Licensing Requirements for Avian Vaccines Within the European Union.

Avian vaccines are a key factor when it comes to ensuring the availability of products derived from healthy poultry and preventing the transmission of infections from domestic and wildlife birds to humans. A marketing authorization for veterinary vaccines is granted after the product's quality, safety, and efficacy have been confirmed. During the licensing procedure, the manufacturing process is assessed to guarantee consistent quality and stability of the vaccine components. Furthermore, both the safety for the target species and the risk for the user, the consumer, and the environment must be demonstrated. In addition, specific tests and studies are required to support the efficacy of the vaccine. The authorization procedures and related licensing requirements for avian vaccines to be marketed in the European Union (EU) based on the requirements of Regulation (EU) 2019/6 Article 8 and the Commission Delegated Regulation (EU) 2021/805 amending Annex II to Regulation (EU) No. 2019/6 are explained in the paper.

Requisitos de licencia para vacunas aviares dentro de la Unión Europea. Las vacunas aviares son un factor clave a la hora de garantizar la disponibilidad de productos derivados de aves sanas y prevenir la transmisión de infecciones de aves domésticas y silvestres a los humanos. La autorización de comercialización de vacunas veterinarias se concede una vez confirmada la calidad, seguridad y eficacia del producto. Durante el procedimiento de concesión de licencia, se evalúa el proceso de fabricación para garantizar una calidad y estabilidad constantes de los componentes de la vacuna. Además, se debe demostrar tanto la seguridad para las especies a las que dicha vacuna está destinada, así como el riesgo para el usuario, el consumidor y el medio ambiente. Además, se requieren pruebas y estudios específicos que respalden la eficacia de la vacuna. En este documento se explican los procedimientos de autorización y los requisitos de licencia relacionados para las vacunas aviares que se comercializarán en la Unión Europea (U.E.) con base en los requisitos de la Regulación (U.E.) 2019/6 Artículo 8 y la Regulación Delegada de la Comisión (U.E.) 2021/805 que modifica el Anexo II del Reglamento. (U.E.) No. 2019/6.

Serologic testing for avian influenza viruses in wild birds: comparison of two commercial competition enzyme-linked immunosorbent assays.

Serologic testing of wild birds for avian influenza virus (AIV) surveillance poses problems due to species differences and nonspecific inhibitors that may be present in sera of wild birds. Recently available competitive enzyme-linked immunosorbent assay (cELISA) kits offer a new species-independent approach. In this study we compare two commercial competitive cELISAs, using a total of 184 serum and plasma samples from 23 species of wild birds belonging to 10 orders. Thirteen samples were from experimentally high pathogenicity AI and low pathogenicity AI infected red-legged partridges (Alectoris rufa), 77 samples were from a flock of sentinel hybrid ducks confirmed infected by AI by real-time PCR, and 94 samples were from wild birds admitted to a rehabilitation center. Both ELISAs detected AI antibodies in the experimentally infected partridges, whereas hemagglutination inhibition (HI) was negative. Concordance in results between the two ELISAs was 51.5%. When specific subtype-H5/H7 HI-positive samples were considered for comparison, ELISA 1 appeared to perform better on ducks, whereas ELISA 2 appeared to perform better in other wild bird species. Overall, 68.2% of H5/H7 positive samples tested positive by ELISA 1 and 36% by ELISA 2. Both ELISAs detected AIV-antibody-positive samples negative by specific HI against 9 of the 16 existing hemagglutinin (HA) subtypes. Presumably this reflects either higher sensitivity of cELISA when compared to HI, presence of antibodies against HA subtypes not tested, or unspecific reactions. Performance of ELISA 1 on ducks appears to be comparable to in-house cELISA previously used by other authors in wild birds, but requires a relatively large sample volume. Alternatively, although ELISA 2 required a smaller sample volume, it was less effective at identifying HI-positive samples. The results reflect the necessity of validation of cELISA tests for individual species or at least families, as required by the OIE.

[Mortality in free living siskins (Spinus spinus Linnaeus, 1758) due to Salmonella typhimurium, phage type DT104 and DT013]. / Todesfälle bei frei lebenden Zeisigen (Spinus spinus Linnaeus, 1758) durch Salmonella Typhimurium DT104 und DT013.

This report deals with an enzootic due to Salmonella Typhimurium in two free living Eurasian siskins (Spinus spinus Linnaeus, 1758). Other birds in the vicinity of the siskins were not affected. Clinical signs consisted of non-specific symptoms such as ruffled plumage, apathy and reduced food intake. During necropsy, gross lesions were enlarged livers with focal necrosis, pale spleens, enlarged kidneys, pneumonia and enteritis. Salmonella Typhimurium was isolated from internal organs in pure culture. Using the polymerase chain reaction, the detection of Salmonella according to EN ISO 6579:2002 was confirmed. The detailed characterisation of both isolates in the Federal Institute for Risk Assessment and in the Robert Koch Institute yielded for the first siskin Salmonella Typhimurium, 4, 5, 12: i : 1, 2, LT DT104, BT a and for the second siskin Salmonella Typhimurium, 4,12 i : 1, 2, LT DT013, BT c. These phage types were identified for the first time in siskins. The detected phage types have importance as causes of disease not only for free living siskins but also as infectious and zoonotic agents for domestic poultry and poultry products.

CFTR-dependent Cl- secretion in Xenopus laevis lung epithelium.

In our present study we used preparations from Xenopus laevis lungs to perform electrophysiological Ussing chamber measurements, unidirectional flux measurements, and employed molecular approaches to elucidate the presence and function of a cystic fibrosis transmembrane conductance regulator (CFTR) homolog in this tissue. Application of different CFTR blockers (NPPB (5-nitro-2-(3-phenylpropylamino)benzoic acid), niflumic acid (NFA), glibenclamide, lonidamine, CFTR(inh)-172) to the apical side of the tissues was able to significantly decrease the measured short circuit current (I(SC)) indicating a Cl(-) secretion due to luminal located CFTR channels. This was further supported by a net (36)Cl(-) secretion determined by radioactive tracer flux experiments. Further, Xenopus pulmonary epithelia responded to apical chlorzoxazone exposure - a CFTR activator - and this activated current was inhibited by CFTR(inh)-172. We performed reverse transcription-PCR (RT-PCR) and Western blot analysis and with both approaches we found characteristic signals indicating the presence of a CFTR homolog in Xenopus lung. In addition, we were able to detect CFTR in apical membranes of Xenopus lung slices with immunohistological techniques. We conclude that Xenopus lung epithelium exhibits functional CFTR channels and that this tissue represents a valuable model for the investigation of ion transport properties in pulmonary epithelia.

Mesenchymal stem cells remain of host origin even a long time after allogeneic peripheral blood stem cell or bone marrow transplantation.

OBJECTIVE: Plasticity of hematopoietic stem cells (HSC) has gained major interest in stem cell research. In order to investigate whether HSC may differentiate into mesenchymal stem cells (MSC), we assessed chimerism in peripheral blood (PB), mononuclear cell fractions (MNC) of bone marrow, and MSC derived from bone marrow (BM) from 27 up to 4225 days after allogeneic transplantation. PATIENTS AND METHODS: We applied fluorescence in situ hybridization using X/Y gene probes in sex-mismatched and STR-PCR in sex-matched patients. MSC could have been generated in 27 of 55 bone marrow samples derived from 20 patients. Fifteen patients received peripheral blood stem cell transplants (PBSCT), including CD34-selected PBSCT in two. Five patients received bone marrow. RESULTS: While all patients had chimerism in PB and MNC of the BM, in all but one patient BM-derived MSC were of recipient origin. This single patient showed reproducibly MSC of donor origin in a frequency of 1% after having received a CD34-selected PBSCT. Looking at graft collections, MSCs were easily generated from BM specimens, while no MSC could be derived from PBSC samples. CONCLUSION: Even though HSC have been found to differentiate into a variety of nonhematological cell types, they usually do not differentiate into MSC after allogeneic transplantation.