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18Nov/20

FDA approvals clear way for flu vaccine marketing

first_imgEditor’s note: This story was updated Aug 7 to include information about the start of influenza vaccine shipments by Novartis.Aug 6, 2008 (CIDRAP News) – The six companies that make influenza vaccine for the US market have won federal approval for their version of this year’s vaccine, in which all three flu strains used in last year’s product have been replaced, the Food and Drug Administration (FDA) announced yesterday.The FDA announcement clears the way for marketing of the vaccines. At least three vaccine makers have begun shipping vaccine to distributors and providers, according to recent company announcements.The six manufacturers and their vaccines are CSL Limited, Afluria; GlaoxSmithKline Biologicals, Fluarix; ID Biomedical Corp. of Quebec (a unit of GlaxoSmithKline), FluLaval; MedImmune, FluMist; Novartis Vaccines and Diagnostics, Fluvirin; and Sanofi Pasteur, Fluzone.In the wake of a relatively poor match between the vaccine and circulating flu strains last season, experts at the World Health Organization and the FDA in February recommended changing all three strains of virus used in the vaccine. In most years only one or two of the three strains are changed.”One of the biggest challenges in the fight against influenza is producing new vaccines every year,” Jesse Goodman, MD, MPH, director of the FDA’s Center for Biologics Evaluation and Research, said in a news release. “There is no other instance where new vaccines must be made every year.”Two of the three strains in the 2008-09 vaccine are included in vaccines now being used in the Southern Hemisphere, where the flu season is under way, the FDA noted.The decision to change all three strains in the vaccine had generated some concern about possible production delays or low yields of the viruses, which are grown in eggs. But Curtis Allen, a spokesman for the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention (CDC) in Atlanta, said today he hasn’t heard of any problems growing the strains.”Vaccine production is always fraught with risk and anywhere along the line things can go wrong, but so far they have not, and we’re looking forward to a season with adequate supplies of vaccine,” Allen told CIDRAP News.At a meeting in May, manufacturers estimated they would produce a record total of 143 million to 146 million doses of flu vaccine for the US market this year. Allen said the estimates of vaccine production have not changed since then. Last year 140 million doses were produced.Allen listed the manufacturers’ production estimates as follows: Sanofi Pasteur, 50 million doses; GlaxoSmithKline (including ID Biomedical), 35 million to 38 million; MedImmune, 12 million; Novartis, 40 million; and CSL, 6 million.Sanofi announced Aug 1 that it had begun shipping the first 1.3 million doses of Fluzone. “Vaccine shipments to healthcare providers and to the [CDC] for distribution through the Vaccines for Children Program will continue through the fall and are planned to be completed in October,” the company said in a news release.The statement indicated that replacing all three strains of virus has not caused any major production problems.”Introduction of three new strains for the influenza vaccine was unprecedented and could have resulted in a low yield or delay given our tight production timeline. Despite these challenges, we are pleased that once again Sanofi Pasteur has demonstrated its reliability in supplying Fluzone vaccine to the US market,” said Wayne Pisano, the company’s president and chief executive officer, in the news release.MedImmune announced yesterday that shipments of FluMist, a nasal-spray vaccine that uses a weakened form of live virus, had begun on Jul 31. In a news release, the company affirmed that it plans to produce about 12 million doses, a record number.FluMist will be available at some retail pharmacies and supermarkets and in nearly 200 school-based vaccination programs and university health centers, the company said. In addition, the federal government, as in past years, is buying some doses for use in military personnel, officials said.Novartis announced Aug 7 that it has begun shipping Fluvirin to US healthcare providers. The company said it expects to deliver 20 million doses by the end of September and aims to deliver the remaining 20 million by Oct 31. Officials said the company has added a second manufacturing facility, located in Rosia, Italy, to help supply flu vaccine earlier in the season. The firm’s other facility is in Liverpool, England.”Despite the new composition [of the vaccine], Novartis made sure we were able to deliver a timely and robust supply of influenza vaccine this year,” said Rajiv De Silva, president of Novartis Vaccines in the US, in a news release.This is the first year the CDC is formally recommending flu shots for school-age children, adding about 30 million people to the ranks of those targeted for vaccination. Allen said the total number of those targeted for vaccination—including people at risk for serious flu complications and their close contacts—is about 258 million, or roughly 84% of the population.See also: Aug 5 FDA news releasehttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116933.htmFDA page with chart of vaccine lot releaseshttp://www.fda.gov/cber/flu/flu2008.htmAug 4 MedImmune news releaseAug 1 Sanofi Pasteur news releasehttp://www.vaccineplace.com/docs/first_shipment_release.pdfMay 13 CIDRAP News story “Flu experts try to ensure record vaccine doses get used”Feb 22 CIDRAP News story “FDA endorses overhaul for 2008-09 flu vaccine”last_img read more

17Sep/20

USC holds Armenian genocide awareness event

first_imgIn commemoration of the 99th anniversary of the Armenian genocide, USC’s Armenian Students’ Association and the Shoah Foundation hosted the Armenian Genocide Awareness Talk at Tommy Trojan on Thursday.Remembrance · Stephen Smith, the executive director of the Shoah Foundation, served as one of the guest speakers at the Armenian Genocide Awareness Talk, which was held Thursday at Tommy Trojan. – Austin Vogel | Daily TrojanAccording to the Armenian National Institute, the genocide officially began on April 24, 1915, when over 200 Armenian community leaders were apprehended and later executed in Turkey during the reign of the Ottoman Empire. Over the next eight years, approximately one and a half million Armenians were killed. The political party in power in Turkey during this time, commonly referred to as the Young Turks, carried out the killings.The event included two guest speakers — Executive Director of the Shoah Foundation Stephen Smith and criminal defense attorney RJ Manuelian — and music including the bands VIZA, Armenian Public Radio and R-Mean, as well as art installations and food displays. The gathering served as a moment to remember those who were killed in the genocide and reflect on the genocide as a whole.Smith spoke about the world’s reluctance to acknowledge the Armenian genocide.“The world has been in denial,” Smith said. “We owe those who have fallen recognition, not only by the    U.S. but by the world.”He continued to speak directly to the students in the audience about how they must carry on the torch.“The obligation is now passed on to the diaspora of Armenians to remember the genocide,” he said. “The obligation is now passed on to all of you.”Haig Aintablian, president of the Armenian Students’ Association, spoke about his personal experience with the genocide, in which some of his family were victims.“My [great-grandmother] was personally in the Armenian Genocide,” Aintablian said. “I heard stories of it from my grandma, very very horrific stories. I didn’t realize it was something that would affect me until I joined the board of the USC ASA.”Aintablian continued to speak about how awareness of the genocide is highly limited.“Historically it’s so sad not to see it widespread and people don’t know about it,” Aintablian said. “The main thing is for USC students to know about what happened. We’re all going to be the next generation of politicians, the next generation to impact the United States. It’s important that we ourselves are knowledgeable on these important events, especially things like genocide.”Those in attendance found the event to be an important medium for increasing awareness.“This is the largest turnout I’ve ever seen,” said Silva Sevlian, a USC alumna and now full-time employee of the Shoah Foundation. “There is actually a substantial Armenian population here at USC. It’s really an important event for them and the community as a whole.”Mariam Mosinyan, a junior majoring in communication, stressed the need to be privy to the past and present.“It’s part of my heritage and my history — it’s important to be aware of what’s going on in the community and contribute in any way,” Mosinyan said. “If me being here and bringing a couple of my friends who aren’t Armenian to learn about the issue helps in any way, then that’s what I am going to do.”Manuelian, the final speaker, discussed USC’s involvement in the remembrance of the genocide as an important responsibility.“This is a place of learning, where denial cannot take place,” Manuelian said. “Today we are here to remember … Remembrance is the first act of knowledge and knowledge is the first act of ensuring that the denial does not continue.”last_img read more

16Sep/20

Slow start hampers Syracuse in 3-1 loss to No. 7 Robert Morris

first_img Published on January 27, 2017 at 11:33 pm Contact Nick: nialvare@syr.edu | @nick_a_alvarez Facebook Twitter Google+ On a night when her teammates came out flat, Syracuse goalie Abbey Miller was tested from the get-go. Eight of Miller’s 20 saves came within the opening minutes as RMU pressured the Orange relentlessly. Within the first minute, SU had conceded two faceoffs in its own zone. Miller’s number was called over and over as the Orange defenders failed to clear the puck.When Syracuse defenders would pass the puck along the boards, desperately keeping their heads above water, RMU’s speedy forwards intercepted the puck and tested the Orange netminder.“I just didn’t think we had much jump,” SU head coach Paul Flanagan said. “The first seven or eight minutes I thought the ship was sinking, it didn’t look good.”After RMU’s barrage of shots to begin the game, a Dakota Derrer hooking penalty gave RMU a skater advantage. Syracuse’s (9-11-5, 8-3-2 CHA) slow start allowed No. 7 Robert Morris (17-2-6, 10-1-2) to control the majority of the game and beat the Orange, 3-1, Friday night at Tennity Ice Pavilion.Syracuse entered the game a win away from tying for first place in the CHA. But poor passes and decision making did not help the cause.AdvertisementThis is placeholder textAs senior forward Jessica Sibley skated down on the left side of the neutral zone, three RMU defenders crashed down on her. Feeling the pressure of the defense, Sibley kicked the puck away into the waiting stick of RMU center Jessica Gazzola. Seconds later, Miller was beat glove side for the second time in as many minutes.Gazzola’s goal doubled RMU’s lead, and Syracuse’s hopes of tying for first place were dashed. A string of errant SU passes followed.“We were really antsy, gripping our sticks pretty tight,” SU defender Megan Quinn said. “We have to forget what we are playing for.”A strong RMU forecheck prevented the SU forwards from getting out in transition. SU’s tendency of passing the puck along the boards proved futile as RMU capitalized off creating traffic.“We weren’t thinking,” Flanagan said. “We weren’t quick enough up here (motioning to his head).”SU forward Stephanie Grossi cited a lack of communication when it came to the teams struggles of clearing the puck. The quickness of the RMU forwards, stifled the Orange offense early on. When the RMU attack trapped the Orange along the boards, SU failed to provide a response.“There has to be someone open on the breakout,” Grossi said. “If we can find that, on offense we will be a lot more successful.” Commentslast_img read more