Welcome to Molecular Ideas, and thank you for sharing your time with us! Today, we will discuss the current state of the COVID-19 vaccine development race and how we can expect the market to evolve in a post-pandemic world.
Hope is on the horizon – Comirnaty®, the Pfizer/BioNTech vaccine and the Moderna COVID-19 vaccine have been approved. They have started to roll out across the country to frontline workers and other critical need populations. With over 300 million vaccine doses secured by the federal government, a future where we can connect without fear appears is coming soon.
However, the road to get here has not been easy. In the US alone, trillions of dollars have been spent in an attempt to close the public health Pandora’s box that is the COVID-19 pandemic. That direct expenditure pales in comparison to the indirect financial and economic costs of this pandemic, to say nothing of the egregious loss of life. It has taken the courage of hospital administrators and frontline workers, the dedication of local and state officials, and the resiliency of each of us to follow the personal protection guidelines to the best of our ability. It has also taken an immense leap of faith by investors and pharmaceutical companies to develop these vaccines. However, Pfizer, BioNTech, and Moderna were not the only candidates in the race. AstraZeneca and Vaccitech have developed a vaccine candidate that appears to be close to approval, despite its clinical and PR challenges. Looking at the RAPS vaccine candidate tracker, there are approximately 55 vaccine candidates still in development and a handful approved in various countries around the world (at the time of writing). Further, there are a number of other supporting therapies still in development.
This leaves the question undoubtedly being discussed in every biopharmaceutical boardroom and Zoom call: Is the race over?
In my opinion – not by a long shot.
We needed each of these programs to maximize our chances of developing a viable vaccine as quickly as possible. Even if Pfizer-BioNTech and Moderna have first-mover advantage in this new market, there is significant public value to having these other candidates still in development.
Through Operation Warp Speed, other associated research grants, and private investment, there have been billions of dollars poured into developing new vaccines, as well as repurposing established therapeutics to manage critical COVID-19 symptoms. Even if this funding is milestone-limited and some vaccine candidates fall out, this funding will enable newer, innovative companies to keep their doors open for the next few years. This not only creates jobs, but provides significant value for the public in the form of accelerated validation for platform technologies. These technologies, such as Novavax’s recombinant nanoparticle platform or Inovio’s SynCon® platform, represent innovative ways to approach the treatment and prevent of COVID-19. However, validation of these platform technologies through a COVID-19 search represent opportunities to swiftly develop, validate, and scale production of vaccines for established diseases and other SARS viruses that have yet to emerge. A frequently referenced silver lining of the COVID-19 tragedy is that we will be better informed on how to manage emerging diseases. The validation of these platforms against the high bar of the Pfizer-BioNTech and Moderna vaccines means that we will have the tools to fight them sooner if we fail to contain outbreaks at the source.
The sad reality is that there are many countries where a COVID-19 vaccine is still far out of reach. As reported by the New York Times, many countries are seeking to partner with promising vaccine producers to secure life-saving doses. Due to the unique properties of the two approved vaccines, there are manufacturing and storage requirements that limit access (e.g., the -70°C storage requirement) and production speed. These other contenders represent a ray of hope that a vaccine candidate will emerge, enabling a lower barrier to access in high-need environments.
Further, COVID-19 isn’t likely to be eradicated in the next year; even if the US and other high-prevalence countries achieve 70-90% immunization around the same time, there are still likely to be pockets of un- or insufficiently vaccinated populations that will allow this disease to persist. While the long-term efficacy of the approved vaccines has yet to be seen in the open broader population, we can look to common trends in the vaccine space to see how these contenders may evolve and shape the patient experience.
Holding efficacy as a constant, we can expect that the market will settle to accommodate future vaccine approvals as a) preferable by means of specific population needs, b) preferable by means of formulation, and/or c) preferable by means of strain coverage.
As has been widely reported, the two approved vaccines are not currently recommended for women who are pregnant or are planning to become pregnant. This is a critical population we cannot afford to leave at risk, especially given that pregnancy naturally necessitates a high number of clinic visits. This increases the risk burden on families. Admittedly, evaluation of a vaccine in pregnant women is possibly the trickiest pairing of therapeutic and population in clinical trials. That said, the pervasive prevalence of COVID-19 demands that it be explored if early data indicates that it is possible.
We can also look to another common vaccine for a hint of what the future COVID-19 vaccine market could look like – a change in formulation that creates a better patient experience. When AstraZeneca’s FluMist® was approved in 2012, I was thrilled. While some people have certain medical barriers to taking vaccines and others are risk-tolerant, there is a simple reality that scares many people away: they don’t like needles. As the name implies, FluMist® is an healthcare practitioner-administered nasal spray that can give you the same protection as the typical flu shot (though the efficacy varies from year-to-year). Changing the route of administration may smooth the way to increasing adoption of the vaccine, especially if COVID-19 becomes a necessary part of our year-to-year vaccination plans.
Finally, the emergence of the new UK strain (dubbed VOC-202012/01) highlights an uncomfortable reality. With each new infection, this virus has the opportunity to mutate, which may potentially render current vaccines ineffective at inducing long-term protection. While it is unclear as to whether our approved vaccines will provide protection against these emerging strains, we have seen established vaccines like Gardasil® (HPV) evolve to encompass numerous valents – leading to the latest iteration, Gardasil®9.
While first-mover advantage in a global market is critical, those who have the ability to provide increasingly relevant coverage with fewer shots represent an opportunity to counter emerging strains of COVID-19 as we attempt to curb the pandemic. This race has just begun.
That’s all for today! As always, leave your thoughts, ideas, opinions, and suggestions in the comments.
