Introducing New Vaccines in Developing Countries

Sonali Kochhar; Barbara Rath; Lea D Seeber; Gabriella Rundblad; Ali Khamesipour; Mohammad Ali


Expert Rev Vaccines. 2013;12(12):1465-1478. 

In This Article

Gathering Robust Data on Vaccine Efficacy & Safety

Robust data on safety, immunogenicity and efficacy (direct vaccine protection) are required by regulatory agencies to license a new vaccine. Such data are typically the only information used as product prescription information and advertising.[37] If data collected in Phase IV trials do not reach the public, vaccines might be underutilized because only direct vaccine protections are communicated to the general public and medical community. Community perceptions developed during vaccine trials can be studied to help in the planning of a general vaccine introduction.[38] Wide dissemination of the data on safety and efficacy is, therefore, important for promoting the use of a new vaccine. It is also good to have a well-developed vaccine safety monitoring system for collecting information on the safety of the vaccines.[5,13,39] Expanded use of vaccines in the absence of such monitoring system could be problematic. Several useful vaccine safety monitoring systems have been developed, including VAERS in the USA, the adverse drug reactions advisory committee database in Australia and several others.[40–49] Although hundreds of millions of doses of vaccines are used every year in developing countries, assessments of regulatory authorities conducted by the WHO demonstrate that few developing countries have programs with the ability to monitor and assure the safe use of vaccines.[106]