Ensuring Uptake of Vaccines against SARS-CoV-2

Six Trigger Criteria for State Covid-19 Vaccination Mandates.

Covid-19 is not adequately contained in the state.

The Advisory Committee on Immunization Practices has recommended vaccination for the groups for which a mandate is being considered.

The supply of vaccine is sufficient to cover the population groups for which a mandate is being considered.

Available evidence about the safety and efficacy of the vaccine has been transparently communicated.

The state has created infrastructure to provide access to vaccination without financial or logistic barriers, compensation to workers who have adverse effects from a required vaccine, and real-time surveillance of vaccine side effects.

In a time-limited evaluation, voluntary uptake of the vaccine among high-priority groups has fallen short of the level required to prevent epidemic spread.
The second criterion is that the Advisory Committee on Immunization Practices (ACIP), after reviewing the safety and efficacy evidence, has recommended vaccination for the persons who would be covered by a mandate. Currently available evidence suggests that the elderly, health professionals working in high-risk situations or working with high-risk patients (e.g., nursing home residents and patients with severe respiratory symptoms), and persons with certain underlying medical conditions may be high-priority groups for the ACIP’s consideration, along with other workers with frequent, close, on-the-job contacts and persons living in high-density settings such as prisons and dormitories. When a vaccine nears approval, the ACIP should review the updated evidence and develop recommendations. Only recommended groups should be considered for a vaccination mandate, though health officials can encourage voluntary uptake for others, using means such as public education campaigns and free vaccination.

The fact that a vaccine has received Food and Drug Administration (FDA) approval — whether under an Emergency Use Authorization (EUA) or ordinary review processes — is an insufficient basis on which to conclude that it should be required. FDA approval reflects a determination that clinical trial evidence shows that the benefits of a vaccine outweigh its risks. ACIP recommendations reflect broader considerations, including values and preferences of affected groups, implementation issues, and health economic analyses. Overweighting FDA decisions would be particularly problematic for SARS-CoV-2 vaccines because EUAs may be based on very limited evidence and consciously or unconsciously influenced by the intense pressure to speed countermeasures to market.2

The third criterion is that there is an adequate supply of vaccine to cover the groups for which a mandate is being considered. Initially, global demand for SARS-CoV-2 vaccines will outstrip supply, making the salient question not who must get them but who will be granted access to them. New York State’s unsuccessful attempt to mandate H1N1 influenza vaccination for health care workers demonstrates that imposing requirements before adequate supply has been secured needlessly provokes controversy and alienates people who have already made sacrifices to fight an epidemic.3

The fourth criterion is that there has been transparent communication of the best available evidence about the vaccine’s safety and efficacy.4 Particularly given the possibility that the evidence underlying FDA approval of SARS-CoV-2 vaccines may be more modest than usual, policymakers and the public will need to understand the limits of what is known. Public trust has already been compromised by federal officials’ endorsement of hydroxychloroquine as a Covid-19 treatment without evidentiary support; the same must not occur for vaccines.  [See how wrong this is.  Remember- Fauci & CDC knew since 2005 hydroxychloroquine was the recommended treatment]

The fifth criterion is that the government has put in place certain support mechanisms for persons required to receive the vaccine. Lessons from past vaccination campaigns suggest that a generous compensation program for people who have serious vaccine side effects should be a centerpiece of these efforts. A federal compensation fund like the Smallpox Vaccine Injury Compensation Program is one attractive model, although identifying compensable injuries may be challenging with a novel vaccine. States will also have to create distribution systems to provide SARS-CoV-2 vaccine to high-priority groups with near-zero financial and logistic barriers — for example, bringing free vaccine to points of care, pharmacies, and work sites. It is equally critical to have a safety-assessment plan in place before vaccines are widely distributed to enable health officials to evaluate safety evidence in real time. States should work with health systems to ensure that reporting systems for vaccine-related adverse events are consistently used and specify a process for reconsidering mandate decisions as evidence evolves.

The last criterion is that vaccination mandates are imposed only after a time-limited trial of voluntary vaccine provision has proved unsuccessful. Principles of public health ethics support trying less burdensome policies before moving to more burdensome ones whenever possible. In this case, the costs of a failed voluntary scheme are sufficiently high that the attempt should be limited to a matter of weeks. States should implement a system for measuring vaccine uptake within each high-priority group against a set of coverage targets. Ensuring that the economic and logistic supports described above are in place will maximize the chances for success.If the proposed trigger criteria were met, what might a vaccination mandate look like? Because the constitutional power to protect public health rests primarily with states, each state will need to adopt its own legislation. Proposed legislation should be supported by attestations from the state health officer, the ACIP, or another expert committee that all trigger criteria have been met. Targeted SARS-CoV-2 vaccination mandate policies may also be appropriate in certain federal contexts, including high-risk groups in active-duty military environments, Veterans Affairs facilities, federal prisons, and immigration detention centers.