Conversation with HSNWDr. Kavita Berger, biosecurity expert

Project BioShield, launched in 2004 with a $5 billion funding from Congress, aims to encourage the development of vaccines against bioterror agents. The project has divided the scientific community with regard to the direction of R&D effort funded by the project. Some scientists in the field argue that the development and stock-piling of vaccines for known diseases, such as polio, plague, botulism, and anthrax, is a waste of funding — funding which could, and should, be used to develop a universal vaccine which would counteract not only known bioterror agents, but yet-unknown agents, also called “designer pathogens.”

Homeland Security NewsWire recently spoke with Kavita M. Berger, Ph.D., associate program director at the Center for Science, Technology, and Security Policy with the American Association for the Advancement of Science (AAS). Berger specializes in biosecurity, global health, and public health preparedness, and response. She is currently focusing on building “trust and relationships between disparate groups to address complex biosecurity, scientific, and public health issues.”

The NewsWire asked Berger whether she thought the idea of a universal vaccine belonged in the domain of science fiction, or whether there had been actual progress in the field. “Some host-pathogen responses can be shared within classes of pathogens and some may be specific to a single type of pathogen or strain of the pathogen. The best approach to developing vaccines is to understand what elements of pathogens cause the most effective set of protective responses from the host.” While vaccines may not necessarily protect against all strains of a given pathogen, certain drugs are effective against several classes of pathogens, such as ciprofloxacin, a synthetic chemotherapeutic antibiotic marketed worldwide with over 300 brand names.

In 2001 a detection threat agency in San Diego identified and created a vaccine for the H1N1 virus within two weeks — a process and concept Dr. Josh Lederberg, a molecular microbiologist, and Dr. George Whiteside, a chemist and professor at Harvard, hypothesized would eventually take twenty-four hours. BioWatch, a federal program to detect the release of pathogens into the air as part of terrorist attack, has refined chemical, biological, radiological, and nuclear (CBRN) detection technologies to the point where the detection and diagnosis of an abnormality in the air could be accomplished within an hour (“Northrop Grumman testing autonomous biodetection instruments for BioWatch,” 22 November 2010 HSNW). First and second generation CBRN technology would normally take up to 24-36 hours to detect an abnormality, and require sending a sample to a laboratory for examination and diagnosis, which would defeat the purpose of quickly isolating any virulent outbreak.

Berger suggested that, in regard to biosecurity, more funding and attention should be paid to educating and training first responders, veterinarians, wildlife experts, health practitioners, and public health officials to recognize typical and unusual symptoms of pathogens and toxins. She said that “…enough attention has been paid to evaluating existing investments in detection and drug/vaccine development/delivery technologies for non-biodefense diseases (whether developed for infectious or genetic diseases).” The attention paid to smallpox vaccines for the Strategic National Stockpile (SNS), which contains pharmaceuticals, vaccines, medical supplies, and medical equipment to respond to terrorist attacks and other emergencies, increased manifold once reports regarding the diluting of the vaccine would create a five-fold increase.

Berger spoke on the implications of this option: “…the effectiveness of vaccines depend on the amount of viral, protein, or bacterial particles; the presence and type of adjuvants; and mechanism and route of exposure.” Vaccines can retain their ability to counteract a disease depending on the conditions for exposure and the vaccine’s components. “Safety and efficacy have to be tested for all formulations, amounts of vaccine, and routes of exposure for every vaccine.”

The FDA’s recent initiative on “regulatory science,” which, as defined by the administration, means the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products, could benefit project BioShield according to Berger. “This initiative could be helpful in addressing scientific and regulatory issues associated with pre-clinical studies, clinical trials, and the animal rule.”