FDA clears CSL's vaccine-finishing facility in US

Aug 18, 2009 (CIDRAP News) – The US Food and Drug Administration (FDA) today approved a vaccine filling and packaging facility in Illinois owned by CSL Biotherapies, one of the five companies under contract to make novel H1N1 vaccines for the United States, the company announced.

The facility, based in Kanakee, includes a high-speed, single-dose vaccine filling line and is intended to help the company expand its capacity to make flu vaccine for the US market. The company, based in Australia, said in a press release that it completed production of its seasonal flu vaccine, Afluria, in early July and will deliver more than 8 million doses, most of it in thimerosal-free prefilled syringes, for the upcoming season.

On May 29 CSL signed a $180 million contract with the US Department of Health and Human Services (HHS) to produce novel H1N1 antigen. Today's FDA approval will enable the company to package the antigen, produced at the company's headquarters in Australia, if requested by HHS. A company spokeswoman said in an e-mail sent to journalists today, "Today's approval of this facility is particularly important as it will allow CSL to fill and package their vaccine against the novel influenza A/H1N1 virus in the US."

On Aug 14 during a National Biodefense Safety Board teleconference to update US officials on pandemic preparations, an HHS official scaled back the predicted initial supply of novel H1N1 vaccine from 120 million doses to 45 million doses by mid October, with 20 million doses arriving weekly thereafter. The official cited a US shortage of vaccine fill-and-finish sites, which are just finishing production of seasonal flu vaccines, as one of the reasons for the vaccine delay.

Bill Hall, an HHS spokesman , told CIDRAP News today that the FDA's approval of CSL's new facility is clearly good news and is part of HHS's strategy to maximize vaccine production and speed delivery. "However, it's too early to predict at this point exactly how much this particular approval will enhance our overall production capacity and vaccine availability," he added.

Another reason cited for the reduced forecast regarding initial H1N1 vaccine supply was CSL's contractual obligation to produce novel flu vaccine first for its home country, Australia, which is in the midst of its winter flu season. Officials also said one of the companies making seasonal flu vaccine is having problems finishing up production.

When the Kanakee facility opens, it will have the capacity to fill and package 10 million doses of CSL's seasonal flu vaccine each year, the company said. Once the site reaches full capacity it will be able to fill and package 20 million thimerosal-free prefilled syringes annually.

Wally Casey, senior vice president and general manager of CSL's Kanakee facility, said in a press release that the FDA's approval today enables the company to rapidly deliver ready-to-administer flu vaccines to US healthcare providers. "It also underscores our support to enhance vaccine administration safety through the use of ready-to-use prefilled syringes," he added.

CSL said in a May 29 press release that it also has a fill-and-finish facility in Marburg, Germany.

See also:

Aug 18 CSL press release

Aug 14 CIDRAP News story "Officials lower expectations for size of first novel flu vaccine deliveries"

May 29 CSL press release

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