In January 2024 the Biotechnology Innovation Organisation (BIO) shared a report, “The State of Innovation in Vaccines and Prophylactic Antibodies for Infectious Diseases”, which examines scientific and investment trends in vaccine development. The report finds that, although the global vaccine and immunisation pipeline “boasts nearly 250 novel clinical-stage programmes”, it “lacks the depth needed to combat many infectious pathogens”.
“Vaccines are a compelling solution to emerging and established infectious disease threats. Vaccination is often cited among the 10 greatest public health achievements of the 20th century – only access to safe and clean water has had a greater impact on human health by preventing disease and extending lifespans.”
The current pipeline
The authors identify 249 novel clinical programmes within the clinical pipeline for infectious disease vaccines. Of these, RNA viruses comprise the majority, with 153 clinical programmes and 69 SARS-CoV-2 programmes, which are grouped separately due to the recent increase compared to other indications. Bacterial programmes are “second by pathogen group” after RNA viruses, with 44 programmes. DNA virus vaccines are represented by 34 programmes. Of the 8 parasitic clinical stage programmes, “most” are malaria. Finally, 10 vaccine programmes are combination products with first-in-class antigenic approaches.
Investment trends
Venture capital investment into companies with “lead products of infectious disease vaccines” between 2013 and 2022 was $2.2 billion in the US and $6.5 billion worldwide, representing 3.4% of total worldwide venture capital raised for biopharmaceutical companies in that time. The authors contrast this with oncology drug development companies, which raised $72.6 billion worldwide over a decade: “12-fold more than investment in vaccines”.
The high point for both oncology and vaccine companies was during the COVID-19 pandemic in 2021, with the former raising $17.9 billion and the latter raising $2.4 billion. The top five largest transactions were associated with companies that developed COVID-19 vaccines.
“Roughly 70% of all public emerging company funding for vaccine companies over the past decade came during the COVID-19 pandemic (2020-2022) ($6 billion of $8.7 billion).”
Concerns from the report
“With the likelihood of FDA approval from Phase I calculated at 11%, this means that to statistically ensure approval of a vaccine for each pathogen, 10 programmes must enter clinical development.”
For many infectious diseases there are “far fewer”, which indicates that “more investment and innovation” will be needed. The authors attribute the “lack of breadth”, in part, to the “unique market issues” that surround vaccines. For example, vaccines that target pandemic pathogens face an “uncertain future market”.
Furthermore, vaccines “endure a hurdle” before they reach the market: government advisory recommendations for use. The two-step process of approval and recommendation means that innovation is “partly driven” by “confidence and understanding” of these factors. After securing recommendations, there are “other key areas” that contribute to market adoption.
Vaccine innovations
“Although more investment is needed to cover future and emerging pandemic threats, as well as regional and tropical infections, much has been achieved through innovations in vaccine science.”
The report identifies the first RSV vaccine approvals as an example and reflects that COVID-19 offered a “new benchmark” for how vaccines can be developed and translated into clinical studies before moving through the development, approval, and manufacturing processes. The report also recognises Ebola and malaria vaccine achievements.
Strengthening innovation
The authors suggest that “four main policy areas” can “stimulate innovation, increase investment, and close gaps”.
“We believe there is a way to make vaccines a more predictable venture, spurring innovation and investment and curing or protecting the world from diseases that debilitate (acutely or chronically) or shorten life spans.”
- Evolve ACIP processes
- Access to vaccines
- Platform technologies
- Rebuilding vaccine confidence worldwide
Rachel King, President and CEO of BIO, commented that the industry is “working tirelessly” on work that has the “potential to save lives, reduce health costs, and better prepare us for future public health threats”.
“To ensure these scientific innovations continue to advance, we must make investing in vaccine development a greater priority.”
David Thomas, Senior Vice President of Industry Research and Analysis at BIO is one of the report authors. He identifies “incredible progress” in areas like RSV and HPV.
“Unless there is more dedicated, persistent investment toward new vaccines, we’ll fall behind.”
Senior Vice President for Infectious Disease and Emerging Science Policy at BIO emphasised the importance of targeting “many common infections” that don’t have vaccines in clinical development.
“We need to pursue both scientific and policy changes that can help spur investment in these vital products.”
How do you think the report can inform these changes to “spur investment” in vaccine products? For more on funding and driving vaccine development do join us in Washington for the Congress this April, and don’t forget to subscribe to our weekly newsletters here.
