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Management: European Medicines Agency (EMA)
Vaccination: Veterinary Vaccinations
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Total 17 results found since Jan 2013.
Evaluation of non-clinical toxicity studies of COVID-19 vaccines
In this study we evaluated the outcomes of non-clinical toxicity studies of various SARS-CoV-2 vaccines produced with different manufacturing technologies, with focus on Repeated Dose Toxicity (RDT) and Developmental and Reproductive Toxicity (DART) studies. We found that RDT and DART studies at doses relevant for human treatment showed no adverse effects while remaining observations were expected findings including local reactogenicity, immune response and macroscopic findings at the injection site. We have also reviewed the European Medicines Agency (EMA) nonclinical assessment reports for market authorization. Regardles...
Source: Regulatory Toxicology and Pharmacology : RTP - June 25, 2023 Category: Toxicology Authors: N K M Schilder B Tiesjema P T Theunissen K Oude Rengerink J W van der Laan Source Type: research
Addressing practical issues in the smooth implementation of revised guidelines for non-clinical studies of vaccines for infectious disease prevention
Regul Toxicol Pharmacol. 2023 May 23:105413. doi: 10.1016/j.yrtph.2023.105413. Online ahead of print.ABSTRACTHerein, we investigated possible practical issues for the smooth implementation of the revised Japanese Guidelines for Non-clinical Studies of Vaccines for the Prevention of Infectious Diseases, which were raised in response to public comments on the proposed guideline revision and a gap analysis of the World Health Organization and European Medicines Agency guidelines. We identified main issues such as the non-clinical safety studies of adjuvants and evaluation of local cumulative tolerance in toxicity studies. The...
Source: Regulatory Toxicology and Pharmacology : RTP - May 25, 2023 Category: Toxicology Authors: Atsuko Okumoto Yumiko Nomura Kazushige Maki Takashi Ogawa Hiroshi Onodera Mayumi Shikano Nobuhiko Okabe Source Type: research
Zoonoses Anticipation and Preparedness Initiative, stakeholders conference, February 4 & amp; 5, 2021
Biologicals. 2021 Nov 1:S1045-1056(21)00085-3. doi: 10.1016/j.biologicals.2021.10.003. Online ahead of print.ABSTRACTThe Zoonoses Anticipation and Preparedness Initiative (ZAPI) was set up to prepare for future outbreaks and to develop and implement new technologies to accelerate development and manufacturing of vaccines and monoclonal antibodies. To be able to achieve surge capacity, an easy deployment and production at multiple sites is needed. This requires a straightforward manufacturing system with a limited number of steps in upstream and downstream processes, a minimum number of in vitro Quality Control assays, and ...
Source: Biologicals : Journal of the International Association of Biological Standardization - November 5, 2021 Category: Biotechnology Authors: Martin Beer Leanne Amery Berend-Jan Bosch Alexander Brix Olalekan Daramola Sophie Inman Carmen Jungb äck Jeroen Kortekaas Viv Lindo Uche Okorji-Obike Sara Rodriguez-Conde Alison Tang Ronen Tchelet Joris Vandeputte Paul J Wichgers Schreur Ab Osterhaus Bar Source Type: research
The contribution of field efficacy studies to the evaluation of applications for veterinary vaccines evaluated through the European Union centralised authorisation procedure
Biologicals. 2021 Apr 8:S1045-1056(21)00024-5. doi: 10.1016/j.biologicals.2021.03.001. Online ahead of print.ABSTRACTTo examine the contribution that field efficacy studies made to the assessment of marketing authorisation (MA) applications, a retrospective analysis was conducted for 100 veterinary vaccines that had been evaluated by the European Medicines Agency (EMA) between 1996 and 2017. For 52 veterinary vaccines, scrutiny of the European Public Assessment Report (EPAR) and/or the summary of product characteristics (SPC) identified objective evidence that field efficacy studies made an important or substantial impact ...
Source: Biologicals : Journal of the International Association of Biological Standardization - April 12, 2021 Category: Biotechnology Authors: David Mackay Cristina Martin Jimenez Faye Ioannou Martin Ilott Source Type: research
