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<BR>Home,Anses,News,Press room,Agenda,Our topics,Food,Animal health and nutrition,Environmental health,Occupational health,Plants,Opinions and publications,Last opinions and reports,Food opinions and reports,Animal health and nutrition opinions and reports,Environmental and occupational health opinions and reports,Plants opinions,Opinions and reports in English,Bulletins and periodicals,Other publications,Subscribe to Anses newsletter,Research and reference,Research program,Laboratories and reference activities, + ,Job opportunities,Public procurement contracts,Our websites,Partners,Extranet / ExpertNet,Kid's area,Legal notice,Contact, ,<BR>The French Food Safety Agency (AFSSA), via the French Agency for Veterinary Medicinal Products (ANMV), today organised an informative meeting in Maisons-Alfort on pharmacovigilance with respect to bluetongue (serotypes 1 and 8) vaccines. At this meeting the Agency presented professionals in the field with its report of the 2008 and 2009 vaccination campaigns, together with the outlook for the 2010 campaign which has just been launched. <BR><BR><BR><BR>Review of the 2008/2009 vaccination campaigns<BR><BR>Due to the extensive bluetongue animal epidemic in 2007, a vaccination campaign was launched in March 2008. 123 million doses of vaccine have since been administered. The limited number of outbreaks shows the positive result of this vaccination effort: while there were 20,000 in 2007 and 32,000 in 2008 there have only been 82 so far since the beginning of 2009.<BR><BR>Under the pharmacovigilance system set up by AFSSA via the ANMV, 1406 declarations notifying adverse effects potentially linked to the vaccine have been filed since the vaccination campaign began. <BR>These declarations mainly concern cattle (86%) and sheep (13%), and describe potential adverse effects in 9415 animals, including 1205 mortalities. <BR><BR>AFSSA has carried out a detailed analysis of each of these declarations. In nine cases, the causal relationship between the adverse affect and the vaccination was assessed as 'probable' and in 20% of the declarations it was considered to be 'possible'. In nearly 80% of the cases it was not possible to confirm a direct causal relationship between the vaccines and the declared adverse affect, either due to a lack of information or because the other possible causes had not been investigated. <BR>In the case of abortions, for instance, information is needed on how long after injection the abortions occurred, the stage of gestation, the associated symptoms (fever, cough, diarrhoea, etc.) and any screening performed for infectious agents such as Q fever, salmonella, leptospira, BVD virus, etc. The lack of information on these other diseases in the pharmacovigilance declarations means that it is impossible to conclude whether or not these causes of abortions had been investigated and excluded. Moreover, it is difficult to isolate the effects associated with restraining the animals (particularly gestating females) or with the vaccination act itself, from those due directly to the vaccines.<BR>With 123 million doses of vaccines having been administered, the approximately 300 cases of adverse effects declared as being possibly related to vaccination (20% of the 1406 declarations) do not call into question the greater benefits to health from vaccination compared to any risks that may arise.<BR><BR><BR><BR>What is the value of pharmacovigilance?<BR><BR>Pharmacovigilance mainly aims to detect and document as early and fully as possible the unexpected or serious adverse effects of medicinal products. This has been achieved for the bluetongue vaccines. The described local reactions to a vaccine against serotype 1 (Zulvac® 1 Bovine) will therefore lead to the summary of product characteristics being modified when its Provisional Authorisation for Use (ATU) is renewed. Nevertheless, pharmacovigilance is not intended to be a substitute for a civil or legal expert assessment in any potential compensation procedure challenging the use of veterinary medicinal products.<BR><BR>As a reminder, all pharmacovigilance declarations should be sent to the Lyons Pharmacovigilance Centre (CPVL), which can also be contacted beforehand (CPVL, École nationale vétérinaire de Lyon, 1 avenue Bourgelat, 69280 Marcy L'étoile, Tel +33 (0)4 78 87 10 40, Fax +33 (0)4 78 87 45 85, email address).<BR><BR><BR><BR>Outlook for the 2010 campaign<BR><BR>Pharmacovigilance with respect to vaccines against bluetongue remains a priority for the forthcoming 2010 campaign for the mandatory vaccination of cattle and sheep.<BR><BR>In agreement with the Lyons Pharmacovigilance Centre and with effect from the beginning of January 2010, the ANMV will be responsible for all feedback to veterinarians filing declarations during the 2009 campaign.<BR><BR>Moreover, since the assessment of cases depends directly on the quality and accuracy of information reported in the declarations, the ANMV is advising veterinarians not to group in the same declaration all cases of adverse effects compiled from a single farm, but rather to separate them into several declarations according to animal species, vaccination protocols (initial vaccination, booster shot, serotypes) and clinical picture observed.<BR><BR> The Agency is also recommending that declarations include the results of autopsies and additional tests, as well as any other relevant information used to interpret the cases. The earlier or concomitant presence of diseases on the farm, or on the contrary the absence of these diseases when screening as part of a differential diagnosis, would enable a better assessment of the causal relationship between the vaccine and the clinical signs reported.<BR><BR>With the Ministry of Agriculture's Directorate General for Food, as part of the health stakeholders' summit meeting and revisions to the health mandate, AFSSA, through the ANMV, also plans to establish a network of 'reference' veterinarians who are aware of and trained in pharmacovigilance.<BR><BR>Lastly, an electronic filing procedure is to be set up in early 2010 to facilitate direct declarations by internet.<BR><BR><BR><BR>Find out more: <BR><BR>- Our Bluetongue close-up<BR>- The Review of adverse effects observed after vaccination against bluetongue, serotypes 1 and 8<BR><BR><BR>Bluetongue (BT): Pharmacovigilance data do not call into question the risk/benefit status of the vaccines <BR>11 December 2009<BR>News<BR>Highlighted news,Archives,-,Archives of AFSSET news,Archives of AFSSA news,<A HREF='PM910006I0.htm'>News</A>
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The French Food Safety Agency (AFSSA), via the French Agency for Veterinary Medicinal Products (ANMV), today organised an informative meeting in Maisons-Alfort on pharmacovigilance with respect to bluetongue (serotypes 1 and 8) vaccines. At this meeting the Agency presented professionals in the field with its report of the 2008 and 2009 vaccination campaigns, together with the outlook for the 2010 campaign which has just been launched.
Review of the 2008/2009 vaccination campaigns
Due to the extensive bluetongue animal epidemic in 2007, a vaccination campaign was launched in March 2008. 123 million doses of vaccine have since been administered. The limited number of outbreaks shows the positive result of this vaccination effort: while there were 20,000 in 2007 and 32,000 in 2008 there have only been 82 so far since the beginning of 2009.
Under the pharmacovigilance system set up by AFSSA via the ANMV, 1406 declarations notifying adverse effects potentially linked to the vaccine have been filed since the vaccination campaign began. These declarations mainly concern cattle (86%) and sheep (13%), and describe potential adverse effects in 9415 animals, including 1205 mortalities.
AFSSA has carried out a detailed analysis of each of these declarations. In nine cases, the causal relationship between the adverse affect and the vaccination was assessed as 'probable' and in 20% of the declarations it was considered to be 'possible'. In nearly 80% of the cases it was not possible to confirm a direct causal relationship between the vaccines and the declared adverse affect, either due to a lack of information or because the other possible causes had not been investigated. In the case of abortions, for instance, information is needed on how long after injection the abortions occurred, the stage of gestation, the associated symptoms (fever, cough, diarrhoea, etc.) and any screening performed for infectious agents such as Q fever, salmonella, leptospira, BVD virus, etc. The lack of information on these other diseases in the pharmacovigilance declarations means that it is impossible to conclude whether or not these causes of abortions had been investigated and excluded. Moreover, it is difficult to isolate the effects associated with restraining the animals (particularly gestating females) or with the vaccination act itself, from those due directly to the vaccines. With 123 million doses of vaccines having been administered, the approximately 300 cases of adverse effects declared as being possibly related to vaccination (20% of the 1406 declarations) do not call into question the greater benefits to health from vaccination compared to any risks that may arise.
What is the value of pharmacovigilance?
Pharmacovigilance mainly aims to detect and document as early and fully as possible the unexpected or serious adverse effects of medicinal products. This has been achieved for the bluetongue vaccines. The described local reactions to a vaccine against serotype 1 (Zulvac® 1 Bovine) will therefore lead to the summary of product characteristics being modified when its Provisional Authorisation for Use (ATU) is renewed. Nevertheless, pharmacovigilance is not intended to be a substitute for a civil or legal expert assessment in any potential compensation procedure challenging the use of veterinary medicinal products.
As a reminder, all pharmacovigilance declarations should be sent to the Lyons Pharmacovigilance Centre (CPVL), which can also be contacted beforehand (CPVL, École nationale vétérinaire de Lyon, 1 avenue Bourgelat, 69280 Marcy L'étoile, Tel +33 (0)4 78 87 10 40, Fax +33 (0)4 78 87 45 85, email address).
Outlook for the 2010 campaign
Pharmacovigilance with respect to vaccines against bluetongue remains a priority for the forthcoming 2010 campaign for the mandatory vaccination of cattle and sheep.
In agreement with the Lyons Pharmacovigilance Centre and with effect from the beginning of January 2010, the ANMV will be responsible for all feedback to veterinarians filing declarations during the 2009 campaign.
Moreover, since the assessment of cases depends directly on the quality and accuracy of information reported in the declarations, the ANMV is advising veterinarians not to group in the same declaration all cases of adverse effects compiled from a single farm, but rather to separate them into several declarations according to animal species, vaccination protocols (initial vaccination, booster shot, serotypes) and clinical picture observed.
The Agency is also recommending that declarations include the results of autopsies and additional tests, as well as any other relevant information used to interpret the cases. The earlier or concomitant presence of diseases on the farm, or on the contrary the absence of these diseases when screening as part of a differential diagnosis, would enable a better assessment of the causal relationship between the vaccine and the clinical signs reported.
With the Ministry of Agriculture's Directorate General for Food, as part of the health stakeholders' summit meeting and revisions to the health mandate, AFSSA, through the ANMV, also plans to establish a network of 'reference' veterinarians who are aware of and trained in pharmacovigilance.
Lastly, an electronic filing procedure is to be set up in early 2010 to facilitate direct declarations by internet.
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