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FDA advisory panel recommends FluMist approval for young children

first_imgMay 17, 2007 (CIDRAP News) – A US Food and Drug Administration (FDA) advisory panel unanimously agreed Wednesday that FluMist, a nasal spray vaccine against seasonal flu, is safe and effective in children 2 years of age and older.The live-virus vaccine, which is manufactured by Gaithersburg, Maryland–based MedImmune, is already FDA-approved for 5- to 49-year-olds. The company has filed a supplemental biologics licensing application (sBLA) to expand its use to children younger than 5.In a 15-0 decision, the panel of outside experts supported the vaccine’s use for children 2 and older who do not have a history of wheezing. The FDA, which is expected to make a decision by the end of May, is not required to follow the panel’s recommendations.”The question remaining is how the FDA ultimately will rule on children under 2,” said MedImmune’s Chief Medical Officer Dr. Edward Connor, according to an Associated Press report.The panel voted 9-6 for the vaccine’s safety and benefits for children between 12 to 59 months without wheezing history and 12-3 against using the nasal spray in children between 6 to 23 months, according to a MedImmune press release.”The vote did demonstrate that there is a safety concern among a significant minority of the advisory committee,” Florence Houn, FDA deputy director of the office handling MedImmune’s application, told the Washington Post. “We do have to be careful about this respiratory adverse event profile and make sure we understand it.”A recent international study published in the New England Journal of Medicine showed children between 6 and 11 months who received FluMist had more hospitalizations and slightly more wheezing than those who got the standard vaccine, CIDRAP News reported in February. However, the same study, which was conducted in the 2004-2005 flu season, revealed 55% fewer cases of flu in the children who received the FluMist.CIDRAP Medical Director Kristine Moore, MD, MPH, said the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommends vaccination for children between 6 and 59 months because they have an increased risk for influenza-related hospitalizations and emergency room visits. Having a vaccine that is not a shot could enhance vaccination rates, Moore said.”It’s more tolerable to younger children,” she noted. “If FluMist is approved for this age-group, it would probably improve compliance to the CDC recommendation.”Currently only injectable inactivated vaccines are available for this group.FluMist vaccine has been on the market since 2003. It is effective against influenza A and B viruses; side-effects of the vaccine based on results from placebo-controlled clinical trials have included runny nose, sore throat, cough, headache, and chills.In January, the FDA also approved a refrigerated formulation of FluMist (previous formulations had to be frozen), which will be available for the 2007-2008 flu season, according to MedImmune.British company AstraZeneca is scheduled to acquire MedImmune in June in a $15.6 billion sale.See also:MedImmune Press ReleaseFeb 16, 2007, CIDRAP News story “Large study supports FluMist use in toddlers”2007 New England Journal of Medicine article [Abstract]last_img read more

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Osborn keeps Lincoln County streak alive

first_imgBy Kelly NinasNORTH PLATTE, Neb. (June 11) – The oval had many racing grooves for the competitors to chal­lenge for supremacy at Lincoln County Raceway Saturday evening. Finding the fastest grooves to were Colton Osborn, Zach Schultz, Casey Werkmeister, Jacob Olmstead and Andrew Baumgardner as all found themselves in the winner’s circle at the end of the evening.Continuing his streak was Osborn, as he captured yet another Xtreme Motor Sports IMCA Modi­fied victory. Osborn started in the third row and took little time to become in the lead group. He passed Dave Pedersen on the 10th lap and never looked back.Pedersen ended as the runner-up and Jay Steffens was third.It was a family battle at the front of the field during the final laps of the Karl Chevrolet Northern SportMod feature with Zach and Dillon Schultz going head-to-head. Zach Schultz took the lead from the onset and was able to avoid all challenges throughout the feature event to claim the check­ered flag and victory.Zach Schultz was stalked by his brother Dillon during the final laps, but Dillon wasn’t able to get past and was forced to settle with runner-up accolades after starting in the fourth row. Brandon Clough was third.For the second week in a row, the most competitive feature event came in the IMCA Sunoco Stock Car division. Leading the way for the final four laps after battling through traffic, Casey Werk­meister crossed the finish line first to score the victory.Werkmeister had started in the fifth row. Kyle Clough recovered quite nicely after losing the lead to finish second. Third was Bob Hoing.Missing out on the heat race did nothing to slow Jacob Olmstead during the IMCA Sunoco Hobby Stock feature, where he snared the lead at the halfway point and never looked back to earn the win. The battle for second place came down to the final inches of the race, with Zach Olmstead edging Robbie Kosmacek by the slimmest of margins at the finish line.Keeping it in the family, Andrew Baumgardner drove his father’s car to the winner’s circle after winning the Mach-1 Sport Compact feature.last_img read more

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Mourinho denies rift with Costa

first_imgThe forward was left on the bench for the 0-0 draw at Tottenham.He also appeared to throw a training bib at Mourinho during the match.The Stamford Bridge boss says there’s no problem with Costa – and he’ll be treated the same as anyone in his squad. Elsewhere, Richie Towell has completed his move to Brighton from Dundalk and one former Ireland international thinks he could still make Irelands squad for Euro 2016.The former Dundalk attacker has joined on a 2 and half year deal but won’t be allowed play until January.last_img read more

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The future is bright at LYIT Careers & Postgraduate Studies Fair – Picture Special

first_imgThe annual LYIT Careers & Postgraduate Studies Fair was another great success this year, with thousands of people attending to discover the many paths available in jobs and in education.The event, which is the largest careers event in the Northwest, took place on the LYIT Letterkenny campus on Monday 21st October.LYIT students and graduates, career changers, and those returning to the workplace gained a wealth of information by attending the fair.  Over 70 employers, universities and colleges, professional bodies and voluntary organisations took part in this year’s event. Recruiters came from a broad range of sectors including IT, Pharmaceutical, Finance, Social Care services, Design, Hospitality and Telecommunications providers.In addition to graduate employment opportunities, attendees had the opportunity to meet with a broad range of postgraduate course providers from Ireland and the UK. The jobs wall and CV clinic were popular draws once more this year.Clive Wasson was there to capture the event for this picture special: Anne McDevitt, DEASP at the LYIT Graduates at 2019 Careers and Postgrad studies Fair. Photo Clive WassonBig demand for LYIT Graduates at 2019 Careers and Postgrad studies Fair -Photo Clive WassonBusy stands at the LYIT Graduates at 2019 Careers and Postgrad studies Fair. Photo Clive WassonBig demand for LYIT Graduates at 2019 Careers and Postgrad studies Fair – at the fair are from left Catherine Lyster, CAreers Officer Student Services and Paul Hannigan, LYIT, President. Photo Clive WassonBig demand for LYIT Graduates at 2019 Careers and Postgrad studies Fair – at the fair are Orlaith Flood, Balke Burke, Darian Loughlin, Fatimah Qureshi. Photo Clive WassonBig demand for LYIT Graduates at 2019 Careers and Postgrad studies Fair – Crowds pictured at the fair on Monday. Photo Clive WassonBig demand for LYIT Graduates at 2019 Careers and Postgrad studies Fair – at the fair are from left Fiona Doherty, Amy Hegarty, Aisling Howe, Niamh Sweeney, Anne Marie McGrath and Melisa Browne. Photo Clive WassonJobs on display at the jobs wall at the LYIT Graduates at 2019 Careers and Postgraduate studies Fair. Photo Clive WassonThe future is bright at LYIT Careers & Postgraduate Studies Fair – Picture Special was last modified: October 23rd, 2019 by Rachel McLaughlinShare this:Click to share on Facebook (Opens in new window)Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Reddit (Opens in new window)Click to share on Pocket (Opens in new window)Click to share on Telegram (Opens in new window)Click to share on WhatsApp (Opens in new window)Click to share on Skype (Opens in new window)Click to print (Opens in new window) Tags:LYITLYIT Careers and Postgraduate Studies Fairlast_img read more

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Fishing The North Coast: Eureka salmon bite remains inconsistent

first_imgSince the opener, the sport salmon season has been somewhat of a roller coaster ride. It started out with a bang, but the fish have been pretty fickle since. With no established pattern or consistent sign, charter and sport boats have been on the hunt almost daily. “Every day has been different,” said Capt. Tony Sepulveda of Shellback Sport Fishing. “We haven’t seen any type of pattern as of yet, nothing really to go back to everyday. And we’ve covered a lot of water, from the Cape to Trinidad …last_img read more

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Raman Singh struck deal with Naxals: Cong.

first_imgSenior Congress leader Digvijaya Singh on Tuesday accused Chhattisgarh Chief Minister Raman Singh and other BJP leaders, who win elections from Naxalism-affected areas, of striking a “deal” with the guerrillas.“I have said this before and am repeating, that Raman Singh and all those BJP leaders who have won from Naxalism-hit areas have struck a deal with Naxals and there is some exchange between them,” he said.Mr. Singh said Naxalism could not be wiped out till the State government took tribals and those living in these areas into confidence and spoke to them. “You cannot end Naxalism till the time you talk to all,” he said.The “inability” of the State government in fighting Naxalism lay in the “lack of will” of the Chief Minister, Congress spokesperson Randeep Surjewala said. He took a swipe at BJP president Amit Shah over his party’s expansion plan.last_img read more

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Rahi Sarnobat creates history becoming the first Women shooter to win Gold at Asian…

first_imgCHANGWON – APRIL 5: Gold medalist Rahi SARNOBAT of India competes in the 25m Pistol Women Finals at the Shooting Range Changwon during Day 2 of the ISSF World Cup Rifle/Pistol on April 5, 2013 in Changwon, Republic of Korea. (Photo by Marco Dalla Dea)AdvertisementThe 27-year-old shooter Rahi Sarnobat did wonders at the 25m Pistol event as she became the first Women shooter for India to claim the highest spot in history. Her inspiration has been another legendary 50m rifle prone world champion Tejaswani Sawant, who is also her coach now.Sarnobat faced a tough challenge from Naphaswan Yangpaiboon, the shooter from Thailand whom she later vanquished by a record score of 34 which led her to win the title.Rahi previously achieved a Bronze medal at the World Cup 2011 and got selected for the London Olympics next year. She also achieved a bronze medal at Icheon on 2014 Asian Games, Commonwealth Gold (2010,2014) and Silver (2010)She received the very prestigious Arjuna Award in May 2015 after being recommended from the National Rifle Association of India which is another reason to laud her.Also Read:Asian Games: A Golden show by 16-year old shooter Saurabh Chaudhary Advertisementlast_img read more

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18 days agoMan Utd hero Ince blasts De Gea for Newcastle interview: Would Schmeichel say that?

first_imgAbout the authorFreddie TaylorShare the loveHave your say Man Utd hero Ince blasts De Gea for Newcastle interview: Would Schmeichel say that?by Freddie Taylor18 days agoSend to a friendShare the loveManchester United hero Paul Ince has blasted David De Gea for his post-match interview after Sunday’s loss to Newcastle United.The Spaniard was at a loss for words when speaking to reporters after the 1-0 defeat at St. James’ Park.”I watched David de Gea’s post-match interview and I was at a loss,” Ince said to PaddyPower.”He’s meant to be one of the leaders. If that was Peter Schmeichel standing there, there’s no chance you’d have seen that interview. Rather than him addressing and recognising where the team were going wrong, it just felt like ‘I don’t know, I don’t know, I don’t know.'”This is one of the top players, the leaders at Man United, who has just signed a five-year contract. And he looks like he doesn’t have a clue what’s going on.”If you’re a United fan listening to your goalkeeper, one of the main leaders in the team, and that’s the interview you hear you’d be right to [think it was a disgrace]. I’d be looking thinking, ‘he doesn’t have a clue what’s going on – I bet he’s regretting signing that contract.'” last_img read more

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Chinas GAC to scrap Trumpsounding brand for US market

first_imgDETROIT – Chinese automaker GAC Motor will scrap the brand name it uses in China when it enters the U.S. market next year because it could be confused with President Donald Trump’s surname.For the past eight years, GAC has sold cars and SUVs under the brand Trumpchi in its home market, but is now researching new names before the company’s expected U.S. debut in the fourth quarter of 2019.“We want to provide the best service for American customers, so we want to not be closely linked with politics,” Wang Qiujing, president of GAC Engineering Institute China, said through an interpreter in an interview at the Detroit auto show. “This is the reason we want to rename the brand.”GAC picked the Chinese name Trumpchi in 2010, well before Trump was elected. The similarity to Trump is just a coincidence, Wang added. GAC will continue to use Trumpchi in China, where the word means legend and good fortune.GAC’s first vehicle in the U.S. will be the GS8, a loaded-out full-size SUV that will cost about $35,000. Two more vehicles are being researched for U.S. sales, but have not been selected yet.The company showed seven different of its models on a video and unveiled two more at the Detroit show. One is a gull-wing compact electric SUV called the Enverge, which is still in the concept phase. The automaker says it will go over 370 miles on a single charge. Also unveiled was the GA4 midsize sedan that will go on sale in China later this month.The GS8 would be comparable to a big luxury SUV, many of which go for more than $60,000. Wang said he didn’t know what the brand’s lowest-price vehicle would be in the U.S.GAC sold just over 500,000 automobiles in China last year, up 37 per cent from 2016.The company says it is negotiating with partner Fiat Chrysler about possible distribution of vehicles. Wang said GAC is the top-ranked domestic brand for initial quality in China in J.D.Power and Associates surveys, and it ranks fourth or fifth when joint ventures with foreign automakers are included. He says the company’s vehicle quality will be ready for U.S. buyers, and it will work with U.S. partners to meet stricter U.S. safety standards.Chinese automakers are advanced and have expertise in mass production but the American market may not be ready yet to accept GAC, said Jake Fisher, Consumer Reports’ director of auto testing.Other Chinese companies showed vehicles at the CES gadget show in Las Vegas last week such as Byton, which unveiled an electric prototype that’s like a Tesla Model X SUV but costs thousands less, Fisher said.“There will be Chinese automakers at the top of the market and at the bottom of the market, and it will be very interesting to see how they are received,” he said.GAC already has a research centre in Silicon Valley and is working on another one in Detroit, as well as a Los Angeles design centre. Initially it will import vehicles from China but depending on sales, plans to build a factory in the U.S.GAC, which stands for Guangzhou Automobile Group Co., also plans to enter other global markets after the U.S., including Europe.____Auto Writer Dee-Ann Durbin contributed to this report.last_img read more

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Data recorder recovered from Leicester owners helicopter

first_imgLEICESTER, England – The flight data recorder from the helicopter that crashed with the Leicester soccer team’s owner on board is being examined by investigators, authorities said, as his family and players paid tribute Monday at a makeshift shrine.Vichai Srivaddhanaprabha and four others were killed when the aircraft spiraled out of control, crashed and burst in flames outside the King Power Stadium following a Premier League game Saturday.Aiyawatt Srivaddhanaprabha, son of the Thai retail entrepreneur, brought a wreath to add to a collection of flowers, jerseys and club memorabilia that was growing after the disaster. Fans who gathered to pay respects broke into applause when Aiyawatt returned to the memorial with the players.Investigators are expected to remain at the site until the end of the week, when the wreckage is to be taken to special facilities for examination, the Air Accidents Investigation Branch said.“We recovered the digital flight data recorder (voice and data) on Sunday afternoon and one of our inspectors travelled back to Farnborough with the recorder the same evening,” the AAIB said in a statement. “Today, our inspectors in Farnborough will start working on the recorder, which was subject to intense heat as a result of the post-accident fire.”Police have not given an update on the investigation but wrote on Twitter its drone “was not in flight at the time the helicopter left the stadium.”Although only with Leicester for eight years, Vichai had a lasting impact on English soccer as the owner of the team that produced one of the greatest shocks in sports by winning the Premier League title at 5,000-1 odds in 2016.Through horse racing and polo, the owner of Thailand’s King Power duty-free chain became known to members of the British royal family, playing on occasion with Princes Charles and William. He spent millions establishing his polo team, the King Power Foxes, which began in 2014 and has enjoyed success at the top levels of competition in Britain.“I was lucky to have known Vichai for several years,” said Prince William, the second-in-line to the British throne. “He was a businessman of strong values who was dedicated to his family and who supported a number of important charitable causes. He made such a big contribution to football, not least through Leicester City’s magical 2016 season that captured the imagination of the world.”Vichai’s close bond with the community in Leicester was reflected in the tributes to the owner who bankrolled the team’s return to the Premier League in 2014 and the improbable title triumph.“The outpouring of grief is a testament to how many people’s lives were touched by those on board,” Prime Minister Theresa May said.Two members of Vichai’s staff, Nursara Suknamai and Kaveporn Punpare, also died along with pilot Eric Swaffer and co-pilot Izabela Roza Lechowicz. In a regular scene after matches that had become a symbol of Vichai’s ownership, the helicopter took off from the centre circle on the field after Saturday’s game against West Ham. It cleared the stadium roof before it plummeted into an adjacent parking lot in flames.Leicester’s next game, which had been scheduled for Tuesday against Southampton in the League Cup, has been postponed.___More AP soccer: https://apnews.com/tag/apf-Soccer and https://twitter.com/AP_Sportslast_img read more

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