Pneumovax 23 Update

The Therapeutic Goods Administration (TGA) has completed their investigation into the cluster of severe local injection site reactions in March 2011 that continued into April 2011.

Advice was then given to not administer the second adult dose of Pneumovax 23.

The investigation has now completed. The TGA considers that the increased reports of local reactions was not batch related but due to two factors. (Pneumovax 23 does have known high rates of local reactions after a repeat dose.)

  • 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.

The TGA has now advised that 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.

Note this now differs from the current Australian Immunisation Handbook (9th edition 2008).

A discussion I had today with the acting in-charge at Communicable Disease Control Directorate, Department of Health, Western Australia indicates the schedule will most likely remain unchanged for Indigenous Australians.

Until this is put to us in writing (Medical Cordinator CDC WA is on leave at present) continue to withhold the second Pneumovax 23 ADULT dose.

The complete TGA advice

Drug-Induced Tooth Discolouration

Interaction

There are a number of drugs that cause tooth discolouration, which may be categorised as arising either intrinsically or extrinsically. Extrinsic discoloration is defined as stains that occur on the outer surface of the tooth structure and are caused by topical or extrinsic agent, and occur after the tooth has erupted.

Exposure to the drug subsequently causes this type of discolouration. Many drugs have been implicated – for example, cholorhexidine produced tooth discolouration in over half of patients who used a mouthwash or rinse for more than six months.

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A joint initiative of the Patient Services Section and the Drug and Therapeutics Information Service of the Pharmacy Department, Repatriation General Hospital, Daw Park, South Australia. The RGH Pharmacy E-Bulletin is distributed in electronic format on a weekly basis, and aims to present concise, factual information on issues of current interest in therapeutics, drug safety and cost-effective use of medications.

Editor: Assoc. Prof. Chris Alderman, University of South Australia – Director of Pharmacy, RGH © Pharmacy Department, Repatriation General Hospital, Daw Park, South Australia 5041.

Under 5s 2010 Influenza Vaccination Program on Hold

Interaction

The Commonwealth Chief Medical Officer Professor Jim Bishop has advised that until further notice children under 5 years of age should not receive the current seasonal Flu vaccine.

The H1N1 Swine flu vaccine can still be given.

The media release is reprinted below. There is a link at the bottom to download the original release.

CHIEF MEDICAL OFFICER Professor Jim Bishop AO
MD MMed MBBS FRACP FRCPA Commonwealth Chief Medical Officer
MEDIA STATEMENT 23rd April 2010

Due to a spike in the numbers of young children in Western Australia experiencing fever and convulsions following seasonal flu vaccinations, Australia’s Chief Medical Officer, Professor Jim Bishop, is advising all GPs and immunisation providers to stop giving seasonal flu vaccine to children five years and under until a cause is established.

This is a precautionary measure while the matter is being urgently investigated by health experts and the Therapeutic Goods Administration (TGA),

Professor Bishop said,

Until it can be established what factors are causing the apparent rise in fevers in some children in WA, I am writing to all immunisation providers to advice them not to administer season flu vaccine to all children 5 years of age and under until further notice.”

Professor Bishop said the medicines regulator, the TGA, is investigating the WA data as a matter of urgency to determine whether the adverse reactions reported in WA relate to the vaccine, or whether factors related to the program delivery in WA are involved.

The TGA has contacted CSL Ltd to confirm which batches of vaccine were used in WA and is obtaining samples of the vaccine to test in its laboratories to determine if there are any abnormalities in the batches of vaccine used in WA,

Professor Bishop said.

The TGA will be urgently reviewing data from WA Health about the adverse events and the vaccine distribution data to see if the rates of fever and convulsions are truly higher than expected. The TGA is convening an expert scientific advisory panel to review the information from WA, and is seeking additional information from the manufacturer, CSL Ltd, and from regulatory colleagues internationally. TGA will test batches of the vaccine used in WA for any abnormalities.

The Department of Health and Ageing has sought advice from the Australian Technical Advisory Group on Immunisation. which is currently reviewing the available information on cases and the Department will be seeking its further advice. States and territories have been asked to report any adverse events related to seasonal influenza urgently to the Therapeutic Goods Administration. States and territories have also been asked to provide details on batch numbers and type of vaccine.

Professor Bishop said people over five years of age can continue to be vaccinated against seasonal influenza as per usual. Flu can be a serious disease especially in people who are in high risk categories including people aged 65 years and over; all Aboriginal and Torres Strait Islander people aged 15 years and over and pregnant women. The Commonwealth Government provides the seasonal flu vaccine is free for these at risk groups.

Professor Bishop said that there do not appear to be implications for the swine flu vaccine Panvax®.

It is safe to have the swine flu vaccine. The TGA’s assessment of clinical trials and the advice of its expert committees is that Panvax® is a safe, effective vaccine for prevention of the H1N1 influenza.

It is expected that the dominant flu this winter season will be swine flu and the specific Panvax vaccine is available free for all Australians.

Media contact: Kay McNiece, 0412 132 585

Seasonal Flu Vaccine and Young Children Media Release (212)
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