Food and Drug Regulations

C.04.116 Smallpox vaccine must demonstrate evidence of disease prevention that is at least equivalent to that of a vaccine that

• (a) is known to prevent human to human transmission of smallpox; and

• (b) meets the potency of equal to or greater than 10⁸ pockforming units per millilitre, as determined using chick embryo chorioallantoic membranes.