Ethical considerations for protecting the options of subjects in primary epidemic vaccine trials

Comments on an article by J. T. Monrad (see record 2020-61038-012). Monrad presented several issues about secondary vaccine trials. It lays out the case in which a vaccine has been tested through phases I-III and is being deployed. Subsequently, consideration is being given to conducting 'trials for another vaccine for the pathogen'. Monrad stated: 'In summary, we may say that researchers have strong prima facie reasons not to conduct a secondary vaccine trial.' Monrad discusses several factors meriting careful consideration about the need for developing and testing more than one vaccine: relative efficacy, length of immunity, adverse reactions (reactogenicity), ease of storage and administration, economic and logistical factors. What is not addressed are the ethical duties that exist when there are competing phase III vaccine candidates for COVID- 19. Ethically, a subject is allowed to quit a trial at any time. But how might this work in a vaccine trial with multiple candidates? If someone has received an experimental vaccine, they need to be informed of what to do should they wish to subsequently try an approved vaccine. But will companies and researchers with financial stakes in one vaccine readily disclose other options either initially or mid-trial? If a subject got experimental vaccine, there may be more of a chance of having an adverse immune reaction to an additional vaccine that is approved. So they may not wish to do anything. Thus, as part of all informed consents for phase three trials, participants need to be told that at the time some vaccine is approved, they will be told whether or not they received the test vaccine or the placebo so as to help participants make their decision as to whether to get another approved vaccine or not. (PsycInfo Database Record (c) 2023 APA, all rights reserved)

Knowledge and Attitudes Toward Covid-19 and Vaccines Among a New York Haredi-Orthodox Jewish Community.

The Covid-19 pandemic has exposed the difficulty of the US public health system to respond effectively to vulnerable subpopulations, causing disproportionate rates of morbidity and mortality. New York Haredi-Orthodox Jewish communities represent a group that have been heavily impacted by Covid-19. Little research has examined their experience or perceptions toward Covid-19 and vaccines. We conducted a cross-sectional, observational study to explore the experience of Covid-19 among Haredim. Paper surveys were self-administered between December 2020 and January 2021 in Haredi neighborhood pediatricians' offices in Brooklyn, New York. Of 102 respondents, 43% reported either a positive SARS-CoV-2 viral or antibody test. Participants trusted their physicians, Orthodox medical organizations, and rabbinic leaders for medical information. Knowledge of Covid-19 transmission and risk was good (69% answered ≥ 4/6 questions correctly). Only 12% of respondents would accept a Covid-19 vaccine, 41% were undecided and 47% were strongly hesitant. Independent predictors of strong vaccine hesitancy included believing natural infection to be better than vaccination for developing immunity (adjusted odds ratio [aOR] 4.28; 95% confidence interval [CI] 1.23-14.86), agreement that prior infection provides a path toward resuming communal life (aOR 4.10; 95% CI 1.22-13.77), and pandemic-related loss of trust in physicians (aOR 5.01; 95% CI 1.05-23.96). The primary disseminators of health information for self-protective religious communities should be stakeholders who understand these groups' unique health needs. In communities with significant Covid-19 experience, vaccination messaging may need to be tailored toward protecting infection-naïve individuals and boosting natural immunity against emerging variants.

Priority vaccination for mental illness, developmental or intellectual disability.

Coronavirus vaccines have made their debut. Now, allocation practices have stepped into the spotlight. Following Centers for Disease Control and Prevention guidelines, states and healthcare institutions initially prioritised healthcare personnel and elderly residents of congregant facilities; other groups at elevated risk for severe complications are now becoming eligible through locally administered programmes. The question remains, however: who else should be prioritised for immunisation? Here, we call attention to individuals institutionalised with severe mental illnesses and/or developmental or intellectual disabilities-a group highly susceptible to the damages of COVID-19, recent research shows, and critical to consider for priority vaccination. The language describing both federal-level and state-level intentions for this population remains largely vague, despite the population's diversity across age, diagnosis, functional status and living arrangement. Such absence of specificity, in turn, leaves room for confusion and even neglect of various subgroups. We review data stressing this group's vulnerability, as well as select state plans for priority vaccination, highlighting the importance of clarity when describing intentions to vaccinate, or even generally care for, diverse populations composed of distinct subgroups in need.

Importance of Pediatric Inclusion in COVID-19 Therapeutic Trials.

Pediatric patients are excluded from most coronavirus disease 2019 (COVID-19) therapeutic trials. We outline a rationale for the inclusion of children in COVID-19 therapeutic trials, which enabled us to include children of all ages in a therapeutic COVID-19 trial at our institution.