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May 31, 2007 3:00 AM (2 mins ago)
by Karl B. Hille, The Examiner
BALTIMORE (Map, News) - FluMist manufacturing problems in Liverpool, England, stalled efforts to get the nasal vaccine spray approved for children ages 1 to 4.
Gaithersburg’s MedImmune released information Tuesday about the Food and Drug Administration’s inspection of its Liverpool manufacturing facility.
The FDA wrote a warning letter to inform the company that problems with contamination have not been properly addressed and that the company’s application to expand the age range for the vaccine will not proceed until these issues are resolved.
“Our plans haven’t changed at this point as far as our timeline for production of FluMist for this season,” company spokeswoman Karen Lancaster said. The vaccine, made from a live-but-weakened flu virus, has been approved for people 5 to 49.
The FDA letter addressed issues of personal exposure — lab workers not wearing safety glasses in the plant — as well as early-stage contamination of the vaccine stock. Later stages were not cited for contamination.<SCRIPT language=JavaScript>document.write('<SCRIPT LANGUAGE="JavaScript1.1" SRC="http://ad.doubleclick.net/adj/examiner.Baltimore/Health;tile=3;dcopt=ist;sz=300x250;ord=\'+ord+\'?" ><\/SCRIPT>');</SCRIPT><SCRIPT language=JavaScript1.1 src="http://ad.doubleclick.net/adj/examiner.Baltimore/Health;tile=3;dcopt=ist;sz=300x250;ord='+ord+'?"></SCRIPT><SCRIPT src="http://pagead2.googlesyndication.com/pagead/show_ads.js" type=text/javascript></SCRIPT><SCRIPT>if ((!document.images && navigator.userAgent.indexOf("Mozilla/2.") >= 0) || navigator.userAgent.indexOf("WebTV")>= 0) {document.write('');document.write('
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“FDA investigators documented significant deviations from current good manufacturing practice (CGMP) in the manufacture of FluMist,” the letter stated.
Viral bodies for vaccines are initially incubated in chicken eggs, according to the FDA Web site. This leads to contamination, but later filtering and processing should eliminate unwanted bacteria.
The agency also approved labeling for the vaccine and post-marketing commitments made by the company in a separate letter, but it reserved final approval until inspection issues are resolved.
“We are going to do whatever we need to do” to reassure the agency, Lancaster said.
“We are pleased with the progress made with the FDA relating to our supplement to extend the age range for FluMist,” Linda Peters, senior vice president of regulatory affairs, said in a statement. “We take the agency’s observations with respect to compliance at our bulk manufacturing plant very seriously.”
No other vaccine production facilities were affected, and MedImmune’s work on a bird-flu vaccine also will continue.
khille@baltimoreexaminer.com
by Karl B. Hille, The Examiner
BALTIMORE (Map, News) - FluMist manufacturing problems in Liverpool, England, stalled efforts to get the nasal vaccine spray approved for children ages 1 to 4.
Gaithersburg’s MedImmune released information Tuesday about the Food and Drug Administration’s inspection of its Liverpool manufacturing facility.
The FDA wrote a warning letter to inform the company that problems with contamination have not been properly addressed and that the company’s application to expand the age range for the vaccine will not proceed until these issues are resolved.
“Our plans haven’t changed at this point as far as our timeline for production of FluMist for this season,” company spokeswoman Karen Lancaster said. The vaccine, made from a live-but-weakened flu virus, has been approved for people 5 to 49.
The FDA letter addressed issues of personal exposure — lab workers not wearing safety glasses in the plant — as well as early-stage contamination of the vaccine stock. Later stages were not cited for contamination.<SCRIPT language=JavaScript>document.write('<SCRIPT LANGUAGE="JavaScript1.1" SRC="http://ad.doubleclick.net/adj/examiner.Baltimore/Health;tile=3;dcopt=ist;sz=300x250;ord=\'+ord+\'?" ><\/SCRIPT>');</SCRIPT><SCRIPT language=JavaScript1.1 src="http://ad.doubleclick.net/adj/examiner.Baltimore/Health;tile=3;dcopt=ist;sz=300x250;ord='+ord+'?"></SCRIPT><SCRIPT src="http://pagead2.googlesyndication.com/pagead/show_ads.js" type=text/javascript></SCRIPT><SCRIPT>if ((!document.images && navigator.userAgent.indexOf("Mozilla/2.") >= 0) || navigator.userAgent.indexOf("WebTV")>= 0) {document.write('');document.write('
“FDA investigators documented significant deviations from current good manufacturing practice (CGMP) in the manufacture of FluMist,” the letter stated.
Viral bodies for vaccines are initially incubated in chicken eggs, according to the FDA Web site. This leads to contamination, but later filtering and processing should eliminate unwanted bacteria.
The agency also approved labeling for the vaccine and post-marketing commitments made by the company in a separate letter, but it reserved final approval until inspection issues are resolved.
“We are going to do whatever we need to do” to reassure the agency, Lancaster said.
“We are pleased with the progress made with the FDA relating to our supplement to extend the age range for FluMist,” Linda Peters, senior vice president of regulatory affairs, said in a statement. “We take the agency’s observations with respect to compliance at our bulk manufacturing plant very seriously.”
No other vaccine production facilities were affected, and MedImmune’s work on a bird-flu vaccine also will continue.
khille@baltimoreexaminer.com
