The TGA investigation of Pneumovax 23 adverse events
Pneumovax 23 vaccination is used to prevent life-threatening infections by pneumococcal bacteria.
In March 2011 a cluster of seven severe local injection site reactions was reported to the Therapeutic Goods Administration (TGA) by NSW Health and as a result a recall of the batch of Pneumovax implicated in these reactions was ordered by the TGA on 25 March 2011.
In April 2011, as a result of a continued increase in severe injection site reaction reports, the TGA issued advice to health professionals not to administer a second or subsequent dose of Pneumovax 23 vaccine pending the outcome of a review, which has now been completed.
Outcomes of the TGA review
Laboratory analysis of the recalled batch (N3336) did not detect any problems related to vaccine manufacture or handling. Following the batch recall, adverse event reports from all Australian states and territories were collated and analysed.
The TGA has now determined that the adverse events were not a batch-related problem. The TGA considers that the increased numbers of reports of severe reactions were a result of:
- the known high rates of local reactions, including severe injection site reactions, which occur more commonly after a repeat dose of Pneumovax 23
- the increased number of people having a repeat dose following the inclusion of Pneumovax 23 vaccine in the National Immunisation Program in 2005 with revaccination after five years
- the increased reporting that followed the publicity of the batch recall.
Updated TGA advice about revaccination
The TGA is advising that revaccination with Pneumovax 23 can be undertaken in accordance with the approved Product Information (PI). In summary, revaccination:
- should not be given routinely to immunocompetent individuals (that is, those with a healthy immune system)
- should be considered for patients at a high risk of serious pneumococcal disease, provided that at least five years has passed since the previous dose of Pneumovax 23.
Full details regarding revaccination are contained in the Pneumovax 23 Product Information.
This advice differs from that in the current Australian Immunisation Handbook (9th edition 2008), which recommends routine revaccination five years after the first dose. The Australian Technical Advisory Group on Immunisation has reviewed the place of Pneumovax 23 in the National Immunisation Program (NIP) and provided updated recommendations.
Adverse reactions to Pneumovax 23
Pneumovax 23 vaccine is known to be associated with a high rate of local injection site reactions. The majority of these are mild, with redness, swelling, pain and a feeling of heat around the site where the injection was given and recovery within a couple of days. Some reactions can result in extensive swelling and pain that can limit the use of the arm. Cellulitis-like reactions and abscesses can also occur.
Injection site reactions are very common but very severe reactions such as cellulitis-like reactions and abscesses are rare. More information about possible adverse reactions is available in the Pneumovax 23 Product Information (PI), which has recently been revised.
Advice is specific to Pneumovax 23
This advice does not apply to the following pneumococcal conjugate vaccines, which are given to young children:
- Prevenar
- Prevenar 13
- Synflorix.
Further information
Health professionals and patients are advised that further information is available in the Pneumovax 23 Product Information and Consumer Medicines Information.
Advice for patients
Patients who have previously been vaccinated with Pneumovax 23 are advised to discuss with their doctor whether they need further vaccination.
The TGA cannot give personal advice about an individual’s medical condition. The TGA strongly encourages patients to seek the advice of a health professional if you are experiencing a problem with a medicine or medical device.
How to report an adverse event
Patients and healthcare professionals are encouraged to report adverse reactions to Pneumovax 23 to the TGA.