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On August 25, 2004, as a result of performing routine testing required by FDA, Chiron identified bacterial contamination in a limited number of lots (approximately 4.5 million doses) of its influenza vaccine and notified FDA of the company's initial findings. At that time, Chiron quarantined all of its flu vaccine for this flu season (approximately 46 million doses) and was conducting an investigation into the cause of the contamination.
After August 25, 2004, FDA and CDC engaged in several calls with Chiron to assess the state of their investigation into the contamination, including results of continuing additional testing. Chiron indicated throughout that it still expected to supply the U.S. market with 46 to 48 million doses starting in October 2004. Chiron informed FDA that it thought it had identified the root cause for the contamination and believed that the contamination was confined to a limited number of final vaccine lots. Chiron indicated that there was no evidence that any other lots were affected, but nonetheless were retesting all final lots. Chiron also informed FDA that all results from the retesting were negative for all other finished product and that its final investigative report would be submitted to FDA during the week of October 4-8.
Even though Chiron indicated throughout that it still expected to be able to supply 46 to 48 million doses beginning in October 2004, CDC and FDA consulted and determined that it would be appropriate for CDC to contract with Aventis Pasteur to purchase several million additional doses of vaccine for the CDC stockpile that could be used later this year. It would not have been possible in August to add significantly more to flu vaccine production because it takes over six months to prepare.
On September 28-30, 2004, MHRA -- the UK equivalent of the FDA -- inspected the manufacturing facility. MHRA did not notify the FDA about its September 28-30 inspection of the Chiron facility or its October 4 decision to suspend the company's license for three months until after the suspension occurred on 10/5/04. MHRA's chief executive, Kent Woods, has indicated that MHRA did not have the legal authority to notify the FDA about the pending suspension until after the suspension had occurred.
On October 5, 2004, after learning of MHRA's suspension of Chiron's influenza vaccine license, FDA contacted MHRA and Chiron to obtain additional information and make arrangements for meeting with the MHRA and inspecting the Chiron facility in Liverpool. In response to our request, Chiron submitted to us on 10/5/04 a draft report of the company's investigation into the sterility failure and a copy of the MHRA's observations from the inspection.
On October 5, FDA organized an expert team to travel to the UK to meet with the MHRA and Chiron, and the team departed for the UK on 10/6/04.
On October 7, an FDA team met with MHRA in the UK and at that time MHRA shared with FDA the inspection concerns that led to their suspension of Chiron's influenza vaccine license for three months.
On October 8, the FDA team met with senior leadership of Chiron. Chiron presented the key results of their investigation, including negative retesting of all other lots, and indicated that they believed that the results, which they had planned to submit to the FDA, supported their conclusion that the contamination problem was confined to a limited number of lots identified by their testing.
On October 9, the FDA inspection team traveled from London to Liverpool and met with 2 MHRA inspectors, who joined the team as observers.
On October 10, the team initiated the inspection at the Chiron facility in Liverpool.
On October 15, FDA completed its investigation and presented its list of inspectional observations to Chiron's management as part of the close -out meeting that is held at the end of every FDA inspection. During that meeting, FDA investigators explained and discussed the observations that were documented during the inspection. FDA's inspection found significant deficiencies in quality control and concerns regarding the test results. Although Chiron's retesting of the unaffected lots of vaccine has been negative for contamination, FDA has determined that it cannot adequately assure the sterility of these lots to our safety standards.