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FDA OK's MedImmune's Flu Vaccine Facility
Posted on 2005-12-27 11:38:00
MedImmune, Inc. announced today that its newly constructed influenza vaccine manufacturing facility in Speke, England has been approved by the U.S. Food and Drug Administration (FDA). The facility allows MedImmune to produce up to 15 million bulk doses per month, or approximately 90 million bulk doses per influenza manufacturing season, of its trivalent, intranasal influenza vaccine, FluMist (Influenza Virus Vaccine Live, Attenuated).
"The approval of our new manufacturing facility demonstrates MedImmune's ongoing commitment to being a worldwide leader in the influenza vaccine market," said Bernardus N.M. Machielse, Drs., senior vice president, operations. "With this state-of-the-art facility, we can substantially ramp up production. It provides the capacity for manufacture of increased supply of FluMist and our investigational, next-generation influenza vaccine, known as CAIV-T (cold adapted influenza vaccine, trivalent). The facility could also be used to produce vaccine year round in the event of an influenza pandemic."
The square footage of the new facility is 10 times larger than MedImmune's existing bulk manufacturing facility in Speke, and features larger testing and storage facilities, as well as automated inoculation capabilities. The facility uses a new filtration process, which is expected to provide greater sterility assurance during bulk production. MedImmune plans to begin manufacturing FluMist at this site in 2006.
In September 2005, MedImmune submitted a supplemental Biologics License Application (sBLA) to the FDA for approval to use CAIV-T, its refrigerator- stable liquid formulation of FluMist, in preventing influenza in healthy individuals 5 to 49 years of age. Included in the sBLA were data from a recently completed pivotal Phase 3 study comparing the immunogenicity of FluMist and CAIV-T, as well as additional preclinical and clinical data supporting the comparability of the two formulations.
MedImmune also recently announced preliminary data from a Phase III study indicating that CAIV-T showed a statistically significant reduction (55 percent) in influenza illness caused by any influenza strain compared to the injectable influenza vaccine (TIV). The influenza attack rate was 8.6 percent for study participants receiving TIV compared to 3.9 percent for those who received CAIV-T (p less than 0.0001). The rates of serious adverse events and adverse events were similar in the two groups. As expected, runny/stuffy nose occurred more frequently in children receiving CAIV-T and site of injection events occurred more frequently among those receiving TIV. In the analyses of medically significant wheezing, the only statistically significant difference was observed in children not previously vaccinated who were under two years of age after the first dose. In this analysis, the rate in the CAIV-T arm was 3.2 percent versus 2.0 percent in TIV recipients. In this same population, no significant difference was observed beyond 42 days after the last vaccination. The goal of the study was to provide the pivotal data to seek regulatory approval for use of the intranasal vaccine in children down to six months of age. This prospective, controlled, Phase 3 trial included approximately 8,500 children between the ages of six months and 59 months, including those with a history of asthma and wheezing. It was conducted at approximately 250 sites in North America, Europe and Asia.
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