Sanofi says H5N1 vaccine with adjuvant may go further

first_imgEditor’s note: The title and first two paragraphs of this story were revised Dec 16 to correct a statement in the original that gave a more positive reflection of the trial results described below than may be warranted. The original version said that Sanofi Pasteur had described the trial results as “promising,” but the company actually said only that the results were “a sign of progress.”Dec 15, 2005 (CIDRAP News) – Sanofi Pasteur today announced preliminary trial results suggesting that using an additive to boost the immune response may help to stretch the supply of a vaccine for H5N1 avian influenza by a modest amount.Previous results had indicated that an H5N1 vaccine without an immune-boosting adjuvant would have to contain 12 times as much antigen (active ingredient) as seasonal flu vaccines do. In the results announced today, it took four times as much antigen as in a seasonal flu vaccine to induce an adequate immune response—an improvement, but far from what is needed to remedy the global shortage of vaccine production capacity.Sanofi tested an H5N1 vaccine it is making for the French government on 300 volunteers, using three different doses: 7.5, 15, and 30 micrograms. The volunteers were divided into six groups, and each group received two doses of vaccine with or without alum, an adjuvant used in many vaccines, according to Len Lavenda, US spokesman for Sanofi. The shots were given 3 weeks apart.”A 30-microgram dose with an adjuvant in a two-dose regimen demonstrated an immune response at levels consistent with requirements of regulatory agencies for licensure of seasonal influenza vaccine,” the company said in a news release.The two 30-microgram doses of vaccine containing alum induced an immune response in line with what the European Agency for Evaluation of Medicinal Products (EMEA) requires for flu vaccines, Lavenda told CIDRAP News.”We saw responses in all six groups, but the two-30-microgram-dose adjuvant group was the only one within the range of EMEA approval,” he said.”The 7.5- and 15-microgram studies provided results that were not as high as the 30, but we are continuing to study that data and we expect to publish the full set within a few months,” Lavenda said.Seasonal flu vaccines typically contain 15 micrograms of antigen, the active ingredient, for each viral strain covered. The amount that proved adequate in the Sanofi trial was 60 micrograms (two 30-microgram doses), four times as much.However, 60 micrograms is a much smaller amount than what was found to be adequate in a trial of an H5N1 vaccine that Sanofi is producing for the US government, according to results announced in August. In that trial, which didn’t involve an adjuvant, the regimen that looked most promising was two 90-microgram doses, a total of 180 micrograms.H5N1 vaccines are being developed in the hope that they will be protective if the H5N1 virus evolves into a pandemic strain. But even if the current experimental vaccines turn out be effective, the world’s current production capacity is far too small to provide enough vaccine for more than a small fraction of the population, according to disease experts. Researchers hope that dose-sparing tools such as adjuvants will help stretch the supply.Sanofi called the new trial results “a sign of progress” that will help guide further development of a pandemic flu vaccine. “Subsequent trials will explore different dosages, which may be helpful in answering questions about dose-sparing strategies,” the company said.The vaccine used in the latest trial is being developed to provide a stockpile for the French government, the company said. It comes from a different human isolate of H5N1 virus than the one used in the vaccine Sanofi is making for the United States, according to Lavenda.See also:Aug 8, 2005, CIDRAP News story “Hopeful news on human H5N1 vaccine, but production concerns considerable”last_img read more

Column: Bumgarner great, but Bochy good, too

first_imgSan Francisco Giants starting pitcher Madison Bumgarner, left, and manager Bruce Bochy stand by the trophies after their 3-2 win against the Kansas City Royals in Game 7 of baseball’s World Series Wednesday, Oct. 29, 2014, in Kansas City, Mo. (AP Photo/Charlie Neibergall)The easiest decision Bruce Bochy had all night was when to put Madison Bumgarner in the game.The hardest thing was supposed to be deciding when to take him out.Actually it wasn’t that tough. You don’t win three World Series in five years without knowing that sometimes the best buttons are the ones not pushed.The hottest pitcher on the planet wanted the ball in the one game that mattered most. Once he got it, the unassuming man just starting to get some credit as one of the great managers of his era stayed out of his way.“Our horse was out there and we rode him,” Bochy said. “He was throwing so well there was no way I was taking him out.”A World Series that struggled to get noticed will now likely be long remembered, thanks to a laconic lefty who won it almost by himself. Bumgarner took the ball on two days of rest in the fifth inning and never came close to giving it up, even when a misplayed single to center put the tying run on third base with two outs in the ninth.San Francisco Giants pitcher Madison Bumgarner holds the World Series trophy after Game 7 of baseball’s World Series Thursday, Oct. 30, 2014, in Kansas City, Mo. The Giants defeated the Kansas City Royals 3-2 to win the series. (AP Photo/Charlie Neibergall)A lot of managers would have gone for their closer by sheer habit by then. Bochy merely stood and watched as Bumgarner got Salvador Perez to foul out to third baseman Pablo Sandoval to cap a World Series performance that brought back memories of pitchers from the past with names like Koufax and Gibson.“I think the best word that comes to mind is legendary,” first baseman Brandon Belt said. “I’m just glad he brought me along for the ride.”Give Bumgarner credit — and plenty of it — for rising to the occasion in a 3-2 win in a World Series that went all the way to the final out of Game 7 before being decided. He won two games, saved the final, and was virtually unhittable each time he took the mound.But give Bochy credit, too, for refusing to bow to pressure and start his ace in Game 4, a game the Giants desperately needed in San Francisco. Give him credit also for opting not to start Bumgarner in Game 7, even when he knew an aging Tim Hudson probably didn’t have what it took to last many innings against the Kansas City Royals.Finally, give him a third World Series ring for bringing Bumgarner in to start the fifth and letting his ace do the rest.“I was trying to think along with Boch and was thinking maybe three (innings) out of him,” catcher Buster Posey said. “But he just kept rolling. It was unbelievable.”The same might be said of the most improbable of the Giants’ three World Series runs with a team that returned only Posey as a position player from the 2010 World Series. It was just a month ago at Dodger Stadium where the Dodgers paused long enough in celebrating their division win to glance over at the Giants’ dugout and see Bochy and his coaches tipping their caps to them.After going through the wild card game to win a third title, maybe it’s time others start tipping their caps to a manager who just seems to find ways to put his players in a position to win.“He always has faith in us and he shows it,” Belt said. “We pick up on it and it makes us play better.”The Giants rewarded Bochy’s faith in them when it counted most, less than 24 hours after getting blown out 10-0 in Game 6. They scratched out a couple of runs early, got the go ahead run in the fourth, then sat back and watched as Bumgarner retired batter after batter in despite throwing 117 pitches on Sunday in San Francisco.Setup man Sergio Romo watched what was happening and didn’t even bother to stretch. He knew he wouldn’t be needed on the one night in baseball when pitch counts meant nothing.In the dugout there was no discussion about when Bumgarner might come out. Bochy simply let his star pitcher do his thing, and five innings of two-hit ball later the Giants were world champions.Afterward, the talk was about dynasties and with three titles in five years the Giants certainly qualify, even if few outside the Bay Area can figure out how they do it. Great pitching helps, of course, but the sum of this team seems to always be better than the players you see on the field.That’s the mark of a good general manager in Brian Sabean, and a man who is in his 20th year of managing in the big leagues seems to have the job down pat.“They know what kind of guys to bring in here,” Bumgarner said. “They’re winners, they got it in their DNA.”That includes the pitcher whose name will be in the record books among the World Series greats.But don’t forget the manager. He’s not too shabby, either.___Tim Dahlberg is a national sports columnist for The Associated Press. Write to him at tdahlberg@ap.org or http://twitter.com/timdahlberglast_img read more

CelebrateLAB Hosts West Africa’s Largest Laboratory Professional Conference

first_imgCelebrateLAB, the largest gathering of laboratory professionals in the ECOWAS region, will host its fifth gathering April 23-24 at the Monrovia City Hall in Sinkor, Monrovia.The two-day event will bring together laboratory scientists from public and private sectors, officials from the World Health Organization, Ministry of Health and the National Institute of Liberia (NPHIL).Laboratory experts and other health officials will share knowledge and experience on best practices that make sense for West Africa. The core audience is the laboratory scientist who makes a difference by treating every patient sample with care. CelebrateLAB Ambassadors from Ghana, Guinea, Nigeria, Sierra Leone, and Liberia have pledged to improve regional laboratory diagnostics. Dr Dougbeh Chris Nyan, one of the conference ambassadors, an industry innovator and Chief Executive and Scientific Officer of Shufflex Biomed (USA and Liberia), said, “we have the ingenuity to take Africa’s scientific destiny into our own hands for the benefit of humanity.” The 2014 Ebola Virus outbreak in West Africa exposed the vulnerabilities of regional health systems and highlighted the urgent need for collaboration and experience-sharing as populations move across borders.This year’s theme, “Bio-risk Management in West Africa,’’ touches all aspects of laboratory medicine. CelebrateLAB 2019 emphasizes strengthening collaborations across West African borders and promoting public-private partnerships. Candace Eastman, CEO of Africabio Enterprises, said “CelebrateLAB is all about striving for better health outcomes.”GIZ, the German development organization is one of the event’s sponsors. GIZ works with the Liberian Ministry of Health and the National Public Health Institute of Liberia to strengthen laboratory and biomedical capacity through training, mentorship, and the establishment of a regional biomedical engineering workshop and microbiology lab.  During the event, GIZ will facilitate a workshop that will focus on product life cycle management, preventive  maintenance, share lessons learned, and emerging best practices for strengthening the workforce and supporting quality improvements in public laboratories and biomedical workshops.Share this:Click to share on Twitter (Opens in new window)Click to share on Facebook (Opens in new window) Dr. Dougbeh Christopher Nyan , CEO, Shufflex Biomed: “we have the ingenuity to take Africa’s scientific destiny into our own hands for the benefit of humanity.” – Advertisement –last_img read more