FDA Calls Chiron Facility Acceptable; GSK Gets Green Light For Flu Vaccine

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA Calls Chiron Facility Acceptable; GSK Gets Green Light For Flu Vaccine

The US Food and Drug Administration (Rockville, MD) has released the results of a nine-day good manufacturing practices inspection of Chiron’s (Emeryville, CA) Liverpool facility, which manufactures “Fluvirin” influenza virus vaccine. The FDA found Chiron's responses and proposed corrective actions to inspection observations to be "generally acceptable."

Chiron can now resume production of the Fluvirin vaccine for the US market by the 2005–2006 influenza season. “We are grateful for the direction and guidance the regulatory agencies have extended to us throughout this process, and we are proud of the dedication our employees have demonstrated in working toward this accomplishment," stated Howard Pien, CEO of Chiron, in a release. "We remain focused on our objective of delivering Fluvirin vaccine to the US market in support of public health efforts to prepare for the upcoming influenza season."

According to a release, Chiron's ability to deliver Fluvirin vaccine to the US market will depend upon successful production and final testing of the vaccine, as well as release of the vaccine by the FDA. Chiron also expects that the MHRA may again inspect Chiron's Liverpool facility before the company commences shipment of Fluvirin vaccine.

"We are pleased that the Chiron Corporation has taken steps to address issues at their facility in Liverpool as they prepare for the upcoming flu season," stated Jesse Goodman, FDA director of the Center for Biologics Evaluation and Research, in a release. "The letter that we issued to them this week is a positive development and shows significant progress on their part.” Goodman says that additional work is still needed to determine the amount of vaccine Chiron may be able to supply the US market for the upcoming flu season.

In related influenza production news, GlaxoSmithKline (Philadelphia,PA, www.gsk.com) has received approval from FDA to produce the influenza vaccine “Fluarix.” The vaccine was approved under the accelerated approval process, which allows drugs necessary for treating severe illnesses to be pushed through the approval process without undergoing broad clinical trials.

According to an Aug. 31 release issued by GSK, the company was pleased that it could bolster the country's supply of flu vaccine in time for the 2005–2006 flu season. "The shortage of flu vaccine last year was a reminder of the importance of vaccines in health care," Jean-Pierre Garnier, CEO of GlaxoSmithKline, said. "GSK worked quickly with government officials to make Fluarix available and increase supply at a critical time. We appreciate the spirit of cooperation and commitment on the part of the FDA and US Department of Health and Human Services. Now we look forward to working with health authorities to encourage vaccination among those who are most vulnerable."

–George Koroneos