Update on Safety Monitoring of H1N1 Vaccines from 3 November 2009 to 31 July 2010 (LATEST)
This safety update is a summary of the adverse events (AE) reports which are suspected to be associated with H1N1 vaccines, submitted by healthcare professionals in Singapore to the Health Sciences Authority (HSA). The local reporting of AEs by healthcare professionals forms part of the intensified safety monitoring program of HSA to monitor the safety profile of these products. Other safety monitoring activities include working closely with the World Health Organisation (WHO) and other international drug regulatory authorities to share and review international experiences with these products on a weekly basis, reviewing the data from ongoing clinical trials to further determine the safety profile, and regular review of scientific reports by the manufacturers of these products.
The information will be updated on a regular basis.
Approved Product Labelling for H1N1 Vaccines
The product labelling for approved H1N1 vaccines will be updated as new data emerges from on-going clinical studies. For the latest approved product labelling, please refer to the links provided below:
- i] Panvax H1N1 Vaccine and Panvax H1N1 Vaccine Junior Product Labelling (8 Dec 2009)
- ii] Pandemrix H1N1 Injection Package Insert (21 Dec 2010)
HSA Approves Two H1N1 Influenza Vaccines
The Health Sciences Authority (HSA) has approved the following two H1N1 influenza vaccines on 9 and 15 Oct 2009 respectively:
- i] Panvax H1N1 Vaccine by CSL Limited, Australia
- ii] Pandemrix H1N1 Injection by Glaxo Smithkline Biologicals
About HSA Regulatory Review on Influenza A H1N1 Vaccines
Due to the urgent need to produce H1N1 vaccines quickly to meet the demands of the pandemic, the Health Sciences Authority (HSA) is employing a 'rolling review' submission of pandemic vaccines. This approach is similar to drug regulatory authorities around the world, who have developed such mechanisms for expediting the review of pandemic vaccines.
Understanding Vaccines, Vaccine Development and Production
Read more to understand vaccines and how they are developed.