tetano
Editor, Senior Moderator
In a statement the TGA says that stability testing has shown a decline in potency of Panvax H1N1 Junior supplied in 0.25 ml pre-filled syringes.
?The TGA has informed the manufacturer, CSL, that its registered 12 month shelf life can no longer be supported and the shelf life has been reduced to 6 months. As a result existing stocks of Panvax Jr should now be considered expired,? it says.
To ensure the vaccine is no longer administered, CSL is retrieving all stock from immunisation providers and vaccine distribution points. CSL will contact all immunisation providers to advise them of this issue and the retrieval process.
According to the TGA, the decline in potency ?appears to be the result of particular characteristics of the H1N1 virus itself?, but it notes that Panvax in multidose vials is not affected by the decline in potency, nor are the trivalent seasonal influenza vaccines all of which include an H1N1 component.
The Australian Techinical Advisory Group on Immunisation (ATAGI) has advised that revaccination of children who have already received two doses of Panvax Junior is not necessary, as the potency of the vaccine administered to date is considered adequate to induce an immune response.
?If a child aged six months to < 3years of age is due to receive a second dose of H1N1 containing vaccine, this can be provided by using the age appropriate dose (0.25ml) obtained from a Panvax multi-dose vial. Alternatively, the 2010 seasonal influenza vaccines (Vaxigrip and Influvac) are also suitable for use,? it advises.
http://www.6minutes.com.au/articles/z1/view.asp?id=522513
?The TGA has informed the manufacturer, CSL, that its registered 12 month shelf life can no longer be supported and the shelf life has been reduced to 6 months. As a result existing stocks of Panvax Jr should now be considered expired,? it says.
To ensure the vaccine is no longer administered, CSL is retrieving all stock from immunisation providers and vaccine distribution points. CSL will contact all immunisation providers to advise them of this issue and the retrieval process.
According to the TGA, the decline in potency ?appears to be the result of particular characteristics of the H1N1 virus itself?, but it notes that Panvax in multidose vials is not affected by the decline in potency, nor are the trivalent seasonal influenza vaccines all of which include an H1N1 component.
The Australian Techinical Advisory Group on Immunisation (ATAGI) has advised that revaccination of children who have already received two doses of Panvax Junior is not necessary, as the potency of the vaccine administered to date is considered adequate to induce an immune response.
?If a child aged six months to < 3years of age is due to receive a second dose of H1N1 containing vaccine, this can be provided by using the age appropriate dose (0.25ml) obtained from a Panvax multi-dose vial. Alternatively, the 2010 seasonal influenza vaccines (Vaxigrip and Influvac) are also suitable for use,? it advises.
http://www.6minutes.com.au/articles/z1/view.asp?id=522513