![]() As of December 2022, Janssen–J&J’s Jcovden vaccine against SARS-CoV-2 remains the only viral-vector vaccine to have received emergency-use authorization (EUA) from the US Food and Drug Administration (FDA), and no such vaccines have gained full approval ( 5). Those products represent significant scientific achievements. Some such vaccines even received emergency authorization and/or regulatory approval in specific regions, including Ad-based candidates developed by AstraZeneca–Oxford University (United Kingdom), Bharat Biotech (India), CanSino (China), and Janssen–Johnson & Johnson (J&J, United States). Globally, several vector-based candidates advanced rapidly into clinical evaluation. A similar surge in interest occurred early in the COVID-19 pandemic as viral vectors emerged alongside messenger RNA (mRNA) as viable vaccine approaches. Although veterinary applications are proliferating ( 4), viral-vector vaccines for humans have experienced little uptake among drug companies - except during public-health emergencies.ĭuring the West African Ebola virus epidemic of 2013–2016, for example, enthusiasm grew for viral vectors as researchers investigated recombinant vesicular stomatitis virus (VSV), Ad, and other such vehicles for antigen-gene delivery. ![]() Researchers have since investigated many vector types, including different strains of adenovirus (Ad), alphavirus, flavivirus, herpesvirus, paramyxovirus, poxvirus, and rhabdovirus (see “Viral Vectors” box) ( 3). reported their development of a hepatitis B vaccine for chimpanzees based on live recombinant vaccinia virus ( 2). used simian virus (SV) 40 to carry genes from enterobacteria phage λ and Escherichia coli ( 1). The first use of a viral vector to express a foreign gene goes back to 1972, when Jackson et al. Viral-vector vaccines are not entirely new technologies. ![]() Compared with such applications, viral-vector vaccines receive far less attention however, they merit serious consideration because they hold much promise for mitigating infectious diseases. The BPI editorial team receives multiple manuscripts each year relating to production, purification, and formulation of adenoassociated virus (AAV) and lentivirus (LV) vectors for in vivo delivery of gene therapies and ex vivo modification of patient/donor cells, respectively. Viral vectors continue to generate considerable excitement in the biopharmaceutical industry, albeit primarily for advanced-therapy applications. 2,000-L bioreactor and associated control system for production of viral vectors at the ReiThera facility in Rome, Italy ( HTTPS://REITHERA.COM)
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