Dear Editor,

The lack of transparency in the relationship between policymakers and scientists may undermine the ethics of the public health decision-making process in the COVID-19 pandemic and represents a fundamental weakness underlying effective science-supported government-based policies and strategies related to COVID-19. To shelter integrity from politics, the US Food and Drug Administration decided that decisions would only be made on the basis of ‘good science and sound data’ before approving or authorizing a COVID-19 vaccine.1

Healthcare policymakers increasingly look at scientific evidence to justify their policies and actions, to avoid criticism by the media and the public, to reduce the risk of vaccine hesitancy, and to forecast vaccine effectiveness, thus improving the responsiveness of a healthcare system. Ethical challenges may arise for policymakers who have to decide between a ‘suppression’ strategy by implementing a strict lockdown, and a ‘mitigation’ strategy, such as ‘flattening the curve’ or mask- wearing. Socio-economic implications derived from this choice, compounded by incompletely understood scientific aspects of COVID-19, complicate decisions pertaining to policy.2

Effective and transparent communication, coupled with real-time epidemiological decisions based on open access data that is critically assessed by scientists, the media, policymakers and the public, i.e., evidence-based policymaking, may result in a more successful and robust strategy to combat COVID-19. The open disclosure of scientific evidence is essential to protect public trust and address confusion regarding policies and hesitation among the public in following government-based recommendations. This can be achieved by open data sharing, blinding patients’ clinical trial data to protect their privacy, and fortifying the integrity of peer review—aspects that can constitute the golden standard in public health during this pandemic, as advocated by the World Health Organization.3

The US Centers for Disease Control and Prevention and the Food and Drug Administration set up a ‘vaccine safety monitoring program’ and an online warning system, the Vaccine Adverse Event Reporting System, to allow healthcare workers, vaccine manufacturers, or the public to report any adverse effects supposedly caused by vaccines. However, since most reports to the Vaccine Adverse Event Reporting System are voluntary, they may be biased, incomplete (due to underreporting), or unverifiable.4 Thus, a coordinated network with open data sharing of adverse effects of vaccines may strengthen current safety monitoring systems.

A sustainable data-driven healthcare system could benefit from business and education continuity planning principles (resolution, resilience, return, reimagining, and reform phases),5 with constant feedback and interaction between scientists, the public, media, policymakers, and government health officials.

references

1. 1. Sharfstein J. How the FDA should protect its integrity from politics. Nature 2020 Sep;585(7824):161.
2. 2. Nicola M, Alsafi Z, Sohrabi C, Kerwan A, Al-Jabir A, Iosifidis C, et al. The socio-economic implications of the coronavirus pandemic (COVID-19): a review. Int J Surg 2020 Jun;78:185-193.
3. 3. Teixeira da Silva JA, Bornemann-Cimenti H, Tsigaris P. Optimizing peer review to minimize the risk of retracting COVID-19-related literature. Med Health Care Philos 2021 Mar;24(1):21-26.
4. 4. CDC. Vaccine Adverse Event Reporting System (VAERS). Last updated: 25 August 2021. [cited 2021 Nov 17]. Available from: https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vaers/index.html.
5. 5. Al Bualy R, Al Sinani S, Al Naamani K. Navigating the ‘next normal’ in medical education post COVID-19. Oman Med J 2020 Jul;35(4):e144.