BOVINE NEONATAL PANCYTOPENIA - EUROPE (02): BVD VACCINE AUTHORISATION SUSPENDED

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Date: Fri 16 Jul 2010
Source: European Medicines Agency, press release EMA/CVMP/416930/2010
[extracted, edited]



Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of
13-15 Jul 2010
----------------------------------------------------------------------
[Under the section 'Community referrals and related procedures', the
following text was included]:

Extract
-------
The Committee concluded the procedure for PregSure BVD and associated
names (inactivated bovine viral diarrhoea (BVD) type 1 virus) from
Pfizer Animal Health. The matter was notified to the Committee by
Germany under Article 78 of Directive 2001/82/EC, due to concerns
relating to animal safety following use of the vaccine in dams and
development of bovine neonatal pancytopenia in calves.

The Committee reviewed pharmacovigilance data, as well as
epidemiological and laboratory data, and, although the aetiology of
the disorder remains obscure at present and the associated risk
factors have yet to be determined, the information available is
sufficient to indicate a potential association with the product.
Therefore, the Committee adopted by majority an opinion concluding
that the marketing authorisations for PregSure BVD and associated
names should be suspended until scientific evidence is available to
demonstrate that the administration of the vaccine to dams according
to authorised conditions of use does not lead to an increased risk of
bovine neonatal pancytopenia or that risk mitigation measures
ensuring the safe use of the product can be implemented. In addition,
the CVMP recommended that all batches of the product be recalled at
wholesale level.

--
Communicated by:
Sabine Zentis
Castleview Pedigree English Longhorns
Gut Laach
52385 Nideggen
Germany


['Bovine neonatal pancytopenia' (BNP) was agreed as the official name
of the syndrome during the Satellite Symposium on Haemorrhagic
Diathesis in Calves, 2 Dec 2009, Marseille, on the occasion of the
European Buiatrics Forum. Previously, it was known as "calf bleeding
syndrome", recorded, since 2007, in several European countries
including Great Britain (England, Wales, and Scotland), Belgium,
France, Netherlands, Italy, Germany, and Ireland. Investigations
concerning the syndrome, in particular related to the possibility of
a role played by BVD vaccination, are being carried out in several of
the said countries.

BNP is suspected to have a multifactorial basis. A causal
relationship between PregSure BVD and BNP has not (yet?) been
established. In June 2010, Pfizer Animal Health (PAH) decided to
voluntarily stop further sales of PregSure BVD pending further
investigations into the BNP syndrome in calves. - Mod.AS]

[see also:
Bovine neonatal pancytopenia - Europe: BVD vaccine susp. 20100607.1896
Bovine neonatal pancytopenia - Germany (02): BVD vaccine susp. 20100603.1845
Bovine neonatal pancytopenia - Germany: vaccinal etiology susp. 20100409.1142
2009
----
Undiagnosed disease, fatal, bovine - Europe (07): Belgium, treatment
20091209.4195
Undiagnosed disease, fatal, bovine - Europe (06): review 20091207.4168
Undiagnosed disease, fatal, bovine - Europe (05): Germany 20091031.3769
Undiagnosed disease, fatal, bovine - Europe (04): Germany 20091018.3578
Undiagnosed disease, fatal, bovine - Europe (03): France 20091006.3465
Undiagnosed disease, fatal, bovine - Europe (02): RFI 20091005.3459
Undiagnosed disease, fatal, bovine - Europe: RFI 20091003.3441
Undiagnosed disease & deaths, bovine - UK: (Scotland) RFI 20090923.3345
Undiagnosed disease & deaths, bovine - Germany (03): ongoing 20090329.1214
Undiagnosed disease & deaths, bovine - Germany (02): sugg. etiology
20090208.0566
Undiagnosed disease & deaths, bovine - Germany: RFI 20090202.0470
Circovirus, swine - Switzerland 20091004.3453]
...................................arn/mj/lm

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