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Rotarix - Presence of Porcine Circovirus Type 1 (PCV-1) - For Health Professionals

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Contact: Biologics and Genetic Therapies Directorate

The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from GlaxoSmithKline Inc.
Contact the company for a copy of any references, attachments or enclosures.

Health Canada Endorsed Important Safety Information on Rotarix (Human Rotavirus, live, attenuated, oral vaccine)

July 12, 2010

Subject: Presence of Porcine Circovirus, Type 1 (PCV-1) in ROTARIX™ (Human Rotavirus, live, attenuated, oral vaccine)

Dear Health Care Professional,

ROTARIX™ is an orally administered vaccine that is authorized for the active immunization of infants from the age of 6 weeks for the prevention of gastroenteritis caused by rotavirus types G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8].

GlaxoSmithKline Inc. (GSK), in consultation with Health Canada, would like to inform health care professionals of new information on the composition of its Human Rotavirus vaccine, ROTARIX™ (live, attenuated, oral vaccine).

The safety and effectiveness of ROTARIX™ has been extensively studied. The safety profile of ROTARIX™ is based on extensive clinical data from the largest vaccine clinical trial program conducted by GSK, enrolling more than 90,000 participants in Europe, Latin America, Asia, Africa and the US. The discovery of PCV-1 in the vaccine is a new finding which GSK continues to investigate. Since material from PCV-1 has been present in ROTARIX™ since the initial stages of its development, the established safety profile therefore reflects exposure to material from PCV-1. ROTARIX™ was authorized in Canada in October 2007 based on data from 12 clinical studies involving over 76,000 subjects.

Post marketing surveillance data of the product reflects more than 69 million doses which have been distributed globally since its launch five years ago. The Canadian Product Monograph for ROTARIX™ will be updated to reflect the discovery of PCV-1. The benefit/risk profile of the vaccine remains unchanged and GSK will continue to work closely with Health Canada on this issue.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious or unexpected adverse reactions in patients receiving ROTARIX™ should be reported to your local public health authority, GlaxoSmithKline or the Public Health Agency of Canada as follows:

GlaxoSmithKline Inc.
7333 Mississauga Road North
Mississauga, Ontario, L5N 6L4
Telephone: 1-800-387-7374

How to report a suspected Adverse Event following Immunization:
If a patient experiences an adverse event following immunization, please complete the Adverse Events Following Immunization (AEFI) Form and send it to the local health department in  your province or territory. The list of contacts is also provided below.

The  Adverse Events Following Immunization Reporting Form and  Guidelines can be found on the Public Health Agency of Canada Web site or in the Canadian Compendium of Pharmaceuticals and Specialties

If you have any questions or have difficulties contacting your local health department, please contact the Vaccine Safety Section at the Public Health Agency of Canada at:
Telephone: 613-954-5590, 1-866-844-0018
Fax: 613-954-9874; 1-866-844-5931

To change your mailing address or fax number, contact the Market Authorization Holder (Industry).

Sincerely,

original signed by

Dr. Tjark Reblin
Vice President, Medical and Chief Medical Officer
GlaxoSmithKline Canada

References
1. Linlin Li, Journal of Virology, Feb 2010, p. 1674-1682.
2. Hatterman Kim, Xenotransplantation, 2004: 11: 284-294.