the importance of building public trust in Covid-19 Vaccine

Since the beginning of the Covid-19 pandemic in early 2020, its global toll is nearly a million lives lost and an estimated 29 million confirmed cases. Many health systems around the world have collapsed under the unprecedented weight of Covid-19 disease burden. Every nations is desperate to end the Covid-19 pandemic. A safe, effective and affordable vaccine provides the most practical path to bringing Covid-19 under control. However the power and potential of vaccines is best realized when scientists and politicians approach the process of getting to a licensed, safe and effective vaccine in a way that strengthens public trust so that individuals would be willing to be vaccinated. Appearances of compromises on medical safety due to regulators being under undue pressure to speed up vaccine approval increases the perception of risk of vaccination to individuals. For example, the US and the Russian Federation have announced their plans to initiate mass vaccination before phase III clinical trials are completed. The WHO has expressed concerns with these plans. The WHO Chief Scientist Dr Soumya Swaminathan announced that WHO will not support mass deployment of any vaccine before the WHO itself, governments and national regulators of target markets have full confidence that a vaccine meets the minimum standards of safety and efficacy.

​A safe, effective and affordable vaccine provides the most practical path to bringing Covid-19 under control. Scientists and regulators have rallied to get a vaccine approved at unprecedented speed. A vaccine development process that normally takes years has been compressed into several months. The three leading vaccine candidates - the Oxford vaccine (Astrazeneca), the American vaccine (Moderna) and the German vaccine (BioNTech SE/Pfizer) are all in phase III clinical trials, the last hurdle to be cleared before regulators approve a vaccine that can be used for mass vaccination. Media reports and press releases by manufacturers suggest that a breakthrough is imminent. Such a breakthrough promises salvation for millions of lives and livelihoods and a path to recovery by a battered global economy. Global salvation will depend on the decisions of individuals whether they trust the vaccine enough to consent to receiving it. 
 
A major factor that could impact individual decisions is their perception of how independent the vaccine approval process has been. The process of developing a Covid-19 vaccine have revealed far too many factors that could force regulators, scientists to make concessions with medical safety in order to have a vaccine approved in the shortest amount of time possible. Amongst the most compelling indications of flaws in the approval process is the effect that the impending US presidential elections appears to have on the regulatory process. There has been enormous political pressure to get a vaccine rapidly approved in order to win the support of the US electorate by showing that President Trump has a solution for mitigating the terrible impact that Covid-19 has had on American lives, livelihoods and the economy. Millions of Americans have lost their jobs and the US government is betting on all three vaccine candidates and wants to have at least one vaccine approved in time for the November 2020 presidential election when he is running for re-elections. A quick vaccine approval promises glory to scientists and redemption to politicians in whom citizens have lost faith. The first company to have its vaccine approved will reap enormous financial rewards. The US alone is spending US$10 billion to secure 300 million doses from all the major Western vaccine efforts. 
 
During the preliminary rounds of vaccinations, Astrazeneca will supply more than 2 billion doses of the Oxford vaccine to the US, Britain, European countries and multilateral organisations. Covax, the global vaccine allocation plan to buy 2 billion doses of approved vaccine, of which 20% (that is 230 million doses) has been reserved by WHO Africa for the 1.3 billion people in Africa. Africa’s vaccine will prioritise vaccinating front-line health care workers and the most vulnerable groups. These initial doses of the first licensed vaccine are a drop in the ocean. The whole world is waiting, and much greater amounts of vaccine are needed. Other efforts will be needed, for example, the Act-Accelerator which promises to produce 2 billion doses of vaccine, 245 million treatments and 500 million tests. 
 
Whilst access to vaccine by all nations is critical to bringing Covid-19 under control, there has been no solidarity in the actions of most nations except through words. A limited few nations will likely have more immediate access to vaccine. The majority will have to wait, possibly years before they can get vaccination. In both cases, individuals will have to decide, to be or not to be vaccinated. Individuals will have to decide for themselves whether the medical safety of Covid-19 vaccine was objectively evaluated and whether they can trust that the vaccine offered to them is safe. Some of the developments in this process deserve further reflection in considering potential risk and issues of trust in a Covid-19 vaccine.
 
US regulators appear to have little flexibility regarding when they are expected to approve a vaccine. This makes it difficult for them to wait for all relevant data to available before they can render judgement on the safety of the vaccine. Normally, regulatory standards require that phase III trials must be completed first before mass vaccination can begin. These are rules that exist to protect public safety. However, the US and the Russian Federation have announced their plans to initiate mass vaccination before phase III clinical trials are completed. This increases the risk that the approved Covid-19 vaccine may not be safe. 
The WHO shares these concerns. In response to these plans, the WHO Chief Scientist Dr Soumya Swaminathan announced that WHO will not support mass deployment of any vaccine before the WHO itself, governments and national regulators of target markets have full confidence that a vaccine meets the minimum standards of safety and efficacy. The US government has already rejected WHO authority with its decision earlier this year to withdraw US membership from the WHO in 2021. In fact, the US has rejected the idea of acting in solidarity with other nations in its “America first” foreign policy approach. However, the political rhetoric of “us versus them” overlooks a simple truth. 
 
Maintaining the domestic health security of Americans or any other nation is less feasible when people in other countries have not been vaccinated. Unless such a nation is willing to cut itself from the rest of the world in order to minimize risk, or to introduce draconian measures that will likely impact trade and commerce. Manufacturers who plan to mass deploy their licensed vaccines to countries outside the US may find it difficult to reject WHO authority on matters of the medical safety of an approved Covid-19 vaccine. WHO facilitation for example through its vaccine prequalification programme may be critical to expediting regulatory approval in target markets globally. For individuals weighing the risk to self, a vaccine that has been approved by the WHO regulators provides much greater assurance than any process that is currently ongoing anywhere in the world.
 
Recent developments suggest that medical safety may be receiving less consideration by regulators in different countries for reasons that are both obvious and less obvious. In the US, the need to prevent delays in getting a vaccine approved before the US Presidential election in November 2020 is major factor. In Russia, the geopolitical tensions with the west may be driving the need for Russia to authorize a vaccine first. Russia could use its the vaccine to exercise soft power to low and middle-income (LMIC) nations and other allies. African nations for instance, plan to supplement the small quantity of vaccine allocation from the West by sourcing additional vaccine doses from Russia and China. 
 
The phase III clinical trial of the Oxford vaccine which is considered to be the front runner was recently paused on 8 September. A week earlier, a healthy volunteer on the UK had developed severe neurological symptoms associated with transverse myelitis, an inflammatory condition of the spine that causes paralysis. The routine is that a trial should be paused following serious adverse effects in any trial participants. Trials would normally resume only after an independent committee of safety experts have evaluated the trial data and determined that the vaccine is not responsible or that there is minimal risk to vaccine recipients. UK regulators rapidly lifted the pause within days allowing the clinical trial to resume whilst safety reviews of the same vaccine were still ongoing in other jurisdiction like South Africa. Any findings by the safety review committee should be applicable to all the trials with the same vaccine. However, it is not clear why the trial was cleared to continue in the UK’s but not outside the UK. 
 
Could it be that the UK lifted the pause as a result of political pressure to resume the trials in the shortest time possible? This might explain the discrepancy. UK regulators could not pressure non-UK regulators to quickly resume trials regardless of their safety concerns. Political pressure from Prime Minister Boris Johnson and the UK government could happen because the government needs to win back the respect of voters. The British public feel let down by its government for failing to protect lives by heeding WHO warnings about Covid-19 sooner. A vaccine provided in record time would allow politicians to reassure the public that the government cares about their wellbeing. 
 
The optics of the safety experts declaring the trial of the same vaccine safe to resume in one country but not in others would have been better and more reassuring if the trials could continue in all trial jurisdictions. This raises greater concerns given that in many countries where the vaccine will be used, the manufacturer of the Oxford vaccine, AstraZeneca, will not be held responsible if the vaccine proves unsafe and causes harm to those who take it. The company has sought and been granted protection from future liability for the Covid-19 vaccine adverse effects. In the US law, these provisions embedded in national law. The law prohibits any potential claims against products used to control a public health crisis. Other pharmaceutical companies developing Covid-19 vaccines like Pfizer, Sanofi and Johnson and Johnson are likely to be granted similar legal exemptions in countries worldwide. 
 
There is no doubt that vaccination is the most important and best-value for money technology that public has for saving lives from infectious disease threats. Their power and potential is best realized when scientists and politicians approach the process of getting to a licensed, safe and effective vaccine in a way that strengthens public trust so that individuals would be willing to be vaccinated. Appearances of compromises on medical safety due to regulators being under undue pressure to speed up vaccine approval increases the perception of risk of vaccination by individuals. US political rhetoric has eroded the appearance of independence and integrity its regulators at the United States Food and Drug Administration Agency (FDA). The agency’s attempts to push back by reiterating its commitment to medical safety and by reiterating that no compromises will be made when evaluating safety and efficacy of Covid-19 vaccines ring hollow when the Covid-19 vaccine approval appears so highly politicised. 
 
Once a vaccine is approved and adequate capabilities to manufacture it in large enough quantities are in place, its widespread adoption will depend on public perception on the risk they might associate with taking the vaccine. However, the actions of nations with vaccine making capabilities suggest that few are willing to compromise their nation’s primacy to accessing vaccine. In the absence of global solidarity. If on top of this, individuals who can access the vaccine are not convinced they can trust the vaccine, the earliest Covid-19 vaccines might be limited in their ability to it facilitate a return life to pre-pandemic conditions that people worldwide are desperate for. This will add another hurdle to the vaccine’s ability to speed up global recovery for the pandemic’s effect.
 
Policymakers need to begin making plans for addressing potential vaccine hesitancy in places that will have immediate access to vaccine. This requires a variety of confidence building measures that effectively builds trust to persuade people to accept vaccination. This may include regulators like the FDA taking measures to further articulate the additional steps they are taking to ensure that the evaluation of Covid-19 vaccine clinical trials and regulatory assessment of safety and efficacy has been done as objectively as possible. Informing the public about what process regulators plan to use to oversee safety and monitoring of the vaccine after it has been granted a license could provide assurance. Building this trust will enable the high vaccine uptake levels needed to reach herd immunity thresholds capable of protecting the population. 
 
Policymakers will need to increase investments in public information and messaging advocacy. The objective will be to keep the public informed of social protection measures, the benefits of vaccination and counter misinformation by antivaccine activists on social media. Messaging would need to inform the public about the vaccine in a way that builds trust. The communication strategy would need to engage and communicate appropriately by having people that are most trusted by communities at its core. For example, religious leaders, community health workers and traditional healers and others. These people would need to provide the message that is adapted to target groups by being culturally and linguistically appropriate.