5. Candidate Vaccine Choice

Consensus:

The same scientific criteria that are used to identify an appropriate candidate vaccine for a ‘developed’ country should be applied to the choice of a candidate vaccine for a ‘developing’ country.

Discussion:

There is not consensus within the scientific community at this time regarding what degree and what components of immunogenicity, what viral subtype specificity and what genetic, nutritional, and environmental factors are important in predicting the likelihood of a candidate vaccine being effective. However, there was consensus within the group that the best available opinion on this matter should guide the choice of candidate vaccines for phase III trials in developing countries. The criteria applied to ‘developing’ populations should be the same as those applied to ‘developed’ populations.

Controversy:

Because criteria for a promising candidate vaccine are not clear, a final decision on whether to conduct a phase III trial must include appropriate local scientific, ethical, and community evaluation. However, there was not agreement within the group about whether a candidate vaccine for which there is not consensus within the scientific community should proceed to a phase III trial even if the host country approves it.