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Saturday 3 December 2016

Vaccine recall over EU calf death fears

Withdrawal of Pfizer vaccine Pregsure BVD ordered by Commission

Published 07/09/2010 | 05:00

A European-wide recall of the Pfizer vaccine Pregsure BVD has been ordered amid concerns about a possible link between the vaccine and calf deaths from haemorrhaging.

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The recall, ordered by the European Commission, was prompted by a possible link between the use of the vaccine in cows and the development of Bovine Neonatal Pancytopenia (BNP), also known as bleeding calf syndrome.

More than three million doses of Pregsure vaccine have been sold in Ireland since it was launched here five years ago and it is understood that around 5,000 doses will have to be recalled locally.

Just six cases of BNP in calves have been confirmed by the Department of Agriculture in Ireland.

BNP was first identified in Europe a number of years ago and an expert European Commission committee was set up to examine all available information on the disease and possible causes.

While the cause of the disorder remains unknown, the committee concluded that the Pregsure BVD vaccination might have been a contributory factor.

"Data evaluated suggests that Pregsure BVD may be one of the contributing factors for BNP although investigations are currently ongoing to determine all the factors associated with the disorder and the underlying cause," the Commission committee findings stated. A statement from Pfizer confirmed the product recall, but insisted the association of BNP with the use of Pregsure BVD was not clear.

"The evidence currently available at European level indicates that BNP is likely to have a multifactorial cause," Pfizer said.

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"The association of BNP with the use of Pregsure BVD is not clear: for example, Pregsure BVD is licensed in 20 European countries, but BNP has only been recorded in 11 countries," Pfizer's statement pointed out.

However, Pfizer has not appealed the Commission decision to recall the vaccine from wholesale level.

The company voluntarily stopped selling Pregsure BVD in Germany, the country with the highest incidence of BNP, last April and voluntarily stopped selling Pregsure BVD in the remaining European countries, including Ireland, in June.

Although the vaccine was not recalled at that stage, veterinary wholesalers and retail suppliers were informed of Pfizer's action and were given the option of returning unused product, if they wanted to do that. Pfizer has confirmed that although unused vaccine on-farm or at retail level is not subject to recall, any farmer who has an unbroached in-date vial of Pregsure BVD that he/she no longer wants to use should contact the retailer who supplied it.

Mike Magan, chairman of Animal Health Ireland (AHI), said the withdrawal of Pregsure BVD vaccine highlighted the need for a national policy on BVD eradication.

The disease costs farmers between €40 and €80 per cow on infected farms.

AHI is currently examining BVD eradication schemes in other European countries and delegates are due to visit Switzerland next week as part of the investigation.

A consultation paper, based on the European study, is due to be published by AHI in mid-November.

BVD is a highly contagious viral disease of cattle that can be transmitted as easily as the common cold.

A relatively new disease to Ireland, experts now estimate that the disease costs Irish farmers a minimum of €1m annually in depressed productivity and mortality.

One of the most high-profile herds to suffer from the disease was Moorepark's Ballydague 180-cow herd.

See page 27

Irish Independent



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