Enhancing public trust in COVID-19 vaccination: The role of governments

 Hi,

This Blog is Based on Role of Governments in developing a good vaccine ecosystem.

While the development of COVID‑19 vaccines has been an extraordinary success, vaccinating most of the global population is an enormous challenge, one for which gaining – and maintaining – public trust in COVID‑19 vaccines and vaccination will be as essential as the effectiveness of the vaccines themselves. Moreover, the experience with COVID‑19 will likely shape confidence in other vaccines making it even more important to build confidence at this time.

Trust in vaccination, and in the ability of governments to communicate, and to successfully deliver a vaccination program, is critically dependent on:

• the extent to which the government can install and maintain public confidence in the effectiveness and safety of the vaccines;
• the competence and reliability of the institutions that deliver them;
• the principles and processes that guide government decisions and actions in vaccine procurement, distribution, prioritization, and administration;
• the capacity and effectiveness of regulatory agencies in handling issues and communicating consistently as events arise, while retaining public confidence in their review processes; and
• the effectiveness of the public engagement and communications that accompany these.

Given the speed at which COVID‑19 vaccine development has taken place it is important for governments to emphasize that no developmental or regulatory corners were cut in the process, as: 

• development was facilitated by extensive prior research, unprecedented levels of international collaboration among researchers, and massive public investment in R&D and manufacturing capacity; and
• approval processes were accelerated, in part through procedures that allow the acceptance of more preliminary evidence in circumstances of public emergency; and with COVID‑19 products accorded the highest priority by regulators.

Successful vaccination campaigns also require governments to partner and support community organizations to conduct extensive and well-managed community engagement. A thorough understanding is needed of different populations’ specific concerns, prior experiences both with vaccination and the health system in general, religious and/or political affiliations, and socio-economic status. It is also important to ensure that government actions are open to public scrutiny, and that public institutions engage with the population, by:

• Proactively releasing timely information on vaccination strategies, modalities and accomplishments in disaggregated, user-friendly and open source formats;
• Enhancing transparent and coherent public communication to address misinformation and the “info emic”; and
• Engaging the public when developing vaccination strategies, and in the form and content of key communications.

Finally, fairness is a hallmark of human behavior that underpins social cohesion and trust. Governments must therefore manage public expectations and explain why it is fair that particular population groups within a country are prioritized for vaccination.

How it was possible to develop and approve COVID-19 vaccines so rapidly:

A number of factors contributed to the speed with which successful COVID‑19 vaccine candidates were able to be developed and tested. These include:

• SARS‑CoV‑2 is genetically close to various other coronaviruses that have been the subject of previous investigation in the past decade, so vaccine R&D did not start from a zero base, even for the newer technological platforms (e.g. mRNA and non-replicating viral vectors);
• Development was facilitated by extensive knowledge gained with previous vaccines, coupled with unprecedented levels of engagement and collaboration among researchers internationally;
• A large number of vaccine candidates have been, and are continuing to be developed and tested in parallel, using a variety of different platforms, increasing the chances that one or more would prove successful;
• Some vaccine candidates (and two of the products already authorized) rely on a novel messenger ribonucleic acid (mRNA) platform, which allows them be developed, modified and manufactured more rapidly than vaccines using traditional platforms;
• Governments invested heavily both in R&D and in manufacturing capacity, the latter to enable the production of large quantities of vaccine before the results of the phase III trials were available, and in many cases potentially absorbing the full financial risks of R&D failure;
• The scale and severity of COVID‑19 underscored the urgency of vaccine development. This drove intensive investment and faster development processes, via for example running trials in parallel that in other circumstances would be conducted sequentially and by combining trial phases I and II, to assess safety and immune responses;
• The combination of the high prevalence of COVID‑19 in many locations and rapid clinical trial recruitment accelerated the demonstration of efficacy in preventing symptomatic infection.

Besides the use of emergency procedures, other factors that helped to accelerate the process of approval included:

• National regulatory agencies engaging with COVID‑19 vaccine developers, and supporting the research and development effort indirectly, in some cases by providing early scientific advice on the most appropriate study designs for generating robust data;

• Regulatory review being expedited via a process known as “rolling review”, whereby developers submit tranches of data incrementally as they become available rather than waiting to assemble a complete dossier before submission;

COVID‑19 products being accorded the highest priority by regulators, with additional resources applied to enable rapid, intensive review of dossiers.

Maintaining trust when adverse events occur:

In early March 2021, cases began to emerge of serious and even fatal thromboembolic events after vaccination with the Oxford/AstraZeneca vaccine. The detection of these adverse events pointed to the strength of pharmacovigilance mechanisms in rapidly identifying a potential safety signal, and prompted precautionary suspension of the use of the vaccine by 12 EU countries and Thailand pending regulatory review to confirm or exclude the existence of a causal link and if necessary, re‑evaluate the benefit-risk profile. On 18 March the EMA recommended the resumption of vaccination with the vaccine, as in its view a causal link with these adverse events had not been established. Despite this, the suspension remained in place in several countries, while others recommenced or continued vaccination with the product albeit with age restrictions reflecting the preponderance of adverse event reports being in people under the age of 50. Subsequently, on 7 April the EMA announced that it had concluded that there was a possible causal link, but that the overall risk/benefit balance remained positive. When a similar pattern of adverse events began to emerge in the United States in relation to the Johnson and Johnson (Janssen) COVID‑19 vaccine, on 13 April the US FDA also temporarily paused use of the vaccine pending investigation by the FDA and the US Centers for Disease Control & Prevention (CDC). Subsequently, on 23 April the FDA and CDC recommended the resumption of the use of the vaccine, confirming that the risk-benefit balance remained favorable.

While these temporary suspensions may be seen as appropriate applications of the precautionary principle, they also prompted concern regarding the risks of slowing down vaccination during the pandemic, as well as the potential effects on overall confidence in the safety of COVID‑19 vaccination. Similar precautionary measures by regulators are not uncommon in the presence of significant potential safety signals, but are not usually undertaken in circumstances of such widespread public attention, and within populations already partly skeptical about the benefits and risks of the intervention. While temporary suspension of the use of the vaccine reflects that potential safety issues were being thoroughly investigated by regulators, it may also have the effect of prompting or augmenting the doubts among certain population groups that have, for example, led significant quantities to remain unused in France and Germany. That said, failure to take such precautionary measures in the face of emerging reports of rare, but in some cases, fatal adverse events, could have resulted in a similar – or potentially even greater – diminution in credibility and trust.

Further, despite subsequent confirmation by the EMA that the risk-benefit balance remains overwhelmingly in favor of the continued use of the Oxford/AstraZeneca vaccine, two jurisdictions opted to discontinue use of the vaccine. Several others elected to limit its use to particular, but varying, age groups, and this lack of consistency may contribute to ongoing confusion and doubt among the public. While regulatory decisions are routinely made at national level, they rarely pertain to products that are disseminated globally on this scale, or subject to such intense public scrutiny. Currently, information about these various decisions is being widely disseminated in the international media, and while the extent to which these have been influenced by the availability of alternative products is unclear, the uncertainty suggested by the different approaches could further undermine confidence in the product, and in vaccination more broadly.

This points to the value of greater co‑ordination among regulators and health authorities that make vaccination policies, and for exceptional care and consistency in messaging around these issues. It is also important to try to improve general levels of science literacy, and to find ways of communicating concepts of risk and benefit in ways that are more easily understood, in order to create a broader appreciation of the risks and benefits of COVID‑19 vaccines relative to the risks posed by COVID‑19 itself.

Integrity and accountability in vaccine development are critical:

Since the beginning of the COVID crisis, governments have had to make quick decisions and implement many unplanned measures to protect communities at risk. In the first months, the widespread use of direct awards as an exceptional measure to procure goods, services and works has drawn attention to potential integrity risks, most notably fraud and corruption, that could seriously weaken the effectiveness of government action if not correctly mitigated. Some instances of irregularities and allegations of corruption in the purchasing and supply of medicines have been reported, as well as other types of misbehaviors such as health professionals stockpiling medications, and a variety of online scams. Yet there has been little discussion on specific integrity risks related to the development and distribution of vaccines, and how these could affect people’s trust in, and the effectiveness of, government vaccination strategies.

Thank you

By - Shrinil Shah 

        B.Tech(Biotechnology)

        Semester-5

        Amity University Rajasthan