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First-generation vaccines
First-generation vaccines used for the eradication of smallpox were grown in the skin of calves or other large animals, a method that is not compliant with current Good Manufacturing Practice (GMP) standards.

The first-generation vaccine is highly effective in preventing disease but can cause serious complications, including postvaccinal encephalitis. The majority of stocks were manufactured 20 or more years ago.


The goal of Baxter was to develop a new, second-generation vaccine (NYCBH-strain) that is equal to the first-generation vaccine in terms of efficacy but with an improved safety profile.

ACAM2000 is a clonal vaccine manufactured using modern, serum and protein-free, cell-culture techniques which comply with current Good Manufacturing Practice (GMP) standards. The benefit of a vaccine developed under serum and protein-free conditions is that it is free from adventitious agents or animal proteins, which could contribute to adverse events. It is a live vaccinia virus vaccine cultured in Vero cells. A continuous mammalian cell line (Vero) ensures a predictable, standardized manufacturing process. The vaccine is currently being developed under an Investigational New Drug (IND) application from the US Food and Drug Administration (FDA).

ACAM2000 had undergone extensive clinical testing including Phase 1-3. The clinical programme is designed to meet the requirements for licensure in the US, Europe and other countries worldwide. Data from the ACAM2000 Phase III trials were analysed and, together with data from previous trials, assembled in preparation for a pre-Biologics License Application (BLA) meeting with the FDA. Following a successful outcome of that meeting, Acambis filed the first portion of the BLA with the FDA in January 2006. As agreed with the FDA, Acambis is submitting the BLA on a "rolling basis".

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