Considerations for Setting the Specifications of Vaccines
Considerations for Setting the Specifications of Vaccines
The first vaccine to be used on a large scale was smallpox and the need for control of its origin, production, potency and purity is clear. The same needs arise with other vaccines or biological medicines, although the basis of the concerns will vary depending on the product and the production process as summarized in Table 1. Specifications for vaccines are unique to the particular vaccine under consideration and can only be shown to be correct through clinical usage either in trials or vaccination programs. However, the specifications ensure that the vaccine is likely to behave in a consistent way; in the absence of the right level of consistency determined by considerations of quality, the clinical trials are unreproducible and not very useful.
Conclusion
The first vaccine to be used on a large scale was smallpox and the need for control of its origin, production, potency and purity is clear. The same needs arise with other vaccines or biological medicines, although the basis of the concerns will vary depending on the product and the production process as summarized in Table 1. Specifications for vaccines are unique to the particular vaccine under consideration and can only be shown to be correct through clinical usage either in trials or vaccination programs. However, the specifications ensure that the vaccine is likely to behave in a consistent way; in the absence of the right level of consistency determined by considerations of quality, the clinical trials are unreproducible and not very useful.