Cross-sectional Retrospective Study on Paracetamol Post Infants' Vaccination in Malaysia

Area of Science:

• Pediatrics
• Immunology
• Pharmacovigilance

Background:

• The use of paracetamol (PCM) post-infant vaccination in Malaysia is controversial due to potential reduced vaccine efficacy.
• Appropriate regulatory measures are needed to guide PCM prescription practices.

Purpose of the Study:

• To determine the prevalence of adverse events following immunization (AEFI) with or without prescribed paracetamol (PCM) in infants post-vaccination in Malaysia.
• To identify factors associated with AEFI, including infant age, vaccine type and stage, and concomitant medications or vitamins.

Main Methods:

• A retrospective cross-sectional study analyzed AEFI data from the National Pharmaceutical Regulatory Agency (NPRA) in Malaysia between 2011 and 2017.
• AEFI cases were categorized based on the potential for PCM prescription.
• Data were analyzed using logistic regression models in SPSS software.

Main Results:

• 359 infant AEFI cases were reported.
• Higher AEFI prevalence was observed with DTaP/Hib/IPV and measles-mumps-rubella (MMR) vaccines.
• DTaP/Hib/IPV vaccination at 2 months showed the highest AEFI rate; DTaP/Hib/IPV (3-4 months) was a significant associated factor.

Conclusions:

• Paracetamol (PCM) prescription post-infant vaccination should potentially be limited to specific vaccine groups.
• Recommendations include restricting PCM use for DTaP/Hib/IPV (2-4 months) and 12-month MMR vaccinations.