Posted on June 1, 2020

NEHI Releases: National Preparedness for COVID-19 Immunization -Time to Act

NEHI releases, "National Preparedness for COVID-19 Immunization -Time to Act" which outlines NEHI's recommendations to ensure safe, effective and widespread vaccine acceptance and uptake.

Wendy Warring, CEO, NEHI wwaring@nehi.net

Thomas Hubbard, Vice President of Policy Research, NEHI thubbard@nehi.net

Kristoffer Szumigalski, Health Policy Associate, NEHI 

National Preparedness for COVID-19 Immunization -Time to Act

Hopes are high for the speedy development and manufacture of safe, effective COVID-19 vaccines. Vaccine discovery and production, though an incredible achievement, will not guarantee successful COVID-19 immunization. We must prepare now to ensure readiness for rapid, orderly, and equitable nationwide immunization. 

National preparedness requires a strategy extending beyond the “warp speed” effort on vaccine trials and manufacturing to downstream planning for the “last mile,” where vaccines are administered to patients. Given the need to immunize a diffuse and heterogenous population of 330 million, including African Americans and Latino Americans who suffered disproportionately from the pandemic, the last mile will be a marathon. COVID-19 immunization will occur in a highly polarized environment. National preparedness requires a workable plan to promote safe, effective and widespread vaccine acceptance and uptake. 

The confusion seen in the deployment of testing and the distribution of personal protective equipment (PPE) shows that immunization preparedness must be data-driven, evidence-based, and grounded in principles of fairness and equity. Ensuring these goals begins with bringing key stakeholders together as equal partners. 

The Trump Administration must make clear that “Operation Warp Speed” is designed with all key stakeholders at the table and subject to active congressional oversight. State and local governments should play a leading role from the start to leverage their longstanding role in regulating local immunizers and administering immunization programs. Public health leaders, health care practitioners and their national professional societies should be involved to critique and inform immunization preparedness so they can act as trusted sources of information. Bi-partisan coalitions of public health and health care experts (such as the group rallying under the #OpenSafely banner) will also be critical in the success of mass COVID-19 immunization. They can amplify sound public health messaging, deliver accurate information and help solve problems with acceptance and uptake, which will likely arise. 

An Unprecedented Challenge for Coordination and Leadership 

COVID-19 is the first 50-state public health emergency ever declared by the federal government. Successful deployment of COVID-19 vaccines requires a level of organization that matches the challenge of manufacturing hundreds of millions of vaccine doses. Federal agencies, Congress, state and local governments and the nation’s public health and medical leadership play roles in meeting the leadership challenge. 

Federal agencies: The federal government has organized and rehearsed pandemic preparedness, including emergency vaccine development and deployment, for over 40 years. Statutes like the Public Readiness and Emergency Preparedness (PREP) Act and the Defense Production Act allow the federal government to trigger emergency vaccine production and delivery. The question now is how to quickly activate the vaccine distribution infrastructure on a massive scale, and whether federal agencies are prepared to support immunization in an orderly manner, guided by transparent and evidence-based standards. These are questions only the Trump Administration can answer. It should report on the state of mass immunization preparedness now, while Congress considers new COVID-19 legislation. The Administration should also convene a special task force on mass immunization that includes non-federal leaders. 

Congress: Congress should fill gaps in mass immunization preparedness by approving new funding and new laws, where needed. Because COVID-19 is caused by a novel coronavirus (SARS-CoV-2), the pandemic raises unanticipated questions, even for the most adequately funded, well-rehearsed, apolitical immunization preparedness. Critical variables may remain unknown for months. For example, will COVID-19 vaccines be administered in one or several doses? If several, will we be prepared to track who needs a second dose? Will some vaccines be better for certain population segments? These and other questions demand contingency planning and resources to support it. Congress should begin with immediate oversight of immunization preparedness in federal agencies and formulate plans to strengthen it. 

State and local authorities: Chaotic PPE distribution highlighted that governors and state public health commissioners must be full partners in national planning. Immunization is a longstanding responsibility of state public health authorities, albeit one shared with the CDC. State law and regulation govern the practice of medicine. States decide who can administer vaccines, and under what terms and conditions. States administer the federal Vaccine for Children program, providing vaccines to over 40,000 sites throughout the country. States operate immunization registries that provide practitioners with access to patient immunization histories. Given the unprecedented complexities of COVID-19 immunization, state laws and regulations may need revision to allow all qualified practitioners to immunize patients and access immunization data. State-managed immunization registries may need to be rapidly upgraded to provide this capability, (and Congress should act quickly to support it through funding to cash-strapped states.) 

The public health and medical communities: Health care providers remain the most trusted sources of information and support for immunization by Americans. Thus, health care providers must trust a new vaccine for it to succeed. As COVID-19 vaccines become available, vocal support of health care providers will be essential to the success of vaccine acceptance and distribution. Professional societies that represent providers should come together in a coalition that will critique federal and state immunization preparedness, promote clear, evidence-based messaging to the public, and build trust in COVID-19 immunization. 

Building Trust in Mass COVID-19 Immunization: Three Challenges 

Three unique challenges loom in building public trust in COVID-19 preparedness. 

Transparency on COVID-19 vaccine safety and effectiveness: COVID-19 vaccines are being tested in novel and accelerated clinical trials. Some use cutting-edge science applied to vaccine development for the first time. Vaccine development at “warp speed” offers hope for relief from the pandemic but will also invite speculation that the FDA may settle for shortcuts and approve unproven science. Approved vaccines may have varying degrees of effectiveness, like that seen in yearly influenza immunizations. The FDA and the Administration’s “Operation Warp Speed” leadership must be transparent on the standards applied to vaccine approval. Without transparency it will be unnecessarily difficult, if not impossible, for the nation’s public health and medical leaders to reach consensus on the safety and efficacy of approved vaccines and play their crucial role in educating patients and the public. 

Consistent, truthful messaging about immunization: Estimates recently published in JAMA suggest that a vaccine refusal rate above 10% could compromise the nation’s ability to reach herd immunity. In recent surveys, only 75% of respondents indicated their intention to be immunized, and only 30% indicated a desire to be immunized immediately. 

Successful immunization will require extraordinarily deft CDC messaging supported by health care providers. Any ambiguity on COVID-19 messaging from the CDC must be clarified and then reinforced by public health and provider communities. The public must understand the safety and efficacy profile of the COVID-19 vaccines approved by the FDA. Consistent messaging should not only address longstanding forms of vaccine hesitancy but also vaccine disinformation. Coordinated disinformation campaigns, from both domestic and foreign sources, are already underway. 

Transparent guidelines for immunization priority-setting and mandates: The federal government and the pharmaceutical industry are taking steps now to make an unprecedented level of manufacturing capacity available once COVID-19 vaccines are approved. Even with this capacity, vaccines will be allocated to high-priority groups first. While it is widely expected that health care workers will get priority, the pandemic has illustrated that the health of a greater number of essential workers (such as delivery, grocery, child care and transit workers) may be a critical priority for restoring the economy. 

Immunization mandates will also be at issue. Many states already impose immunization mandates on health care workers to protect patients. COVID-19 immunization mandates may also be required for some categories of non-health care employment. Individuals who are not prioritized for the first immunization phases may need to remain physically distanced. The public will need to understand and trust these expectations in advance. Here again, transparency and close collaboration among government officials, public health and clinical leaders is crucial. 

National preparedness will require a fair, transparent plan for state and local vaccine allocation. Attention is now focused on the threat “vaccine nationalism” may pose if countries refuse to share vaccines with other countries. Nationally, “vaccine sectionalism” may be an equally difficult threat. States, cities and health care systems have been pitted against each other in pursuit of PPE and other equipment. The Department of Health and Human Services has authority to stockpile and deploy vaccines, and should be explicit about the principles and evidence used to justify decisions. These decisions should be clear enough so that non-government organizations (such as public health and medical societies) can affirm and support them. 

Planning for Rapid Vaccine Uptake: Three Issues 

Three additional issues must be addressed to plan for national COVID-19 immunization success. 

Payment policy that supports uptake of immunization: Although several companies developing COVID-19 vaccines have committed to favorable pricing or pricing at-cost, COVID-19 payment policy remains unsettled. Consumer costs influence vaccination rates, so costs of immunization to patients must be minimized to maximize uptake. This could mean having a short-term or emergency period in which the immunization cost is subsidized, while planning for different terms of extended, perhaps permanent, coverage of COVID-19 immunization within commercial and public insurance plans. It is entirely possible that COVID-19 immunization may become a permanent, guideline-based practice. Rapid, mass immunization will be thwarted if out-of-pocket or other costs deter Americans from accepting immunization. 

Integration with other (non-COVID) public health priorities: COVID-19 threatens to exacerbate health risks from other vaccine-preventable diseases. The pandemic threatens to lower rates of influenza immunization among adults and has already depressed pediatric immunization. Uptake of most CDC-recommended vaccines for adults remain well below optimal rates and represent a major missed opportunity for safeguarding Americans’ health and for reducing avoidable health care costs. Seizing the opportunity to reduce these costs now has new urgency to avoid creating additional health problems. 

Innovation: A comprehensive national strategy for COVID-19 immunization preparedness should place a high priority on innovative ways to quickly reach patients in need. The pandemic has exposed and widened gaping disparities in the health risks and access to care faced by Americans. African Americans, Latino Americans, older Americans, Americans with complex and chronic conditions, and Americans in congregate settings have suffered disproportionately. A full range of needed innovations will likely include expanding the corps of immunizers, enabling mobile immunization units, and utilizing social media and other communications platforms to educate citizens on the safety and effectiveness of vaccines. 

What Next? 

Recently the editor of JAMA Pediatrics, Dr. Dimitri Christakis, called for the creation of a special task force, comprising experts from multiple sectors, to devise an evidence-based, data-driven strategy for re-opening schools throughout the country, (“School Reopening — The Pandemic Issue That Is Not Getting Its Due.”) Like school reopening, COVID-19 immunization is an issue that is not yet getting its full due, and an issue only solved with strong collaboration among federal, state, public health and clinical leaders. 

In the coming weeks, Congress will debate new legislation to fight the pandemic and restore the economy. In this short window of time, the Administration must release or revise a working plan on COVID-19 immunization preparedness that encompasses distribution and administration over the immunization last mile. The Administration should create a special task force on immunization to build trust among the nation’s health care practitioners and the public. The task force should critique and further craft the national plan and ensure it is grounded in transparent, evidence-based preparedness standards. Congress should exercise its oversight authority and fill gaps in preparedness planning. State government, public health and medical leaders should be active members of the task force. 

Outside the federal government, state governors, philanthropies, professional societies, and leading clinicians, researchers and health policy experts have played an important role in the COVID-19 response, as evidenced by the ad hoc coalitions of governors that have been formed to coordinate purchasing of PPE, and the #OpenSafely group cited above. Citizen action is now as essential as comprehensive government planning to make COVID-19 immunization successful. We urge key stakeholders to come together, setting aside traditional boundaries in a working coalition to support a data-driven, evidence-based and transparent campaign for equitable COVID-19 immunization. There is no time for any stakeholder to take success for granted.

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