WHO COVID-19 vaccines risk communication plan

GACVS was informed about the risk communication activities of a number of WHO programmes.

Planning for acceptance and uptake of COVID-19 vaccines

The aim of the WHO COVID-19 vaccine(s) communication plan is to achieve high acceptance and uptake of the vaccines while simultaneously reinforcing routine immunization programmes and uptake of all vaccines. This is to be achieved by increasing public knowledge, awareness and confidence, anticipating and communicating risks promptly and effectively and informing national policy-making, planning and implementation.

The target audiences of the plan are global and regional partners and scientific collaborators, national policy-makers and decision-makers, including national technical advisory groups on immunization, the health workforce, civil society organizations, the public and the media. The plan will be aligned with the main phases of vaccine R&D: in clinical trials, manufacture, licensure, policy and allocation, distribution and uptake of the vaccine(s).

A number of risk communication scenarios will be developed to cater for differences in factors such as vaccine supply, vaccine policy and allocation, the effectiveness, safety and duration of protection and whether booster doses will be necessary. To build and maintain trust and confidence in a situation full of unknowns, it will be important to communicate transparently, early and often, in ways that people trust; to communicate clearly and for various levels of health literacy; acknowledge uncertainty in both qualitative and quantitative terms; communicate honestly and openly; listen and respond to the specific concerns of stakeholders; and prioritize key population groups.

The data required for planning will be obtained from a combination of programme and survey data (e.g. the behavioural and social drivers of vaccination taxonomy), media monitoring and social listening, with due attention to the context in which they are generated. Data will be collected on the COVID-19 vaccine(s) and on routine vaccination both globally and nationally in order to understand the behaviour and intentions of individuals with respect to vaccination. The draft plan covers activities for each audience (e.g. a community engagement toolkit and a training curriculum for health care workers) with the desired outcomes.

The immediate priorities are lists of frequently asked questions, standard operating procedures, a communication plan and a monitoring and evaluation framework, initially for internal WHO use but intended for use in countries. Public communication will begin with a WHO webpage designed for audiences with different levels of health literacy, with shareable, highly visual infographics and videos and information on how vaccines work, how they are made and why they are safe. Regions can provide tailored context and strategic advice. In countries, the priority is communication for the health workforce. The draft plan will be adapted continuously to reflect input from WHO departments and regional offices, with an implementation plan that includes resources and a standing crisis communication plan.

“Infodemic” management as a pillar of the COVID-19 response

The World Health Assembly and the United Nations Secretary-General have recognized the importance of disseminating scientific information on the COVID-19 pandemic and countering the large volume of false information. WHO held an ad hoc online consultation in early April 2020 on a potential framework for pandemic information management, including ways of amplifying health messages and engaging new stakeholders, such as trade unions and the hospitality industry, in passing information to their constituents. Participants requested relevant tools for monitoring different stages in spreading information, focusing on the emotions behind messages and on meeting the audience’s information needs promptly, thereby leaving less room for misinformation.

WHO is preparing a number of tools, including an “infodemic” observatory, social listening (including online forums and radio broadcasts), artificial intelligence and a global fact-checking and misinformation centre. Other possible tools include network analysis of social media discourse and advanced computational analysis to develop metrics for the spread of information. WHO is working with UNESCO on training for radio and television journalists and with the International Telecommunication Union on an SMS message library for mass communication campaigns via mobile phone. In a project with UN Global Pulse, the Secretary-General’s big-data initiative, WHO is using artificial intelligence techniques and computer speech recognition to analyse radio broadcasts and public speeches. Countries are encouraged to set up observatories to monitor locally relevant information.

Approach and a roadmap to COVID-19 vaccines benefit–risk communication

A GACVS subgroup prepared an outline for communication about the development and deployment of COVID-19 vaccines, based on the above principles and sound communication science. The group will finalize the principles and approaches to vaccine safety communication by mapping ongoing initiatives, tools and guidance and identifying potential gaps; identifying mechanisms for evaluating communication interventions; evaluating lessons for vaccine safety communication learnt from earlier epidemics and pandemics; outlining various scenarios and possible communication strategies; and evaluating the potential role of journalists. This information will be used in WHO’s broader communication work.

In the pre-licensure phase to October 2020, the working group will outline a plan for communicating the benefits and risks of vaccines and identify approaches to messaging about vaccine safety. In the pre-launch phase, GACVS will assess technical information on potential safety concerns for each vaccine and provide guidance on communication. After introduction of the vaccine(s), the working group will collect evidence on emerging technical issues and public concerns to further improve communication on vaccine safety.

Conclusions and recommendations

GACVS recommended that infrastructure and capacity for surveillance of the safety of COVID-19 vaccines should be in place in all countries and existing infrastructure be reactivated and engaged before a vaccine is introduced, which will require local, national, regional and global collaboration. Countries should include preparedness plans for COVID-19 vaccine safety in their overall plans for vaccine introduction, building on WHO guidance.

GACVS recommended that a working group of experts be established to provide guidance to countries and regions on prerequisites for vaccine introduction that could be adapted by each country; alignment of COVID-19 vaccine safety preparedness and leveraging of existing national AEFI surveillance systems as far as possible; adequate data management systems; tools for decision-making by national programme managers; and a vaccine safety communication strategy.

As knowledge about COVID-19 disease and the new vaccines is evolving continuously, GACVS recommends creation of a basic list of AESI, which would be reviewed continuously in the light of evolving knowledge. Background rates for the events on the list should be generated when possible, so that all countries need not undertake hypothesis-testing studies of associations.

Prioritization of the AESI to be included in common protocols for rapid assessment or hypothesis-testing studies for active surveillance (e.g. self-controlled case series, cohorts, case–control studies) may be based on AEFI identified in clinical trials.

As regions have differential ability to generate background rates or to participate in studies of active surveillance, there must be good collaboration and exchange of information among countries and regions so that data can be pooled to increase the possibility of identifying and responding to AESI.

GACVS emphasized that regional capacity to pool data and increase sensitivity for identifying and responding to safety signals and AEFI should be enhanced.

GACVS recommended that existing and new Brighton Collaboration case definitions for AESI, tools for assessing the certainty of cases, algorithms and codes for identifying cases from data collections (e.g. MedDRA, ICD revisions 9 and 10), be shared widely for countries to align their data, thus facilitating pooling of results.

GACVS recommended that a working group be established to incorporate case definitions in the absence of Brighton Collaboration definitions for the prioritized AESI and that countries acquire minimum institutional capacity for their identification.

GACVS advised countries to consider using a Delphi method when case definitions are not available from the Brighton Collaboration. WHO should work with national teams of the Expanded Programme on Immunization to strengthen routine monitoring of vaccine safety with COVID-19-related activities.

GACVS noted that vaccine developers should draft and implement appropriate risk management plans and safety studies for the early phase of vaccine deployment and for adapting risk management plans to emerging data and practical considerations during scale-up.

National regulators should review the risk management plans obtained from vaccine developers and, to the extent possible, provide a summary of the plans to immunization programmes and other stakeholders. Vaccine developers are encouraged to share their plans with immunization programmes and other stakeholders in countries and to incorporate them into their vaccine safety preparedness strategies at the time of vaccine introduction.

The Committee recommended that developers share national, regional and international data on safety, including summaries, with the reviewing regulatory authority.

GACVS stressed the importance of immunization registers of case data and barcodes for tracking vaccine distribution and of training vaccinators.

After the vaccines are deployed, safety data received by regulators and immunization programmes should be shared with or made accessible to other relevant stakeholders.

GACVS recommended that any review of the safety of new vaccines be based on the appropriate Brighton Collaboration standardized templates for benefit–risk assessment of vaccines (by technology platforms) when available and approved, which offer a structured approach to evaluating safety. GACVS advised that templates be pilot-tested in a number of scenarios and then adapted accordingly.

GACVS members stressed the importance of an ambitious, proactive plan for communicating vaccine safety. They observed that, while social media comments are highly visible and may influence political decision-making, they do not necessarily influence individual behaviour. Less visible social media such as WhatsApp and Tiktok are very influential in certain groups and should be monitored as closely as possible. Local communication teams can provide valuable information about local situations and current misinformation.

GACVS members noted that communication approaches should clearly explain the difference between AESI and AEFI to relevant stakeholders.

GACVS endorsed WHO’s proposed safety communications approach to COVID-19, which incorporates a plan for communicating the benefits and risks of vaccines, a roadmap and proposed outputs. WHO will establish a task force to implement the roadmap in the period May–December 2020.