Print | Need Larger Text? | Share

RotaTeq - Presence of Porcine Circovirus (PCV) DNA - For Health Professionals

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

(PDF Version - 43 K)

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 Merck Frosst Canada Ltd.
Contact the company for a copy of any references, attachments or enclosures.

Health Canada Endorsed Important Safety Information on RotaTeq (rotavirus vaccine, live, oral, pentavalent)

July 13, 2010

Dear Health Care Professional,

Subject: New Information Regarding the Presence of Porcine Circovirus (PCV) DNA in Rotavirus Vaccines, Including RotaTeq^®

Merck Frosst Canada Ltd., in consultation with Health Canada, would like to inform you of important new information regarding the presence of DNA from porcine circovirus types 1 and 2 (PCV1 and PCV2) in RotaTeq^® (rotavirus vaccine, live, oral, pentavalent).

RotaTeq^® is indicated for the prevention of rotavirus gastroenteritis caused by the serotypes G1, G2, G3, G4 and G-serotypes that contain P1A[8], when administered to infants between the ages of 6 to 32 weeks.

An independent research team and the U.S. Food and Drug Administration (FDA) tested both rotavirus vaccines for PCV DNA and the findings were communicated in March 2010. Porcine circovirus type 1 (PCV1) and type 2 (PCV2) are small viruses composed of a single strand of DNA. At that time, PCV DNA was not detected in RotaTeq^® by the assays that were used initially. Subsequently, Merck initiated PCV testing of RotaTeq^® using highly sensitive assays. Merck's testing detected low levels of DNA from PCV1 and PCV2 in RotaTeq^®. Merck immediately shared these results with Health Canada and other regulatory agencies.

There is no evidence that these findings pose a safety risk to infants. The benefits of rotavirus vaccines are substantial, and these benefits outweigh the risk, which is theoretical. No additional medical follow-up is warranted for infants who have been vaccinated with RotaTeq^®.

The Canadian RotaTeq^® Product Monograph will be updated to reflect this new information under Part I: Health Professional Information and Part III: Consumer Information. The most recent RotaTeq^® Product Monograph can be accessed at http://www.merck.ca or on the Health Canada web site.

Merck remains confident in the safety profile and quality of RotaTeq^®. RotaTeq^® was studied in nearly 70,000 infants in one of the largest pre-licensure vaccine clinical trials ever conducted. Post-marketing surveillance data through March 2010 reflects more than 37 million doses of RotaTeq^® distributed worldwide since 2006. The safety profile of the vaccine has been and continues to be evaluated by Health Canada, other regulatory agencies throughout the world, and Merck.

Merck is fully committed to working closely with Health Canada and regulatory agencies throughout the world, to continue conducting and sharing comprehensive research related to this finding, and taking appropriate action. While additional research is ongoing to further understand this emerging area of new viral detection techniques and their associated challenges, Merck is committed to initiating the following actions:

• Identifying the source of the DNA from PCV recently detected in RotaTeq^®
• Developing approaches to enhance screening for and removal of PCV from RotaTeq^® in the future
• Continuing to share data with regulatory agencies, health care providers, the scientific community, the public health community, and the public as more information becomes available

Merck will also work with scientific experts and regulatory authorities throughout the world to further understand current and emerging technologies and evaluate how they may supplement our current methods of quality assurance.

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 RotaTeq^® should be reported to your local public health authority, Merck Frosst Canada Ltd., or the Public Health Agency of Canada as follows:

Merck Frosst Canada Ltd.:
By toll-free telephone: 1-800-567-2594
By toll-free fax: 1-877-428-8675
By regular mail:
P.O. Box 1005
Pointe-Claire - Dorval, QC
H9R 4P8

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).

Should you have any questions regarding RotaTeq^® or require any further information, please contact Merck Frosst Canada Ltd. at 1-800-567-2594.

Sincerely,

original signed by

Michel Cimon, MD
Medical Executive Director, Medical Affairs

^®Registered Trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Used under license.