Sep 28, 2007 (CIDRAP News) – The Food and Drug Administration (FDA) today announced the approval of an Australian-made influenza vaccine called Afluria for use in adults, raising the number of US-licensed flu vaccines to six.The vaccine, made by CSL Limited, based in Parkville, Australia, was approved for protecting people aged 18 and older from type A and B influenza viruses.Like most flu vaccines, Afluria contains inactivated (killed) flu viruses grown in chicken eggs. People who are allergic to eggs should not receive the vaccine, the FDA said in a news release.The vaccine is given as a single injection in the upper arm. It will be available in single dose, preservative-free syringes and in multiple-dose vials containing thimerosal, a mercury compound, as a preservative, the FDA said.CSL expects to supply up to 2 million doses of the vaccine in the United States this season, according to Paul Perreault, executive vice president of commercial operations for the company’s US division, CSL Biotherapies, based in King of Prussia, Pa. Plans call for delivering all the doses to the United States by the end of October, the company said in a news release today.The FDA said the Centers for Disease Control and Prevention (CDC) has estimated that the six vaccine makers will supply a record total of 132 million doses of flu vaccine in the United States this year. The CDC had cited the same figure at a news conference last week, without mentioning the CSL vaccine.”The licensure of this additional flu vaccine contributes to having an adequate supply of seasonal influenza vaccine for Americans, one of FDA’s highest priorities,” said Jesse L. Goodman, MD, MPH, director of the FDA’s Center for Biologics Evaluation and Research, in the agency news release.CSL Biotherapies announced its filing for FDA approval of Afluria in April. The application included the results of a phase 3, randomized, placebo-controlled clinical trial that involved 1,357 volunteers at nine US sites, the company news release said. Sponsored by the National Institutes of Health, the study evaluated the safety and immunogenicity of thimerosal-free and thimerosal-containing formulations of the vaccine.The FDA used its accelerated approval pathway in evaluating the vaccine. “The manufacturer demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza,” the agency said. “As part of the accelerated approval process, the manufacturer will conduct further studies to verify that the vaccine decreases seasonal influenza disease after vaccination.”CSL-branded flu vaccines are approved and sold in 16 countries, and the company provides bulk antigen for flu vaccines sold in 24 countries, according to the CSL news release. Officials said the company has been making flu vaccines for 40 years.Perreault told CIDRAP News that the bulk antigen for the vaccine is made in Australia, and this year the product will be finished and packaged in a facility in Germany. But in the future the finishing and packaging will be moved to a CSL plant in Kankakee, Ill., he said.In August, CSL announced plans to expand the Kankakee plant by adding a line to fill single-dose syringes. The company plans to start operating the line and packaging flu vaccine at the plant in 2010, according to the August announcement.Last year CSL announced it would spend $60 million to double the capacity of the company’s Melbourne, Australia, plant to 40 million doses per year, making it one of the largest flu vaccine production facilities in the world.Other injectable flu vaccines licensed in the United States, with their manufacturers, are FluLaval, ID Biomedical; Fluarix, GlaxoSmithKline; Fluzone, Sanofi Pasteur; and Fluvirin, Novartis. The other licensed product is FluMist, the nasal-spray vaccine made by MedImmune.See also: Sep 28 FDA news releasehttp://www.fda.gov/bbs/topics/NEWS/2007/NEW01714.htmlSep 28 CSL Biotherapies news releaseOct 5, 2006, CIDRAP News story “FDA approves 5th flu vaccine”
Last week, Saudi Arabia agreed to permit UAE flights to “all countries” to overfly the kingdom, as Israeli premier Benjamin Netanyahu announced the launch of regular direct flights linking the UAE with the Jewish state.The announcement came just days after the first direct commercial flight from Tel Aviv to Abu Dhabi passed through Saudi airspace, marking the normalization of Israel-UAE ties under a US-backed deal known as the Abraham Accords.Riyadh’s decision marked another concrete sign of Saudi Arabia’s cooperation with Israel even after it publicly refused to follow the UAE’s move.”President Trump… welcomed the opening of Saudi air space to flights between Israel and the United Arab Emirates, beginning with last week’s historic commercial flight from Tel Aviv to Abu Dhabi,” said a White House readout of the phone call. “President Trump highlighted the significance of the Abraham Accords and discussed ways to enhance regional security and prosperity.”Allowing flights between Israel and the Emirates to cross Saudi airspace saves long detours around the Arabian peninsula.Saudi Arabia, the Arab world’s biggest economy and home to Islam’s holiest sites, faces more sensitive political calculations than the UAE.Despite its clandestine relations with Israel, a formal recognition of the Jewish state would be seen by Palestinians and their supporters as a betrayal of their cause and hurt the kingdom’s image as the leader of the Islamic world, analysts say.Trump also urged Saudi Arabia to “negotiate with other Gulf countries” to resolve a regional rift with Qatar, the White House added.Riyadh and its allies severed ties with Doha in a shock move in 2017, accusing the gas-rich emirate of backing extremists and siding with Saudi Arabia’s regional rival Iran. Qatar denies the charges.The crisis shows no sign of relenting despite rising international pressure. Topics : Saudi Arabia supports a “fair” solution for the Palestinian cause, King Salman has told Donald Trump in a phone call, as the US President praised the kingdom for opening its airspace to Israel-UAE flights.Saudi Arabia has said it will not follow the United Arab Emirates, which announced last month it would establish diplomatic ties with Israel, until the Jewish state has signed an internationally recognized peace accord with the Palestinians.In a phone call to Trump on Sunday, King Salman affirmed the “kingdom’s keenness to reach a lasting and fair solution to the Palestinian cause to bring peace”, the official Saudi Press Agency reported.
LONDON, England (Reuters) – South African strike bowler Kagiso Rabada is eager to return to action for this week’s third Test against England at The Oval after serving a one-match suspension for disciplinary reasons, bowling coach Charl Langeveldt said yesterday.The 22-year-old missed the second Test in Nottingham after being banned for what the International Cricket Council (ICC) called “inappropriate language” towards England batsman Ben Stokes in the first Test at Lord’s.“He is the type of guy who steps up when the heat is on. Having KG back is a big bonus for us,” Langeveldt told reporters ahead of the third Test which starts on Thursday.“He is a youngster with a lot of energy, he will come with a lot of energy. I have no doubt he will step up … he will be raring to go,” Langeveldt added.Rabada was handed one demerit point for giving Stokes a send-off after the all-rounder was caught behind in the first Test, which England won by 211 runs, but under ICC regulations was banned for accumulating four points in a 24-month period.The fast bowler had already been penalised three points for “deliberate physical contact” with Sri Lanka’s Niroshan Dickwella in February, but Langeveldt said the incident has not affected Rabada’s morale.“He has been positive. He was obviously disappointed about what happened but he has learned from that. The important thing about an incident like this is to learn from it so that it doesn’t happen again,” Langeveldt said.“KG is a strong character and he was positive the whole week. He said come Thursday he wants to be ready for the Test.” South Africa won the second Test by 340 runs to level the four-match series at 1-1.
Press Trust Of India “I think he’ll play three times,” he said. “He still wants to captain this team (but) I know he’ll play three days.”I picked him when he was like 400th in the world to come down here and play,” added Couples. “I picked him three months early and took a bunch of grief for it. He should be on every team. That’s how good he is.” Tiger Woods will combine his captain’s duties with playing most likely three times during the Presidents Cup, his deputy Fred Couples revealed on Wednesday. There has been fervent speculation leading up to the biennial match-play showdown between the United States and an international team led by Ernie Els about how much the US superstar might contribute with the clubs after awarding himself a captain’s pick. Couples, who captained the team in 2009, 2011 and 2013, has long championed Woods as capable of assuming the dual roles and said he anticipates he will play a big part on the course at Royal Melbourne.READ | Vijender Lauds IOC Decision To Ban Russia From Tokyo Olympics For Dope Offences SUBSCRIBE TO US LIVE TV Written By First Published: 11th December, 2019 11:06 IST COMMENT READ | ‘I Have Questions’: Russian High-jump Star Lasitskene Slams OfficialsWoods is the first playing captain since Hale Irwin in the inaugural Presidents Cup in 1994, placing greater responsibility on Couples and his fellow vice-captains Steve Stricker and Zach Johnson. “He is a heck of a captain, which you would think, and he’s a great player to be on your team. So we have both,” said Couples. “When he’s playing, you know, there’s not like Zach is the captain. We’re all captain, and it depends on where we are on the course.” The Presidents Cup begins Thursday with the first five fourball matches. The draw for the first day’s pairings takes place later WednesdayREAD | British Olympic Association Angered By Athletes’ Legal ActionREAD | NBA Trade Rumours: Kevin Love On Verge Of Leaving Cleveland Cavaliers For Boston Celtics WATCH US LIVE Last Updated: 11th December, 2019 11:06 IST US Captain Woods Likely To Play Three Times At Presidents Cup Tiger Woods will combine his captain’s duties with playing most likely three times during the Presidents Cup, his deputy Fred Couples revealed on Wednesday FOLLOW US