Monday, 19 August 2013

Adverse Reactions to HPV Vaccine in Malaysia in 2011

According to Malaysian Adverse Drug Reactions (MADRAC) Newletter, a total of 3183 AEFI reports were received in year 2011, the highest record since  year 2000. This figure is a 32.6% increase from year 2010 and projected to INCREASE. Out of this total, 3,031 reports (95%) were Human Papillomavirus (HPV) vaccine and 152 reports (5%) involved other than HPV vaccine.Wow, that's a lot of cases and most likely there are a lot more cases that aren't reported since people are unaware of vaccine reactions and how to report it.

Where did this sudden spike of reports come from? The HPV vaccine that was launched in year 2010 for Malaysian girls around 13 years old (Form 1). "In year 2011, 3,026 reports were received for Cervarix and 5 (five) for Gardasil. The large number of reports received for Cervarix commensurate with its use as the sole HPV vaccine supplied under the National HPV Vaccination Program."

Sadly, nothing will be done to halt the increase in cases since the report assures us the vaccine adverse effects are relatively mild, the benefits outweighs the risks and the vaccine has no quality issues. Looks like the National HPV Vaccination Program needs to take a cue from Japan, at least Japan suspended its recommendation for the HPV vaccine!

Garis Panduan Farmakovigilans - Keselamatan Vaksin di Malaysia A guide on how to report adverse vaccine effects. The following vaccine information should be collected whenever a vaccine is administered: i) Product registration number ii) Batch number iii) Dose number iv) Date administered


  1. MADRAC ADR 2012 - April

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