An oral formulation could greatly facilitate vaccine administration, particularly during a pandemic when rapid distribution is needed. During the 2009 H1N1 pandemic, when vaccine was in short supply, individual county health departments in California had to have a plan for distribution. In Los Angeles County, approximately 60 points of distribution (PODs) were tasked to administer the vaccine. Approximately 247 persons per hour lined up, and the rate of immunization was approximately 239 person per hour at each POD (Saha et al. Emerging infectious diseases 2014; 20(4): 590-5). For the PODs in Los Angeles County, this translated to 143,000 people per day. In a city of 9 million, assuming supplies or qualified personnel were not in short supply, it would take more than 60 days to complete an immunization campaign. As an alternative, if the H1N1 pandemic vaccine was delivered by US mail and self-administered by tablet, all 9 million subjects could be immunized within a single day without people having to stand in line, and risking exposure to the growing outbreak. While there are regulatory hurdles to overcome, our tablet vaccine appears to be stable at room temperature for greater than 270 days and can tolerate short-term excursions at higher temperatures (G. Trager, un- published data), which should make this approach technically feasible.
[0222] In summary, oral influenza vaccine based on rAd administration can elicit antibody responses to influenza in greater than 90% of subjects. While this is an early clinical stage study and several studies will need to be completed that address issues such as interference and repeated seasonal use, these results look encouraging for safety and immunogenicity.
