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Robert Roos * News Editor
Jun 29, 2010 (CIDRAP News) ? The US Food and Drug Administration (FDA) has reported some problems at a CSL Biotherapies facility in Australia that makes influenza vaccine for the US market, including a failure to fully investigate particles found in some vaccine vials.
The FDA yesterday released a copy of a letter to CSL about what it called "deviations from current good manufacturing practice (CGMP) requirements" in the production of a seasonal flu vaccine, Afluria, and a monovalent vaccine for the 2009 H1N1 virus.
The company said the concerns raised by the FDA are not related to the higher-than-expected rate of fever and convulsions reported recently in young Australian children who received a seasonal flu vaccine made by CSL, according to a Reuters report published today. Those adverse events were associated mainly with Fluvax, according to earlier reports.
The FDA letter said the deficiencies were found during an inspection of the CSL facility in Parkville, Victoria, Australia, between Apr 19 and 28. The letter was signed by Mary A. Malarkey, director of the compliance office in the FDA's Center for Biologics Evaluation and Research.
The letter says the company's investigation into "the formation of dark particles" in multi-dose vials of Afluria was "inadequate." The investigation did not document that corrective and preventive actions were traceable, and it did not examine the possibility that the particles were caused by an interaction between the vaccine and the vial or stopper, the letter states.
The FDA said further that CSL was still using a certain type of rubber stopper on multi-dose vials containing the preservative thimerosal, although the manufacturer had advised that the stoppers may react with thimerosal. Also, the company did not study possible interactions between the vaccine and the stoppers and vials used in 29 lots of Afluria and H1N1 vaccine that were marketed in the United States, the letter says.
The agency also asserted that the company failed to ensure that samples from vaccine lots were tested at least once a year for evidence of deterioration.
The letter acknowledges a written response provided by CSL on May 14, in which the company promised to address problems the FDA had previously communicated to the firm. But the letter asks for more information and a meeting with CSL officials to discuss the issues.
Efforts to reach CSL officials for comments on the FDA letter today were unsuccessful. According to today's Reuters report, CSL said letters like the one from the FDA are "not uncommon," but the company is taking the issues raised by the FDA "very seriously."
"The FDA has stated that there is no direct connection between the increase in reports of fever and febrile convulsions reported in young children in Australia this season and the issues raised" in the FDA letter, CSL officials said, as reported by Reuters.
The increased adverse events in vaccinated Australian children were first reported in late April. They prompted the company to stop distributing its pediatric flu vaccine and caused Australian authorities to advise providers to stop immunizing children 5 years old and younger, pending an investigation. So far, investigations by the company and Australian authorities have not yielded an explanation.
Jun 29, 2010 (CIDRAP News) ? The US Food and Drug Administration (FDA) has reported some problems at a CSL Biotherapies facility in Australia that makes influenza vaccine for the US market, including a failure to fully investigate particles found in some vaccine vials.
The FDA yesterday released a copy of a letter to CSL about what it called "deviations from current good manufacturing practice (CGMP) requirements" in the production of a seasonal flu vaccine, Afluria, and a monovalent vaccine for the 2009 H1N1 virus.
The company said the concerns raised by the FDA are not related to the higher-than-expected rate of fever and convulsions reported recently in young Australian children who received a seasonal flu vaccine made by CSL, according to a Reuters report published today. Those adverse events were associated mainly with Fluvax, according to earlier reports.
The FDA letter said the deficiencies were found during an inspection of the CSL facility in Parkville, Victoria, Australia, between Apr 19 and 28. The letter was signed by Mary A. Malarkey, director of the compliance office in the FDA's Center for Biologics Evaluation and Research.
The letter says the company's investigation into "the formation of dark particles" in multi-dose vials of Afluria was "inadequate." The investigation did not document that corrective and preventive actions were traceable, and it did not examine the possibility that the particles were caused by an interaction between the vaccine and the vial or stopper, the letter states.
The FDA said further that CSL was still using a certain type of rubber stopper on multi-dose vials containing the preservative thimerosal, although the manufacturer had advised that the stoppers may react with thimerosal. Also, the company did not study possible interactions between the vaccine and the stoppers and vials used in 29 lots of Afluria and H1N1 vaccine that were marketed in the United States, the letter says.
The agency also asserted that the company failed to ensure that samples from vaccine lots were tested at least once a year for evidence of deterioration.
The letter acknowledges a written response provided by CSL on May 14, in which the company promised to address problems the FDA had previously communicated to the firm. But the letter asks for more information and a meeting with CSL officials to discuss the issues.
Efforts to reach CSL officials for comments on the FDA letter today were unsuccessful. According to today's Reuters report, CSL said letters like the one from the FDA are "not uncommon," but the company is taking the issues raised by the FDA "very seriously."
"The FDA has stated that there is no direct connection between the increase in reports of fever and febrile convulsions reported in young children in Australia this season and the issues raised" in the FDA letter, CSL officials said, as reported by Reuters.
The increased adverse events in vaccinated Australian children were first reported in late April. They prompted the company to stop distributing its pediatric flu vaccine and caused Australian authorities to advise providers to stop immunizing children 5 years old and younger, pending an investigation. So far, investigations by the company and Australian authorities have not yielded an explanation.
