After validating the submission and reviewing the responses, a second list of questions and outstanding issues is expected from the Committee for Medicinal Products for Veterinary Use (CVMP). The Company estimates that it is on track for a positive opinion from the CVMP during Q2 2021.
The vaccine has been developed with an innovative technology and is based on recombinant fusion proteins. The research behind the vaccine's technical platform has been done together with researchers at
"Upon approval, Strangvac will be the first Swedish Animal Health Vaccine to receive marketing authorization by the centralised EMA procedure covering all 27 member states of the
The MAA for Strangvac is based on a successful series of clinical studies demonstrating the safety, immunogenicity, efficacy and DIVA capability of this exciting vaccine. DIVA (Differentiation of Infected from Vaccinated Animals) capability is a key feature for prevalent endemic diseases such as equine strangles in order to distinguish vaccinated animals from those that have been exposed to the bacteria Streptococcus equi.
For more information please contact:
Phone: +46 (0)8 120 10 601, Cell: +46 (0)73 335 99 70
E-mail: andreas.andersson@intervacc.com
This information is information that
About
About Strangvac
Strangvac, a modern vaccine against Strangles, is a highly contagious and serious infection in horses caused by the bacterium Streptococcus equi. Strangvac consists of only soluble recombinant proteins, is injected intramuscularly and totally devoid of any living infectious agent. This results in a well-tolerated vaccine with excellent safety profile.
Contact information for Certified Adviser
E-mail: adviser@eminova.se, Phone: +46 (0)8 - 684 211 10
https://news.cision.com/intervacc/r/intervacc-announces-submission-of-responses-to-ema-day-120-questions,c3266843
https://mb.cision.com/Main/4632/3266843/1358355.pdf
https://news.cision.com/intervacc/i/a-new-generation-of-vaccines-within-animal-health,c2866266
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