At the beginning of the coronavirus pandemic, Dr Tedros Adhanom Ghebreyesus, Director General of the World Health Organization (WHO), dramatically told a G20 Leaders’ Summit that “we are at war with a virus that threatens to tear us apart.”
At the same meeting, António Guterres, UN General Secretary, said “we are at war with a virus – and not winning it… this war needs a war-time plan to fight it”.
While there has been contention and debate about the appropriateness of the wartime analogy, it does seem to work to describe the unprecedented scale and effort required to sequester and defeat this virus. And while not military strategists, we can speculate that any “war-time plan” should be made up of a number of parts and that its success is reliant on the sum of those parts. In this case, a significant component is the successful development and roll out of a COVID-19 vaccine.
At the beginning of November, Pfizer and BioNTech announced that their vaccine candidate was more than 90% effective at preventing COVID-19 infection, based on initial results from their ongoing Phase 3 clinical trial. While the roll out of this vaccine still requires approvals by many national regulatory agencies, at the time of writing, both the UK and Canada had moved ahead with authorizations of the vaccine (for more on the role our firm played in the Canadian announcement, please see: Solid science, clear communications and hope). Furthermore, the companies stated they could have as many as 50 million doses produced by the end of 2020 and 1.3 billion doses by the end of 2021. Since this initial announcement, other good news in vaccine development has followed, with companies and collaborations, including Moderna and the AstraZeneca/University of Oxford team, publishing similarly positive trial results.
This is a phenomenal feat and one that would have been largely unimaginable just one year ago. Vaccines pass through multiple stages of development and in normal times, it wouldn’t be unusual for the process to take 10–15 years. In COVID-19 times, this process has taken less than 12 months.
It is one of the greatest breakthroughs in modern medicine to have developed a vaccine in this timescale. But a vaccine is only as effective as its deployment and uptake. There should be no doubt that when the first COVID-19 vaccine is approved, a very difficult logistics game will ensue. The reality is that a COVID-19 vaccine will present a whole new unfamiliar set of operational challenges. (For more on some of these operational and other considerations, please see: We finally have a vaccine, but will this bring about a return to normality?)
In the situation where the vaccine gets to everyone who would benefit from it, millions of doses will need to travel hundreds, if not thousands, of miles from manufacturers to hospitals, to general practices and pharmacies, which in turn must store, track and eventually administer the vaccines. This isn’t completely new territory; organizations such as the Centers for Disease Control and Prevention (CDC) in the United States, which distributed flu vaccines during the 2009 H1N1 pandemic with the help of local organizations, manage the roll out of routine immunizations every day. (For more on considerations relating to flu vaccines, please see: Taking steps to ensure flu vaccinations are a priority in a pandemic.)
A few of the coronavirus vaccines being trialled use “messenger” RNA (mRNA) technology. While this novel vaccine technology has never received approval before, it looks like it may be one of a few optimal and innovative immunization approaches. After injection into muscle, the synthetic mRNA is taken up by cells and the cell’s machinery reads it to make a surface protein of the SARS-CoV-2 virus, called the “spike protein”. The rest of the process is identical to that used by other vaccines, where the immune system mounts a response by recognizing the viral protein as foreign and develops antibodies against it.
One of the reasons these vaccines have progressed so quickly to, and through, clinical trials is because they are the fastest to make and manufacture. Within weeks, clinical batches can be generated through a process that is cell-free and scalable. However, on the flip side, these vaccines may also be the slowest or most difficult to deploy. While they rely on a technology whose central advantage hinges on rapidity of manufacture, its downfall is extreme physical fragility.
These first mRNA vaccines must be frozen at extremely low temperatures, and once thawed, will stay intact for only a short period of time. Furthermore, these vaccines must be given in two separate doses, administered weeks apart and both doses must come from the same manufacturer. This means that vaccine administration will require careful record tracing and tracking, which may be less of a challenge in a single-payer health system, but poses a whole set of challenges for countries and states that do not have immunization registries or ways of tracking patients. In time, some of these challenges may be overcome, for example, if the technology used for mRNA vaccines advances to allow them to be stored at higher temperatures. However, the novelty of these vaccines means that even the manufacturers are still figuring out these challenges.
Another, and perhaps grander, challenge is one of global vaccine equity and reducing inequalities in access. One of the ways the world is looking to mitigate this is through the COVAX initiative, which is co-led by the Coalition for Epidemic Preparedness Innovations (CEPI), the Global Alliance for Vaccines and Immunisation (GAVI) and the WHO. COVAX is a multinational collaborative platform that is supporting the research, development and manufacturing of a wide range of COVID-19 vaccine candidates. All participating countries, regardless of income levels, will have equal access to these vaccines once they are developed. The initial aim is to have 2 billion doses available by the end of 2021, which should be enough to protect high-risk and vulnerable people, as well as frontline healthcare workers. Without the successful implementation of COVAX, there is a very real risk that the majority of people in the world would go unprotected against COVID-19 and the pandemic would continue to wreak havoc.
To have a truly effective prevention approach, first we need COVID-19 vaccines that are both safe and effective; we then need these to be manufactured at scale; and finally, we need them to be deployed effectively and to all corners of the world. Of course, another key piece of an effective vaccination roll-out is being able to communicate to the public about all of these aspects of a complicated topic (for more on communications considerations regarding patient anxieties, please see: Understanding people’s fears and concerns relating to COVID-19 vaccines).
The above is not an exhaustive list, but should illustrate that this is not going to be a straightforward exercise. While a lot of the messaging around ending the pandemic has been reliant on the success of a vaccine, this does not mean that once a vaccine has arrived, the pandemic is over. (For more on message considerations relating to vaccines as well as other healthcare communications, please see: What can we learn about effective healthcare comms from the current vaccine media frenzy?) There are still a lot of kinks to work out and a lot of challenges to overcome. The development of an effective vaccine remains truly a phenomenal feat, but it is only step one, and the healthcare industry would be doing the world a disservice if it did not acknowledge that.
It is also critical to understand that a vaccine is not the only piece to the pandemic puzzle. Whilst it remains one of the components (albeit a key one), there are other key components, including effective therapeutics and lifestyle interventions – all of which will play their part in our success.
There are currently more than 170 candidate vaccines in development, each with its own benefits and each with its own challenges. Where one vaccine may be more stable and easier to store, another may be more effective in older people, and another may require fewer doses. We are on the cusp of modern medicine’s most impressive influx of innovation and the first wave of vaccines are certainly not going to be the only important ones.
To end with the contentious war-time analogy – we may be well on our way to winning this battle, but we are still fighting a war. All of us—across industry, advocacy organizations and policymakers—have some more time ahead of us in the trenches before we can claim ourselves victorious.
As companies continue to publish positive results from vaccine trials, it will be critical for the pharmaceutical sector, advocacy organizations, and decision makers to consider how to ensure all of those who will benefit most urgently from a vaccine, receive it. As healthcare policy specialists, we must work to support organizations and stakeholders during this time to navigate a complex and evolving landscape.
To further explore how we can support companies and advocacy partners during this complex time, please contact us.