The rapid development of Covid-19 vaccines was a historic medical triumph. But hastening the end of the pandemic may only be the beginning. The science behind Covid-19 breakthroughs could soon lead to vaccines for other infectious diseases, such as HIV and Zika. Other types of advancements in vaccine technology could also enable us to create new immunizations for anthrax, cholera, whooping cough, and hepatitis B.
By almost any measure, vaccines are among the most transformative medical technologies ever invented. Only access to clean water has had a larger impact on global health. Any disease we can prevent or suppress with a vaccine is one from which people will suffer much less — and for which the treatment burden on our healthcare system and economy will be massively reduced. Consider that between 1994 and 2018, vaccines saved society $1.9 trillion total — and $406 billion in direct medical costs.
Despite this enormous promise, efforts to create new and more effective vaccines still face daunting challenges. Overcoming these barriers will require new approaches to vaccine development — as well as a concerted effort to build public confidence in these life-saving medicines.
As a new report from the Biotechnology Innovation Organization notes, the biopharmaceutical sector is currently at work on 249 clinical-stage infectious disease vaccine programs for 48 unique pathogens. That’s a positive signal about the promise of vaccine science. But there are gaps we can fill through better public policy. For example, most of those pathogens only have one or two potential vaccine candidates.Among the six so-called ESKAPE pathogens — deadly “superbugs” that have evolved to resist existing antimicrobials — only two have active vaccine programs. Diseases such as West Nile virus and Lyme disease each currently have only one vaccine candidate in the works. We can do better.
Unfortunately, mere entry into the drug development pipeline is no guarantee of success. New vaccines only have an 11% likelihood of winning FDA approval after entering phase 1 clinical trials. This implies we need 10 vaccines entering clinical trials for each pathogen, which is far more than the current number for most.
Additionally, the size of clinical trial studies can be orders of magnitude larger for vaccines than for other disease areas. For example, oncology Phase III trials often enroll under 1,000 patients, whereas vaccine Phase III trials can number in the tens of thousands. This has a direct impact on costs and timelines for vaccine development.
Investors seeking to support vaccine research also face bigger risks, because unlike other disease areas — such as oncology — vaccines are specific to a single disease. Oncology therapies that fail in one indication can often prove effective against other cancers, increasing the odds of success for a drug developer. But vaccine development is generally aimed at a single pathogen.
The difficulty in bringing vaccines to market has resulted in years of underinvestment. As the BIO report notes, just 3.4% of the venture capital raised in the past decade flowed into biotechnology companies working to develop vaccines. That’s compared to 38% that went to companies developing oncology drugs.
There are several readily achievable measures that could jumpstart vaccine innovation, investment, and streamline the development process.
Reform can begin at the federal level. The CDC should continue strengthening the vaccine evaluation and recommendation process via the Advisory Committee on Immunization Practices (ACIP). This process has major implications for the potential market size for specific vaccines. By making ACIP procedures simpler and more predictable, the CDC could help spur a new wave of investment in vaccine innovation.
Ready access also matters. The sooner we get these lifesaving medicines into the arms of the people who will most benefit from them, the better. Improving access is sometimes a matter of overcoming geographical barriers — for example, by making sure local pharmacies and healthcare facilities are well-stocked and qualified personnel are on hand. It can also entail making sure personal finances don’t present a barrier. It is critical that insurance plans fully cover necessary preventive immunizations.
We also need a policy environment that facilitates the use of newer vaccine technology platforms for a range of pathogen families. One such platform is mRNA technology, which allowed companies to produce vaccines for Covid-19 in record time. By prioritizing such technologies, the industry can help bring more efficiency and speed to the development process.
Finally, we must raise awareness about the safety and efficacy of vaccines. Without an effort that presents relevant evidence to the public in an accessible way, hesitancy will grow unchecked — which in turn could drive investment away from vaccine development, leaving promising areas of medical research unexplored.
Vaccines have been a boon to humanity since the development of the first smallpox vaccine in the late 1700s. Since then, we’ve managed to develop effective immunizations for an additional 34 pathogens. There should be a clear path to conquering far more. Reforms aimed at increasing volume and efficiency through the development pipeline will save lives, eradicate disease, and help protect us from the next pandemic.
David Thomas is Senior Vice President of Industry Research and Analysis at the Biotechnology Innovation Organization (BIO).
