Baxter says cell-based H5N1 vaccine shows potential in trial

first_imgOct 17, 2006 (CIDRAP News) – Low doses of a cell-based avian flu vaccine triggered a good immune response to the H5N1 avian influenza virus, according to preliminary results of a clinical trial by Baxter International of Deerfield, Ill., maker of the vaccine.The vaccine induced an immune response not only against the targeted H5N1 strain, but against other strains as well, according to Baxter. The company announced results of the phase I/II trial Oct 4 but had not released study data until Oct 11, at the World Vaccine Congress in Lyon, France.”This is the first clinical demonstration that a candidate H5N1 vaccine can induce antibodies that neutralize widely divergent strains of H5N1,” said Hartmut Ehrlich, MD, vice president for global research and development, in an Oct 4 Baxter news release. He added that the data “suggest that the vaccine may provide wider protection for a larger number of people before and during a pandemic.”The vaccine was produced using Baxter’s vero cell–based technology and dead whole viruses of wild-type H5N1 avian influenza strain A/Vietnam/1203/2004.Cell-based vaccines are grown in mammalian cells (often from kidneys) instead of chicken eggs and in theory could help meet “surge capacity” needs because the cells can be frozen for stockpiling. The method also can shave about a month off the production time for flu vaccines, which is normally about 6 months. But cell-based flu vaccines face practical hurdles, as discussed below.The cell-based vaccine was administered to 270 healthy adults aged 18 to 45 in Austria and Singapore. Groups of 44 to 48 volunteers received either 3.75, 7.5, 15, or 30 micrograms (mcg) of the vaccine with an aluminum oxide adjuvant, a substance that stimulates immune response. Two other groups of 45 each received 7.5 or 15 mcg of vaccine without an adjuvant. All volunteers were vaccinated on the first day of the trial and again 21 days later.Three weeks after the second injection, testing of serum samples showed that 15 of 23 (65%) volunteers in the 3.75-mcg group had a strong antibody response to the vaccine virus (microneutralization titer 1:20 or higher). In comparison, 15 in 20 (75%) of the adjuvanted 7.5-mcg group and 22 of 27 (82%) of the nonadjuvanted 7.5-mcg group showed a strong antibody response.The vaccine also showed evidence of cross-protection against other H5N1 strains. Microneutralization testing for antibody response to a 1997 Hong Kong strain showed a 71% (12 of 17) rate of response in the 3.75-mcg group, compared with an 81% (13 of 16) and a 96% (21 of 22) response in the adjuvanted and nonadjuvanted 7.5-mcg groups, respectively.For a 2005 H5N1 strain from Indonesia, the rates of antibody response were 35% (6 of 17), 63% (10 of 16), and 68% (15 of 22), respectively.Commenting on the diverse makeup of these nontargeted H5N1 viruses, Ehrlich told CIDRAP News via e-mail, “They are strains that are substantially different from Vietnam 1203. One is the same clade [family] but emerged 7 years earlier; the other one is a different clade. [This is] in contrast to many other strains—for example, Vietnam 1194—which are very similar to Vietnam 1203 and are expected to therefore induce cross-neutralization . . . and were indeed protective in our animal studies.”Ehrlich, who presented the data in Lyon, said the serum samples from the volunteers who received 15 or 30 mcg of the vaccine had not yet been analyzed. Final results of the study will be available by the end of the year, according to the Baxter news release.The rate of adverse events, released this week, demonstrated the apparent safety of the vaccine. After two injections, 3% of patients (6 of 201) had fever, 6.0% (12 of 201) experienced malaise, and 3.5% (7 of 201) reported shivering, the company said.Commenting on the implications of the findings, infectious-disease expert Michael T. Osterholm, PhD, MPH, said Baxter’s vaccine—like other H5N1 vaccines in development—is a long way from offering an early solution to the threat of a flu pandemic. Osterholm is director of the University of Minnesota Center for Infectious Disease Research and Policy, publisher of the CIDRAP Web site.Aside from the problem that it will take months to develop a specific vaccine once a pandemic strain of flu emerges, the Food and Drug Administration has not yet approved any cell-culture flu vaccine, Osterholm told CIDRAP News. “In fact, they’re a long ways from licensure,” he said.In addition, efforts to use a vaccine during a pandemic will encounter a host of practical problems, he added. “We have to think of the whole supply chain. What about syringes? Will they be available when a pandemic hits? What about a whole host of supplies that we’ll need during a pandemic that won’t be available because of our just-in-time infrastructure?”These practical considerations are so crucial that, if all these new vaccines were released today, none of them would make the world a safer place.”Baxter said it plans to begin phase III trials of the vaccine early next year.Baxter is collaborating with DynPort Vaccine Corp. to develop cell-based vaccines. In May, the US Department of Health and Human Services awarded DynPort a $41 million contract for cell-based flu vaccine work. The funds came from $3.3 billion that Congress appropriated for pandemic preparedness last December.See also:Baxter news release 4 CIDRAP News story “US awards $1 billion for cell-based flu vaccines”Jun 27, 2005, CIDRAP News story “Momentum builds for cell-culture flu vaccines”last_img read more

Companies receive HHS orders for novel flu vaccine

first_imgMay 26, 2009 (CIDRAP News) –Two vaccine companies, Sanofi Pasteur and GlaxoSmithKline, recently announced they received their first orders from the US government for a vaccine and adjuvant to protect the country against the novel H1N1 virus.Sanofi, in a statement released yesterday, said the initial order it received from the Department of Health and Human Services (HHS) covers the production of bulk vaccine and related activities and is worth $190 million. On May 22, Glaxo said in a press release that HHS ordered vaccine antigen and the company’s proprietary adjuvant system, AS03. Adjuvants are compounds that enhance a vaccine’s immune response, offering the possibility of stretching antigen supplies.The announcements from the two companies follow a May 22 announcement from HHS that secretary Kathleen Sebelius was directing about $1 billion in existing funds toward clinical studies and commercial production of bulk vaccine antigen and adjuvant.Federal officials have announced plans to support the development of a novel H1N1 vaccine, but have taken pains to explain that the decision to use it would be made separately.The Centers for Disease Control and Prevention (CDC) has said it hopes to wrap up work on a seed strain to send to vaccine makers within the next few weeks. Once companies receive the seed strain, they can develop pilot lots to begin safety, efficacy, and dosage testing.The federal government’s placement of the orders falls under existing contracts that the Biomedical Advanced Research and Development Authority (BARDA) established with the companies in 2004 as part of the nation’s pandemic influenza strategy.Sanofi said it hopes to begin work on a pilot lot in June after the US Food and Drug Administration approves its working seed. The company said clinical trials could begin as early as August, but a timeline for final formulation, filling, and distribution has not been set.Wayne Pisano, Sanofi’s president and chief executive officer, said in the press release that though a number of complex steps need to be taken before a vaccine is available, the company’s experience in developing the prepandemic H5N1 avian influenza vaccine will be helpful. “We look forward to further demonstrating our experience and expertise in vaccine development as we prepare for this new threat from AH1N1,” he said.Production of the new H1N1vaccine for HHS will take place at the company’s recently licensed new production facility in Swiftwater, Pa. As soon as the company finishes production of seasonal influenza vaccine at its second Swiftwater facility, it can produce the novel H1N1 vaccine at both plants. The two plants, when operating at full capacity, can make about 150 million doses of seasonal flu vaccine.Meanwhile, Glaxo said it expects to fill HHS’ adjuvant order within the next few months and hopes to produce the first antigen doses 4 to 6 months after receiving the novel H1N1seed strain. The company said its proprietary adjuvant, already approved as a component of the H5N1 vaccine in Europe and some Asian countries, is the subject of 15 additional clinical trials, including one involving a seasonal flu vaccine.Both Sanofi and Glaxo said they are in ongoing discussions with other countries about producing novel flu vaccine for national stockpiles.See also:May 25 Sanofipress releaseMay 22 Glaxopress releaseMay 22 HHS press releaseMay 6 CIDRAP News story “FDA approves new vaccine facility”last_img read more

Hohe See and Albatros Turbines Halfway There

first_imgEnBW has installed 44 of the 87 Siemens Gamesa wind turbines on the Hohe See and Albatros offshore wind farms in the German North Sea.Fred. Olsen Windcarrier’s installation vessels Brave Tern and Blue Tern load the components for four wind turbines at a time at the port of Esbjerg in Denmark and attach them offshore to foundations already installed in the seabed.The first turbine was installed at the site some 95 kilometres north of Borkum and 100 kilometres northwest of Helgoland in early April.The total of 87 Siemens Gamesa 7MW wind turbines with 609MW of installed output are due to be connected to the grid by the end of 2019.The project is being coordinated by the offshore branch of EnBW in Hamburg. The Canadian energy infrastructure company Enbridge Inc. holds 49.9 percent of the shares in the 71-turbine Hohe See and the neighbouring 16-turbine Albatros. EnBW has retained the remaining 50.1 percent in both projects.Photos: Fred. Olsen Windcarrier AS/Tony Catolast_img read more

Japan at ‘crossroads’ on virus outbreak, expert warns

first_img Promoted ContentThe Very Last Bitcoin Will Be Mined Around 2140. Read MoreBest & Worst Celebrity Endorsed Games Ever MadeWho Earns More Than Ronaldo?Top 10 Most Romantic Nations In The World6 Ridiculous Health Myths That Are Actually True13 kids at weddings who just don’t give a hootPlaying Games For Hours Can Do This To Your Body8 Best 1980s High Tech Gadgets6 Extreme Facts About HurricanesEver Thought Of Sleeping Next To Celebs? This Guy Will Show YouWho Is The Most Powerful Woman On Earth?Nothing Compares To Stargazing Places Around The World But he said the government had faced a difficult situation with limited capacity to conduct a quarantine onshore and pressure not to put those on board through a second isolation period.“Doing more than 14 days of quarantine… might have been the way to go,” he said.“But I also have to say that this process… must have been quite difficult,” he noted.Read Also: Virus hits Super Rugby as Japan match in doubtHe cautioned there was no evidence yet that passengers had infected others after leaving the boat.“We have to see what happens in the next coming one to two weeks… if the secondary infections from the passengers of the cruise happen, we have to really think about it,” he said.“These kind of ways may have not been perfect.”FacebookTwitterWhatsAppEmail分享 “We are now on the crossroads for the containment of the COVID-19… within our country,” said Ohmagari, director of the department of infectious diseases at Japan’s National Center for Global Health and Medicine. Japan has confirmed at least 186 domestic infections, including three deaths since the outbreak began, and the government has come under pressure for a relatively hands-off approach. But Ohmagari, who helps advise the government, defended measures, including requesting – but not ordering – the cancellation of major events, and encouraging teleworking and off-peak commuting.“If we keep going with what we are doing right now we do have (the) significant possibility for the containment or the elimination of this COVID-19,” he said.He conceded however there is still significant uncertainty, which has cast a shadow as Tokyo gears up to host the Olympics from July.Ohmagari said he would want to see domestic transmissions of the virus brought under control before the Games.“We have to see the situation at least three weeks from now,” he said.“If we can contain the secondary transmission within the country… I think that’s a very good sign, and it’s a very good signal for us to decide ‘go’ for the Olympics and Paralympics.”But if infections are continuing domestically, authorities will face a “big, big decision”.“If there is a significant outbreak or… a pandemic of this kind of infectious disease, we really have to think about holding this kind of large event, is it feasible or not?”– Boat quarantine was ‘not perfect’ –The government’s handling of the crisis has come under scrutiny internationally and domestically, with opposition lawmakers questioning the relatively low number of tests administered in Japan, compared to 57,000 in South Korea.The outbreak of COVID-19 has cast a shadow over preparations for the Tokyo 2020 Olympics which open in July Loading… center_img Japan is at a “crossroads” in its bid to prevent a major coronavirus outbreak and may need to reconsider the Olympics if domestic transmissions are not brought under control, an expert advising the government has warned. Japan faced significant criticism for its handling of a cruise ship placed in quarantine after a former passenger contracted the virus Norio Ohmagari, an infectious disease specialist, told AFP in an interview he believes measures being taken by the government can still prevent the virus from spreading more widely, but that the next three weeks will be critical.Advertisement Ohmagari acknowledged that “limiting the number of tests makes grasping the true number of cases impossible,” but said the tests could not always detect infections.“Catching all the people who are having this virus is impossible” he said. “We can see the trend.”Japan has also faced significant criticism for its handling of a cruise ship placed in quarantine after a former passenger contracted the virus.More than 700 people who were on board the Diamond Princess have so far tested positive for the virus, with multiple new cases emerging while the ship was in quarantine and even among passengers allowed off the boat after initially testing negative.“The process with the quarantine has not been perfect,” Ohmagari said.“I think that is a fact, we are now seeing it.”Japan’s government has urged the cancellation, delay or downsizing of major events in coming weeks to limit the spread of the virus Japan may need to reconsider holding the Olympics if it cannot bring domestic transmissions of the new coronavirus under control, an expert has warnedlast_img read more

Top Euro clubs will trade players rather than buy – Barca vice president

first_imgBarcelona’s vice president Jordi Cardoner has told ESPN that his club, along with most other clubs in Europe, will likely be trading rather than buying players this summer. Speaking frankly in an interview quoted by Simon Kuper, the Barca administrator admitted that the club had already lost between €120m and €140m in lost revenue due to the ongoing hiatus. He also asserted that the transfer market was going to be very different this year – and perhaps for a lot longer: “[Player exchanges] will be part of the game. This is the way things will happen for next season for European clubs,” the Spaniard explained.Advertisement Promoted Content15 Extremely Surprising Facts About Disney Princesses10 Irresistibly Gorgeous Asian Actresses10 Extremely Dirty Seas In The WorldThe Very Last Bitcoin Will Be Mined Around 2140. Read More5 Of The World’s Most Unique Theme ParksBest & Worst Celebrity Endorsed Games Ever Made9 Heroes Of Popular Memes Then And NowA Guy Turns Gray Walls And Simple Bricks Into Works Of ArtThe 90s Was A Fantastic Decade For Fans Of Action MoviesWhich Country Is The Most Romantic In The World?6 Most Overpowered Live Action Disney CharactersContemplate Life At These 10 Stargazing Locations Loading… That seems likely, but even then only top teams like Barcelona have the depth and the quality players in their squad to allow them to pull off these kinds of deals. Barcelona vice president Jordi Cardoner  Read Also: Setien: Messi, Barcelona will always be together It’s hard to imagine teams lower down the pyramid being able to engage even in simple loan trades. The fact that Barcelona have a stable of young players, like other top clubs, means they have a much stronger hand to work with. The executive also suggested three party deals could become more common as teams desperately look for solutions in a truncated transfer period. FacebookTwitterWhatsAppEmail分享 last_img read more

Serie A: Osimhen ‘feared racism’ before signing for Napoli

first_img “Then I visited the city of Naples, saw the environment with my own eyes and realised that I am in a wonderful city. “(Racism) is a worldwide issue. I’m sure I have chosen well and the Neapolitans will make me feel at home with their love.” Racism has been a recurring problem in Italian stadiums, including monkey noises directed at black players.Last season Brescia’s Italy international Mario Balotelli threatened to walk off the pitch after being targeted at Lazio and Hellas Verona.But Osimhem said he had “always been convinced that Naples was the best choice for me both for the present and for the future.“Both as a man and as a footballer.”Napoli’s Senegalese international defender Kalidou Koulibaly confessed Osimhen had asked him about racism in Italy before joining the club.“He called me, we talked about racism, I told him that coming to Naples he won’t have these problems, he will choose the right city,” Koulibaly told La Gazzetta dello Sport.“I too felt the bitterness of the racist insult, but never in Naples. I reassured him, I told him that if he comes, he will have made the best choice.”Interestingly, Osimhen was one of the most expensive players in Serie A history, costing almost double Napoli’s previous club record of around 40 million euros paid for Gonzalo Higuain in 2013 and Hirving Lozano last year.“Playing with Napoli is a dream,” he said.“I thank (owner Aurelio) De Laurentiis and (coach Gennaro) Gattuso who immediately considered me as their son.“I decided to accept the challenge with Napoli right after speaking with them. Loading… Read Also: Messi speaks out amid Barcelona exit talks“For a young player like me, having this warmth is essential.”Napoli finished seventh in Serie A last season and qualified for the Europa League after winning the Italian Cup, their first trophy in six years.The new Serie A  season kicks off on September 19.FacebookTwitterWhatsAppEmail分享 center_img Super Eagles forward and Napoli new signing Victor Osimhen admitted on Wednesday he was skeptical of  joining the Serie A club because of the racist reputation of some fans in Italy. Napoli splashed out a club record fee of up to 80 million euros ($94.6 million) to sign the Nigeria international from French outfit Lille. “There was a bit of scepticism on my part, because the issue of racism is a problem that exists everywhere,” Osimhen told journalists.Advertisement Promoted Content10 Phones That Can Easily Fit In The Smallest Pocket8 Superfoods For Growing Hair Back And Stimulating Its GrowthA Guy Turns Gray Walls And Simple Bricks Into Works Of Art5 Of The World’s Most Unique Theme ParksThe 10 Most Irresistible Asian Actresses7 Black Hole Facts That Will Change Your View Of The Universe10 Phones That Can Work For Weeks Without RechargingCan Playing Too Many Video Games Hurt Your Body?Some Impressive And Almost Shocking Robots That ExistWho Earns More Than Ronaldo?Which Country Is The Most Romantic In The World?5 Of The World’s Most Unique Theme Parkslast_img read more

Saints battle for point

first_img Southampton created the first decent opening when a low centre from Schneiderlin was beaten away by Norwich keeper Mark Bunn, who then tipped over Lallana’s rising 20-yard drive. Norwich were struggling to get hold of the ball in midfield and when right-back Russell Martin did get forward and float in a teasing ball through the penalty area, goalkeeper Boruc got there ahead of Kei Kamara, making his first start since a loan move from Kansas City. Southampton broke quickly on 28 minutes through Rickie Lambert and his onward pass found Gaston Ramirez in space at the edge of the Norwich penalty area, but his attempted chip was palmed out by Bunn as Javier Garrido mopped up the loose ball. Jay Rodriguez burst down the left early in the second half and cut into the penalty area and his cross was cleared by Sebastien Bassong, but the ball fell to Lallana some 12 yards out. However, with the goal at his mercy, the Southampton skipper could only blaze the ball high into the Barclay End. The pace of the match intensified as Japan defender Yoshida produced a superb block to prevent Holt getting on the end of Snodgrass’ cross after a great knockdown by Kamara. At the other end, Snodgrass was played in by Hoolahan, but the ball ran away from the Scotland international as he went around the goalkeeper, which allowed Yoshida to hack clear. There was late drama as Shaw’s nudge on Holt saw Clattenburg give a penalty but Boruc guessed right and earned Southampton a draw. Norwich captain Grant Holt saw his stoppage-time penalty saved as Southampton battled to a goalless draw in atrocious conditions at Carrow Road. Press Associationcenter_img With heavy rain before kick-off being followed by sleet, chances were few and far between. Saints skipper Adam Lallana blasted over when in front of an open goal, while Japan defender Maya Yoshida made vital blocks to prevent Holt and Robert Snodgrass scoring. There was late drama, though, as Luke Shaw was ruled to have pushed over Holt just inside the penalty area, as referee Mark Clattenburg pointed to the spot after consulting with his assistant. Southampton, though, felt justice was served as Artur Boruc produced a decent stop down to his left to secure a point for the visitors. last_img read more

US Coast Guard seizes more than $228 million in drugs in Port Everglades

first_imgThe US Coast Guard is reporting that it has seized more than $228 million dollars in marijuana and cocaine in an operation at Port Everglades.According to the report, the shipment contained nearly 11,500 pounds of cocaine and nearly 17,000 pounds of marijuana and was offloaded on Thursday.“We are proud to support the President’s national security strategy by keeping illegal drugs off American streets,” Capt. Timothy Cronin said. “I am extremely proud of this crew as they sailed short-handed due to the COVID-19 pandemic an delivered tremendous results.”last_img

CPL organisers, CWI agree on August start date for 2020 tournament

first_imgGROS ISLET, St Lucia (CMC) – Caribbean Premier League (CPL) organisers have struck an agreement with Cricket West Indies (CWI) which will see the popular domestic Twenty20 tournament revert to the August start date.The tournament, the eighth edition, will be played from August 19 to September 26, ensuring the availability of all West Indies contracted players.“We are very pleased to be playing our tournament in August and September, a time of year that is perfect for us and our fans,” said CPL’s chief operations officer, Pete Russell.“Having the best Caribbean cricketers and the world’s best overseas players is the foundation of our tournament and this period gives us that.“We may be just days away from the 2019 tournament, but we are already making plans for next year to ensure that we continue to see the phenomenal growth and economic impact that CPL has seen over the years.”This year’s tournament was initially carded for August 21 to September 27 but had to be pushed back to accommodate India’s tour of the Caribbean which concluded on Monday.The campaign bowled off yesterday in Port of Spain and will run until October 12.CWI chief executive Johnny Grave said it would be even more critical that all marquee West Indies players were available for the 2020 tournament, especially with the Caribbean side defending their T20 World Cup title in Australia next year.“The Hero CPL has developed into one of the best and most exciting T20 competitions in the world and we look forward to hosting another successful tournament next month,” he said.“We are pleased that we have once again found a window in our international calendar for the 2020 season to ensure that the best West Indian cricketers can take part, as the tournament plays a crucial role in our preparations and planning for the ICC T20 World Cup in 2020.”last_img read more

USC Hillel celebrates new additions to its building

first_imgFour decades after being built, USC’s Hillel center received renovations last summer after receiving funding from the Jewish Federation of Greater Los Angeles.Renovations began in early May, after the center hosted an event honoring former USC President Steve B. Sample. Renovations concluded before move-in week in August.The building was very run-down before the improvements, said Michael Jeser, executive director of Hillel. It was filled with donated items and used, torn up furniture. The flooring hadn’t been replaced in more than a decade, which Jeser said caused the building to lack a welcoming, modern atmosphere.“[We wanted] to upgrade the facility, make it more welcoming and open for students,” Jeser said. “[We wanted to] create more of a space that students could use for recreational, social, and academic purposes.”Modernization was a key part in the renovation, Jeser said. New furniture, flooring, glass windows and paint brought a more contemporary atmosphere to the building.“It used to be empty, like a warehouse feel. There were a few couches, but now there are dedicated spaces that students can use for meetings, social activities, and watching movies,” Jeser said.Cameron Roth, USC Hillel student president, said the new additions to the center automatically welcome students and make them feel more comfortable.“The first day people came back, people walked in the door and went straight to these lounge areas. No one used to come over here; it was uninviting,” said Roth, who also said he was glad to see the new wheelchair-accessible ramp at the University Walk entrance.A new drought-tolerant landscape was installed outside in order to help the environment, Jeser said. Other water-saving features were also installed in the bathrooms.“People feel more comfortable coming in with the change to the exterior,” Roth said. “Now people notice the building is here and they want to peek in. Getting them interested on their own is a great way to get them to come to events.”More entertainment and audiovisual equipment have been added as well. A large flat-screen TV greets visitors at the entrance to Hillel, with slideshows of activities and announcements. Two more flat screens occupy the building, and all TVs have Direct TV. Other technology upgrades include free WiFi throughout the building and video surveillance for enhanced security.The Jewish Federation of Greater Los Angeles, which contributes the most funding to Hillel, played a vital role in the renovation. The Real Estate Principals Organization, which is affiliated with the Jewish Federation and led by USC alumnus Jon Monkarsh, donated $75,000 to help fund the renovations.“It really is with great pride that we have supported Hillel at the federation, and especially the contribute we made to this facility. Not only the financial contribution but the time and the effort we put in,” said Richard Sandler, chairman of the Jewish Federation of Greater Los Angeles. “Here at Hillel, you are carrying forward really the greatest traditions of our culture, and that is education and values.”The renovation effort was led by USC Hillel Chairman Jaime Gesundheit. Gesundheit, who is an alumnus from the School of Architecture, spearheaded the entire design effort, with assistance from designer Nichole Sassaman.On Wednesday evening, Hillel celebrated the “Extreme Hillel Makeover” with keynote speaker President C.L. Max Nikias. Nikias spoke about the relationship between USC and the Jewish community, and the importance of a strong, vibrant Hillel at USC.“[Hillel] helps our students connect to the rest of the university and the larger world. USC Hillel plays an important role of connecting the students today with the traditions of the past,” Nikias said. “As president of USC I pledge to you that this partnership will continue. This Hillel will flourish.”Members of the USC Board of Trustees — including Dr. Andrew Viterbi, Stanley P. Gold, Kenneth Leventhal, Alan Casden and Daniel Epstein — participated in a Jewish ceremony to celebrate the opening of the newly renovated building.“When people feel comfortable enough to treat this place like a home instead of another university building, that’s when you know Hillel has done its job,” Roth said. “We can provide any amount of programming but nothing beats a home away from home.”last_img read more