Biodefense vaccines– overview, stockpiling and regulation

biodefense vaccines

The first session of Day Three, Track B, at the World Vaccine Congress & Expo USA 2013 was about biodefense vaccines. The chairman of the session, Dr David Walker, Executive Director, Center for Biodefense and Emerging Infectious Diseases, UTMB, introduced the first speaker of the morning – Dr Michael Kurilla, Director, Office of BioDefense Research Affairs, Associate Director for BioDefense Product Development, DMID, NIAID, NIH, DHHS. Dr Kurilla gave a presentation on "Biodefense vaccines – overview", where he gave an overview of biomedical product development and product development paths. He listed some Phase I and II clinical trials involving small pox, anthrax, plague and tularaemia viruses, and discussed the desirable attributes of biodefense vaccines – including long shelf life, rapid onset of immunity, post-exposure prophylaxis and/or therapeutic capability, minimal necessary training, and surge capacity for production. He discussed some current funding opportunities of interest, and next generation concepts including stabilization excipients and novel formulations such as encapsulation methodology (where two vaccinations could be given at the same time, with the encapsulation giving a boost in a few weeks time).

Next to speak on biodefense vaccines was Dr Robert Brey, Chief Scientific Officer, Soligenix. He gave a presentation entitled "Stockpiling biodefense vaccines – technology innovation". Here, he spoke about stockpiling vaccines and biologics for long term storage, and the sensitivity of vaccines to thermoinstability. He discussed the temperature sensitivity of marketed vaccines, and the cold chain management cycle. He spoke about addressing vaccine instability, including with lyophilisation. He gave a case study of Soligenix's RiVax ricin vaccine – a vaccine based on the A chain of ricin.

To conclude the session, Dr Luciano Borio, Assistant Commissioner for Counterterrorism Policy' Director, Office of Counterterrorism & Emerging Threats, Office of the Chief Scientist, Office of the Commissioner, FDA, gave a talk on the "Regulatory landscape for biodefense vaccines".

Were you at World Vaccine Congress USA 2013? Do you have any comments about Day Three's Biodefense Vaccine presentations? You can leave a comment in the box below, or on LinkedIn group discussion.

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