The Advisory Committee on Immunization Practices (ACIP) met on Monday to discuss COVID-19 vaccines. Topics covered at the meeting included discussions on ethical principles for allocating initial supplies of COVID-19 vaccines, a look at the Evidence to Recommendation Framework for each domain and discussions around initial phased allocation of COVID-19 vaccines.
Vaccines in Progress
During the opening remarks, they shared a summary of the phase III results from the two mRNA Vaccines. The first vaccine, BNT162b2 vaccine (Pfizer), showed 95 percent effectiveness seven days after the second dose and 94 percent effectiveness in adults 65 years and older. The Pfizer vaccine submitted an emergency use authorization (EUA) on Friday, Nov. 20. The second vaccine, mRNA-1273 vaccine (Moderna), showed 94.5 percent effectiveness two weeks after the second dose, with EUA submission coming soon. Both vaccines show no serious safety concerns.
Public Health, Resource Use and Equity
ACIP then moved into discussions regarding the Evidence to Recommendations (EtR) Framework. However, no vote occurred. During this first EtR Framework discussion, the domains of public health problem, resource use and equity were reviewed.
1) The first domain was regarding COVID-19 disease being of public health importance. After reviewing data for the number of total cases of COVID-19, number of hospitalizations and the number of COVID-19 associated deaths, the ACIP Committee all agreed that COVID-19 disease is of public health importance.
2) The second domain addressed the topic of COVID-19 vaccine ‘X’ being a reasonable and efficient allocation of resources. Currently there are no published cost-effective analyses available. Cost-effectiveness analysis and economic impact of vaccination depend on factors that are currently unknown. These factors include duration of vaccine protection, vaccination coverage levels, and implementation costs associated with a large vaccination program. Discussions occurred around how cost-effectiveness may not be a primary driver for decision-making during a pandemic but will need to be reassessed for future recommendations. The ACIP Committee agreed and concluded that it would be a reasonable and efficient allocation of resources.
3) The last domain was regarding the impact of COVID-19 vaccine ‘X’ on health equity. There was significant discussion on identifying groups that might be disadvantaged in relation to COVID-19 disease burden or receipt of COVID-19 vaccine ‘X’. The vaccine must be accessible, acceptable, effective and used by the most disadvantaged groups within that population to truly be effective at reducing inequities. Having successful implementation of the COVID-19 vaccination program and confidence in COVID-19 vaccines will be pivotal to reducing health inequities. The ACIP Committee agreed and discussed how group-specific education is needed for transparency and to build confidence in the vaccine.
The next EtR Framework discussion centered on the domains of values, acceptability and feasibility. It was found that the overall acceptability of a COVID-19 vaccine was moderate. Some strategies to consider for overcoming barriers to vaccine acceptance are to engage trusted sources, develop communication materials, ensure providers have accurate and up-to-date information, and provide education throughout the jurisdiction, including non-clinical facility administrators. The next domain was a discussion around key stakeholders’ acceptability regarding COVID-19 vaccine ‘X’. Currently there are no published provider knowledge, attitudes or practice surveys.
Vaccine Hesitancy & Education
During a recent CDC survey of 34 state health officers in October, common concerns about vaccine hesitancy, vaccine safety and communications were brought up. In addition, a survey of nurses reported that most were confident in the safety and effectiveness of the vaccine; however, fewer would voluntarily receive the COVID-19 vaccine if it were not required. The last domain discussed was regarding the feasibility to implement COVID-19 vaccine ‘X’. Possible barriers to implementation include financial barriers, complexity of recommendations, access to healthcare providers, and vaccine storage and handling requirements. Discussions addressing these barriers included expanded funding opportunities, pharmacy partnerships, second dose reminders, unique packing containers for maintaining ultra-cold temperatures, and detailed state micro-planning.
The ACIP Committee continued their discussion on the importance of education and how healthcare providers are an integral part in ensuring acceptability of the COVID-19 vaccine. A strong provider message encouraging the public to receive the vaccine will be key. Education regarding the need for a second dose of the vaccine, for those vaccines that require two doses, was an important point raised. Due to the reactogenicity of the COVID-19 vaccine, ACIP felt that those who received the vaccine first, will be pivotal in helping to explain the signs and symptoms of an immunogenetic reaction and its importance in building an immune response.
Phased Allocation Plan
The last presentation of the meeting reviewed the phased allocation of COVID-19 vaccines. The proposed vaccine allocation was put into three phases (phase 1a, 1b, and 1c). This has changed slightly since the previous ACIP meeting held in October 2020. Data illustrated that long-term care facility (LTCF) residents and staff accounted for 6 percent of cases and 39 percent of deaths in the U.S. The largest impact in averted deaths and infections is the timing of vaccine introduction to specific groups in relation to increases in COVID-19 cases.
Below is the proposed interim phase 1 sequence:
- Phase 1a
- Healthcare personnel
- Long-term care facility residents
- Phase 1b
- Essential workers (examples: education sector, food and agriculture, utilities, police, firefighters, corrections officers, transportation)
- Phase 1c
- Adults with high-risk medical conditions
- Adults 65 years and older
ACIP agreed with the proposed vaccine allocation plan put forth by the COVID-19 vaccine workgroup. Further, they discussed how this phased approach will occur over several weeks and that one phase does not need to end before starting the next phase. The allocation policy will need to be dynamic and adapt as new information, such as vaccine performance and supply and demand, become clear. Specific criteria will be necessary to move from one phase to the next. Jurisdictions will be required to identity critical sectors at risk and optimal strategies to reach all non-healthcare personnel essential workers. Following vaccination, measures to stop the possible spread of SARS-CoV-2, such as masks and social distancing, will still be needed.
Final decisions on who should get priority access to COVID-19 vaccines will be made after the Food and Drug Administration (FDA) authorizes them under its EUA protocol. Once the FDA clears the vaccines for use, the ACIP will meet and issue recommendations on the populations that should be eligible to be vaccinated. It is expected that CDC Director Robert Redfield will sign off on ACIP’s recommendations immediately after they are made, clearing the way for vaccination efforts to begin across the country.
Here is a link to the ACIP presentation slides for the November 2020 Meeting.
ACIP will make vaccine allocation recommendations during the period when the U.S. supply of COVID-19 vaccines is limited. In addition to scientific data and implementation feasibility, the following four ethical principles will assist ACIP in formulating recommendations for initial allocation of COVID-19 vaccine: maximizing benefits and minimizing harms, promoting justice, mitigating health inequities and promoting transparency.
Ethical principles will aid ACIP in making vaccine allocation recommendations, and state, local and tribal public health authorities will be able to develop vaccine implementation strategies based upon these recommendations. ACIP’s recommendation process includes an explicit and transparent evidence-based method for assessing a vaccine’s safety and efficacy and considers other factors, including implementation.
1. Maximize benefits and minimize harms: Allocation of COVID-19 vaccine should maximize benefits of vaccination to individual recipients and the population overall. These benefits include the reduction of SARS-CoV-2 infections and COVID-19–associated morbidity and mortality, which in turn reduces the burden on strained health care capacity and facilities, both of which provide essential services to the COVID-19 response.
2. Promote justice: Allocation of COVID-19 vaccine should promote justice by intentionally ensuring all persons have equal opportunity to be vaccinated, both within the groups recommended for initial vaccination and as vaccine becomes more readily available. This includes a commitment to removing unfair, unjust and avoidable barriers to vaccination that disproportionately affect groups that have been economically or socially marginalized, as well as a fair and consistent implementation process.
3. Mitigate health inequities: Disparities in the severity of COVID-19 and COVID-19–related death, as well as inequities in social determinants of health that are linked to COVID-19 risk, such as income or health care access and utilization, are well documented among certain racial and ethnic minority groups. Therefore, vaccine allocation strategies should aim to both reduce existing disparities, through identifying and removing obstacles and barriers to receiving COVID-19 vaccine, and to not create new disparities.
4. Promote transparency: The underlying principles, decision-making processes and plans for COVID-19 vaccine allocation must be evidence-based, clear, understandable and publicly available. When possible, public participation in the creation and review of the decision-making process should be facilitated and tracking administration of vaccine can contribute to transparency and trust in the process.
