“Starting today, October 24th, we’re making influenza shots available to everyone,” said Health and Human Services Secretary Mike Leavitt. “There’s no reason for anyone to delay or go without their seasonal flu shot.” Von Eschenbach announced that the FDA is forming a “rapid response team” of experts to help make sure antiviral drugs are available in the event of a flu pandemic. In early September, the Centers for Disease Control and Prevention (CDC) had recommended that flu shots be reserved for people at risk for serious flu complications until today. (The recommendation did not apply to MedImmune’s live-virus vaccine [FluMist], which is licensed only for healthy people between ages 5 and 49.) Despite some scattered shortages caused by delayed vaccine deliveries, the CDC stuck to that timetable. See also: “Providers in areas with sufficient flu vaccine already should open up their programs to the expanded group of people” not at high risk for complications, she said. She recommended that clinicians who have an ample supply of vaccine inform local public health officers so the latter can help shift surplus doses to providers who need them. CDC officials repeated their estimate that at least 71 million doses of flu vaccine will be available in the United States this season, compared with about 60 million last year, when the loss of 48 million doses expected from Chiron triggered shortages. CDC Director Dr. Julie Gerberding said the flu season is just beginning. “We’re seeing very sporadic activity in seven states, and local activity in one state.” Leavitt observed that oseltamivir has been “much in the news” because of the chance that H5N1 avian flu will lead to a human flu pandemic. Many countries, including the United States, are trying to build stockpiles of oseltamivir, but the drug takes a long time to produce. Some localized vaccine shortages have been reported as a result of delayed deliveries, but they are expected to clear up soon, Gerberding said. At a news briefing, officials also warned that the threat of a flu pandemic may spur the sale of fake versions of the antiviral drug oseltamivir (Tamiflu). To make sure they get the genuine article, officials said, people should seek the drug through their physician. The best way to avoid fake oseltamivir is to get it from state-licensed pharmacies, said von Eschenbach. “We feel strongly that the best protection for patients is to avail themselves of the drug in the context of a doctor-patient relationship.” He added that people seeking a flu shot should make an appointment, because some providers may not have received their vaccine yet. In a news release issued this afternoon, he said, “Using the Rapid Response Team approach, we believe we could review a complete drug application in six to eight weeks.” Because demand for the drug far exceeds the supply, said Leavitt, “We’re concerned about the threat of counterfeiting of Tamiflu.” The CDC still expects 60 million doses from Sanofi Pasteur, 3 million from MedImmune, and 8 million from GlaxoSmithKline, said CDC spokeswoman Christina Pearson. She said the agency also expects up to 18 million doses from Chiron, which until last week was projecting 18 million to 26 million. Gerberding said that right now she does not expect a shortage of oseltamivir for use against seasonal flu. “The manufacturer still has several million doses in the pipeline,” she said. “The doses that haven’t been distributed yet exceed the number prescribed last year by a significant amount. At this point there’s no evidence of a shortage that’s going to result in any clinical impact on patients. We’ll monitor that.” Oct 24, 2005 (CIDRAP News) Seasonal influenza shots are not just for high-risk groups anymore, and everyone interested in a shot should go ahead and seek one out, federal health officials said today. Gerberding said people who experience flu symptoms and have not been vaccinated, especially if they are in a high-risk group, should call their physician promptly to find out if treatment with an antiviral drug would be appropriate. Preventive treatment with an antiviral may be indicated n some cases, such as for people who can’t be vaccinated because of an egg allergy. In response to questions, Leavitt and Andrew von Eschenbach, acting commissioner of the Food and Drug Administration (FDA), said they had seen no evidence of counterfeiting to date. But Leavitt said, “It’s a situation that’s ripe for counterfeiting. The WHO [World Health Organization] now indicates that counterfeit drug making is a $34 billiona-year industry. We’re seeing it in many other instances.” FDA news releasehttp://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108502.htm
Winning Post: Swedish regulator pushes back on ‘Storebror’ approach to deposit limits August 24, 2020 StumbleUpon Soft2Bet continues new market drive with Irokobet launch August 26, 2020 Share Submit Share Related Articles Global Gaming adds sportsbook extension to Ninja property August 25, 2020 Swedish gambling regulator Spelinspektionen has ruled that four operators have been cleared following allegations that they had offered markets on sporting events which included a ‘majority of participants’ under the age of 18. ATG, Betsson, Hillside Sports and Kindred Group-owned Spooniker all had cases cleared by Spelinspektionen after it was initially thought that the four operators had offered markets on the individual performances of under-18 players in a football match. Swedish laws and definitions on underage match wagering are established under ‘Gambling Act Chapter 8‘ provisions.The regulator has previously suggested that offering markets on underage players can be seen to increase the danger of minors being exposed to attempts to manipulate sporting results.Hillside, the operating subsidiary of bet365 in Sweden, has previously been issued a penalty fee of SEK10m (£801,108) after the regulator said the operator had offered odds on five football matches in which a majority of players were underage. Spelinspektionen has since reviewed the penalties, stating that none of the four operators had breached license conditions as the featured players who were eligible for the bets in the games were, for the most part, over the age of 18.In its ruling, Spelinspektionen has confirmed that it is working towards the development of regulations which will focus on bans and restrictions on betting in order to tackle match-fixing in professional sport. The regulator said betting on the individual performance of under-18s will be taken into account when drafting these rules.