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Coronavirus Biology and Pathogenesis
On the Front Lines
Approaches to Vaccines and Drug Development
Blocking SARS Virus Fusion
Lessons in Interventions for SARS
Status of Drug Screening vs. SARS
Adenovirus Vector Technologies for Vaccines
Some Approaches to Vaccine Development
Panel 3 Discussion
Future Perspectives on Emerging Infections
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SARS in the Context of Emerging Infectious Threats SARS in the Context of Emerging Infectious Threats
Approaches to Vaccines and Drug Development
Some Approaches to Vaccine Development

Thomas Monath, Acambis, Cambridge, MA
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Considerations for a Potential SARS Vaccine
• Pursuing a vaccine against SARS will require multiple approaches, a significant effort, and will require collaboration among molecular biology, virology, immunology, animal experimentation.
• A vaccine needs to be administered pre-exposure, induce protection against clinical disease and perhaps against infection and transmission, be given in few doses, elicit neutralizing antibody response, be safe and immunogenic, and be manufactured efficiently on a large scale.
• Robust mucosal immune response may be needed and is difficult to achieve with many vaccines.
• Antigenic variation of SARS CoV needs to be monitored.

Animal CoV Vaccine Results
• Mucosal immunization strategies are required to protect newborn animals.
• Partial protection is demonstrated with live or inactivated vaccines in some cases, but is not durable.
• Subunit vaccines are not particularly effective except for priming and boosting.
• Antigenic variation is a problem with IBV.
• Live vectors show promise in some models.
• Feline infectious peritonitis vaccine enhances disease.

Evaluating Possible Approaches
• For inactivated whole-virus vaccine, the method of inactivation may be important to preserve the native structure; these may not provide long-lasting immunity and require multiple boosting.
• Recombinant subunit vaccine will require adjuvant and likely mucosal delivery.
• Live vectors or replicons may be problematic because of anti-vector immunity.
• Live-attenuated virus may be the best approach to induce mucosal and systemic immunity, or could be part of a priming and boosting regime, and would not have manufacturing issues.
• DNA alone has not been a successful vaccine and faces regulatory issues.

Timeline and Cost
• An aggressive timeline puts a "go/no-go decision" at 18 months after beginning vaccine development.
• Development would cost 60 to 100 million dollars and five to six years at a minimum.

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