COVID-Vaccine: We’re not out of the woods yet, and here’s why…

It’s November, and as accurately predicted in my previous paper, the COVID-19 vaccine is here. Not one, but three different vaccines with reportedly equivalent levels of efficacy. While the news lifted everything from stock markets to my cat’s mood, this monumental scientific breakthrough represents only one step of many to come to get us all out of these dire straits. Indeed, the road travelled by the vaccine doses from the lab to putting down the curtains on this pandemic remains as treacherous as swimming blindfolded with tiger sharks. In a nutshell, there are two major upcoming challenges with varying impacts: Logistics and Communication.

Logistical loopholes:

From the capacity to timely produce the vaccine volumes required by the various countries, to supply chain delays and batches becoming ineffective because their transport and/or storage hasn’t respected the required temperatures, everything will be tested. While this is expected to happen in some instances, the impact of such events will be insignificantly focal. These logistical challenges will emerge through a wide array of triggers ranging from innocent inexperience to blatant incompetence. Time will help patch them and diligent leadership will plan to avoid them. To mitigate the risk of unequal global vaccine distribution, many dedicated NGOs and the WHO have already setup global distribution policies and channels to ensure poor populations get timely access to this drug intervention too.

Communication gaps:

As these injections get underway, recent flu vaccine-related events in South Korea call for special attention and project parallels regarding the spread of falsehoods, misinformation and the ultimate erosion of trust in public health systems. However, before we dive into this rather uneasy part of the chapter, let me pin down a few hard facts to frame the current context in an objective way:

1. Public distrust in Big Pharma has historically emanated from the for-profit nature of their business and sometimes the deliberately selective disclosure of clinical trial data. But despite these ethical biases, we have to admit there have never been any clinical trials in history that were as anticipated, as scrutinised by the public eye, the scientific community and mainstream media, and therefore as transparent, as the ones for the current COVID-19 vaccines.
2. We can therefore expect that the safety and efficacy reports issued by the relevant pharmaceutical companies in this regard to be as rigorous, precise and accurate as they can ever be. In the opposite case, I believe irregularities will come to light even before the vaccines get their final approvals. In fact, as I’m writing this, I read AstraZeneca failed to disclose that some of their clinical trial patients had not received the second part of the vaccine. So there you go!
3. Vaccine efficacy: The US Food and Drug Administration (FDA) guidance set as an expectation for licensure that a COVID-19 vaccine would prevent disease or decrease its severity in at least 50% of people who are vaccinated. The numbers provided by the pharma companies involved in the current vaccine research and development (all above 90%) give a rough idea on the level of protection to be expected from such an intervention. However, there’s always a margin of error related to various factors like under-represented patient groups in the clinical trial cohorts. Children, pregnant women and older individuals will always be studied after safety has been documented in previous groups.
4. The elephant in the room is vaccine safety: It is likely that the vaccination will be associated with mild adverse events. Indeed, Both Moderna and Pfizer with BioNTech vaccines are second generation, messenger RNA-based (mRNA) molecules. Although these firms reported no serious safety concerns during the trials, it is noteworthy that some transient side effects — called reactogenicity, have been observed. Scientists believe that a tiny fat bubble called a lipid nanoparticle used to deliver the mRNA in the body is causing the short-term side effects. We know this because the delivery of this nanoparticle without mRNA caused the same reactions in animals. Both companies reported fewer than 2% of recipients developed severe fevers (39c to 40c) during Phase III of their trials. But if they gain regulatory approvals and 100 Million people will be supplied with these vaccines, 2% will represent 2 Million people with severe fever. Although this sounds like a lot of people will be unpleasantly limited in their daily activities, this is neither dangerous nor lasting. Other transient side effects like sore arms, fatigue, muscle and joint pain have have been reported with higher rates of occurrence than with the flu vaccine, even the high-dose ones. More serious adverse but rare events like otherwise unexplained neurologic or inflammatory process would raise concerns and will require more investigations. Patients need to understand rare events will only be detected as the vaccine is widely used. With the current state of data, given the higher incidence of reactogenicity with the new COVID-vaccine, we have to remember two things: 1. These are mostly transient, non-dangerous reactions and 2. the vast majority of recipients will escape them. Finally, the reason these vaccines will get market approvals is the documented benefits that far outweigh any risks, at population and individual levels. It is a matter of record that we’ve been able to eradicate polio, measles, rubella and most recently HPV-related cervical cancer.
5. Vaccine Licensure: It is important to understand the circumstances under which the COVID-vaccines will be licensed. National Food and Drug agencies have a long track record of licensing other vaccines that have protected the public against diseases like pneumonia, rubella, polio, etc. These agencies have stated that they will apply the same standards for the COVID vaccines. These standards mean clinicians can have confidence is what is know about safety and efficacy. However, Drug Approval Agencies like the US-FDA would make use of a so-called Emergency Use Authorisation (EUA) instead of a full license. Rather than a proof of safety and efficacy, EUAs will require agencies to only state the vaccine “may” be effective and and benefits are likely to outweigh risks. In the current COVID-vaccine cases, FDA officials have affirmed in recent guidance that they would only issue an EUA with substantial evidence of safety and efficacy. Nonetheless, there is widespread concern a vaccine might be prematurely authorised under political pressure.
6. Vaccination policies will vary from one jurisdiction to another. Indeed, as the European Union is getting its act together on this, some Asian countries like Singapore, Hong Kong and Taiwan are expected to mandate the COVID-19 vaccine to all adult residents and probably also incoming travellers. The news of Qantas Airlines requiring a vaccine from all its international flights’ passengers is a first, but expect it to spread. In any case and at this stage, we shall expect these policy decisions to be a haunting nightmare for governments, travel companies and the general public as there will always be something that gives: either freedom of choice or health safety.

The single biggest threat to swiftly end this pandemic is the impact of manipulation through propaganda and trust-eroding misinformation.

A Simple Action Plan to Quash Vaccine Misinformation:

1. Rebuilding Trust & Ensuring Psychological Safety: Vaccine manufacturers, administrators and governments need to clearly communicate the potential and extent of the aforementioned side effects to ALL recipients. Providing upfront, evidence-based information to cover most common basic questions will be particularly important in an environment of polarisation and mistrust.

• How much does a vaccine reduce the risk of COVID-19 and its complications? — and more importantly understanding to what extent the vaccine will reduce mild but also more severe diseases, including the impact on hospitalisations and deaths.
• How safe is the vaccine candidate? — including what monitoring mechanisms have been put in place to detect, evaluate, communicate and clinically address the potential occurrence of rare but more serious adverse events. Indeed, governments need to create a psychological safety net for their people by ensuring they will be taken care of at no extra costs in case these serious side effects occur.
• Will the vaccine be effective for all patients (indications)? — COVID-19 is more common and severe among individuals often under-represented in clinical trials, including older individuals, people with chronic illnesses, and persons in racial/ethnic minority populations. It will be important to communicate this information to clinicians and the general public once data become available and inform or redress vaccination policies accordingly.
• Was important information made public and reviewed by independent experts? — This will increase transparency and reduce bias and error.
• Is a vaccine licensed or provided under an Emergency Use Authorisation? — including a process that would allow outside expert input to enhance the transparency of the evaluation.
• Will all COVID- 19 vaccines be the same? — Vaccines are very likely to perform differently by type and by population segment. clinicians should be made aware of the difference to be able to make recommendations accordingly.

People will feel they are being told the truth and this could be a unique, key success factor to the campaigns. Think about this: having 2 Million people publicly complaining about a high post-vaccine fever nobody told them about prior to receiving the vaccine, has the potential to unnecessarily trigger a mass freakout, inducing another dangerous public health crisis nobody needs right now. In game theory, this issue of trust is typical of the Prisoners’ Dilemma.

Ending this pandemic will heavily depend on the level of success or failure of effective, timely and evidence-based communication to debunk falsehoods — And this requires steady leadership!

2. Responsible self-preservation: At individual levels, I’d like to appeal to your sense of duty to:

• Fact-check and challenge every piece of information you encounter, that seems logical on the surface but contradicts the one shared by your Governments and the WHO. Remember, truth is always one click away!
• Report potential side effects and abnormal reactions occurring to you after a received vaccine to your doctor immediately. Please do not share this information on social media as you have no proof of causality effect and a thorough analysis will still need to take place to establish a link and clear doubts. Anything else will be irresponsible, confusing and counter-productive.

As I rest my case, I’d like to kindly ask you to share this humble paper!

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Mehdi is a medical doctor specialised in internal medicine and an international expert in health systems and digital health strategies.
Mehdi declares no conflicting interests for this work.