Literature DB >> 33627051

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

Toby Pepperrell1, Florence Rodgers1, Pranav Tandon2, Kelly Sarsfield3, Molly Pugh-Jones3, Theo Rashid4, Sarai Keestra5,6.   

Abstract

Coronavirus disease 2019 (COVID-19) mortality and morbidity have been shown to increase with deprivation and impact non-White ethnicities more severely. Despite the extra risk Black, Asian and Minority Ethnicity (BAME) groups face in the pandemic, our current medical research system seems to prioritise innovation aimed at people of European descent. We found significant difficulties in assessing baseline demographics in clinical trials for COVID-19 vaccines, displaying a lack of transparency in reporting. Further, we found that most of these trials take place in high-income countries, with only 25 of 219 trials (11.4%) taking place in lower middle- or low-income countries. Trials for the current best vaccine candidates (BNT162b2, ChadOx1, mRNA-173) recruited 80.0% White participants. Underrepresentation of BAME groups in medical research will perpetuate historical distrust in healthcare processes, and poses a risk of unknown differences in efficacy and safety of these vaccines by phenotype. Limiting trial demographics and settings will mean a lack of global applicability of the results of COVID-19 vaccine trials, which will slow progress towards ending the pandemic.

Entities:  

Keywords:  Covid-19; clinical trials; ethnic minorities; health equity; vaccines

Mesh:

Substances:

Year:  2021        PMID: 33627051      PMCID: PMC7919886          DOI: 10.1080/16549716.2021.1892309

Source DB:  PubMed          Journal:  Glob Health Action        ISSN: 1654-9880            Impact factor:   2.640


  21 in total

1.  Diabetes, cardiovascular disease, and ethnicity.

Authors:  Prakash Deedwania
Journal:  J Am Coll Cardiol       Date:  2013-02-28       Impact factor: 24.094

2.  COVID-19 vaccines: how to ensure Africa has access.

Authors:  John N Nkengasong; Nicaise Ndembi; Akhona Tshangela; Tajudeen Raji
Journal:  Nature       Date:  2020-10       Impact factor: 49.962

3.  Africa in the Path of Covid-19.

Authors:  Wafaa M El-Sadr; Jessica Justman
Journal:  N Engl J Med       Date:  2020-04-17       Impact factor: 91.245

Review 4.  Risk factors for lactic acidosis and severe hyperlactataemia in HIV-1-infected adults exposed to antiretroviral therapy.

Authors: 
Journal:  AIDS       Date:  2007-11-30       Impact factor: 4.177

5.  An mRNA Vaccine against SARS-CoV-2 - Preliminary Report.

Authors:  Lisa A Jackson; Evan J Anderson; Nadine G Rouphael; Paul C Roberts; Mamodikoe Makhene; Rhea N Coler; Michele P McCullough; James D Chappell; Mark R Denison; Laura J Stevens; Andrea J Pruijssers; Adrian McDermott; Britta Flach; Nicole A Doria-Rose; Kizzmekia S Corbett; Kaitlyn M Morabito; Sijy O'Dell; Stephen D Schmidt; Phillip A Swanson; Marcelino Padilla; John R Mascola; Kathleen M Neuzil; Hamilton Bennett; Wellington Sun; Etza Peters; Mat Makowski; Jim Albert; Kaitlyn Cross; Wendy Buchanan; Rhonda Pikaart-Tautges; Julie E Ledgerwood; Barney S Graham; John H Beigel
Journal:  N Engl J Med       Date:  2020-07-14       Impact factor: 91.245

Review 6.  Posttrial Access to Medical Interventions: Intricacies, Challenges, and Solutions.

Authors:  Harmanjit Singh; Sunil Vishwas Rao; Ashish Kumar Kakkar; Jagjit Singh; Hasitha Daina Manohar
Journal:  Int J Appl Basic Med Res       Date:  2019 Jan-Mar

7.  Comparative genetic analysis of the novel coronavirus (2019-nCoV/SARS-CoV-2) receptor ACE2 in different populations.

Authors:  Yanan Cao; Lin Li; Zhimin Feng; Shengqing Wan; Peide Huang; Xiaohui Sun; Fang Wen; Xuanlin Huang; Guang Ning; Weiqing Wang
Journal:  Cell Discov       Date:  2020-02-24       Impact factor: 10.849

8.  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.

Authors:  Merryn Voysey; Sue Ann Costa Clemens; Shabir A Madhi; Lily Y Weckx; Pedro M Folegatti; Parvinder K Aley; Brian Angus; Vicky L Baillie; Shaun L Barnabas; Qasim E Bhorat; Sagida Bibi; Carmen Briner; Paola Cicconi; Andrea M Collins; Rachel Colin-Jones; Clare L Cutland; Thomas C Darton; Keertan Dheda; Christopher J A Duncan; Katherine R W Emary; Katie J Ewer; Lee Fairlie; Saul N Faust; Shuo Feng; Daniela M Ferreira; Adam Finn; Anna L Goodman; Catherine M Green; Christopher A Green; Paul T Heath; Catherine Hill; Helen Hill; Ian Hirsch; Susanne H C Hodgson; Alane Izu; Susan Jackson; Daniel Jenkin; Carina C D Joe; Simon Kerridge; Anthonet Koen; Gaurav Kwatra; Rajeka Lazarus; Alison M Lawrie; Alice Lelliott; Vincenzo Libri; Patrick J Lillie; Raburn Mallory; Ana V A Mendes; Eveline P Milan; Angela M Minassian; Alastair McGregor; Hazel Morrison; Yama F Mujadidi; Anusha Nana; Peter J O'Reilly; Sherman D Padayachee; Ana Pittella; Emma Plested; Katrina M Pollock; Maheshi N Ramasamy; Sarah Rhead; Alexandre V Schwarzbold; Nisha Singh; Andrew Smith; Rinn Song; Matthew D Snape; Eduardo Sprinz; Rebecca K Sutherland; Richard Tarrant; Emma C Thomson; M Estée Török; Mark Toshner; David P J Turner; Johan Vekemans; Tonya L Villafana; Marion E E Watson; Christopher J Williams; Alexander D Douglas; Adrian V S Hill; Teresa Lambe; Sarah C Gilbert; Andrew J Pollard
Journal:  Lancet       Date:  2020-12-08       Impact factor: 79.321

9.  Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine.

Authors:  Lindsey R Baden; Hana M El Sahly; Brandon Essink; Karen Kotloff; Sharon Frey; Rick Novak; David Diemert; Stephen A Spector; Nadine Rouphael; C Buddy Creech; John McGettigan; Shishir Khetan; Nathan Segall; Joel Solis; Adam Brosz; Carlos Fierro; Howard Schwartz; Kathleen Neuzil; Larry Corey; Peter Gilbert; Holly Janes; Dean Follmann; Mary Marovich; John Mascola; Laura Polakowski; Julie Ledgerwood; Barney S Graham; Hamilton Bennett; Rolando Pajon; Conor Knightly; Brett Leav; Weiping Deng; Honghong Zhou; Shu Han; Melanie Ivarsson; Jacqueline Miller; Tal Zaks
Journal:  N Engl J Med       Date:  2020-12-30       Impact factor: 91.245

10.  Neurobiological and Systemic Effects of Chronic Stress.

Authors:  Bruce S McEwen
Journal:  Chronic Stress (Thousand Oaks)       Date:  2017-04-10
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  7 in total

1.  Quantifying Diversity and Representation in Pivotal Trials Leading to Marketing Authorization in Europe.

Authors:  Zachary Smith; Emily Botto; Kenneth Getz
Journal:  Ther Innov Regul Sci       Date:  2022-06-09       Impact factor: 1.337

Review 2.  An Updated Review of SARS-CoV-2 Vaccines and the Importance of Effective Vaccination Programs in Pandemic Times.

Authors:  Cielo García-Montero; Oscar Fraile-Martínez; Coral Bravo; Diego Torres-Carranza; Lara Sanchez-Trujillo; Ana M Gómez-Lahoz; Luis G Guijarro; Natalio García-Honduvilla; Angel Asúnsolo; Julia Bujan; Jorge Monserrat; Encarnación Serrano; Melchor Álvarez-Mon; Juan A De León-Luis; Miguel A Álvarez-Mon; Miguel A Ortega
Journal:  Vaccines (Basel)       Date:  2021-04-27

3.  Who funded the research behind the Oxford-AstraZeneca COVID-19 vaccine?

Authors:  Sabrina Wimmer; Sarai Keestra; Samuel Cross; Yeanuk Rho; Henna Reddy; Toby Pepperrell; Florence Rodgers; Rhiannon Osborne; Ayolola Eni-Olotu; Rishi Banerjee
Journal:  BMJ Glob Health       Date:  2021-12

Review 4.  COVID-19 Vaccination: The Mainspring of Challenges and the Seed of Remonstrance.

Authors:  Hoda Najjar; Hadeel T Al-Jighefee; Abeer Qush; Muna Nizar Ahmed; Sara Awwad; Layla Kamareddine
Journal:  Vaccines (Basel)       Date:  2021-12-13

Review 5.  Cochleovestibular findings linked to COVID-19: A scoping review for clinical care planning in South Africa.

Authors:  Katijah Khoza-Shangase
Journal:  S Afr J Commun Disord       Date:  2022-08-12

6.  Perceptions of COVID-19 Vaccine, Racism, and Social Vulnerability: An Examination among East Asian Americans, Southeast Asian Americans, South Asian Americans, and Others.

Authors:  Tsu-Yin Wu; Olivia Ford; Alice Jo Rainville; Xining Yang; Chong Man Chow; Sarah Lally; Rachel Bessire; Jessica Donnelly
Journal:  Vaccines (Basel)       Date:  2022-08-17

7.  COVID-19 Pandemic and Equal Access to Vaccines.

Authors:  Matteo Bolcato; Daniele Rodriguez; Alessandro Feola; Giulio Di Mizio; Alessandro Bonsignore; Rosagemma Ciliberti; Camilla Tettamanti; Marco Trabucco Aurilio; Anna Aprile
Journal:  Vaccines (Basel)       Date:  2021-05-21
  7 in total

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