Chiron gets FDA nod to ship flu vaccine

first_imgOct 13, 2005 (CIDRAP News) – Armed with full federal approval for the first time in more than a year, Chiron Corp. says it may start shipping influenza vaccine to US distributors next week.Chiron’s first shipments since contamination problems blocked the company’s vaccine shipments last year could help ease vaccine shortages caused by slow deliveries, a Centers for Disease Control and Prevention (CDC) official said.The Food and Drug Administration (FDA) yesterday approved the first three lots of Chiron’s Fluvirn vaccine for shipment, according to company officials. The lots amount to about 1.5 million doses.Chiron spokeswoman Alison Marquiss in Emeryville, Calif., said the company needs to complete its own testing on the three lots before shipping them, which could happen in a few days.”We’re very close to the finish line for these first lots,” she told CIDRAP News. “We’d expect to release them to distributors in the coming days for them to ship to their customers.”In a survey of 120 local health departments last week, all but six reported that vaccine shipments were delayed or orders were not completely filled, according to an Associated Press report today. The survey was done by the National Association of City and County Health Officials (NACCHO).The survey indicated that somewhere between zero and 40% of flu vaccine orders have been filled so far, Curtis Allen of the CDC’s National Immunization Program in Atlanta told CIDRAP News.”A lot depends on who they ordered from and when they ordered it,” Allen said. “Many of those that have ordered from Sanofi [Sanofi Pasteur] have received at least 20% of their orders.” He said Sanofi has been trying to make sure that customers get enough vaccine to cover people who have an increased risk of serious flu complications.With Chiron having received FDA clearance, Allen added, “Hopefully those who have ordered vaccine from Chiron should be getting some soon.”In September the CDC recommended that flu shots be reserved for people in high-risk groups until Oct 24. Despite the delayed deliveries, the agency has no current plans to change that date, Allen said.Contamination problems at Chiron’s Liverpool, England, vaccine plant forced the company in October 2004 to cancel the planned shipment of about 48 million doses to the United States.British authorities restored Chiron’s manufacturing license last March, and the FDA inspected and approved the Liverpool plant in August. In September the FDA approved the company’s vaccine formulation for this year. The agency also must inspect and approve each lot of vaccine before it can be shipped.”The [FDA] release yesterday was the last regulatory step,” said Marquiss.”In the past year we’ve been working on remediating our facility and at the same time producing vaccine for this upcoming season,” she said. “So what we’re doing right now is a step that normally would’ve happened a month ago. We just need to catch up.”As reported previously, Chiron expects to produce between 18 million and 26 million doses of flu vaccine this year, Marquiss said. “Our third-quarter earnings report is October 25, so we hope to have a more concrete number then, or even before then.”She predicted it would take until early December to finish delivering vaccine for this season.Allen said the CDC has not changed its estimate of flu vaccine supplies for this year: 60 million doses from Sanofi Pasteur, 8 million from GlaxoSmithKline, 3 million from MedImmune, and 18 million to 26 million from Chiron. That comes to 89 million to 97 million doses in all, as compared with about 60 million doses made available last year.last_img read more

USC students participate in Women’s March

first_img“The problem with USC is that you have to look very deeply to find the communities that you want,” Camacho said. “USC is not notoriously known for it’s very outspoken mannerisms, or dealing with these sorts of issues.” The march’s leaders have received criticism in the past regarding issues of anti-Semitism. Tamika Mallory and two other original founders of the march were criticized for allegedly supporting Louis Farrakhan, the leader of the Nation of Islam, who has made numerous anti-Semitic and racist remarks, according to reports by The New York Times. The Times also reported that a founding member was allegedly pushed out of the organization for anti-Semitic reasons. Speakers like women’s rights attorney Gloria Allred, who represents some victims of former campus gynecologist George Tyndall, L.A. city councilmembers Nury Martinez and Monica Rodriguez and actress Laverne Cox celebrated the increased number of women in Congress while calling for equal pay and reproductive rights, among other issues. Tucker Judkins/Daily Trojan Tucker Judkins/Daily Trojan School of Dramatic Arts professor Mike Stutz, who attended the Women’s March with a group of activists painted blue called the “Blue Wave,” said he thinks it’s important for students to use their voices. Camacho said she has not been able to easily find a sense of solidarity among people who are social justice-oriented on campus and that “slacktivism,” or lazy activism, is apparent within the student body. At protests like that against conservative commentator Ben Shapiro’s appearance on campus in October, Camacho said a small number of students turn out and that they often lack a cohesive message. Some Jewish students at the march said they considered not going, but ultimately decided to voice their support for the movement. Mike Stutz, a professor at the School of Dramatic Arts, painted himself blue in protest against the current administration. (Tucker Judkins/Daily Trojan) “I think I’ve been desperately looking for some sense of solidarity, whether it be my identity as a woman, as a Latina woman or as a queer Latina woman,” Camacho said. “I’m just trying to find a community that I can stand behind and rally behind … just because I feel like there’s been a lack of that.” “I really love the display of unity and, hopefully, intersectionality that would include both Jewish and Muslim women who are oppressed in different ways,” Montooth said. “I think I am seeing that a lot in the women who are here, even if it is not really seen in the leadership.” Tucker Judkins/Daily Trojan “I see a lot of individual optimism, which is good and bad,” Montooth said. “I do think I see a lot of open discussions. And even though we’re in L.A., … I do see opinions from all over the spectrum on each side of everything.” Emily Wulf, a freshman majoring in environmental studies, said that though some of the founders of the march were controversial, attending has more to do with showing solidarity with the women marching.center_img Wulf said the Women’s March was a perfect opportunity for USC students to demonstrate their interest in activism. She also said she believes the culture of activism and social justice on campus reflects a minimal effort. “For me, I feel like [the] social justice presence on campus has always remained very surface level and pseudo-knowledgeable,” Wulf said. “You see a lot of people who try to remain politically active, but they do it in the bare minimum way.” Out of 34 Women’s March chapters around the United States, 23 have officially separated themselves from Women’s March Inc., the movement’s parent organization. Last month, Women’s March California issued a statement saying it “does not share leadership, structure or funding with Women’s March Inc.” “[Students] are the future of this country, to state the obvious,” Stutz said. “Get involved now and you understand what a difference you can make. I think the saddest thing out there is someone who thinks they have no effect on the world around them.” Tucker Judkins/Daily Trojan USC students, faculty and alumni joined protesters marching through downtown Los Angeles for the third annual Women’s March Saturday. They carried homemade signs that read “Jewish Women Are Powerful,” “#TheFutureIsBlue” and “Feminism Is Big Dick Energy,” among others. “This year I felt it was really important to come and support my Jewish women,” said Assaf Manor, a freshman majoring in theatre and political science. “Because the L.A. Women’s March made such an effort to distance itself from all of those problems and publicly denounce anti-Semitism, I felt like it was a good place to come and show my support.” Members of USC student organizations, including Student Assembly for Gender Empowerment, Environmental Student Assembly, USC College Democrats, Trojan Advocates for Political Progress and Residential Education at USC attended the march, which saw over 600,000 people fill the streets of downtown, according to a Facebook post from Mayor Eric Garcetti. Montooth said though the majority of USC’s population does not actively participate in protests, she believes that open discussion takes place on an individual level. Tucker Judkins/Daily Trojan Amelia Montooth, a senior majoring in international relations global business, said she appreciated the diversity among the march’s participants. Maria Camacho, a freshman majoring in international relations, said the Women’s March helped her find an outlet to strengthen her involvement with activism. last_img read more