MCD Inc.

Vaccine Introduction


It has already been shown that immunization with metabolically active, non-replicating (attenuated or weakened) sporozoites protects humans. Thus, the clinical hypothesis has already been proven. Development and commercialization of this vaccine is not dependent on major new scientific breakthroughs. Success will occur as a result of a systematic, organized, knowledge-based approach to production and testing of the vaccine.

Development of radiation attenuated sporozoites as a human vaccine was never seriously pursued for two major reasons.

It was considered technically impractical or impossible.

It was considered unnecessary since modern "subunit" vaccines would solve the problem.

We examined the issues and determined that it was practical, possible, and necessary. We concluded that there were three critical questions that had to be answered before moving into manufacturing and clinical trials.

We Can one administer the vaccine by a route that is clinically practical?

We Can one produce adequate quantities of sporozoites?

We Can sporozoites be produced with the physical characteristics that meet regulatory, potency, and safety requirements to be a licensed vaccine?

Work carried out during the past three years has indicated the answer to all questions is yes. Sanaria now intends to demonstrate:

It is possible to manufacture and administer an attenuated P. falciparum vaccine that is acceptable to the Food and Drug Administration and other regulatory authorities.

The vaccine protects at least 90% of human recipients against experimental challenge with P. falciparum sporozoites.

The vaccine can be produced with an efficiency that makes it economically feasible.

The vaccine protects at least 90% of African infants and children from infection and thus prevents severe morbidity and mortality.