Update on the recent finding of porcine circovirus-1 (PCV-1) DNA fragment in rotavirus vaccine (Rotarix®)

The Health Sciences Authority (HSA) would like to update healthcare professionals on the recent findings by researchers from the University of California, San Francisco regarding the presence of DNA fragment of porcine circovirus (PCV-1) found in the rotavirus vaccine, Rotarix® (GSK) and HSA's interim position on this matter.

An independent research team from the University of California, San Francisco, has identified a DNA fragment of porcine circovirus 1 (PCV-1) in Rotarix®. The PCV-1 DNA fragment has been incorporated into the vaccine during  the manufacturing process. Based on the available information from clinical trials and  the post-marketing surveillance data, there is no evidence at this time that this finding poses a safety risk.The Vigilance Branch has also not received any local adverse event  reports associated with rotavirus vaccines which appear to be related to this issue. While HSA is reviewing the significance of this finding, healthcare professionals are advised to consider deferring  immunisation with Rotarix® or consider an alternative vaccine till more information becomes available.

Healthcare professional, Therapeutic Products
Published:

Dear Healthcare Professional Letters

12 Dec 2019

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.