Springer Nature. 2020;6. doi:https://doi.org/10.1038/s41421-020-0147-1.
   Google Scholar
• Nguyen A, David JK, Maden SK, et al. Human leukocyte antigen susceptibility map for severe acute respiratory syndrome coronavirus 2. J Virol. 2020 Apr 17;94. doi:https://doi.org/10.1128/JVI.00510-20
   Google Scholar
• Lactic Acidosis International Study Group. Risk factors for lactic acidosis and severe hyperlactataemia in HIV-1-infected adults exposed to antiretroviral therapy. AIDS. 2007 Nov 30; 21:2455–2464.
   PubMed Web of Science ®Google Scholar
• Burger D, Van Der Heiden I, La Porte C, et al. Interpatient variability in the pharmacokinetics of the HIV non-nucleoside reverse transcriptase inhibitor efavirenz: the effect of gender, race, and CYP2B6 polymorphism. Br J Clin Pharmacol. 2006 Feb;61:148–154.
   PubMed Web of Science ®Google Scholar
• Venter WDF, Moorhouse M, Sokhela S, et al. Dolutegravir plus two different prodrugs of tenofovir to treat HIV. N Engl J Med. 2019 Jul 24;381:803–815.
   PubMed Web of Science ®Google Scholar
• Freeman D, Loe BS, Chadwick A, et al. COVID-19 vaccine hesitancy in the UK: the Oxford coronavirus explanations, attitudes, and narratives survey (Oceans) II. Psychol Med. Cambridge University Press. 2020 Dec 11:1–15. doi: https://doi.org/10.1017/S0033291721000283
   Google Scholar
• Declaration of Helsinki. The World Medical Association(WMA) [Internet]. [cited 2020 Dec 31]. Available from: https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/
   Google Scholar
• Singh H, Rao SV, Kakkar AK, et al. Posttrial access to medical interventions: intricacies, challenges, and solutions. Int J Appl Basic Med Res. 2019;9:3–8. [cited 2020 Dec 31]. Available from: /pmc/articles/PMC6385540/?report=abstract
   PubMedGoogle Scholar
• Winning A. South Africa to pay $5.25 a dose for AstraZeneca vaccine from India’s SII. Reuters. 2021 Jan 21. [cited 2021 Feb 11]. Available from: https://www.reuters.com/article/uk-health-coronavirus-safrica-vaccines-idUSKBN29Q1O2
   Google Scholar
• Research Ethics Committee. Standard operating procedures. Health Research Authority. [cited 2021 Jan 1]. Available from: https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/research-ethics-committee-standard-operating-procedures/
   Google Scholar