There is a mountain of uncertainty and risk to overcome in order to achieve a successful national rollout of the COVID-19 vaccine. Here’s how we can be ready.
What will determine success?
Operation Warp Speed, a government-wide collaboration led by the Departments of Defense and Health and Human Services, intends to accelerate the development of a safe and effective COVID-19 vaccine. This will mean the delivery and administration of 300M doses to Americans once the vaccine is available. So far, the federal government has invested $10B to achieve this unprecedented effort, with over half of the funds allocated to support up to 800M doses of COVID-19 investigational vaccine candidates. The Federal government acknowledges that it is taking on significant financial risk with OWS. However, there are significant elements of uncertainty that must be overcome to have a success national rollout. A rollout grounded in transparency, integrity, and trust will instill nationwide confidence in the intentions and competence of the American healthcare system.
Ensuring safety & efficacy
An accelerated COVID-19 vaccine testing and approval process, which normally requires about 10 years, introduces significant safety concerns that weigh heavily on the minds of many Americans, particularly vulnerable populations. This hesitancy is exacerbated by the sociopolitical climate, inconsistent communications, and safety concerns. Recent issuance and revocation of the FDA’s Emergency Use Authorization raises concerns of lowered regulatory standards for vaccine approval. While the safety pledge in September was a great first step, drug safety and surveillance, clinical trial safety management, and pharmacovigilance should be established and adhered to. This will ensure proper safety reporting procedures, institutional review boards (IRB), and regulatory authorities for patient protection, safety, and the integrity of clinical trial results.
Strengthening trust and adoption through effective communications
Even quicker than the spread of COVID-19 is the spread of misinformation around its gravity. Effective and timely communication is crucial to resolving uncertainty. Varying interpretations and media coverage on the COVID-19 vaccine influences perceptions and drives vaccine attitudes and decision making. Therefore, to effectively share information related to the vaccine, credibility must underpin every message, and each message should come from trusted leaders within the community (e.g., healthcare coalitions, community health centers). Vaccine manufacture and administration data must be documented, forthcoming, and meet all data requirements on CDC’s Immunization Information Systems website. It is important that public health, external agencies, and community partners use standard communications to accommodate those individuals with varying levels of health literacy. Clear, consistent communication is critical to strengthening trust
in a vaccine.
Equitable screening & selection
Timing of vaccine administration is another element critical to Operation Warp Speed’s success. The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices should identify critical populations with three main questions:
- What is the criteria for vaccination selection (e.g., health conditions, age, race, occupation, access, environment)?
- What is the associated risk level (low, moderate, high)?
- How will this information be used to drive fair and equitable distribution across the U.S. and inform capacity needs?
The creation of universal and peer-reviewed criteria will allow health care providers to screen patients and select those with the highest risk of contracting COVID-19. Since the pandemic has disproportionately impacted populations based on racial factors and health risks, these categories will screen the most vulnerable populations such as the elderly, essential workers, as well as those with compromised immune systems. Risk profiles based on needs and vulnerability creates an equitable, ethical, and uniform process for distribution of the COVID-19 vaccine across demographically diverse regions.
Robust supply, distribution, and administration
How will the supply chain target the geographical areas or populations most impacted by COVID-19? Given the potentially limited initial supply, vaccine distribution and administration efforts across jurisdictions must consider the screening and selection process. The designated risk profiles should serve as triage criteria to guide vaccination provider recruitment, training, and distribution and ensure that the organizations and geographies best suited to serve high-risk populations have access to the vaccine. The following are notional prioritized focus populations for vaccination distribution:
- High risk populations
- Essential or front-line workers
- Elderly (not included in high risk populations)
- Nursing homes
- Detention population
- Educational institutions
- General population
Continuously monitoring vaccine delivery to high risk populations is of high priority since exclusion from clinical trials means practitioners are even more uncertain on how effective or safe the vaccine will be among different risk groups. Public health practitioners, health care providers, information systems, drug companies and other medical personnel must work together to carefully monitor high-risk populations and respond with targeted distribution and safety guidelines.
Leadership commitment and diligent stakeholder coordination across jurisdictions is required to address all elements of uncertainty around vaccine safety, efficacy, and supply chain, among other determinants. A successful national rollout of the COVID-19 vaccine, grounded in integrity, transparency, and trust, will uphold the public’s faith in the competence and intentions of the American healthcare system. As Operation Warp Speed proceeds, some immediate actions include:
- Establishing a COVID-19 vaccination program management office to maintain standards, documentation, guidance, metrics, etc.
- Developing a scaled tracking system to monitor, track, and report on the COVID-19 vaccine supply chain
- Producing a national COVID-19 response dashboard and supporting system infrastructure, data requirements, and data management plan to track and monitor planning, implementation, and administration data
- Drafting a COVID-19 vaccination program effectiveness plan to monitor and report program and vaccine effectiveness, as well as adverse events and regulatory compliance across jurisdictions
These common sense steps can mean the difference between success and failure in the distribution and administration of an effective Coronavirus vaccine. Ignoring them may mean our suffering will persist much longer than necessary.
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