Thermostable Vaccines: Overview and Market Opportunity

ach year, a significant portion of vaccines lose their potency, become ineffective, or can become hazardous due to problems in transportation and storage. These failures add to the overall cost of vaccines, limit availability, and threaten public safety.

VBI’s LPV™ technology enables the development of vaccines and biologics that can withstand storage or shipment at constantly fluctuating or elevated temperatures. Once commercialized, this technology could increase vaccine safety, efficacy, and access in both established and emerging markets. Learn more about our thermostable vaccine program  >>

The Vaccine Distribution Process and Its Shortcomings

The total established vaccine market was approximately $24B in 2013 with the large majority of vaccines requiring “cold chain” transportation to remain viable. The World Health Organization (WHO) estimates that nearly 50% of lyophilized (freeze-dried) and 25% of liquid vaccines are wasted each year.¹ One of the biggest contributors to this wastage is disruption of the cold chain.

A break in the cold chain can reduce the efficacy or potency of a vaccine and in some cases can lead to toxicity or public safety concerns. In addition to maintaining the cold chain, there is a separate challenge of verifying any lapses in the chain and in testing the viability of the vaccine before it is administered, particularly in poor or remote areas.

Large public health organizations, including The Bill and Melinda Gates Foundation, have long advocated for innovations that will enable the development of more stable vaccines. However, the challenges of developing thermostable vaccines have been greater than expected. In a 2010 interview with the New York Times,² Bill Gates commented that he hoped that there might be a single thermostable vaccine candidate by 2015. Five years earlier, he was optimistic that there would be a number of thermostable vaccines by 2010.

Vaccines vary greatly in their ability to remain viable under fluctuating temperatures. The stability of a particular vaccine formulation depends on many factors including the type of antigen (active ingredient) and the presence of other vaccine components such as adjuvants, stabilizers, and preservatives.

25%

LIQUID VACCINES WASTED

50%

LYOPHILIZED VACCINES WASTED

VBI’s LPV™ Platform

Changes in temperature degrade vaccines and other protein-based compounds by altering their molecular structure. VBI’s proprietary thermostable technology platform, known as LPV™, creates lipid vesicles (small lipid bubbles) which surround and enclose the antigen (active component) of a vaccine. These structures are then ‘freeze-dried’ in a process designed to improve vaccine stability.

VBI’s platform has several unique attributes that give a competitive edge in terms of speed, cost, flexibility, and consistency:

• Based upon well-established lipid components: LPV™ is built upon novel fully synthetic lipid combinations with well-established safety profiles.
• Technique can be used on different types of vaccines: LPV™ technology can be used for new or existing vaccine formulations; it has been used to stabilize several styles or ‘classes’ of vaccine antigen, including protein-based, whole-inactivated, and live-attenuated vaccines.
• Simple and scalable process: The LPV™ process has been successfully tested in a GMP-compliant production plant at pilot levels. Data demonstrates that the process is consistent across batches, which should aid regulatory approval and market acceptance.
• Long-lasting stability across a variety of conditions: LPV™ has demonstrated potency in multiple preclinical animal models, including non-human primates, and has demonstrated efficacy in mice and ferrets with aged vaccine formulations stored at 4° C and 40° C.

LPV™ Market Opportunity

Keeping vaccines in a narrow band of acceptable temperatures during shipment is challenging and expensive – the “cold chain” consumes about 80 percent of the total cost of vaccination programs according to the U.S. National Sciences Foundation (NSF).³

Annual expenditures on vaccines are estimated at $24B worldwide currently, up from $5 billion in 2000.⁴ WHO believes the market will grow up to 15% annual, reaching $100 billion by 2025.⁵ Improved thermostability can increase access to life-saving vaccines in emerging economies, a major area of growth in the vaccine market.

Thermostability technologies like LPV™ could provide vaccine manufacturers with a significant market advantages. Moreover, the critical issue of public health safety and strict quality controls could drive acceptance for LPV™ technology by governments and global health organizations, even in areas where a cold-chain already exists.