EU approves Novartis’s ‘mock-up’ pandemic vaccine

first_imgMay 9, 2007 (CIDRAP News) – The European Union (EU) this week approved a “mock-up” influenza vaccine made by Novartis to permit a faster start on vaccine production in the event of a flu pandemic.When the World Health Organization (WHO) declares a flu pandemic, the vaccine, called Focetria, will be adapted to contain the pandemic virus, the Swiss-based drug company announced yesterday. The vaccine will not be manufactured until a pandemic is declared.The European Medicines Agency’s (EMEA’s) Committee for Medicinal Products for Human Use (CHMP) recommended approval of Focetria on Feb 22. A CHMP statement on that date said the vaccine was based on a 2004 strain of H5N1 avian flu from Vietnam.The vaccine contains Novartis’s proprietary adjuvant MF59, an immune-boosting chemical, which can reduce the amount of active ingredient needed in each dose, the company says. The dose used in the approved mock-up vaccine is 15 micrograms (mcg), according to the CHMP.”Once the WHO declares a pandemic, Novartis will submit a revised application to the European Medicines Agency to incorporate the identified viral strain,” Novartis officials said in a news release yesterday. “The Focetria mock-up file submitted for EU approval in early 2006 was based on clinical studies involving the MF59 adjuvant and different influenza strains with pandemic potential, including H5N1 and H9N2.”A CHMP statement from December 2006 defines a mock-up vaccine as one “that mimics the future pandemic influenza vaccine in terms of its composition and manufacturing method” but contains a different flu strain.Novartis said it is also seeking EU approval for a prepandemic H5N1 vaccine that includes MF59 and is based on the same technology as Focetria. The vaccine is intended for use before a pandemic declaration to help “prime” the immune system to fight off H5N1 infections, the company says.Both Focetria and the prepandemic vaccine involve the conventional production method of growing the vaccine virus in eggs, according to Eric Althoff, a Novartis spokesman in Emeryville, Calif.Once a pandemic flu strain is identified, it will take at least 6 months to adapt the virus for production in eggs and start producing the vaccine in quantity, Althoff told CIDRAP News yesterday.”It’ll be at least 6 months, just from the simple time of getting enough raw material, ie, eggs, to have full-scale production,” he said.On Apr 26 the CHMP recommended EU approval of a Novartis seasonal flu vaccine grown in cell culture instead of in eggs. Althoff said the company also aims to make a cell culture–based pandemic flu vaccine, but development is in an early stage.Cell-culture production is described as somewhat faster and much more flexible than egg-based production. No cell-based flu vaccine has been marketed anywhere as yet, though the EU in 2001 approved a cell-based seasonal flu vaccine made by Solvay Pharmaceuticals for sale in the Netherlands.Althoff said Novartis is talking with US regulators about how to seek approval for both pandemic mock-up and prepandemic vaccines. European authorities provided guidance earlier than the US Food and Drug Administration (FDA) did on the steps needed to get approval for a mock-up vaccine, he said.”That pathway hadn’t been mapped out by the FDA or how to handle the review and approval of such a vaccine,” he said. But an FDA advisory committee recently prescribed the necessary steps, he added. “I think there’s great progress now and more clarity about how to move forward.”In April the FDA approved an H5N1 vaccine made by Sanofi Pasteur, despite only modest immunogenicity demonstrated in clinical trials. The Department of Health and Human Services has been stockpiling the vaccine for use in a pandemic.See also:May 8 Novartis news release on Focetria 17 CIDRAP News story “FDA approves first H5N1 vaccine”last_img read more

COVID-19: Ride-hailing apps temporarily disable ‘ojek’ service as part of PSBB policy

first_imgMulti-service apps Gojek and Grab have disabled their ojek (motorcycle taxi) option for customers in Jakarta following the implementation of large-scale social restrictions (PSBB) that prohibit their drivers from transporting passengers amid the fight against COVID-19.Customers will still be able to hail a car, send packages and get food delivered.For Grab, users are directed to the GrabCar service instead, while Gojek users in Jakarta will not see the Go-ride option on the app’s home screen at all, Kompas Tekno reported. Topics : Grab Indonesia managing director Neneng Goenandi confirmed that Grab had temporarily disabled its GrabBike feature to support large-scale social restrictions.“The GrabBike feature can still be used by users in Depok [West Java], Tangerang [Banten], Bekasi [West Java], as well as other cities in Indonesia,” Neneng said in a written statement received by The Jakarta Post on Friday.Neneng added that Grab had prepared 1,000 cars equipped with plastic partitions to separate the driver and passenger seats as part of preventive measures. The company has also prepared 1,000 GrabBike motorcycles across Indonesia to help transport medical workers to and from the hospital.Jakarta Governor Anies Baswedan said on Friday that Jakarta would follow Health Ministry Regulation No. 9/2020 on large-scale social distancing, which states that ride-hailing services can only be used to transport goods and not passengers.Jakarta is imposing the PSBB for 14 days starting on Friday, during which public transportation is restricted and large gatherings prohibited in order to stem the spread of COVID-19.last_img read more

Indonesia withdraws from 2020 Thomas and Uber Cup over COVID-19 concerns

first_imgThe Indonesian Badminton Association (PBSI) has withdrawn its players from this year’s Thomas and Uber Cup championships due to concerns over their safety amid the COVID-19 pandemic.In a statement issued on Friday, the association said participating in the biennial event, set for Oct. 3 to 11 in Aarhus, Denmark, might expose athletes and team officials to infection while traveling or even at the venue.Athletes and officials also voiced their concerns over the lack of guarantees from the Badminton World Federation (BWF) on who would take responsibility for the team members if one of them catches the disease. “We have sent a letter to the Youth and Sports Ministry to relay a statement to the BWF on the matter. The decision was made following a discussion with athletes and team officials,” said PBSI secretary-general Achmad Budiharto.Read also: Sport leagues grapple with COVID-19 impactIndonesia joins Australia, Taiwan, Thailand and South Korea in backing out of the competition due to the novel coronavirus concerns.The pandemic had already forced organizers to postpone this year’s Thomas and Uber Cup twice. The championships were initially scheduled for May 16-24 and were then postponed to Aug. 15-23. The BWF eventually decided to hold the competition in October.Apart from the Thomas and Uber Cup, Indonesian badminton athletes will not participate in the 2020 Denmark Open I on Oct. 13-18 as well as the Denmark Open II on Oct. 20-25 in Odense.Topics :last_img read more

Four bidders fought it out to secure this Teneriffe home on a very small block

first_img32 Small St, TeneriffeTENERIFFE once again proved to be an in-demand suburb for buyers four parties battling to secure a home at 32 Small St at auction.The home, had three bedrooms and was on a 204 sqm block of land. It was designed by renowned Architect Kevin Hayes.It was listed through Nicholas Given or Ray White New Farm.Auctioneer Haesley Cush said it was in a great street and described it as a contemporary little home.Three bidders were at the auction while another was on the telephone.More from news02:37Purchasers snap up every residence in the $40 million Siarn Palm Beach North1 hour agoNew apartments released at idyllic retirement community Samford Grove Presented by 32 Small St, TeneriffeBidding started at $1 million.“It went up in $100,000 rises and a buyer on the floor bid $1.35 million,’’ Mr Cush said.Bidding paused and came back on at $1.4 million, it then went to $1.45 million and was declared on the market with the phone bidder the successful buyer.“It was a good result,’’ Mr Cush said.“It is a good sign for the market, that is our third property to sell in that $1.4 million to $1.5 million price range in the last 60 days on that 200 sqm size allotment,’’ he said“There is a lot of interest coming from people looking for low maintenance contemporary lifestyle.’’last_img read more

Norwegian pension fund manager KLP divests from coal industry

first_imgNorway’s largest pension fund manager KLP is divesting from coal companies and committing to investing an extra NOK500m (€60m) in increased renewable energy capacity.It said it was doing this to contribute to the “urgently needed” switch from fossil fuel to renewable energy.KLP defines coal companies as coal mining companies and coal-fired power companies that derive a large proportion of their revenues from coal.At the very least, KLP will exclude those with 50% of revenues from coal-based business activities. The names of the companies to be excluded will be published in an updated KLP list on 1 December.KLP’s divestment from coal companies also applies to the KLP funds.The public service pensions provider said preliminary estimates showed the divestment would lead to the sale of shares and bonds worth just under NOK500m.At present, the divestment does not apply to oil and gas companies.KLP said this was because coal companies were considered to have the largest negative impact, both in terms of carbon emissions per unit of energy produced and local pollution in the vicinity of the coal-based facilities, even though there are significant variations between the different types of oil, gas and coal.But KLP also said a withdrawal of investments in oil and gas companies would probably have a material impact on future returns, unlike the retreat from coal company stocks.At the request of the Norwegian municipality of Eide, one of its customers, KLP carried out an assessment on the feasibility of pulling its investments out of oil, gas and coal companies without affecting future returns, in order to contribute to a better environment.The report found no support for the “stranded assets” hypothesis, which posits that investments in companies with major fossil fuel reserves represent a greater financial risk than is normal for this type of undertaking.It said: “On the contrary, a divestment from all fossil fuel companies would significantly increase KLP’s risk, particularly with respect to Norwegian shares.“However, depending on the definition applied, divestment from coal companies alone would not represent any significant financial risk for KLP.”Sverre Thornes, chief executive at KLP, said: “KLP will continue to be an active and engaged owner of the companies in which we invest, with a clear ambition to influence them to take responsibility for lower greenhouse gas emissions.”The KLP Group, with total assets of NOK470bn, is already a major investor in renewable energy, with NOK19bn invested in Norway alone.Last year, it also established a partnership with Norfund for direct investment in renewable energy and finance.The additional NOK500m will be used for direct investments in increased renewable energy capacity in emerging economies, where KLP considers the need to be greatest.last_img read more

Won but Lost More

first_imgSports writers were worried that LeBron James would lose another NBA Championship.  Of course, this did not happen.  If it had happened, he would not have been alone.  Jack Nicklaus won 18 major titles but had 19 near misses in his long golf career.Elgin Baylor and Jerry West (LA Lakers) lost 8 NBA finals–7 of them as teammates.  West was the only one of the two who won an NBA title as Baylor had already retired by then.  Gordie Howe of the Redwings won 4 Stanley Cups but lost it 7 different times.Elston Howard and PeeWee Reese competed many times in the World Series as members of the Yankees and Dodgers.  Howard won 4 rings but lost 5.  PeeWee only won one title as a Dodger.  As you can see, even Hall of Famers do not win all the time.  In fact, it is rare that anyone wins more than they lose in most sports endeavors.last_img read more

O’Mahony hails Ireland’s fight

first_imgIreland’s raw desire shocked Wales into RBS 6 Nations submission, according to man-of-the-match Peter O’Mahony. O’Mahony praised forwards coach John Plumtree for his new raft of ideas and methods that had elevated Ireland’s driving game to new heights in their two-straight Six Nations wins so far this term. But he also laid credit at the door of line-out gurus like captain Paul O’Connell and hooker Rory Best, for their endless hours of analysis and meticulous tinkering. “John has put a big emphasis on our maul and our line-out, he wants us to be a great mauling and line-out team,” said O’Mahony. “You’ve guys there like Paul O’Connell, Devin Toner, Rory Best, Sean Cronin and Dan Tuohy – these guys spent an awesome amount of time on laptops and a savage amount of work. “Credit has to go to all of them. “John has put in great structures put the players are really driving that on.” Ireland will now chase the Triple Crown when they face England at Twickenham on February 22. O’Mahony said captain O’Connell sought a “statement” performance from Ireland against Wales that his side duly delivered. Despite Ireland’s flawless start to the tournament, O’Mahony believes it is too soon to be talking titles. “You all know the way Paul gets stuck in and he’ll lead from the front always, he was looking to put a statement in and it was a good one,” said O’Mahony. “It was a good way to start for us, it was a great team performance but we won’t be getting carried away. “We’ll give plaudits for the boys but we have a lot of work to do especially going to Twickenham for a seriously physical game. “We have a lot of work to do over the next two weeks. “It’s always a huge game against England. “It is always savagely physical, a game you love playing in an Irish jersey.” Ireland will reconvene in a training camp later this week ahead of the first fallow weekend of the Six Nations sequence. With two weeks to prepare to face England, head coach Joe Schmidt has plenty of time to switch the gameplan again. Schmidt’s bullish tight-game blueprint for Saturday caught Wales off guard. The Ireland boss claimed that was entirely based around expecting horrid weather that never quite materialised. Schmidt is canny enough to play down his influential interventions at every turn, and O’Mahony said it is too early to know just how Ireland will approach their Twickenham showdown. “The weather justified a lot of what we did [against Wales],” O’Mahony added. “We knew the maul was going to be important in a tight game. “We could see that coming earlier in the week with the forecast so that played a big factor. “We haven’t looked at England yet so it will be interesting to see how we approach that.” Head coach Warren Gatland was forced to concede Wales had few answers, and had struggled for emotional intensity. O’Mahony hailed Ireland’s “savage” training-ground work to hone their technically-sound driving maul, but pinpointed that mental edge as vital to victory. “A lot of that has to go down to the fight and the want that we showed,” said O’Mahony. “At the end of the day we wanted it more than they did, that was evident by the end of it. “I don’t think the scoreline flattered us, but we fought for everything. “That is where we need to be at, we need to be fighting for every 50:50 ball, everything that goes on the ground. “They are the ones that make the difference.” Ulstermen Chris Henry and Paddy Jackson both claimed first international tries as Ireland plundered match-winning dividend from their driving maul. Relentless flanker O’Mahony overwhelmed much-vaunted Sam Warburton at the pivotal battle of the breakdown in Ireland’s 26-3 demolition of Wales on Saturday. The 24-year-old Munster captain spearheaded Ireland’s controlled aggression and fire, completely catching Wales unawares. Press Associationlast_img read more

Lazio rule out Van Persie move

first_img Van Persie, who is tied to United for another season, was spotted in Rome this week, leading to speculation that the 31-year-old could join Lazio. “On Van Persie, all I can say is that I respect him as a striker but unfortunately, he is outside our parameters,” Tare told Lazio Style Radio. “There has never been a meeting, this is gossip, not transfer news. Press Association Lazio sporting director Igli Tare has ruled out a move for Robin van Persie, claiming the Manchester United forward is “unfortunately, outside our parameters”.center_img “We don’t want to create illusions, this is not true.” Van Persie moved to Old Trafford from Arsenal in the summer of 2012 and scored 26 goals and set up eight more in 38 Premier League appearances in his first season with the team. The Holland captain has struggled to show the same form the past two years, scoring 12 league goals in the 2013-14 campaign and just 10 this season. Van Persie claimed last week while on international duty with Holland that he needed to evaluate his future. Lazio, coached by Stefano Pioli, finished third in Serie A to assure themselves of a spot in next season’s Champions League qualifying round. last_img read more

City : Uncovering an explorer: Officials worked to clean paint off prominent Columbus statue

first_img Published on November 29, 2011 at 12:00 pm Comments While some brave shoppers were out early Friday in search of the best Black Friday deals, at least one person went out of his or her way to send a message.The Christopher Columbus monument, located in Columbus Square in downtown Syracuse, was vandalized Friday. Red paint was splashed on the monument as well as the message: ‘500 years of genocide and imperialism; wake up.’Syracuse Police Department spokesman Sgt. Tom Connellan said police were notified early Friday that there was damage to the monument. They filed a police report and a detective is working on the case. So far, he said there are no suspects and no indication as to what the graffiti means.The Columbus monument was built in 1934 by Italian immigrants as a tribute to Columbus, according to the Preservation Association of Central New York’s website. The Italian-Americans wanted to dedicate the monument to the city of Syracuse as thanks for finding work there upon immigrating to America. It has been the focal point of downtown Columbus Square since its completion.Pete O’Connor, commissioner of the Syracuse Department of Public Works, said after they were notified of the vandalism, he sent a crew to take off the paint.AdvertisementThis is placeholder text‘There’s a city crew called Steel Trades,’ O’Connor said. ‘They have painters, carpenters, electricians and plumbers. Since the monument involved paint, we called on them to get it off using a high-powered steam gun.’The workers determined that whoever vandalized the statue filled balloons and latex gloves with paint and threw them at the monument, according to a Nov. 25 article by The Post-Standard.O’Connor said it took his crew about five hours to completely remove the paint. The bronze sculpture of Columbus atop the monument, which stands at 11 feet tall, was splashed with paint, so the crew used a bucket truck to remove it.The Department of Public Works crew was done by 11 a.m. and then they completed the rest of the work they were scheduled to do that day.O’Connor said it was fairly easy for his crew to remove all the paint because of the cooler temperature Thursday night into Friday morning. Had it been any warmer, the paint would have been sticky, and it would have been harder for the crew to remove.This isn’t the first time there have been vandalized buildings in the area, Sgt. Connellan said, but ‘this was a specific act of public vandalism.’In Oct. 2010, the door of the Westcott Community Center was sprayed with white paint and graffiti. It was the third incident in three weeks in the Westcott area. But Connellan said graffiti usually isn’t a problem.He said: ‘We usually get calls about petty graffiti on public or private property, but it’s almost always sporadic occurrences.’[email protected] center_img Facebook Twitter Google+last_img read more

GHPL: More goals scored in second halves in first round

first_imgIt turns out that in the 15 rounds of matches played in the Ghana Premier League, second halves turned out to be more productive than the first 45 minutes of matches.This was captured in the general statistics  of the league shared by the Ghana FA on Tuesday.The information stated that 150 goals were scored in the second half of matches played as compared to the 127 scored in the first halves.The stats also said that Week 1 of the league had 16 second half goals which was the highest of all the match weeks of the first round.In that week, the following matches had goals in their second halves:Dreams vs King Faisal, Hearts vs Berekum Chelsea, Liberty vs Legon Cities, Karela vs WAFA, Dwarfs vs Medeama, Aduana Stars vs Inter Allies, AshGold vs Great Olympics, Bechem United vs Elmina Sharks.The highest number of first half goals (13) was scored in Week 10 and in that week, the following matches saw those first half goals:Hearts vs Bechem United, Medeama vs Elmina Sharks, Liberty vs Aduana Stars, Dwarfs vs Karela, Berekum Chelsea vs Inter Allies, Legon Cities vs Great Olympics, and Eleven Wonders vs King Faisal.The trend was studied over the 133 matches played in the first round.The league has been on a freeze from March 15 due to the Coronavirus pandemic in Ghana.last_img read more