Hexavalent IPV-based combination vaccines for public-sector markets of low-resource countries

Abstract

In anticipation of the successful eradication of wild polio virus, alternative vaccination strategies for public-sector markets of low-resource countries are extremely important, but are still under development. Following polio eradication, inactivated polio vaccine (IPV) would be the only polio vaccine available, and would be needed for early childhood immunization for several years, as maintenance of herd immunity will be important for sustaining polio eradication. Low-cost combination vaccines containing IPV could provide reliable and continuous immunization in the post-polio eradication period. Combination vaccines can potentially simplify complex pediatric routine immunization schedules, improve compliance, and reduce costs. Hexavalent vaccines containing Diphtheria (D), Tetanus (T), whole cell pertussis (wP), Hepatitis B (HBV), Haemophilus b (Hib) and the three IPV serotype antigens have been considered as the ultimate combination vaccine for routine immunization. This product review evaluates potential hexavalent vaccine candidates by composition, probable time to market, expected cost of goods, presentation, and technical feasibility and offers suggestions for development of low-cost hexavalent combination vaccines. Because there are significant technical challenges facing wP-based hexavalent vaccine development, this review also discusses other alternative approaches to hexavalent that could also ensure a timely and reliable supply of low-cost IPV based combination vaccines.

Hexavalent vaccinations: The future of routine immunization?

“…Also, the IAP Advisory Committee on Vaccines & Immunization Practices VOLUME 54 __ JANUARY 15, 2017 EDITORIAL (ACVIP) recommends that DTaP vaccine/combinations should preferably be avoided for the primary series and if any acellular pertussis containing vaccine is used, it must at least have three or more components in the product, which is not the case in this investigational vaccine [4]. Interestingly, no hexavalent combinations with whole cell pertussis (wP) are commercially available or in late-stage of development because of numerous technical and logistical issues, and are unlikely to be available in next few years [3]. The classic wP vaccine with thimerosal also faces a major challenge of incompatibility with IPV antigens.…”

“…Therefore, the hexavalent vaccines that are most likely to be available now, or in the very near future are primarily intended and priced for private markets. With regard to the newer Sabin IPV, although some vaccine manufacturers have access to the Sabin strains (for OPV product), further effort and time would be needed to develop an inactivated form that is compatible for combination vaccine development [3].…”

“…Combination (multivalent) vaccines have the potential to simplify the currently complex childhood immunization schedules, improve caregiver compliance, and reduce healthcare costs. Hexavalent vaccines containing Diphtheria (D), Tetanus (T), Pertussis (P), Hepatitis B (HBV), Haemophilus influenzae B (Hib) and the three IPV antigens have been considered logically and scientifically sound charioteers of such a strategy, and have been touted to be the ultimate combination vaccine for routine immunization [3]. Another bugbear in the success of any vaccination strategy (both public and private) is the high injection density during infancy, which cannot be ignored.…”

Assessing vaccine effectiveness of publicly funded vaccination programs in Queensland

“…Currently, the pentavalent DTwP, hepatitis B and Haemophilus influenzae type b (DTwP-HBV/Hib) vaccine is the standard combination vaccine used in low-income countries (219) with separate administration of oral polio vaccine (OPV) (155). It is predicted that inactivated polio vaccine (IPV) would replace the live OPV following the last cases of polio, and that IPV will be used for several years to ensure polio eradication (155).…”

“…In response to these concerns, aP vaccines containing up to five purified In 2012, global coverage with three doses of a diphtheria, tetanus and pertussis containing vaccines was estimated to be 83%, with pertussis mortality continuing to decline (153). Due to the substantially greater expense of aP vaccines, historically costing ≥10 times than wP vaccines (154), aP vaccines are not affordable for many lower income countries, where multivalent vaccines containing wP continue to be the predominant vaccine in use (155).…”