Ronan Kelly
Retired 2020
CSL Recalls Flu Shot as Side Effects Rise Nine-Fold (Update1)
June 01, 2010, 6:22 AM EDT
By Simeon Bennett
June 1 (Bloomberg) -- CSL Ltd., the Southern Hemisphere?s only flu vaccine maker, recalled its seasonal shot for children in Australia after investigations failed to explain a nine-fold increase in fever and convulsions.
CSL is voluntarily withdrawing unused doses of its Fluvax Junior shot from clinics and distributors, the Melbourne-based company said in a statement today. Jim Bishop, Australia?s chief medical officer, said vaccinations should continue to be suspended for children under 5 years, a recommendation initially made on April 23.
Fluvax was linked to febrile convulsions in about 9 children in every 1,000 who got the shot, higher than the expected rate of 1 per 1,000, Bishop said in a separate statement. It?s unclear whether Sanofi-Aventis SA?s Vaxigrip and Solvay SA?s Influvac caused similar side effects because insufficient doses have been used in Australia, he said.
The investigation ?identified no apparent clinical, biological or epidemiological factors that would explain the higher-than-expected observed rates of fever with convulsions,? Bishop said. Laboratory tests and an inspection of CSL?s factory ?revealed no abnormalities to explain this event,? he said.
Fluvax is the first seasonal influenza vaccine to contain the H1N1 strain of swine flu. Panvax, a separate shot for swine flu, has been shown to be safe and effective in young children, Bishop said.
Retrieval Program
CSL called the product withdrawal a ?retrieval? and said it?s occurring outside the regulatory process.
The company said it isn?t able to provide a figure for the withdrawal because it doesn?t know how many doses have been used. The pediatric vaccine hasn?t been distributed outside Australia this year, CSL said in an e-mail.
The recall ?is unlikely to be material? to CSL?s earnings because only a small volume of the vaccine probably remains on the market, UBS AG said in a note.
At least 55 children younger than 5 years in Western Australia have been identified with possible convulsions after receiving the shot and a further 196 had less serious reactions such as fever, vomiting and inflammation at the injection site, the state health department said in April. As many as 30,000 children in the age group have been vaccinated so far this year, the department estimated.
More children have been vaccinated in Western Australia than elsewhere in the country because they receive free shots under a program in the state. The plan cut hospitalizations by 88 percent in 2008, the state?s health department said last year.
--Editors: Lena Lee, Phil Serafino.
http://www.businessweek.com/news/20...-as-side-effects-rise-nine-fold-update1-.html
June 01, 2010, 6:22 AM EDT
By Simeon Bennett
June 1 (Bloomberg) -- CSL Ltd., the Southern Hemisphere?s only flu vaccine maker, recalled its seasonal shot for children in Australia after investigations failed to explain a nine-fold increase in fever and convulsions.
CSL is voluntarily withdrawing unused doses of its Fluvax Junior shot from clinics and distributors, the Melbourne-based company said in a statement today. Jim Bishop, Australia?s chief medical officer, said vaccinations should continue to be suspended for children under 5 years, a recommendation initially made on April 23.
Fluvax was linked to febrile convulsions in about 9 children in every 1,000 who got the shot, higher than the expected rate of 1 per 1,000, Bishop said in a separate statement. It?s unclear whether Sanofi-Aventis SA?s Vaxigrip and Solvay SA?s Influvac caused similar side effects because insufficient doses have been used in Australia, he said.
The investigation ?identified no apparent clinical, biological or epidemiological factors that would explain the higher-than-expected observed rates of fever with convulsions,? Bishop said. Laboratory tests and an inspection of CSL?s factory ?revealed no abnormalities to explain this event,? he said.
Fluvax is the first seasonal influenza vaccine to contain the H1N1 strain of swine flu. Panvax, a separate shot for swine flu, has been shown to be safe and effective in young children, Bishop said.
Retrieval Program
CSL called the product withdrawal a ?retrieval? and said it?s occurring outside the regulatory process.
The company said it isn?t able to provide a figure for the withdrawal because it doesn?t know how many doses have been used. The pediatric vaccine hasn?t been distributed outside Australia this year, CSL said in an e-mail.
The recall ?is unlikely to be material? to CSL?s earnings because only a small volume of the vaccine probably remains on the market, UBS AG said in a note.
At least 55 children younger than 5 years in Western Australia have been identified with possible convulsions after receiving the shot and a further 196 had less serious reactions such as fever, vomiting and inflammation at the injection site, the state health department said in April. As many as 30,000 children in the age group have been vaccinated so far this year, the department estimated.
More children have been vaccinated in Western Australia than elsewhere in the country because they receive free shots under a program in the state. The plan cut hospitalizations by 88 percent in 2008, the state?s health department said last year.
--Editors: Lena Lee, Phil Serafino.
http://www.businessweek.com/news/20...-as-side-effects-rise-nine-fold-update1-.html
