The TGA has issued an immediate recall of Batch N3336 of the vaccine Pneumovax® 23 manufactured by Merck Sharp and Dohme (Australia) Pty Limited (MSD). This batch of vaccine has only been supplied in New South Wales and the Australian Capital Territory and there is no indication of problems with any other batch of Pneumovax® 23.
This recall is being undertaken as a precautionary measure following reports of a small number of adverse reactions in some patients who have received the vaccine. As of 24 March 2011 the TGA had received 10 reports of severe skin reactions with surrounding inflammation at the site of the vaccine injection.
At this stage it is not known if there is a problem with the particular batch of vaccine used in these patients, or whether these reactions are reports of a well known side effect that can occur with any injection. While the TGA is investigating it has stopped any further use of this batch of vaccine. State and Terrritory departments of health and vaccine providers are being notified of the need to return any supplies of the affected batch of Pneumovax® 23 to the supplier.
The TGA is currently testing samples of the vaccine from the affected batch and is working with State and Territory health authorities to investigate the nature of the adverse reactions. Further advice will be issued regarding the outcomes of these investigations as soon as they are complete. In the meantime vaccine providers should not use this batch of Pneumovax® 23.
Any patients concerned that they may have had a reaction to the vaccine should see their medical practitioner for assessment.
Background information
Pneumovax® 23 is used for immunisation against a bacteria known as Streptococcus pneumonia which can cause pneumonia or meningitis.
The Product Information for Pneumovax 23 lists common adverse effects as 'injection site reactions including soreness, erythema, warmth, swelling and local induration'. It also states that cellulitis-like reactions can occur 'very rarely'.
Information for consumers
If you have recently received a vaccination against pneumococcal disease and are concerned about swelling or soreness around the injection site, please see a health practitioner.
Information for health care professionals
Only a single batch (N3336) of Pneumovax® 23 is being recalled. Other batches of Pneumovax® 23 can continue to be used.
Information for providers of Pneumovax® 23 batch N3336
The batch being recalled is: Pneumovax® 23 injection (pneumococcal vaccine polyvalent, MSD) 0.5 mL vial (AUST R 10507; CSL code 0786100110 pack vials); batch no. N3336; expiry 22 June 2011.
This batch was distributed only in New South Wales and the Australian Capital Territory.
Providers of Pneumovax® 23 batch N3336 should:
- Quarantine all stock
- Record the exact quantity of stock held
- Arrange to return the stock to the supplier
Immunisation providers can contact CSL Medical Information on 1800 642 865 for more information.
Reporting a problem
Information on how to report a suspected problem with a medicine or medical device to the TGA can be found at 'Report a problem with a therapeutic product'.