The COVID-19 vaccine rollout has raised issues about trust among many Americans who are hesitant or unwilling to take the vaccine. The issue of trust is especially problematic among minority communities that have been harmed in historic medical and research incidences. People also are skeptical of a vaccine that was developed in record time, considering most vaccines take 10-15 years to make it to market.
The first month of the COVID-19 vaccine rollout among frontline healthcare workers was a reality check to the human research world after many people said no to the vaccine. There are several reasons for vaccine hesitancy, including distrust in the accelerated vaccine development process.
With the first vaccine for SARS-CoV-2 on the horizon and targeted for healthcare workers, there are safety concerns and trust issues that threaten to undermine immunization. However, all new vaccines are followed closely for adverse effects, and the oversight of COVID-19 immunization will include multiple systems of passive and active surveillance.
The sheer size of the COVID-19 vaccine clinical trials will enhance prelicensure safety and efficacy evaluation. Many post-market evaluations are in development to bolster existing surveillance for adverse events.
The 2020 landscape for clinical trials looks different than it did five or 10 years ago. Even before the worldwide disruption in research from the COVID-19 pandemic, there were systemic shifts that have squeezed trials in ways that add pressure to investigators and IRBs.
All human research, including COVID-19 vaccine trials, should be guided by the four ethical principles of autonomy, beneficence, nonmaleficence, and justice. When researchers, data safety monitoring boards, or the Food and Drug Administration decide to stop a clinical trial or expedite approval or use of an investigational product, these principles still apply.
The United States is at a challenging and possibly dangerous crossroad as the desire for speedy development of a COVID-19 vaccine might be pushing political concerns ahead of safety, efficacy, and the regulatory process, bioethicists and researchers say.
One barrier to enrolling minorities in research involves resources. For some studies, such as pediatric oncology clinical trials, there might not be enough resources to enroll one or two patients at a single site.