No TB cattle vaccine until 2023 – EU Commission
THE European Commission has told Defra that a cattle vaccine for bovine TB (bTB) is unlikely to be commercially available until 2023.
In a recent letter to Defra Secretary Owen Paterson, EU health Commissioner Tonio Borg said vaccination against bTB is ‘explicitly forbidden’ in EU legislation on disease control and in ‘intra-Union trade legislation’.
He said the main reason for the ban was, due to the ‘suboptimal protection’ from cattle vaccines, the risk that vaccinated animals may become infected but could not be distinguished from uninfected vaccinated animals because vaccination ‘interferes’ with the TB skin test. “This would jeopardise current bTB control and eradication policy,” he said.
He said a recent vaccination workshop in Cardiff ‘clearly indicates’ that ‘many knowledge gaps’ exist concerning the performance of the ‘only available candidate, live BCG vaccine, its safety, conditions for use and the suitability of a DIVA test to distinguish infected and uninfected vaccinated animals.
He said the ‘fundamental scientific information’ necessary to change EU policy on cattle vaccination accompanied by a DIVA test was not yet available.
Mr Borg said future studies were needed to address food safety concerns, such as the shedding of vaccine strain in milk and human health concerns as BCG is the only vaccine available for humans. Its use in cattle may lead to the selection of BCG-resistant strains of bTB that may affect also humans, he said.
Research is also needed to address animal health and trade concerns, including proper discrimination between vaccinated and infected animals and the acceptability of vaccinated animals in international trade.
But he outlined a ‘tentative timeline for bTB vaccination of cattle in UK’, which indicates that a workable cattle vaccine is at least 10 years away.
2015-16: Completion of field trials on BCG vaccination.
2016-17: If scientific consensus is reached on the conditions for use of vaccine and DIVA test, vaccine to undergo marketing authorisation procedure.
2017-18: Debate on veterinary conditions to allow use of vaccine and possible authorisation.
2018-23: Practical experience using the vaccine and DIVA test under the new rules.
2023: Possible changes to EU rules on vaccinated animals and herds to enter intra-Union trade in parallel with amendments of international standards.
Mr Paterson said Mr Borg’s letter ‘recognises that we are on course to deploy a vaccine’. “The legal and scientific process could take up to 10 years. In the meantime, we will continue to use all the tools at our disposal.