Tuberculosis BCG Vaccine Recall

Factsheet

News article

21 June 2012

Why is the BCG vaccine is being recalled?

The Ministry of Health has been advised by the vaccine supplier (sanofi-aventis) that the BCG vaccine available in New Zealand is being recalled. The same vaccine is being recalled in Australia and Canada.

The company advise that this is because checks of the air quality found a problem and they cannot be completely confident that the vaccine is sterile. This action is precautionary and has not been prompted by any alerts of problems caused by the vaccine in New Zealand.

This particular vaccine has only been available in the New Zealand since November 2011. Another BCG vaccine was used before this date from a different manufacturer and is not affected by this recall.

What is BCG vaccine?

This vaccine, known as the Bacille Calmette-Guerin (BCG) vaccine, is a live vaccine which can provide partial protection against tuberculosis (TB).

Who might have received this vaccine?

This vaccine is not given routinely as part of the normal vaccines offered to all children in New Zealand.

In countries where the prevalence of TB is relatively low, such as New Zealand, the role for BCG vaccination is limited. It is only offered to people who are considered to be at high risk, such as babies living with a person/whānau who currently has or has had TB.

The vaccine is also offered to babies who have one or more parents who lived for a period of 6 months or longer in a country with a TB rate of more than 40 per 100,000 in the last 5 years, and for children under 5 years old who will be living for 3 months or longer in a country with a high rate of TB. A list of these countries can be found on the Tuberculosis page.

Just under 7,000 doses of this BCG vaccine were distributed in New Zealand since November 2011. Not all of these doses will have been given to patients.

What if my child has recently received this vaccine?

There are no reasons for anyone who has received this vaccine to be concerned as this is recall is being taken as a precaution only.

The monitoring system in New Zealand for adverse reactions from medicines and vaccines (CARM) has not received any increase in reports of adverse reactions from BCG vaccine since this vaccine has been available.

Like all vaccines, pain and redness at the injection site, and sometimes mild fever can occur. BCG vaccines may also cause some pus and scabbing where the vaccine was given and sometimes causes swollen glands in your armpit. These reactions would occur within a few days or weeks of vaccination and are expected reactions to the vaccine.

If you are concerned about you or your child please see your usual health practitioner, visit the clinic where you had the vaccine, or contact:

  • Healthline on 0800 611 116 for free advice from our trained registered nurses
  • 0800 IMMUNE (0800 466 863) for questions relating to immunisation and vaccination-preventable diseases.

What do I do if my child was due to be vaccinated?

The Ministry of Health is working with the New Zealand supplier to establish another supply of BCG vaccine, however at this stage it is unclear how long this process will take.

Health practitioners will be informed when a new supply of vaccine is available.

As New Zealand does not have a high rate of TB, the risk of catching TB while waiting for new vaccine supplies is low. The effective treatments we have for TB are still available.

If you are concerned that your child is at risk of TB, please talk to your usual health practitioner.

Where can health practitioners find more information?

A recall notice about the vaccine is on the Medsafe website.

General information about BCG vaccination can be found in the Immunisation Handbook 2011.

More information about the vaccine recall can be also be found on the Australian Government website:

More information about tuberculosis can be found on the Tuberculosis page.

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