Vaccine quality and safety: scrutinizing the reported 3-fold increase in adverse effects following immunization (Aefi) in India.

BACKGROUND: There has been major controversy over vaccine safety in India following newspaper reports citing right to information (RTI) disclosure that there have been increasing vaccine related deaths following immunization in children in the recent years.

METHODS: Secondary data analysis.

RESULTS AND CONCLUSION: Adverse effect following immunization (AEFI) events in recent years are being linked to closure of three government owned vaccine producing public sector units (PSU) closures in India. The media reports quoting government sources suggest that the total number of reported deaths due to AEFI in a pre-closure of vaccine PSUs 7 years (2001-2007) was 136, whereas it is 355 in the post vaccine PSU closure 3 years (2008 to 2010). There is an issue of comparability of numbers of AEFI deaths pre- (2001-2007) and post-vaccine PSU closure era (2008-2011) and linking increased AEFI deaths to vaccine PSU closure.