Date: June 15, 2010
Title: The Cool Chain
Source: BBC Radio, World Service
Summary: In this special report, Geoff Watts investigates the science, politics, and economics of the global vaccine cold chain. Various experts are interviewed, including Mobido Dicko (World Health Organization), Oz Mansoor (UNICEF), Mercy Ahun (GAVI Alliance), and Debra Kristensen, PATH’s group leader of Vaccine Technologies.
Listen to the program at BBC Radio here.

Date: March 2010
Title: Stabilization of vaccines: Lessons learned
Source: Human Vaccines
Summary: In this guest editorial, PATH explores the key logistical, regulatory, procurement, and policy issues associated with the development and use of temperature-stabilized vaccines. Authors Debra Kristensen, group leader of vaccine technologies, and Dexiang Chen, lead vaccine formulation scientist, reflect on nearly 8 years of work to optimize the heat- and freeze-stability of 7 types of vaccines with 33 collaborators.
Read the editorial in Human Vaccines here.

Date: January 1, 2010
Title: Developing a vaccine that is stable at room temperature for 8 weeks
Source: Pharmaceutical Technology Europe
Summary: Dr. Satoshi Ohtake, a senior scientist at Aridis Pharmaceuticals, details research efforts conducted in collaboration with PATH which resulted in the formulation and development of an improved measles vaccine formulation that is stable for at least 8 weeks at 37°C. This article is based on a presentation given by Dr. Ohtake at the 2009 American Association of Pharmaceutical Scientists Annual Meeting and Exposition.
Read the article on the PharmTech website.

Date: January 2010
Title: Heat-stable measles vaccine produced by spray drying
Source: Vaccine
Summary: Scientists at Aridis Pharmaceuticals and PATH have produced heat-stable measles vaccine powder using a combination of unique stabilizers and mild spray-drying process conditions. Spray drying was identified as the optimal processing method for the preparation of dried vaccine, as it generally resulted in negligible process loss and comparable, if not better, storage stability compared to other processes. Processing methods and formulation components were developed and a measles vaccine was produced that was stable for up to 8 weeks at 37°C, which surpassed the World Health Organization requirement for heat stability of 1 week at that temperature. Key stabilizers identified during the formulation screening processes were L-arginine, human serum albumin, and a combination of divalent cations.

Date: November 1, 2009
Title: Efforts to improve vaccine stabilization heat up
Source: Nature Medicine
Summary: Here, Nature Medicine reports that freeze protection for hepatitis B and potentially other alum-adjuvanted vaccines may be at hand. Senior Contributor Meredith Wadman examines PATH’s development of a hepatitis B vaccine formulation that does not lose potency after repeated freezing at minus 20°C. Wadman also explores PATH’s recent progress—in collaboration with Arecor Limited—at addressing the more widely recognized problem of heat damage to vaccines. Discussion of the advancements and the challenges in developing formulations that help to protect vaccines from damage caused by exposure to heat and cold are framed within the context of technologies that are meant to improve global health.
Article available to subscribers on the Nature Medicine website.

Date: September 1, 2009
Title: New innovation makes vaccines more resilient
Source: Worldchanging
Summary: Temperature regulation is one of the biggest challenges to vaccine use worldwide. PATH’s group leader for Vaccine Technologies, Debra Kristensen, recently discussed with Aman Bhandari—co-founder of Global Health Ideas and contributor to Worldchanging—the impact that protecting vaccines from heat and cold could have on global health. Here, the conversation focuses on breakthrough achievements by PATH and partners in temperature regulation of hepatitis B vaccine.
Read the article on the Worldchanging website.

Date: August 4, 2009
Title: PATH scientists discover cheap, easy way to protect vaccines from hot and cold
Source: Xconomy
Summary: Scientists at PATH have found a cheap and simple way to tackle the challenges associated with protecting hepatitis B vaccine effectiveness when the vaccine gets too hot or too cold. Here, Luke Timmerman, the national biotechnology editor for Xconomy.com, reports on PATH's recent success in applying heat and freeze stabilization technologies to hepatitis B vaccine.
Read the article on the Xconomy website.

Date: August 3, 2009
Title: PATH develops technology that protects hepatitis B vaccine from heat and freeze damage
Source: PATH
Summary: PATH scientists and collaborators have developed formulation methods that protect hepatitis B vaccine from heat and freeze damage. In partnership with Arecor and the University of Colorado Denver School of Pharmacy, PATH developed a new hepatitis B vaccine formulation exhibiting nine-week stability at 55°C and at least six-month stability at both 37°C and 45°C. Further testing found the new hepatitis B vaccine formulation to be heat-stable for 12 months at 37°C in addition to proving freeze-stable at −20°C.
Read the press release.

Date: August 2009
Title: A heat-stable hepatitis B vaccine formulation
Source: Human Vaccines
Summary: A collaborative effort between PATH, Arecor, and the University of Colorado Denver School of Pharmacy has resulted in a new formulation for recombinant hepatitis B vaccine that demonstrates improved stability at elevated temperatures. The formulation exhibited nine-week stability at 55°C and was also shown to be stable at both 37°C and 45°C for at least six months. This new vaccine formulation has the potential to be stored at room temperature for part of its shelf life and will help ensure the potency of the vaccine in areas where the cold chain is insufficient.
Read the journal article.

Date: July 23, 2009
Title: Characterization of a thermostable hepatitis B vaccine
Source: Vaccine
Summary: A new hepatitis B vaccine formulation developed and tested by PATH scientists and partners at Arecor and the University of Colorado Denver School of Pharmacy has proven stable against repeated freezing at −20°C. In addition, it has proven stable for 12 months at 37°C. The formulation was also found to be well tolerated in rabbits without any significant local or systemic side effects. Overall, the improved stability of this hepatitis B vaccine could be a key factor in ensuring vaccine effectiveness, extending immunization coverage, simplifying immunization logistics, and reducing the costs associated with the cold chain.

Date: May 1, 2009
Title: Opportunities and challenges of developing thermostable vaccines
Source: Expert Review of Vaccines
Summary: This article reviews approaches being used to develop thermostable vaccine formulations that would be resistant to damage caused by freezing or excessive heat, and that could reduce dependence on the cold chain. The challenges associated with the implementation of these novel formulations are discussed, as well as the potential benefits of protecting vaccines from damage caused by breaks in the cold chain.
Read the journal article.

Date: May 1, 2009
Title: Technology solutions for global health, vaccine stabilization
Source: PATH
Summary: As part of PATH’s series on technology updates in Global Health, this fact sheet describes PATH's latest achievements and scope of work in vaccine stabilization (as of May 2009).
Read the fact sheet.

Date: January 21, 2009
Title: Seattle-based PATH develops new ways to protect vaccines
Source: Seattle Post-Intelligencer
Summary: No one knows how many children worldwide receive vaccines rendered useless from exposure to extreme temperatures during storage and distribution, but Seattle-based PATH has come up with yet another way to prevent this problem.
Read the article on the Seattle Post-Intelligencer website.

Date: January 21, 2009
Title: PATH develops technology that protects lifesaving vaccines from freeze-damage
Source: PATH
Sumary: PATH scientists have developed a vaccine formulation method that preserves the effectiveness of specific types of vaccines even after repeated exposure to freezing. This formulation method is applicable to vaccines containing aluminum adjuvants—including hepatitis B, diphtheria, tetanus toxoid, and pertussis vaccines.
Read the press release.

Date: January 1, 2009
Title: Development of a freeze-stable formulation for vaccines containing aluminum adjuvant
Source: Vaccine
Sumary: Vaccines containing aluminum salt adjuvants are prone to inactivation following exposure to freeze–thaw stress. Here, scientists describe an approach to protect vaccines from freeze–thaw inactivation. By including polyethylene glycol 300, propylene glycol, or glycerin in a hepatitis B vaccine, particle agglomeration, changes in the fluorescence emission spectrum—indicative of antigen tertiary structural changes—and losses of in vitro and in vivo indicators of potency were prevented following multiple exposures to −20°C.
Read the journal article.

Date: December 2008
Title: Summary of stability data for commonly used vaccines and novel vaccine formulations
Source: PATH and Working in Tandem, Ltd.
Sumary: PATH summarizes stability data for commonly used vaccines as well as research efforts to improve the stability of these products.
Read the summary.

Date: July 2007
Title: An economic evaluation of thermostable vaccines in Cambodia, Ghana, and Bangladesh
Source: Vaccine
Summary: Single-dose presentations of thermostable vaccines are potentially cost-effective interventions to reduce childhood deaths and disability in low-resource settings in Asia and Africa. This paper evaluates the incremental health and programmatic cost impacts of theoretical new vaccine products as compared to the standard vaccine products in multi-dose vials in Cambodia, Ghana, and Bangladesh. The authors use a cost-effectiveness model to estimate the impacts of introducing four thermostable vaccines with single-dose presentations: measles, yellow fever, bacille Calmette-Guerin, and diphtheria–tetanus–pertussis–hepatitis B. The effectiveness of all of the vaccines increases with the thermostable formats. The incremental costs associated with the introduction of thermostable vaccines increases for three out of four vaccines.
Read the journal article on the JournalsConsult website.