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TGA issues precautionary advice about Pneumococcal disease vaccine

Media release

19 April 2011

Australia's medicines regulator, the Therapeutic Goods Administration, has today issued precautionary advice to doctors not to give patients a second dose of the vaccine Pneumovax 23 pending completion of an investigation into an increased rate of adverse events in people receiving the vaccine for the second time.

Pneumovax vaccine, manufactured by Merck Sharp and Dohme, is provided free under the Australian government's National Immunisation Program for adults over 65 years old, Aboriginal and Torres Strait Islander people over 50 years old, Aboriginal and Torres Strait Islander peoples aged 15 to 49 years old who are tobacco smokers or who have certain medical conditions and for some children at high risk of invasive pneumococcal disease.

Pneumovax 23 is used to prevent a potentially life-threatening bacterial infection that can cause meningitis, pneumonia, sepsis and death.

Only a limited number of doses of the vaccine are required and they are given five years apart. This year there is a higher rate of reports of pain, swelling and soreness at the site where the vaccination has been given. These adverse events are well described in the product information accompanying the vaccine but there has been an increase in the rate of reports in 2011 compared to previous years that requires further investigation.

In March 2011 a cluster of 7 severe local injection site reactions was reported to the 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. Details of this were provided on the TGA website.

Following this recall the TGA has been working with all State and Territory health authorities to provide enhanced monitoring of rates of adverse reactions with the Pneumovax vaccine to assess whether the NSW reports were an isolated phenomenon related to that batch or whether there was a broader issue.

As of 14 April 2011 the TGA has received 173 reports of adverse reactions to Pneumovax, compared to 63 at a similar date in 2010 and 34 in 2009.

Analysis of these adverse reactions suggests that the largest number of reactions is occurring in people receiving their second five yearly dose of Pneumovax.

Further detailed analysis of case reports, adverse reaction databases and clinical trial data is required and will be undertaken by the TGA and the Australian Technical Advisory Group on Immunisation (ATAGI).

Until this analysis is complete, the TGA is recommending, as a precautionary measure, that patients do not receive a second dose of the Pneumovax vaccine.

State and Territory Health Departments, GP's, and Specialist groups have been contacted to advise their members of the need to avoid giving a second dose of Pneumovax to patients until further notice.

The TGA and ATAGI will issue further advice about the ongoing use of Pneumovax once a detailed analysis of these data is complete.

More detailed information can be found on the TGA website.

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