key: cord-1002335-x3d34eb1
authors: Salari, Nader; Vepa, Abhinav; Daneshkhah, Alireza; Darvishi, Niloofar; Ghasemi, Hooman; Khunti, Kamlesh; Mohammadi, Masoud
title: Efficacy of COVID-19 vaccines by race and ethnicity
date: 2022-05-05
journal: Public Health
DOI: 10.1016/j.puhe.2022.04.009
sha: 1adfeeda6ad20197163660e6fca8b5246379c213
doc_id: 1002335
cord_uid: x3d34eb1

Objectives Vaccine uptake amongst ethnic minority populations has been persistently lower which may be due to socioeconomic factors such as health literacy, health insurance status. this review aimed to assess to what extent COVID-19 clinical trials have considered the impact of race and ethnicity on COVID-19 vaccine safety and efficacy. Study design Systematic review. Methods Data regarding ethnicity in COVID-19 vaccine clinical trials was systematically reviewed according to PRISMA guidelines in this systematic review, which ran from inception until June 2021. three international databases: PubMed, Scopus, and Web of Science (WoS) were used to conduct systematic article searches. Only two studies reported vaccine efficacy among ethnic minority groups. Results The efficacy of the mRNA-1273 vaccine was confirmed to be 95% in Caucasians and 97.5 percent in ‘people of colour’ in a study by Baden et al, In another study by Polack et al, BNT162b2 mRNA vaccine efficacy was reported to be 95.2 percent in Caucasians, 100 percent in Afro-Caribbean or African Americans, 94.2 percent in Hispanic or Latinx, and 95.4 percent in non-Hispanic, non-Latinx people. Conclusions Given the highly differing effect of COVID-19 upon the Afro-Caribbean, Hispanic and south Asian populations, it is imperative for COVID-19 vaccine clinical trials to thoroughly assess the safety and efficacy of vaccines in different ethnicities, and if necessary, develop ethnicity-specific protocols which can minimize the disproportionate effect of COVID-19 on ethnic minority populations.

Globally, it is well established that ethnic minority populations such as Afro-Carribeans, South Asians and Hispanics, have been identified as carrying a higher risk of mortality from COVID-19 [1] . However, despite this, vaccine uptake amongst ethnic minority populations has been persistently lower which may be due to socioeconomic factors such as health literacy and health insurance status, mobility, and social marginalization [2, 3] . Addressing injustice and inequality in the impact of the vaccine on different ethnic groups requires a multifaceted approach that focuses on the needs of marginalized groups and ethnic groups [4] . Distrust of science and treatment, as well as vaccination, is rooted in a history of mistrust resulting from immoral research, especially on African-American, Latino, and Asian-American populations [4, 5] . Racism is an important factor in creating inequality in the face of disease, morbidity and mortality, especially vaccination against various diseases, and the same is true for COVID-19 [4] [5] [6] .Policies that are designed to benefit many and to the detriment of others, so that some races and ethnicities have unequal access to care and health care, and even educational and employment opportunities [4] [5] [6] .

Given the complex interplay between ethnicity and COVID-19 disease and considering that the effect of race and ethnicity on the safety and efficacy of COVID-19 vaccine has not been studied in general and its aspects are still unknown, This systematic review study was conducted to investigate the effect of different races, the effect of racial issues and racism on clinical trials of the effect of the Covid-19 vaccine in order to reveal all aspects of this effect.

The research protocol was registered in the PROSPERO (CRD42021261961). Data regarding ethnicity in COVID-19 vaccine clinical trials was systematically reviewed according to PRISMA guidelines in this systematic review, which ran from January 2020 until June 2021. Three international databases: PubMed, Scopus, and Web of Science (WoS) were used to conduct systematic article searches. In addition, the Google Scholar search engine was examined. A survey was then performed to collect gray literature from libraries. In accordance with PECO guidelines, the keywords used for the search in this study were chosen 7) and (8) low quality studies with a quality score of less than 16.

The quality of confirmatory studies was assessed with the STROBE checklist. The checks in this checklist were performed using 32 different items (scores between 0-32). In this study, studies that received a score of 16 or higher from the authors were selected and selected as mediocre and good-quality articles. Studies that received a score below 16 were considered poor quality and were excluded from the study. In these studies, none of the articles were deleted due to poor quality.

The studies, as shown in Table 1 , included phase 1, 2 and 3 trials, as well as different vaccines. The total population included in the 11 studies was 90,095, of which 85% were of a Caucasian ethnicity. Only two studies reported vaccine efficacy among ethnic minority groups. The efficacy of the mRNA-1273 vaccine was confirmed to be 95% in Caucasians and 97.5 percent in 'people of colour' in a study by Baden et al [13] . In another study by Polack et al BNT162b2 mRNA vaccine efficacy was reported to be 95.2 percent in Caucasians, 100 percent in Afro-Caribbean or African Americans, 94.2 percent in Hispanic or Latinx, and 95.4 percent in non-Hispanic, non-Latinx people [17] . The remaining studies did not look at the efficacy or effects of vaccines based on ethnicity or race.

( Table 1 Here)

Overall, Overall, our results indicate that ethnic minority populations are often excluded or underrepresented in clinical trials. Various reasons have been postulated to account for this phenomenon such as language barriers, health illiteracy, mistrust of research, stigma, cultural factors, and loss of earnings in deprived populations [2, 18] . In addition to reduced clinical research participation by ethnic minority groups, many clinical trials also often do not report ethnicity despite its clinical relevance [19] .

In conclusion, it is evident that several COVID-19 vaccine clinical trials have not considered the impact of ethnicity on the safety and efficacy of COVID-19 vaccines, in concordance with the surrounding literature [19] .

Various studies have raised various debates about racism as a key factor, which may cast doubt on the effectiveness of the vaccine among different ethnic groups. Anisah B. Bagasra et al. Reported in their study that, a significant difference in the level of trust in the government's response to the COVID-19 pandemic with Indian / Alaskan Natives reporting lower trust compared to Whites, Blacks, and Asians [6] .

The study by Mahvash Hussain -Gambles et al. Also reports that ethics committees can address racial and ethnic inequalities by providing guidance to researchers and more rigorously reviewing clinical trial protocols [20] .

The study by Justine M. Kahn et al. Also reports that the scientific community must systematically collect accurate data on race and ethnicity in order to eliminate ethnic inequalities in clinical settings and provide appropriate feedback at the individual and Create social [21] . 

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

Vaccine Hesitancy Is a Scapegoat for Structural Racism

Medical Apartheid: The Dark History of Medical Experimentation on Black Americans From Colonial Times to the Present

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Phase 3 randomized, stratified, observer blinded, placebocontrolled trial 30351 (Caucasian:24024, Asian:1382, Afro-Caribbean Or African American:3090

Phase 1, dose-escalation, openlabel clinical trial 40 (Asian:1, Caucasian:39, Hispanic Or Latino:1) 98 / 2%

ChAdOx1 nCoV-19 vaccine (intervention) -MenACWY vaccine (control) Phase 1/2, participant-blinded, multicentre

mRNA-1273 vaccine candidate, encodes the S-2P antigen Phase 1, dose-escalation

Asian:17, Afro-Caribbean Or African American:2, Multiracial:1, Native Hawaiian Or Other Pacific Islander:1, Not Reported:0, Caucasian:103

Other:9) 2 placebo-controlled, observer-blinded dose-escalation study 45 (Caucasian:37

Caucasian:31266, Afro-Caribbean Or African American:3492, Asian:1608, Native American Or Alaska Native:201, Native Hawaiian Or Other Pacific Islander:76, Multi-Racial:855, Not Reported:208, Hispanic Or Latinx:10543) -blind, randomized, controlled 552 (Caucasian:524, Afro-Caribbean Or Afro-Caribbean British:1, Asian Or Asian British:19

SCB-2019 vaccine Phase 1, randomized, doubleblind, placebo-controlled trial 151 (Race: Asian:16, Afro-Caribbean:1, Caucasian:132, Other:2 / Ethnicity: Hispanic Or Latino:10

Afro-Caribbean or African American:2, multiracial:1, native Hawaiian or other pacific:1, Caucasian:103