Optimizing presentation and packaging for HPV vaccinesby Debbie Kristensen and D. Scott LaMontagne, PATH
Working in collaboration with the Vaccine Presentation and Packaging Advisory Group (VPPAG), representatives from the public health community have initiated a series of studies to guide presentation and packaging decisions for future iterations of human papillomavirus (HPV) vaccines destined for low-income countries. Presentation and packaging decisions, such as the number of doses per container, type of container, and recommended storage temperatures greatly impact the way vaccines are handled, the quantity of vaccine doses wasted, and the ability of health workers to get the vaccines to remote, low-resource settings. By influencing these decisions early in the development process, public health officials can make sure that the specific needs of developing countries are considered.
HPV vaccines present unique characteristics that differentiate them from current World Health Organization (WHO)-prequalified infant vaccines. HPV vaccines target an older, gender-specific population; are currently available at higher prices than most existing WHO-prequalified vaccines; offer promising heat-stability profiles; and similar to pneumococcal vaccines, are currently available only as liquid formulations, in one- and two-dose vials, without preservative.
The following are a list of studies recently initiated to gather data from users, procurement specialists, and economists to better understand needs and constraints regarding HPV vaccines:
A retrospective, cross-sectional analysis of data on vaccination session size from three HPV vaccine demonstration projects in Uganda, Peru, and Vietnam.A small-scale, time-and-motion study to assess the time and ease of vaccine delivery across different HPV vaccine presentations.Documentation of ambient temperatures experienced during the final stages of HPV vaccine distribution and use in Vietnam and Uganda to assess the feasibility of controlled ambient temperature storage and transport.Surveys with immunization program managers and health workers in Vietnam involved in the HPV vaccine demonstration project to sample preferences for HPV vaccine presentation, packaging, and logistics. (Note: similar surveys may also be conducted in Uganda and Peru).Breakeven analysis of potential price, wastage, and cold chain costs for various HPV vaccine presentations using the Vaccine Presentation Assessment Tool.Analysis of qualitative data from questionnaires that assess individual experiences of those involved in HPV vaccine demonstration project activities in Uganda, Peru, and Vietnam.The VPPAG will compile the results of these studies and additional data available from industry into a preferred product profile for HPV vaccines describing characteristics, including optimal vial size, presentation, and storage temperature requirements, for future HPV vaccines for use in developing countries.
We invite you to comment on or post a question relating to this article by clicking the “post reply” button on this page. You will have to log in or register; the process is very simple.
To link back to the Optimize e-newsletter, click here.
Thank you for this useful update.
It is essential at this stage of health care service delivery, to also
consider the safe and sufficient disposal among the parameters of
optimizing presentation and packaging for future iterations of vaccines,
including for HPV. This final stage of the life cycle is now being
considered for some health care commodities. It can be the only way to
ensure that the products truly first do no harm. If possible, please
inform how this element will be included, to ensure that the
presentation and packaging optimization process is comprehensive and
complete.
Thank you in advance and with best regards for your good work.
Marcia N. Rock, MPH
Technical Officer
HCWM Focal Point
John Snow, Incorporated
1616 N. Fort Myer Drive
Arlington, VA 22209-3100
Tel (703)310-5257
Fax (703)528-7480
Marcia Rock raised an excellent point. In just a few weeks (December 12,
2009), the Copenhagen Climate Council will start the discussions on policies
to reduce carbon dioxide emissions and so forth. I am sure the logisticians
in Optimize will agree that incorporating healthcare waste management
considerations at the beginning of these "packaging" plans would be a more
effective way of staying in line with these new policies than trying to
figure it out as an after-thought. It is in our collective interest that any
new project be -at a minimum- mindful of the new climate (literally and
figuratively) we are working in.
Jules Millogo, MD, MSc
Public Health Policy and Planning
Washington
[email protected]
-----
I wholeheartedly agree that disposal issues should be a major concern during the design phase of new products. The Vaccine Presentation and Packaging Advisory Group (VPPAG) is addressing the environmental impact of vaccine presentations and packaging as part of their work on a generic preferred product profile (gPPP) for vaccines (see: http://sites.google.com/site/vppagp/gppp). The profile contains the following recommendation: “Use materials for delivery devices, primary containers and secondary and tertiary packaging that minimize the environmental impact of waste disposal for resource limited systems.” In addition, the VPPAG is undertaking a work program to “Consult with industry on feasible recommendations for packaging materials as well as maximum volume recommendations for primary containers and secondary and tertiary packaging for different vaccine types and containers and advise the WHO on setting these as recommendations for prequalified vaccines.” Thanks for raising this important issue. We hope to have further documents to share with Technet members in the near future as we develop recommendations with more specificity.
Debra D. Kristensen
Group Leader, Vaccine Technologies
PATH
1455 NW Leary Way
Seattle, WA 98107 USA
Telephone: (206) 285-3500; Fax: (206) 285-6619
Email: [[email protected]][email protected][/email]; Web site: www.path.org
Before printing, consider our environment | Avant d'imprimer, pensez a l'environnement | Antes de imprimir, piense en el medio ambiente
Well said. I fully agree with your views. Thanks for brnging up the
issue in a positive way. The whole group have done well in considering
such issues in the begining. Congratulations.
Nagaraj
I have just learned of a new publication that finds that: "Switching from the 10-dose to the 5-dose, 2-dose and 1-dose vial sizes decreased the average availability of EPI vaccines" (My emphasis).
A summary of the publication can be seen here that includes some Background, Methods, Results and a Conclusion. The full text can also be seen here.
I hope it's useful
Thank you for pointing out this useful modeling exercise by VMI in which they apply their HERMES model to evaluate the impact of different container sizes for measles vaccine in Niger. The results are, of course, country specific. I believe that a similar exercise by VMI looking at measles vaccine container sizes in Thailand did not show the same cold chain constraints as in Niger, though the overall cost findings were similar. The results are also antigen specific. There are some distinct differences between measles and HPV vaccines. HPV vaccine is a liquid so there is only one vial (rather than two for diluent and vaccine) and no need for reconstitution syringes. HPV vaccine is also much more expensive than measles vaccine. Lastly, the HPV vaccines that are commercially available do not contain preservative. The concern that they might mistakenly be kept for more than one session after opening has prompted industry to keep the doses per container down to one or two. This preference is also reflected in WHO's programmatic suitability of vaccines for prequalification document. I personally am supportive of this "safety first" approach. What do others think?
All the best,
Debbie Kristensen
Group Leader, Vaccine Technologies, PATH
Mail: PO Box 900922 | Seattle, WA 98109, USA
Street: 2201 Westlake Avenue, Suite 200 | Seattle, WA 98121
TEL 206.285.3500 | FAX 206.285.6619
Email: [email protected]; Web site: http://www.path.org
- Page :
- 1
There are no replies made for this post yet.