First Approval For SB's Infanrix Hep B

SmithKline Beecham Biologicals has been granted the first world approvalfor Infanrix Hep B, its combined diphtheria, tetanus, acellular pertussis and hepatitis B pediatric vaccine, in all 15 member states of the European Union.

SB notes that Infanrix Hep B is the first acellular pertussis-based vaccine to offer protection against all these diseases in one product, and reduces the number of injections needed from six to three. The company already offers a combination whole-cell DTP-HBV vaccine, Tritanrix-HBV, in certain countries where acellular pertussis vaccination has not yet been embraced, having been granted EU centralized approval for the product in July 1996. The World Health Organization has set an objective for universal child vaccination against hepatitis B by the end of 1997.

A spokesman for SB said that launches of Infanrix Hep B would occur on a country-by-country basis, once the product gets recommended by national vaccination committees. Pricing will not be divulged until the first launch takes place, he said. The product has not been filed in the USA, and there has been speculation that this may be because SBBio plans to wait until it can file for one of its other Infanrix-based combination vaccines (see below).