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Regulatory considerations for new stabilised poliovaccines
1Global Programme for Vaccines and Immunization, World Health Organization, Geneva, Switzerland.
Developments in Biological Standardization
|January 1, 1996
Summary
Adding deuterium oxide to oral poliovaccine (OPV) significantly increases its heat stability by up to 1000-fold. This enhanced oral poliovaccine formulation is undergoing regulatory review for improved vaccine stability.
Area of Science:
- Vaccinology
- Biochemistry
Background:
- Oral poliovaccine (OPV) is the least heat-stable vaccine in national immunization programs.
- Improved thermal stability of OPV is crucial for global polio eradication efforts.
Purpose of the Study:
- To evaluate the stabilization effect of deuterium oxide on oral poliovaccine (OPV).
- To assess the regulatory considerations for a novel, stabilized OPV formulation.
Main Methods:
- Oral poliovaccine trivalent bulk vaccines were diluted in 87% deuterium oxide.
- Stability was assessed after incubation at 45°C for one week.
Main Results:
- Dilution in 87% deuterium oxide resulted in a significant stability increase of up to 1000-fold for OPV.
- The established safety and efficacy profiles of OPV and deuterium oxide support the investigation of their combination.
Conclusions:
- Deuterium oxide effectively enhances the thermal stability of oral poliovaccine.
- Regulatory discussions are underway with the European Medicines Evaluation Agency for this stabilized vaccine formulation.