Deliberate release in Belgium of GMOs other than higher plants for any other purpose than for placing on the market (e.g. clinical trials with GM medicinal products) - Submitted according to Part B of the Royal Decree of 21 February 2005
The Belgian Biosafety Server contains a database providing the following additional information for each GMO:
| Ref. | Notifier | GMO | Advice of the Council | Status |
|---|---|---|---|---|
| B/BE/25/BVW7 | AbbVie Deutschland GmbH & Co. KG | Non-replicating recombinant vector derived from adeno-associated virus AAV8 |
Not applicable |
Ongoing |
| B/BE/25/BVW6 | University of Tokyo | Recombinant live attenuated virus |
Not applicable |
Ongoing |
| B/BE/25/BVW5 | Asklepios BioPharmaceutical (AskBio) | Non-replicating recombinant adeno-associated vector |
Download
(13-10-2025) |
Concluded |
| B/BE/25/BVW4 | SparingVision | Non-pathogenic recombinant adeno-associated viral vector |
Download
(29-07-2025) |
Concluded |
| B/BE/25/BVW3 | CSL Behring LLC | Non-pathogenic recombinant competent adeno-associated viral vector |
Download
(17-06-2025) |
Concluded |
| B/BE/25/BVW2 | AstriVax NV | Recombinant live attenuated Yellow Fever Virus |
Download
(07-04-2025) |
Concluded |
| B/BE/24/BVW6 | AstriVax NV | Recombinant live attenuated Yellow Fever Virus |
Download
(23-01-2025) |
Concluded |
| B/BE/24/BVW5 | Pfizer | GM adeno-associated viral vector derived from a naturally occurring AAV serotype (Rh74) |
Download
(31-05-2024) |
Concluded |
| B/BE/24/BVW4 | Sarepta Therapeutics | Non-replicating recombinant vector derived from adeno-associated virus serotype rh74 |
Download
(27-05-2024) |
Concluded |
| B/BE/23/BVW3 | AstriVax NV | Recombinant live attenuated Yellow Fever Virus |
Download
(28-03-2024) |
Concluded |
| B/BE/23/BVW2 | Janssen-Cilag International NV | GM adeno-associated virus AAV2 |
Download
(15-06-2023) |
Concluded |
| B/BE/22/BVW6 | Sarepta Therapeutics | Non-replicating recombinant vector derived from adeno-associated virus serotype rh74 |
Download
(25-08-2023) |
Concluded |
| B/BE/22/BVW5 | F. Hoffmann-La Roche | Non-replicating recombinant vector derived from adeno-associated virus AAV |
Download
(17-07-2023) |
Concluded |
| B/BE/22/BVW4 | Nouscom Srl | Non-replicating recombinant adenovirus and orthopoxvirus |
Download
(19-01-2023) |
Concluded |
| B/BE/21/BVW9 | Merck Sharp & Dohme | Live attenuated dengue quadrivalent vaccine |
Not applicable |
Withdrawn by the notifier |
| B/BE/21/BVW8 | Meira GTx UK II Limited | Non-replicating recombinant vector derived from adeno-associated virus AAV 5 |
Download
(19-04-2022) |
Concluded |
| B/BE/21/BVW7 | SCS Boehringer Ingelheim Comm.V | Recombinant vesicular stomatitis virus |
Download
(03-06-2022) |
Concluded |
| B/BE/21/BVW6 | GlaxoSmithKline Biologicals SA | Recombinant viral vectors |
Download
(23-02-2022) |
Concluded |
| B/BE/21/BVW5 | Sarepta Therapeutics | Non-replicating recombinant adeno-associated virus serotype rh74 |
Download
(30-05-2022) |
Concluded |
| B/BE/21/BVW4 | AMAL Therapeutics | Recombinant vesicular stomatitis virus |
Download
(17-02-2022) |
Concluded |
| B/BE/21/BVW3 | Prevail Therapeutics | Replication-incompetent adeno-associated virus, AAV9, lacking all AAV viral genes and encoding for the human Progranulin (GRN) gene |
Download
(12-11-2021) |
Concluded |
| B/BE/21/BVW2 | Larissa consortium and Wageningen Bioveterinary Research | Live-attenuated vaccine |
Download
(06-08-2021) |
Concluded |
| B/BE/20/BVW6 | Pfizer | Recombinant non-replicating adeno-associated viral vector (AAV2/6) containing a codon-optimised version of the human Factor VIII gene |
Not applicable |
Withdrawn by the notifier |
| B/BE/20/BVW5 | Nouscom srl | Recombinant GAd20 Gorilla adenovirus and Recombinant vaccinia virus Ankara (MVA) that contain the information to produce patient-specific cancer 'neoantigens' for treatment of skin and lung cancer |
Download
(11-02-2021) |
Concluded |
| B/BE/20/BVW4 | Pfizer | Recombinant AAV vector lacking viral genes and containing a gene encoding a shortened, but functional variant of the human dystrophin gene for treatment of Duchenne Muscular Dystrophy |
Download
(05-02-2021) |
Concluded |
| B/BE/20/BVW3 | Transgene | Replicative oncolytic vaccinia virus with deletion of the viral thymidine kinase and ribonucleotide reductase genes, and addition of genes encoding for the human granulocyte-macrophage colony-stimulating factor cytokine and for a monoclonal antibody targeting the Cytotoxic T-Lymphocyte-Antigen 4 |
Download
(20-10-2020) |
Concluded |
| B/BE/20/BVW2 | Vaccitech Ltd | Recombinant replication-incompetent chimpanzee-derived adenovirus, and recombinant modified vaccinia virus Ankara vector (MVA), modified with Human Papillomavirus (HPV) surface antigens |
Download
(05-06-2020) |
Concluded |
| B/BE/19/BVW4 | Merck Sharp & Dohme | Recombinant Vesicular Stomatitis Virus (rVSV) in which the gene coding for the VSV glycoprotein G has been deleted and replaced with the gene encoding the Zaire Ebola virus (ZEBOV) glycoprotein |
Download
(17-09-2019) |
Concluded |
| B/BE/19/BVW3 | Amgen Ltd | Herpes simplex virus 1 (HSV-1) with gene expressing granulocyte-macrophage colony-stimulating factor (GH-CSF) and deletion of 2 HSV-1 genes |
Download
(13-05-2019) |
Concluded |
| B/BE/19/BVW2 | BioMarin Pharmaceutical Inc. | Recombinant Adeno-associated virus vector with gene cassette expressing human factor VIII |
Download
(24-05-2019) |
Concluded |
| B/BE/18/BVW9 | GSK Biologicals SA | Recombinant chimpanzee-derived group C adenovirus expressing three proteins from the Respiratory Syncytial Virus (RSV) |
Download
(22-01-2019) |
Concluded |
| B/BE/18/BVW7 | uniQure Bioipharma BV | Recombinant adeno associated viral vector containing a derivative of human coagulation factor IX cDNA |
Download
(11-12-2018) |
Concluded |
| B/BE/18/BVW6 | AveXis, Inc. | Recombinant adeno-associated virus serotype 2/9 (AAV2/9) containing the cDNA of the human SMN (Survival Motor Neuron) gene |
Download
(07-01-2019) |
Concluded |
| B/BE/18/BVW5 | Intrexon | Lactococcus lactis genetically modified to produce human interleukin-10 and proinsulin |
Download
(13-09-2018) |
Concluded |
| B/BE/18/BVW4 | GSK Biologicals SA | Recombinant replication-defective simian (chimpanzee-derived) group C adenovirus, and recombinant modified vaccinia virus Ankara vector (MVA) |
Download
(01-10-2018) |
Concluded |
| B/BE/18/BVW3 | Oragenics | Lactococcus lactis expressing human Trefoil Factor 1 (hTFF1) |
Download
(11-09-2018) |
Concluded |
| B/BE/18/BVW2 | University Antwerp, Belgium | Novel live attenuated serotype 2 oral poliovirus vaccines (nOPV2) candidates |
Download
(10-08-2018) |
Concluded |
| B/BE/17/BVW2 | Amgen Ltd | Herpes simplex virus 1 (HSV-1) with gene expressing granulocyte-macrophage colony-stimulating factor (GH-CSF) and deletion of 2 HSV-1 genes |
Download
(27-09-2017) |
Concluded |
| B/BE/17/BVW1 | Transgene S.A. | Modified Vaccinia virus Ankara (MVA) with sequences coding for human mucine 1 (MUC1) antigen and interleukin-2 (IL2) |
Download
(05-09-2017) |
Concluded |
| B/BE/16/BVW1 | Amgen Ltd | Herpes simplex virus 1 (HSV-1) with gene expressing granulocyte-macrophage colony-stimulating factor (GH-CSF) and deletion of 2 HSV-1 genes |
Download
(13-12-2016) |
Concluded |
| B/BE/15/BVW2 | Amgen Ltd | Herpes simplex virus 1 (HSV-1) with gene expressing granulocyte-macrophage colony-stimulating factor (GH-CSF) and deletion of 2 HSV-1 genes |
Download
(12-01-2016) |
Concluded |
| B/BE/15/BVW1 | Amgen Ltd | Herpes simplex virus 1 (HSV-1) with gene expressing granulocyte-macrophage colony-stimulating factor (GH-CSF) and deletion of 2 HSV-1 genes |
Download
(12-10-2015) |
Concluded |
| B/BE/14/BVW1 | Amgen Ltd | Herpes simplex virus 1 (HSV-1) with gene expressing granulocyte-macrophage colony-stimulating factor (GH-CSF) and deletion of 2 HSV-1 genes |
Download
(24-02-2015) |
Concluded |
| B/BE/12/BVW2 | Celladon | Recombinant Adeno-associated virus (rAAV) expressing SERCA2a enzym |
Download
(23-01-2013) |
Concluded |
| B/BE/12/BVW1 | Theravectys | Two recombinant non-pathogenic, non-replicative Lentiviruses for therapeuthic vaccination of HIV infected patients |
Download
(11-09-2012) |
Concluded |
| B/BE/11/V3 | Laboratorios Hipra | Recombinant Actinobacillus pleuropneumoniae with modified virulence factors |
Download
(16-04-2012) |
Concluded |
| B/BE/11/BVW2 | Bn Immuno Therapeutics | Recombinant Vaccinia virus and Fowlpox virus expressing PSA and immunological costimulatory molecules |
Download
(07-08-2012) |
Concluded |
| B/BE/11/BVW1 | Transgene | Recombinant Vaccinia virus expressing MUC1 antigen and hIL-2 |
Download
(30-09-2011) |
Concluded |
| B/BE/09/BVW1 | Roche | Recombinant Vaccinia virus expressing hIL-2 and proteins of HPV virus |
Download
(09-09-2009) |
Concluded |
| B/BE/08/BVW1 | MedImmune | Recombinant bovine Parainfluenza virus with genes of human Parainfluenza virus and Respiratory syncitial virus |
Download
(18-06-2009) |
Concluded |
| B/BE/07/BVW3 | GENimmune | Recombinant Vaccinia virus with gene of Hepatitis B virus |
Download
(07-03-2008) |
Concluded |
| B/BE/07/BVW1 | Actogenix | Recombinant Lactococcus lactis expressing hIL-10 |
Download
(18-01-2008) |
Concluded |
| B/BE/04/BV1 | Pfizer Animal | Recombinant feline herpes virus |
Download
(15-07-2005) |
Concluded |
| B/BE/03/B3 | Transgene | Human adenovirus serotype 5 deleted in E1 and E3 |
Concluded |