8 August 2008

1 minute read

Europe

In that Undertaking, signed on 14 February 2008, Pfizer accepted the decision of the Committee and undertook, in relation to any promotion of Spirovac®:

• (a) Forthwith to cease and immediately to suspend any practice which includes any claim that Spirovac® “works” against L. hardjo prajitno, or which by other words, connotations or means, suggests or implies or tends to imply that that product provides protection against that strain; or
• (b) Forthwith to cease and immediately to suspend any practice which includes any reference to Spirovac® being licensed for use against L. hardjo prajitno.

However, three promotional items issued following the Undertaking were deemed by the Code of Practice Committee to be in breach of this Undertaking, and this decision was then reported to the NOAH Board.

Pfizer was formally reprimanded for their conduct. Pfizer will be writing to all recipients of the offending material to apologise, and to correct any misunderstanding that may have arisen, namely to explain that Spirovac® only has a licensed claim for protection against one of the two strains of bovine leptospirosis, the hardjo bovis strain. Although Spirovac® has been shown to stimulate an antibody response against the second strain, hardjo prajitno, protection against this strain has not been demonstrated by challenge studies and it therefore has no licensed claim against this strain.

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