Patricio V. Marquez, Betty Hanan, Sheila Dutta, Mary Mulusa

The announcement last week by Pfizer and the German company BioNTech, and early this week by Moderna, that their COVID-19 vaccines are 90% and 94% effective, respectively, is making the world optimistic about the possibility that we may overcome the pandemic in a not too distant future. The optimism was further reinforced by news that Russia’s Sputnik V vaccine may be as effective as these two candidate vaccines. 

While waiting for peer-reviewed data from the phase III clinical trials and the formal approval of the vaccines by regulatory bodies, the critical challenge facing all countries is how to ensure that “the most logistically difficult vaccination campaign in history” is conducted in the face of a “hesitant and weary public”, and at least one vaccine with “unprecedented cold chain requirements.” 

So, what needs to be in place at the country level to move from vaccine promises to actual vaccination?  On the basis of an initial review of available literature, we prepared a summary that highlights some key structural and process building blocks.

1. An integrated approach to healthcare delivery is key for a successful immunization campaign effort

Accumulated experience with the delivery of vaccines under the essential program of immunizations (EPI) suggests that a strong public health and primary care partnership is vital to achieving national vaccination coverage targets and control the spread of disease.  While primary care benefits from public health’s role in policy, population health, health equity, and education, public health benefits from primary care’s ability to provide individual patient assessment, disease management, screening of patients, care coordination, and quality improvement. 

To articulate this partnership for the delivery of a new COVID-19 vaccine, sustained effort is needed to support governments in strengthening some key Core Activity Areas, in accordance to country-specific context and epidemic status.

2. Core Activity Areas

Four core activity areas are identified and discussed below.

Core Activity Area 1:  Planning and Management 

Activities in this Area include: 

• Development of national deployment and vaccination plans.  Since at this time there are not as yet COVID-19 vaccines that have been approved for use, the focus of national plans may center on two major phases of vaccine availability and distribution: Phase 1 will be when there is limited vaccine availability and will focus on target/priority groups to receive vaccination.  Phase 2 will be wide scale distribution vaccine associated with broad availability to the general population.

• Identification of target populations and development of micro-plans.  This is an important activity as it would help identify and prioritize critical populations for the different phases of vaccine availability, consistent with the World Health Organization (WHO) Fair Allocation Framework.  More specifically, it would help estimate numbers for priority groups, and establish a transparent allocation.  For example, in some countries vaccination could focus initially in the workforce that provides healthcare and maintains essential functions of society, staff and residents in long-term care facilities, elderly people and those with two or more co-morbidities that put them at high risk for complications from COVID-19.

• Use and deployment of real-time monitoring tools such as RapidPro, a free, open source software, used by UNICEF, governments, and civil society partners.   RapidPro collects data via short message service (SMS) and other communication channels (e.g. voice; social media channels, such as Facebook Messenger, Telegram, WhatsApp) to enable real-time data collection and mass-communication with target end-users, including beneficiaries and frontline workers.

• Strengthening national immunization budgeting and budget tracking capacity. This would need to include the identification of options to address the investment cost implications, including recurrent costs, associated with the introduction of the vaccine for country health spending, and how the vaccine can be sustainably deployed moving forward. We should be clear that additional health workers/staff will be required to carry out this unprecedented effort and their salaries should be budgeted and funded. The new vaccine and its administration, therefore, will require a substantial increase in public health financing in many countries.

Core Activity Area 2:  Supply and Distribution

Key activities under this Area include:   

• Procurement and distribution of COVID-19 vaccine and ancillary supplies  

Some countries may choose to purchase vaccines through multilateral mechanisms such as the COVAX Facility, which is co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO.  Other countries may choose to purchase vaccines directly via bilateral deals or may choose to pursue multiple mechanisms for vaccine purchase.  

In undertaking this activity, due consideration needs to be given to the threshold for eligibility for vaccine purchase either: (i) approval by Stringent Regulatory Authorities (SRAs), or (ii) WHO prequalification and approval by SRAs.

The procurement of ancillary supply kits may also be necessary, including needles, syringes, alcohol prep pads, COVID-19 vaccination record cards for each vaccine recipient, and a minimal supply of PPE, including surgical masks and face shields, for vaccinators.

• COVID-19 Vaccine Allocation

Support is needed to develop country-specific mechanisms for the allocations of the COVID-19 vaccine to jurisdictions in accordance with multiple factors, including, but not limited to, priority populations, current local spread and prevalence of COVID-19, and COVID-19 vaccine production and availability.  This would include coordination with manufacturers and procurement agents on freight, logistics, insurance and storage to deliver COVID-19 vaccine doses.  

Key activities include:

Ensuring adequate logistics and transportation capacity, including conducting fleet assessments; and procurement and deployment of trucks (e.g. cold trucks) and vehicles.

Strengthening immunization supply chain system, including capacity building with respect to both supply chain systems and training of health sector human resources; and adoption of global tools and best practices.

Leveraging innovations and technology to: test and pilot track & trace technology; strengthen remote temperature monitoring systems; and strengthen logistics information systems to accommodate COVID-19 vaccines

• Ensure Quality of Vaccination Services

Quality assurance is very important for vaccine delivery. Vaccines must be stored at correct temperatures and safely handled to ensure the best protection.  Training and technical assistance are needed to support health personnel effectively implement vaccination programs.  Also, support is needed to conduct monitoring and supervision activities to ensure appropriate vaccine storage and handling practices, and to identify opportunities to improve vaccination coverage of target populations. To this end, support would be required to further strengthen vaccine distribution and cold chain systems while awaiting vaccine availability.

If current cold chain gaps and new requirements are addressed in a timely way, it will facilitate widespread administration, not only of a new COVID-19 vaccine, but will also help revamp the delivery of routine vaccines, particularly those for children.  The latter task is of critical importance since the pandemic has disrupted national immunization programs.

Core Activity Area 3: Program Delivery

Key activities to be supported under this Area include:

• Community Engagement and Advocacy

Vaccine hesitancy is expected to be high, so public communication efforts should focus on building a foundation of trust. Public communication about COVID-19 vaccinations should aim to influence the population in a country to: trust the information that they receive from national and local public health institutions, increasing knowledge of vaccine and the process of COVID-19 vaccine development; understand the benefits and risks, setting and managing expectations by clearly informing about limited availability of vaccines at the onset of the vaccine delivery and on the need to prioritize administration of available vaccines to high risk group; make informed decision; and know how and where to get a COVID-19 vaccination.

To this end, support would be needed to strengthen risk communication and community engagement could be expanded, with a focus on increasing awareness for COVID-19 prevention and to strengthen strategic communication addressing demand-side challenges for vaccine uptake.  Such communications efforts need to address specific national/subnational knowledge, attitudes, and beliefs about vaccination. 

Ensure vaccines reach the target populations.  This will require: (i) adequate amount of vaccinators / health workers; (ii) support training of vaccinators and health workers; (iii) adopting global tools to local context; and (iv) funding of targeted outreach to ensure prioritized population know where and when to receive vaccinations.   

• Define Access Points for Vaccine Administration

This would include identification and enrollment of  providers into the COVID-19 vaccination program for early narrow and later broad vaccination plans, such as broad-based healthcare partners (primary and specialty care providers, skilled nursing facilities, other long-term care settings, local public health agencies, hospitals and health systems, pharmacies, mobile vaccination providers, occupational health for large employers, providers serving incarcerated populations, and payers); preparations for vaccinations through regular healthcare channels and new mobile or community-based mass vaccination sites;  community partners to increase accessibility, uptake, and reach by creating a transition plan from low supply/high demand to high supply/low demand. 

Support would also be provided for:  creation of a registry to identify priority target populations and develop strategies for outreach, specifically a list of front-line healthcare workers, the elderly, and those with pre-existing conditions.  

• Adequate Waste Management System in Health Facilities

Good practices for safely managing health care waste and infection prevention and control should be followed, including assigning responsibility and sufficient human and material resources to dispose of such waste safely.  All health care waste produced during the care of COVID-19 patients should be collected safely in designated containers and bags, treated, and then safely disposed of or treated, or both, preferably on-site. This also would be an opportunity to ensure that health facilities possess at least a minimum level of WASH facilities.

Core Activity Area 4: Supporting Systems and Infrastructure

Key interventions under this Area include:

• COVID-19 Vaccine Safety Monitoring

A comprehensive and effective vaccination program requires a robust data infrastructure at different levels of a health system.  This is needed to: (i) further strengthen vaccination practices in both the public and private sectors; (ii) assesses the impact of vaccination programs through disease surveillance; (iii) provide credible evidence-based information to healthcare consumers; (iv) support outbreak investigation and control; and (v) monitor vaccine coverage, effectiveness, and safety. 

Post-vaccine surveillance needs serious attention given risk of adverse vaccine effects.  Clinically important, adverse events following any vaccination must be reported by healthcare providers to the Pharmacovigilance System (PVS) as required of all COVID-19 vaccination providers. Adverse events will also be monitored through electronic health record and claims-based systems.  

This is of importance because before a medicinal product is marketed, its safety and efficacy exposure are limited to its use in clinical trials.  Generally, clinical trials cover limited number of patients with strict inclusion criteria, often excluding special patient groups like those with co-morbid conditions, children, elderly and pregnant women.  Hence, they do not reflect the experience in larger population sand in different geographical regions.  People from different geographical regions differ from one another with respect to genetics, food habits, life style, or clinical practices.  This makes it obligatory to maintain a constant vigil on the use of medicinal products during the post-marketing period.

Strong testing systems are essential for vaccine surveillance. Testing is a critical tool to be used alongside vaccines, given that: vaccine induced immunity must be monitored with testing on a population level; the real-world effectiveness of COVID-19 vaccines will be largely uncertain and possibly variable across settings and populations; and vaccine coverage will be incomplete and focused on priority populations. To this end, support may be required for:  developing/adapting the national diagnostic strategy and plans as new diagnostic technologies become available, selecting of diagnostic tests for appropriate use following international guidelines and national priorities, and, training on infection prevention and control (IPC) measures, provision of IPC supplies (e.g. hand hygiene products, disinfectants), biosafety measures (e.g., safe specimen collection and handling and appropriate disposal of diagnostic tests and supplies), and availability of protocols for proper testing at facility and community levels. 

It would also be of paramount importance to get a baseline sero-surveillance study done - representative samples of target populations to receive the COVID-19 vaccine to be able to distinguish between infection and vaccine acquired immunity.

• WASH in health care settings

Existing recommendations for water, sanitation and hygiene measures in health care settings are important for providing adequate care for patients and protecting patients, staff and caregivers from infection risks.  Hand hygiene is also extremely important.  Cleaning hands with soap and water or an alcohol-based hand rub should be performed according to instructions. Functional hand hygiene facilities should be present for all health care workers at all points of care and in areas where PPE is put on or taken off.

3. How are governments going to address compensation issues related to the liability shield offered to pharmaceutical firms that will be supplying the COVID-19 vaccines?

This question is of particular importance for middle-income countries that have to assume this obligation, including under COVAX arrangements. Low-and lower middle-income countries are expected to be covered under a proposed scheme co-led by WHO to set up a compensation fund for people in poor nations who might suffer any side-effects from COVID-19 vaccines, aiming to allay fears that could hamper a global rollout of shots.

The public sector guarantors of the liability shield offered to pharmaceutical firms will have to look at how to manage this.   It is critical, therefore, to have clarity about this now, i.e. before vaccines start flowing.  With the scale of distribution of the vaccines even rare side effects could end up affecting thousands.

A recent review of existing compensation programs in the world shows that the benefits most referred to in existing no-fault compensation programs were: fair compensation for individuals inadvertently injured by a vaccine meant for public good and increasing confidence in public vaccination programs. The most notable operational challenge of existing programs was identified to be lack of public awareness of programs existence, strict requirements for standard of proof that vaccine caused injury, and long timelines for filing claims and receiving compensation.

Conclusion

It should be clear to all that the approval of effective COVIX-19 vaccine is only the first step in the process to reverse the global pandemic.  We also have to realize that multiple vaccines to meet demand would add complexity of the delivery effort.   Besides the supply of vaccines, a key challenge to deal with is gaining public trust, including among healthcare workers who will be asked to take the vaccine first as part of the priority population groups.

Hence, the activities outlined above will need to be undertaken sooner, rather than later, to address the logistical and cold chain challenges enabling the rapid distribution and administration of COVID-19 vaccines.  

 

Photo credit:

Luca Lorenzelli

Stock photo ID:1212565443