Advanced Development of the rF1V and rBV A/B Vaccines: Progress and Challenges

Table 1

Required performance parameters for the rBV A/B and rF1V vaccines.

Key Performance Parameter: FDA Licensure
Performance attribute	Development threshold		Development objective
	rBV A/B	rF1V	rBV A/B	rF1V
Efficacy	Protect 80% of immunized persons		Protect 90% of immunized persons
Immune response	An immune response sufficient to meet threshold efficacy requirements for this vaccine within 210 days of the initial vaccine dose		An immune response sufficient to meet threshold efficacy requirements for this vaccine within 30 days of the initial vaccine dose
Duration of protection	Protection for at least one year from completion of the primary vaccination series		Protection for five years after the administration of a single-dose vaccine
Number of doses to achieve protection (primary series)	3		1
Shelf life	1 year		5 years