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Presentation matters: Buffers, packaging, and delivery devices for new, oral enteric vaccines for infants
Manjari Lal1, Courtney Jarrahian1
1a PATH , Seattle , WA , USA.
Insights
Oral vaccines offer a simpler alternative to injections, especially for infants. Developing effective oral vaccines for childhood diarrhea requires careful consideration of formulation, packaging, and delivery systems for low-resource settings.
Area of Science:
- Vaccinology
- Pediatric Infectious Diseases
- Global Health
Background:
- Oral vaccine administration is simpler and more acceptable than injections, particularly for infants.
- This route is promising for vaccines targeting enterotoxigenic Escherichia coli (ETEC) and Shigella, major causes of childhood diarrhea in low-resource countries.
Purpose of the Study:
- To highlight key considerations for the development of oral vaccines, focusing on formulation, packaging, and delivery systems.
- To emphasize the importance of early consideration of these factors for maximizing the impact of new enteric vaccines.
Main Methods:
- The abstract discusses the challenges and requirements for oral vaccine development.
- It reviews factors including antigen/adjuvant stability in the stomach, infant-specific buffering needs, container/closure compatibility, cold chain impact, and administration device design.
- Manufacturing capabilities and cost-effectiveness for immunization programs are also considered.
Main Results:
- Oral vaccines require buffering against stomach acidity.
- Container/closure systems must protect the vaccine and maintain the cold chain.
- Accurate and easy-to-use administration devices are crucial for healthcare workers in low-resource settings.
Conclusions:
- Successful development of oral vaccines for childhood diarrhea necessitates a holistic approach.
- Early consideration of formulation, packaging, and delivery is essential for optimizing vaccine impact in target populations.
- Addressing these multifaceted challenges will facilitate the successful implementation of new oral vaccines in global immunization programs.
Abstract:
Oral administration of vaccines is simpler and more acceptable than injection via needle and syringe, particularly for infants (Fig. 1) This route is promising for new vaccines in development against enterotoxigenic Escherichia coli (ETEC) and Shigella that cause childhood diarrhea with devastating consequences in low-resource countries. However, vaccine antigens and adjuvants given orally need buffering against the degradative effects of low stomach pH, and the type and volume of antacid buffer require special attention for infants. In addition, container/closure systems must be compatible with vaccine formulations, protect against water and gas transfer, and have minimal impact on the cold chain. Health care workers in demanding low-resource settings need an administration device that is easy to use, yet will accurately measure and safely deliver the correct vaccine dose. Developers must consider manufacturing capabilities, and immunization program managers want affordable vaccines. As new combination enteric vaccine candidates advance into clinical evaluation, features of the final vaccine presentation-liquid or dry format, diluent, buffer, primary and secondary packaging, and administration device-should be taken into account early in product development to achieve the greatest possible impact for the vaccine.
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