Questions and Answers - Porcine Circovirus Found in Rotavirus Vaccines

1. What is rotavirus?
2. What are the symptoms of rotavirus infection?
3. How is rotavirus infection treated?
4. Can rotavirus disease be prevented?
5. Are there rotavirus vaccines in Canada?
6. What is porcine circovirus types 1 and 2?
7. Why is porcine circovirus found in rotavirus vaccines?
8. Are the rotavirus vaccines safe for my child?
9. Should my child see a doctor if he/she has received a rotavirus vaccine?
10. Are porcine circovirus -1 and porcine circovirus -2 pig material?
11. What illness does porcine circovirus -2 cause in pigs?
12. Why was porcine circovirus DNA not detected in rotavirus vaccines earlier?
13. What are Health Canada and the vaccine manufacturers doing about porcine circovirus DNA contamination in rotavirus vaccines?

Questions and Answers

1. What is rotavirus?

Rotavirus is a virus that has been known to cause rotavirus gastroenteritis in infants. Rotavirus gastroenteritis is a highly infectious form of diarrhoea in infants and young children that can cause severe vomiting and dehydration resulting in hospitalization and can be life-threatening. Children under five years of age, especially those between six months and two years, are most vulnerable to the disease.

Rotavirus is the most common cause of severe diarrhoea in infants and young children globally but severe diarrhoea is not a major public health issue in Canada. Rotaviruses are estimated to be responsible for approximately 527,000 deaths each year, with most of these deaths occurring in low-income countries in Africa and Asia, and over two million people are hospitalized each year with pronounced dehydration.

2. What are the symptoms of rotavirus infection?

Rotavirus infects the intestines. The illness usually begins with fever, an upset stomach, and vomiting, followed by diarrhoea, and generally lasts three to eight days.

3. How is rotavirus infection treated?

There is no specific treatment for the rotavirus infection. Symptoms are treated mostly by oral rehydration to prevent dehydration, the most serious problem caused by the disease. Oral rehydration therapy is a simple treatment for dehydration that consists of a solution of salts and sugars which is taken by mouth. Severe cases of dehydration require administration of intravenous fluids in a hospital.

4. Can rotavirus disease be prevented?

Rotavirus disease can be prevented by vaccination.

5. Are there rotavirus vaccines in Canada?

In Canada, two rotavirus vaccines are authorized to protect against the human rotavirus that cause vomiting and diarrhoea in infants, Rotarix (GlaxoSmithKline) and RotaTeq (Merck Frosst).

The RotaTeq and Rotarix product monographs can be found on the Health Canada website.

Currently, Rotarix and RotaTeq are not part of the routine immunization programs in Canada. For more information on routine immunization programs, please contact your provincial or territorial public health authority.

6. What is porcine circovirus types 1 and 2?

Porcine circovirus-1 and porcine circovirus-2 are both small, circular viruses composed of a single strand of DNA.

Porcine circovirus-1 and porcine circovirus-2 are common in pigs. Porcine circovirus-1 does not cause illness in any animal but porcine circovirus-2 may cause illness in pigs. Humans may be exposed to porcine circoviruses through diet or from exposure to farm animals but porcine circoviruses are not known to cause illness in humans.

7. Why is porcine circovirus found in rotavirus vaccines?

Porcine circovirus DNA can be a contaminant of an enzyme obtained from pig pancreas. This enzyme is used during some manufacturing steps in the production of rotavirus vaccines. As such, porcine circovirus is considered a contaminant in rotavirus vaccines.

8. Are the rotavirus vaccines safe for my child?

Yes, neither porcine circovirus-1 nor porcine circovirus-2 are known to cause illness in humans. In fact, Health Canada has no evidence that either porcine circovirus-1 or porcine circovirus-2 poses a safety risk. Both vaccines have a successful track record of safety and effectiveness. The benefits of the vaccines for infants are substantial, and include prevention of hospitalization for severe rotavirus disease in Canada.

9. Should my child see a doctor if he/she has received a rotavirus vaccine?

Health Canada currently has no evidence to suggest that human rotavirus vaccines containing DNA from the porcine circovirus (PCV-1 or PCV-2) pose a safety risk. Canadians should contact their health care professional if they have questions or concerns about rotavirus vaccine.

Both Rotarix (GlaxoSmithKline) and RotaTeq (Merck Frosst Canada) vaccines have strong safety records, including clinical trials involving tens of thousands of patients and clinical experience with millions of patients.

10. Are porcine circovirus -1 and porcine circovirus -2 pig material?

No, porcine circovirus is not pig or other animal material. Porcine circovirus is a virus.

Porcine circovirus has sometimes been referred to as the 'pig virus' by the media but this is only because the virus is commonly found in pigs.

11. What illness does porcine circovirus -2 cause in pigs?

Porcine circovirus type 2 (PCV-2) is a DNA virus that infects pigs and contributes to the development of post-weaning multisystemic wasting syndrome (PMWS) in pigs aged four to fourteen weeks old. Symptoms of the condition are poor growth rate and/or acute malnutrition and weight loss.

While porcine circovirus- 2 infect swine worldwide, only a small proportion of pigs develop post-weaning multisystemic wasting syndrome and other porcine circovirus- 2 associated diseases.

It is important to remember that humans may be exposed to porcine circoviruses through diet or from exposure to farm animals but porcine circoviruses are not known to cause illness in humans.

12. Why was porcine circovirus DNA not detected in rotavirus vaccines earlier?

The identification of DNA fragments by the academic researchers has only recently become possible due to new technological developments.

Health Canada stresses that the findings do not present a Canadian public health threat. However, given that DNA fragment testing is now available, Health Canada and other international regulatory agencies now expect the manufacturers to establish a plan to manufacture porcine circovirus-free vaccines.

13. What are Health Canada and the vaccine manufacturers doing about porcine circovirus DNA contamination in rotavirus vaccines?

Health Canada has been working closely with vaccine manufacturers and other international regulators, including the US Food and Drug Administration and the World Health Organization, to facilitate an international response to this issue.

On March 26, 2010, GlaxoSmithKline posted information on their website relating to the manufacture of Rotarix and the presence of PCV-1. Health Canada then posted a statement to our website that same day to notify Canadians and health care professionals that no lots of Rotarix were on the market in Canada and that the Canadian RotaTeq vaccine was not known to be contaminated with PCV-1.

On May 7, 2010, Merck posted information on their website relating to the presence of PCV-1 and PCV-2 in their RotaTeq vaccine and GlaxoSmithKline posted an information update on their website disclosing the presence of PCV-1 in their Rotarix vaccine. That same day, Health Canada issued an information update for Canadians and health care professionals that indicated that the Department had become aware that extremely low levels of two types of porcine circovirus DNA (PCV-1 and PCV-2) have been detected in the Canadian RotaTeq vaccine.

Since this time, Health Canada has continued to work closely with rotavirus vaccine manufacturers, GlaxoSmithKline and Merck Frosst. Both manufacturers have conducted an investigation on this issue, updated their product labelling to reflect the presence of porcine circovirus DNA and informed health care practitioners of the new labelling. This information can now be found on the Health Canada website for both Rotarix and RotaTeq.

New information will be communicated to Canadians and health care professionals as it becomes available and Health Canada will take appropriate regulatory action as needed. Canadians should contact their health care professional if they have questions or concerns about rotavirus.