DNA Vaccines: Regulatory Considerations and Safety Aspects.

DNA vaccination for prostate cancer: key concepts and considerations

While locally confined prostate cancer is associated with a low five year mortality rate, advanced or metastatic disease remains a major challenge for healthcare professionals to treat and is usually terminal. As such, there is a need for the development of new, efficacious therapies for prostate cancer. Immunotherapy represents a promising approach where the host's immune system is harnessed t...

Regulatory and Biosafety Challenges for Vaccines

The global regulatory plan for vaccines provides a unique opportunity to develop safe and effective ones with assured quality. Methods used by regulators address challenges of new products and technologies and also increase understanding of benefits and risks of existing products. First, the laboratory-based regulatory sciences evolve correlates of immunity and safety; or improve the product ch...

Comparison of Current Regulatory Status for Gene-Based Vaccines in the U.S., Europe and Japan

Gene-based vaccines as typified by plasmid DNA vaccines and recombinant viral-vectored vaccines are expected as promising solutions against infectious diseases for which no effective prophylactic vaccines exist such as HIV, dengue virus, Ebola virus and malaria, and for which more improved vaccines are needed such as tuberculosis and influenza virus. Although many preclinical and clinical trial...

Technical considerations of cholera vaccines and some results of cholera - El-Tor mass immunization

The OECD Blue Book on Recombinant DNA Safety Considerations: it's influence on ISBR and EFSA activities.

Biosafety regulatory frameworks are intended to serve as mechanisms for ensuring the safe use of biotechnology products without imposing unacceptable risk to human health or the environment, or unintended constraints to technology transfer. The OECD Blue Book on "Recombinant DNA Safety Considerations", setting out principles and concepts for handling genetically modified organisms safely outsid...