Status: approved/stockpiled in European and other countries; controlled/government distribution

Organizations involved:

Bavarian Nordic A/S – Manuf.; R&D; Tech.; World mark.

Cross ref.: See the entries for Smallpox Vaccine Products (#535) and other smallpox vaccines.

Description: Elstree-BN is a lyophilized (freeze-dried) smallpox vaccine containing live Elstree-BN strain vaccinia virus, which was directly developed from the original first-generation Lister-Elstree vaccinia strain which was successfully used along with Dryvax in the World Health Organization’s (WHO) global smallpox eradication programs in the 1960s and ’70s. Elstree-BN is manufactured using modern cell culture techniques and serum free media that comply with internationally-accepted (cGMP) manufacturing standards. The freeze-dried formulation ensures long-term stability in stockpiles. It is supplied in a box containing 10 vials of freeze-dried powder and 10 ampules (in amber glass) of diluent/re-constituting fluid. The vaccine is stored refrigerated. As with Dryvax and other smallpox vaccines, the vaccine is delivered into the skin with a bifurcated needle through the process of scarification and results in the classic, “pock mark,” indicating a “take” or successful vaccination.

Companies.: Elstree-BN was developed and is manufactured and marketed by Bavarian Nordic A/S.

Status: This vaccine is not currently fully approved by any country, although, as an equivalent of a proven vaccine (Lister-Elstree), many countries are purchasing it for biodefense stockpiling. This vaccine has not been used in the U.S., and is not among the vaccines being purchaed by the federal government for biodefense. Estree-BN has been purchased primarily for biodefense stockpiling by other governments.

Trials: In 2004, a Phase I study was showed that Elstree-BN has a safety and efficacy profile similar to historical smallpox vaccine strains, confirming experience gained from its use in international smallpox irradication programs with Lister-Elstree and similar vaccines. The vaccine induced a typical vaccine take reaction in all 32 subjects with no unexpected adverse reactions. The subjects were monitored for a one-year follow-up.

Market: Bavarian Nordic has in recent years delivered more than 60 million doses of Elstree-BN smallpox vaccine to governments and military around the world. This includes supplies sold to Germany. U.K. and New Zealand. About 17 million doses were sold in 2005. The company received supply contracts from the German government in Oct 2002 and Feb. 2003. In April 2002, the company joined in a collaboration with PowderJect (now Chiron Corp.), which received a 17.6 million Euro contract from the U.K. government for supply of Elstree-BN