The collaboration established between the Indian and Canadian NRAs and WHO facilitated the registration in India as well as the prequalification by WHO.
For the demonstration scenario, it was assumed that supply would not be constrained by manufacturing capacity and that all countries would require vaccine prequalification by WHO.
Tanzania also reported that for products with prior regulatory approval from a stringent National Regulatory Authority (Canada, Japan, Australia, EU and USFDA) or prequalification by WHO could be reviewed using an abridged dossier.
Fourth, Shantha constructed its own cGMP facility, which established credibility for vaccine prequalification by the World Health Organization and generated interest from large pharmaceutical companies in its contract research services.
In the case of vaccines against diseases of high public health importance such as a group A meningococcal (MenA) conjugate vaccine for Africa and where the vaccine will be purchased and distributed by United Nations (UN) procurement agencies, a prequalification by WHO is also required.
The vaccination was intentionally conducted as a demonstration project in contradistinction to a vaccine trial to assess the feasibility of the use of the vaccine nationally because the OCV already had an extensive safety and efficacy record that had led to prequalification by WHO.
