– Advertisement – – Advertisement – Russell Wilson connects with David Moore for a 55-yard touchdown against the Bills Prior to the season wide receiver Tyler Lockett detailed the unwavering culture across the organisation as a key to the Seahawks’ success under Carroll.“I think the biggest thing is what he [Carroll] brings to the table never changes,” Lockett told Sky Sports on NFL 32 LIVE.“Sometimes it’s just the players that change, but it’s still the same players, they’ve got the same grit, they want to be able to make a difference, and they get a lot of people that come on the team and they don’t want to be about themselves but they want to be about something greater, and for us it’s just really being able to fall behind leadership and that’s what we did.”Sky Sports NFL is your dedicated channel for NFL coverage through the season – featuring a host of NFL Network programming, a new weekly preview show as well as at least five games a week and NFL Redzone, you won’t miss a moment. Don’t forget to follow us on skysports.com/nfl, our Twitter account @SkySportsNFL & Sky Sports – on the go! The Seattle Seahawks have made the playoffs in eight of 10 seasons under Pete Carroll, winning four NFC West titles and lifting the Lombardi Trophy on one of two trips to the Super Bowl. Carroll is also the winningest head coach in franchise history By Cameron HogwoodLast Updated: 09/11/20 11:57am A look back at the action and talking points from Week 9 of the NFL season 0:47 Russell Wilson connects with David Moore for a 55-yard touchdown against the Bills – Advertisement – A look back at the action and talking points from Week 9 of the NFL season The Seattle Seahawks and Pete Carroll have agreed a four-year contract extension set to make him one of the highest-paid head coaches in the NFL.ESPN were first to report the news prior to the Seattle Seahawks’ Week Nine defeat to the Buffalo Bills, with NFL Network’s Ian Rapoport following suit.The new deal ties the 69-year-old down in Seattle through the 2025 season, following on from Carroll’s claim earlier this year that he wished to coach for at least five more years.Seattle have reached the playoffs in eight of 10 seasons since Carroll’s arrival in 2010, winning one of two Super Bowl appearances as well as clinching four NFC West titles.Carroll is the winningest head coach in Seahawks history with a record of 106-60-1, while his 139-91-1 career regular-season record and 150-91-1 record including playoffs both rank 22nd all time in the NFL. – Advertisement – 4:04
For the latest tech news and reviews, follow Gadgets 360 on Twitter, Facebook, and Google News. For the latest videos on gadgets and tech, subscribe to our YouTube channel. Veer Arjun Singh Veer Arjun Singh is Deputy Editor, News at Gadgets 360. He has written many in-depth features on technology, healthcare, hospitality, and education in the last seven years, besides reviewing latest gadgets across categories. He has also profiled CXOs, entrepreneurs, social workers, lawyers, chefs, and musicians. You can find him as @arjunwadia on Twitter or email him at firstname.lastname@example.org with tips, suggestions, and general observations.More The changelog detailed along with the post mentions many system fixes — including the ones reportedly introduced by the last update — with the major ones being an abnormal call recording issue and a problem with alarms getting deactivated when the phone was powered off. As mentioned, the update brings the September 2020 Android security patch to the OnePlus 5 and 5T, but updates the GMS package to August 2020.Among the major improvements that the Oxygen OS 10.0.1 brings to the aeging OnePlus 5 and 5T is electronic image stabilisation that is known to improve camera capabilities by reducing the chances of blurred pictures. The OnePlus 5T will also get the option to enable the Android 10 back gesture that works by swiping up from the bottom of the screen.Is OnePlus 8T the best ‘value flagship’ of 2020? We discussed this on Orbital, our weekly technology podcast, which you can subscribe to via Apple Podcasts, Google Podcasts, or RSS, download the episode, or just hit the play button below.- Advertisement – OnePlus 5 and 5T will be getting a new Oxygen OS 10.0.1 update that brings several bug fixes to the Android 10-based Oxygen OS 10 rolled out for the devices earlier. OnePlus had acknowledged problems with the build of the Oxygen OS 10 after users reported several issues. The company had assured that the product teams were working on a fix “at the highest priority”. The Android 10 update had come to the OnePlus 5 and 5T — launched in 2017 — in May this year, which was much later than expected. The new update claims to fix many system bugs and bring camera improvements along with the September 2020 Android Security Patch.The news of the new update was shared via a post on the OnePlus community page created for the OnePlus 5 series. The post says that the update is being rolled out in a staged manner to make sure it does not have any critical bugs. It says that only a select few users will receive the update today with the rest of them getting it after a few days. It also clarified that using a VPN won’t help in getting it sooner as the update is not region-specific.OnePlus 5, 5T Oxygen OS 10.0.1 update changelog- Advertisement –
Jan 26, 2006 (CIDRAP News) – An influenza vaccine conference in Atlanta this week brought predictions of a record supply of flu vaccine next year and talk of extending vaccination recommendations to include children between the ages of 2 and 6.The meeting also featured discussions about expanding the federal government’s role in buying and tracking vaccine in an effort to eliminate shortages and distribution problems, according to federal officials and press reports.Vaccine manufacturers represented at the meeting predicted they may produce as many as 130 million doses for the 2006-07 season, according to Lola Russell, a Centers for Disease Control and Prevention (CDC) spokeswoman. That compares with roughly 86 million doses produced for this season.Sanofi Pasteur estimated next year’s production at 50 to 60 million doses, while Chiron Corp. estimated it would provide 40 million, Russell told CIDRAP News.GlaxoSmithKline, which entered the US market this season, estimated next year’s production at 7 million to 9 million doses, but said it might expand to 20 million to 30 million, according to Russell. She said MedImmune, maker of the nasal-spray vaccine FluMist, did not give an estimate.According to an Associated Press (AP) report, manufacturers cited several factors that warrant increased production: better government reimbursement for shots, signals that federal officials may eventually recommend flu shots for almost everyone, and public fears of avian flu (even though seasonal flu shots would not protect people from avian flu). The record amount of vaccine is 95 million doses, set in 2002-03, the report said.Figures from Russell add up to between 86 million and 87 million doses of vaccine produced for the current season. The numbers include 63 million doses from Sanofi, slightly less than 15 million from Chiron, 7.5 million from GlaxoSmithKline, and about 1.5 million from MedImmune.”We don’t know how many of the 86 million have been sold,” Russell said. “We know that vaccine is available. Chiron said they had 1.3 million available to be sold.”Recent flu seasons have brought varying degrees of vaccine shortages, usually temporary. Most seasons have ended with millions of doses unused. In 2004-05, the supply was drastically reduced by the contamination-related shutdown of a Chiron plant in England, leading to widespread US shortages in the fall. But after millions of healthy people skipped their shots in favor of those in greater need, the season ended with about 3 million doses unsold out of roughly 61 million produced for the US market.This week’s conference was billed as an opportunity to assess flu vaccination efforts during the current season and develop strategies for future seasons, according to the CDC, which sponsored the meeting in cooperation with the American Medical Association.Reports from the meeting suggest a good possibility that the CDC will include 2- to 6-year-old children in its formal flu vaccination recommendations soon.”That’ll be on the agenda at ACIP,” the Advisory Committee on Immunization Practices, when it meets in February, Russell said. But she couldn’t predict how soon the committee might decide.CDC officials at the meeting said a decision on recommending shots for 2- to 6-year-olds is expected by the end of the year, according to a report published today by the Boston Globe.Flu shots are currently recommended for various groups at risk for serious flu complications, including people aged 50 and older and toddlers aged 6 to 23 months, plus people in close contact with those groups.”A lot of people think it makes sense to routinely offer influenza vaccine to more children,” the Globe report quoted Dr. Ray Strikas, a CDC flu expert, as saying.Some studies have suggested that children play a key role in spreading flu to adults and that vaccinating more children would therefore pay big dividends.In other discussions at the meeting, CDC officials promised to consider expanding the government’s role in buying vaccine and tracking its distribution, according to a Jan 25 Boston Globe report.For this season the CDC bought about 11.5 million doses and then resold many of them to state health departments, the report said. CDC Director Dr. Julie Gerberding was quoted as saying that because the agency doesn’t own the vaccine supply, it can’t do a lot to support appropriate distribution.According to Russell, Gerberding said the CDC is considering various options to remedy that situation, including buying more vaccine, helping to direct early-season vaccine to private physicians and clinics, taking more control over distribution, and expanding vaccination recommendations.See also:CDC flu sitehttp://www.cdc.gov/flu/
Jun 27, 2006 (CIDRAP News) – Department of Homeland Security (DHS) officials broke ground yesterday for the National Biodefense Analysis and Countermeasures Center (NBACC) at Fort Detrick in Frederick, Md. Construction of the NBACC is slated for completion in 2008, DHS officials said in a news release. The facility’s estimated cost is $128 million, according to an April 2005 Congressional Research Service (CRS) report. See also: The new center is a component of the Bush administration’s “Biodefense in the 21st Century” initiative and meets requirements in the Homeland Security Act of 2002, the DHS statement said. The facility will include laboratories with the highest level of biosecurity, Biosafety Level 4, for handling dangerous pathogens, according to the CRS report. “Scientific research is fundamental to reducing the high consequences of a biological attack,” said DHS Deputy Secretary Michael Jackson, as quoted in the DHS press release. “Our threat picture is ever-changing, and this facility will provide enduring biodefense capability against these types of emerging threats.” Congressional Research Service report, Apr 25, 2005http://www.fas.org/sgp/crs/homesec/RL32891.pdf The NBACC will be located at the new National Interagency Biodefense Campus (NIBC). The campus includes laboratories belonging to the Department of Defense, the Department of Agriculture, the National Institutes of Health, and the Centers for Disease Control and Prevention, according to DHS. (Fort Detrick is the home of the US Army Medical Research Institute of Infectious Diseases.) The 160,000-square-foot facility will house two centers, the Biological Threat Characterization Center (BTCC) and the National Bioforensic Analysis Center (NBFAC). The BTCC’s task is to define biothreat agents and conduct risk assessments to guide research, development, and acquisition efforts and to support the intelligence community, according to DHS. The NBFAC is the lead federal facility for conducting forensic analysis after a biological attack.
Apr 20, 2007 (CIDRAP News) – Faced with the reality that an effective vaccine is not likely to be available for at least the first several months of an influenza pandemic, some corporations are buying antiviral medications for their employees—both to protect them and to improve the chances that the company could keep providing vital products and services through a pandemic.Few companies have revealed their plans concerning the use of antivirals, but two of them recently described their plans to supply employees with oseltamivir (Tamiflu): the US division of Roche, the company that makes Tamiflu, based in Nutley, N.J., and Public Service Enterprise Group (PSEG), an energy company that serves nearly 2 million electric customers and 1.6 million gas customers in New Jersey.Tamiflu is a neuraminidase inhibitor that the World Health Organization (WHO) recommends as the treatment of choice for people infected with H5N1 avian influenza; it is regarded as the best hope for treatment if H5N1 evolves into a pandemic strain. The WHO lists the other licensed neuraminidase inhibitor, zanamivir (Relenza), as a second option for treating H5N1.Roche and PSEG are among the first large companies to supply their employees with Tamiflu, and their experiences may hold lessons for other companies considering such programs.Employee antiviral programs gain momentumAntiviral programs for businesses range from modest stockpiles that would cover only certain at-risk employees to more comprehensive plans intended to cover all workers and even their families.Roche spokesman Terry Hurley told CIDRAP News that 350 corporations have purchased Tamiflu for their employees. Companies don’t order the drug directly from Roche; they obtain the medication either from distributors that ship it to a company clinic, from a pharmacy benefits manager (PBM) that mails the medication to employees, or from local pharmacies.The idea of companies supplying their employees with antiviral medication, however, has generated some controversy. When Roche rolled out a pandemic planning Web site last July to market Tamiflu to companies, some medical and policy experts charged that the company was favoring more lucrative corporate requests over government stockpile orders.Mike McGuire, vice president of anti-infectives for Roche, said the company waited until its production capacity reached 400 million treatment courses per year before following though with its employee program. The company’s US facilities can produce 80 million treatment courses annually, he said. “Once we filled a number of government orders around the world, had enough for seasonal orders, and had enough to fill our other orders, then we decided to fill our own,” he said.The decision to stockpile or supply antiviral medications isn’t an easy one for businesses. Medication cost is one factor to consider, said Stuart Weiss, MD, an emergency medicine physician, pediatrician, and disaster planning expert who has worked for government agencies and healthcare organizations. Also, employee antiviral programs should include a strong educational component and medical screening, which also add to program costs, he said.”Just giving someone a box of pills without the educational component is wrong,” said Weiss, who is a founding partner of MedPrep Consulting Group, based in New York City.Other factors that companies may weigh when considering an employee Tamiflu program include the drug’s 5-year shelf life and scientific uncertainty about efficacy and dosing against an emerging pandemic influenza strain. Antiviral-resistant H5N1 strains have been isolated from a few patients in Vietnam and Egypt. The WHO suggested this week that physicians might consider doubling the standard dosage of Tamiflu for H5N1 patients.Weiss said companies shouldn’t substitute an employee antiviral program for a comprehensive pandemic plan. “Just buying antivirals in a vacuum is a waste of time and resources,” he said. Plans to protect employees should also involve social distancing, personal protective equipment, and other mitigation strategies.Why now?Representatives from both Roche and PSEG said the decision to supply employees with Tamiflu represents the next step in their pandemic planning. “We need to still be able to produce lifesaving drugs [during a flu pandemic], and we’re extremely proactive,” McGuire said. The unpredictability of a pandemic drove Roche’s decision to have the drug ready for employees ahead of time. “We’re not even sure the doctors will be in their offices when the pandemic hits,” he said.Ronald Mack, MD, medical director at PSEG, based in Newark, N.J., said the company takes the threat of a pandemic very seriously. “We have been sensitized to this type of threat by our past experience responding to 9/11, SARS [severe acute respiratory syndrome], anthrax, the Northeast blackout [of August 2003], and the terrorist threats against downtown Newark,” he said.Implementing an employee Tamiflu program for a large organization takes time, Mack said. “We considered that it would be difficult to do for the first time under urgent circumstances, which would produce competition for resources, and elected to act now,” he said.Who receives it?All Roche employees are eligible to receive Tamiflu, said Ann Peterka, MD, the company’s director of employee health services. The company plan is intended both to maintain the company’s ability to continue producing essential drugs and to protect employees, she said.”We provided Tamiflu to all of our employees since everyone will be needed to get the business back to normal once a pandemic wave has subsided,” Peterka said. “And since we have a critical role in ensuring that we are able to supply Tamiflu to all of our stakeholders during a pandemic without interruption, it is important to protect our employees from getting infected so we have the best chance of accomplishing this objective.”Alex Nawotka, director of commercial operations at Roche, said covering all employees will help company operations return to normal more quickly after pandemic waves pass. “We felt that all of our employees are important in that effort,” he said.PSEG’s Tamiflu program also includes employees’ spouses, dependent children, and domestic partners, Mack said. The goals are to further protect employees and decrease their worries about their families during a pandemic, he said. “The sense is that our workers would not appear [for work] unless they felt that their families were secure. We are a very family-oriented company—multigenerational employment is not unusual,” he added.Neither company was willing to reveal how much Tamiflu would be supplied to each employee or family member.Steps for prescribingSources at both PSEG and Roche say the employee Tamiflu program is just one facet of a broader pandemic flu awareness program, and employees are educated before doctors screen and prescribe them the drug. Other elements include hygiene messages on hand washing and cough etiquette.Roche employees must complete a computerized educational module before they qualify for the Tamiflu program, Peterka said. After they finish the module, they meet with a company doctor who reviews their medical histories, clears them to receive the drug if no contraindications are found, and gives them Tamiflu packaging materials to review. Roche has contracted with a physician network that can do the screenings on- or off-site, she said.After an employee has completed the educational material and met with a physician, the prescription is sent to a PBM, which mails the employee his or her Tamiflu supply.At PSEG, employees attend one of several group information sessions, held February through May and led by physicians, Mack said. Employees complete three brief forms—a medical history, a privacy statement, and an education acknowledgement form—and meet individually with a physician. Those who are cleared to receive Tamiflu are given a supply of the drug, along with instructions for taking it.In June, after employee prescriptions are processed, said Mack, family members will go through a similar process to receive their supplies of Tamiflu.What triggers taking the drug?Another issue for employee antiviral programs is what to tell workers about when to take the drug. Using it for treatment means using it only during the illness, but taking it for prevention during a pandemic could mean taking it for many weeks. Roche and PSEG take different approaches on this point.Roche said its employee Tamiflu program follows World Health Organization guidelines for seasonal flu treatment and prevention (the WHO says that antivirals can be used preventively as well as for treatment). However, Peterka said employees are told to consult a medical practitioner before they take the drug. “We don’t want them self-diagnosing,” she said.Mack said for now PSEG intends for employees to use the antiviral medication to treat flu symptoms in the event of a known pandemic but not for prevention. “This may be modified if an actual pandemic evolves,” he said.Maintaining awarenessBoth companies said their Tamiflu programs are just one element of ongoing pandemic communication with employees. Mack said PSEG uses seasonal flu as “practice” for a pandemic; for example, the company makes it easy for employees to get their seasonal flu shots by offering them during work at company expense.Roche and PSEG have installed touchless water faucets and towel dispensers and have posted educational messages on proper handwashing techniques and cough etiquette.The Tamiflu program isn’t a one-shot educational push, Nowatka said. Some of the ongoing efforts at Roche are aimed at teaching employees the difference between seasonal flu, pandemic flu, and the common cold, he said. “We use a variety of venues: e-mail, kiosks, posters, and weekly newsletters,” he said.See also: WHO guidelines for pharmacologic management of H5N1 patients, May 2006Apr 19 WHO statement mentioning possible high-dose oseltamivir treatment for H5N1 patients
Sep 13, 2007 (CIDRAP News) British officials who are investigating the latest outbreak of foot-and-mouth disease (FMD) said today that initials tests show the virus strain matches the strain found in outbreaks that surfaced in late July at two nearby farms. The focus of the outbreaks is an area in Surrey on the outskirts of London. The two earlier incidents are believed to have been caused by FMD virus that leaked from wastewater drains at a laboratory facility in nearby Pirbright. The facility houses a commercial FMD vaccine producer and a government-funded research institute. The United Kingdom’s Department for Environment, Food, and Rural Affairs (DEFRA), in a statement today, said initial virus sequencing indicates the virus in the new outbreak is type 01 BFS67, the same strain found in the earlier outbreaks. The latest cases were confirmed yesterday. In the two earlier FMD outbreaks, which were confirmed in early August, veterinary authorities culled nearly 600 animals to control the spread of the disease. A massive outbreak in Britain in 2001 led to the destruction of 7 million cattle to stop the disease. DEFRA said yesterday that animals on a farm next to the infected site would be destroyed as a precautionary measure. See also: Sep 12 CIDRAP News story “UK reports another foot-and-mouth outbreak” The current outbreak site is a farm near the town of Egham, about 10 miles from the two earlier outbreaks, the London Telegraph reported yesterday. Cattle on the farm were culled, and protection and surveillance zones were set up around the area, DEFRA reported. FMD is an extremely contagious disease that affects cattle, sheep, pigs, and other ruminants, causing sores in the mouth and on the hooves. The debilitating condition does not usually kill adult animals, but it drastically reduces milk production. The disease very rarely affects humans, according to DEFRA.
“We have been working at the federal, state, even the local level to try to make sure this issue is visible,” he said. “To date, the results have been underwhelming.” “Everyone understands that if you don’t have vaccine you are dead in the water, but what has not been dealt with is that, if you don’t have the syringes and needles, the vaccine doesn’t do you any good,” said George Goldman, senior director for hypodermics at BD Medical Surgical Systems in Franklin Lakes, N.J. “Six hundred million devices, which is what in theory would be required to vaccinate the US population twice, is a very large volume if you plan for it and an even larger volume if you produce them in a reactive mode. We do not believe the industry is capable of producing that kind of volume in any short period of time under the best of circumstances” (see Bibliography: BD 2007). Food and Drug Administration (FDA) planners have accepted that, absent rapid changes in current flu-vaccine manufacturing techniques, delivering the earliest doses of a vaccine tuned to a newly emerged pandemic strain would take a minimum of 4 months (see Bibliography: Goodman 2006). A vaccine-industry scenario, described in August in the journal BioPharm International, goes out 6 months: 3 to 4 months to generate a seed strain, 4 to 6 weeks of manufacturing set-up, and 18 weeks of production, including 2 to 3 weeks of quality assurance and regulatory approvalall adding up to a vaccine product that would arrive roughly in time for the pandemic’s second wave but long after the first patients had recovered or died (see Bibliography: Thomas 2007). The nine countriesFrance, Germany, Italy, The Netherlands, Switzerland, the United Kingdom, the United States, Canada, and Australiatrade vaccine across borders but are unlikely to keep doing so in a pandemic, he added: “In 2000, a total of six western European companies distributed 66 million doses of vaccine to 18 western European countries. Only 42% of these doses were distributed within the countries that produced them; the remaining 58% were exported to other western European countries. For the rest of the world, about 40% of the doses used in central and eastern Europe, 60% of the doses used in the western Pacific and Southeast Asia, and virtually 100% of the doses used in Latin America, the eastern Mediterranean, and Africa were imported from one or more of the nine vaccine-producing developed countries” (see Bibliography: Fedson 2003). While the US government has taken initial steps to support manufacturerswitness the $133 million given to two manufacturers this past summer to retrofit existing plants and the $1 billion awarded for cell-culture researchmuch more is needed (see Bibliography: HHS 2006, 2007). What about vials and syringes? While vaccine manufacturers are likely grateful for the HHS funding, others in the industry say the investment is incompletebecause it does nothing to expand capacity for critical downstream tasks such as bottling and administering completed vaccine. But the more difficult obstacle is not the time needed to produce vaccinewhich newer technologies such as cell culture could shorten to some degreebut the amount of vaccine needed. Despite years of work, the grave mismatch between predicted demand and likely supply has yet to be solved. Little incentive to buildMany experts have warned that the only way to expand flu-vaccine manufacturing capacity is to get governments to pay for it. In its 2004 “Consultation on priority public health interventions before and during an influenza pandemic,” the WHO cautioned: “Industry has little incentive to build additional manufacturing capacity, which requires very large long-term investments for an event that occurs only rarely and unpredictably.” (See Bibliography: WHO 2004) Last year, Britain’s Royal Society added bluntly: “It is not commercially viable for the vaccine industry to commit the necessary resources to scale up production in advance of a pandemic when there is no existing market, the threat of a pandemic may be years away and the risk in any single year may be considered to be low” (see Bibliography: Royal Society 2006). The pandemic vaccine puzzle Manufacturing 600 million syringes would take 2 years if manufacturers used only their existing excess capacity, Goldman said, and creating a new manufacturing line takes approximately a year. A vaccine embargo?The WHO analysis hides a number of highly optimistic assumptions, including zero glitches in production and 100% cooperation by regulators. But the greatest assumption may be that the newly produced pandemic vaccine would be distributed equitably to all comers around the globe. It is more likely that vaccine would never leave the countries where it is produced. The WHO plan asks countries that do not now use seasonal flu vaccine to launch new seasonal vaccination campaigns as a way of stimulating demand. It also asks countries with existing vaccination programs to increase vaccine use, so that 75% of those for whom vaccination is recommended are taking the shot. Both recommendations may be unrealistic: The United States, which uses more vaccine than any other nation, has never reached 75% uptake even among groups that are urged to take the shot because they are at high risk for flu complications. In the 2005-06 flu season, according to CDC data published in September, the highest acceptance of seasonal flu shots69.3%was among adults older than 64, who are considered “high risk” because of their age. Fifty- to 64-year-olds who are at high risk because of chronic medical conditions had a vaccination rate of 48.4%; only 32.3% of those in the same age range who had no high-risk conditions took the flu shot, and only 18.3% of healthy adults between 18 and 50 did so (see Bibliography: CDC 2007). The “fill-finish” sectorwhich puts bulk manufactured vaccine into vials or syringesis not being asked to prepare for any excess capacity, said Jack Lysfjord, vice-president for pharmaceutical consulting in the Valicare division of Robert Bosch Packaging Technology Inc., in Brooklyn Park, Minn., a leading manufacturer of production and fill-finish equipment. “We are talking to some companies, but we are not hearing that they plan to buy twice as much from us in the next five years,” he said. “If they want to expand, they should be starting production now” because building an automated filling line can take 2 years (see Bibliography: Bosch 2007). “I have never believed that boosting seasonal flu-vaccine demand was the way to prepare for pandemic flu,” said Michael Osterholm, PhD, MPH, director of the University of Minnesota Center for Infectious Disease Research and Policy (CIDRAP), which publishes CIDRAP News, and of the National Institutes of Health (NIH)funded Minnesota Center of Excellence for Influenza Research and Surveillance. “That economic model doesn’t work on its own and it has no scalability to provide flu vaccine for the rest of the world” (see Bibliography: Osterholm 2007). The companies that occupy the end of the vaccine-production process are also experiencing anxietyon their own behalf and for the pharmaceutical manufacturers who feed product to themthat their operations will be disrupted by the start of a pandemic if they are brought into the process too late. In one example of the supply-demand mismatch, the United States plans to secure enough pandemic vaccine to deliver two doses to all 300 million of its residents (see Bibliography: FDA 2007: Committee meeting transcript). But current US manufacturing capacity tops out at 150 million 15-mcg doses, a total that is expected to rise to 250 million when a new Sanofi Pasteur plant comes online in 2008 (see Bibliography: Sanofi Pasteur 2007), but that still falls far short of the number the federal government hopes to deploy. And those hoped-for 600 million doses do not include the 40 million destined for the US pandemic stockpile that must be replaced periodically as flu strains mutate or the vaccine expires (see Bibliography: Riley 2007). As a foreign-owned company, with its US unit in Minnesota and headquarters and manufacturing plants in Europe, Bosch feels this acutely. Much of the fill-finish equipment sold out of its US plant undergoes preliminary assembly in Germany, and many of the manufacturers for whom Bosch makes equipment rely on pharmaceutical ingredients or production components sourced from around the world. The same frustration is evident at BD (formerly Becton, Dickinson and Co.), the dominant company in syringe manufacturing. To be useful, those investments must be made well in advance of when vaccine is needed: The WHO estimates that building and licensing a new vaccine production line takes up to 5 years (see Bibliography: WHO 2004). The same scenario could happen again. “The U.S. will have a serious problem if the pandemic doesn’t strike in the next couple of years, because interest will decline and demand will go down again,” said Hedwig Kresse, an associate analyst for infectious diseases with the British-based market analysts Datamonitor. “Governments will have to guarantee a certain sales volume to keep [manufacturers] in the market and to keep these capacities up” (see Bibliography: Kresse 2007). Creating enough vaccine-manufacturing capacity to protect the world’s population is not cheap. The price tag is likely to be at least $2 billion and could rise to $9 billion, according to a WHO estimate (see Bibliography: WHO 2006: Global pandemic influenza action plan). Experts within the vaccine industry say that expecting manufacturers to make the investment asks companies to spend against their own best interest. “In the US market alone by the year 2010 there could be a surplus capacity resulting from ‘building for demand’ for pandemic preparedness but ‘suboptimal utilization’ based on significantly lesser demand for seasonal vaccines,” an engineer and two strategists from the Danish biotech firm NNE PharmaPlan wrote in the industry journal BioPharm International. “In Europe, Asia and the rest of the world, planned future capacities for ‘pandemic preparedness’ would have to address how potential surplus capacities can be effectively used in markets where there is little or no demand for seasonal vaccines” (see Bibliography: Thomas 2007). “If we really want to have surge capacity for pandemic vaccine, we have to invest in it like we do our oil reserves, or military reserve capacity,” Osterholm said. “The facilities may sit for years before they are utilized. But the analogy is having an airport fire department in case of a plane crash: You hope never to use it, but you invest as though it were a possibility” (see Bibliography: Osterholm 2007). Oct 26, 2007 (CIDRAP News) The difficult reality is that, even if influenza science were perfect and research funding were abundant, achieving a widely deployable pandemic vaccine is currently out of reach. Chief among the reasons: The world lacks the manufacturing capacity to make enough vaccine to matter. “You have to think about every part of the components,” Lysfjord said. “The machines, the plants, the chemicals; the stopper, the glass, the aluminum overcast for the top of the vial; the labels. You’re not aware of how well-connected the system is until it breaks, and it is going to break big-time.” The United States has already experienced the aftermath of vaccine companies’ feeling overextended. Between 1998 and 2002, two of the four companies that then supplied seasonal flu vaccine left the market, citing losses on investment and increased regulatory demands. In the 2000-01 and 2003-04 flu seasons, the country experienced significant shortages of flu vaccine, with long lines, panic buying, price-gouging, and subsequent congressional investigations (see Bibliography: GAO 2001, 2004; Grady 2004). The World Health Organization’s (WHO’s) own best-case analysis, published in the agency’s 2006 “Global Pandemic Influenza Action Plan to Increase Vaccine Supply,” and updated in an Oct. 23, 2007, press release, breaks down the situation this way. In 2006, global manufacturing capacity for seasonal flu vaccine was 350 million doses per year of trivalent vaccine (comprising one 15-microgram [mcg] dose of each of three flu strains’ antigens). This year, according to the WHO, capacity could rise as high as 565 million doses, a total that incorporates both actual capacity increases achieved by manufacturers and theoretical capacity that would be created if manufacturing lines ran around the clock for the entire calendar yearsomething they do not do for seasonal flu-vaccine production. Given that a pandemic vaccine would be aimed at a single strain rather than three, global capacity could thus rise as high as 1.5 billion doses. But a pandemic vaccine would need to be given twice, because, unlike with seasonal flu, there would have been no prior exposure to the novel strain. So absent the use of adjuvants to stretch limited antigen supplies, industry could produce at best enough vaccine for 750 million people, far short of the amount needed to cover the world’s 6.7 billion inhabitants (see Bibliography: WHO 2006: Global influenza action plan; WHO 2007: Projected supply of pandemic influenza vaccine; Palkonyay 2007). The role of seasonal flu vaccine demandThe WHO action plan avers that manufacturers will significantly expand production capacity by 2012, largely because demand for seasonal flu vaccine will risebut it offers no evidence that demand can be stimulated to levels that will persuade manufacturers to invest (see Bibliography: WHO 2006: Global pandemic influenza action plan). In the United States, for instance, the amount of vaccine manufactured has risen nearly every year, but so too has the amount returned to manufacturers unused. In the 2006-07 season, manufacturers selling to the US market delivered 120.9 million doses, the highest on record; they received back 18.4 million unused doses, also a record (see Bibliography: Santoli 2007). Editor’s note: This is the second in a seven-part series investigating the prospects for development of vaccines to head off the threat of an influenza pandemic posed by the H5N1 avian influenza virus. The series puts promising advances in vaccine technology in perspective by illuminating the formidable barriers to producing large amounts of an effective and widely usable vaccine in a short time frame. Part 1 described how flu research has been a relatively low priority until very recently, which has left many important scientific questions unanswered. Seven hundred and fifty million “is fewer than the number of people that live in the nine countries that produce 85% of the world’s supply of flu vaccine,” said David Fedson, MD, a retired academic and vaccine-industry executive who has published critical analyses of pandemic-vaccine planning. “Which means that, if you live outside of a vaccine-producing countrywhether that means Indonesia or Sweden or Spainyou get nothing” (see Bibliography: Fedson 2007: Author interview). Part 1: Flu research: a legacy of neglectPart 2: Vaccine production capacity falls far shortPart 3: H5N1 poses major immunologic challengesPart 4: The promise and problems of adjuvantsPart 5: What role for prepandemic vaccination?Part 6: Looking to novel vaccine technologiesPart 7: Time for a vaccine ‘Manhattan Project’?Bibliography
Tony Milici, MD, PhD, GeneThera’s chairman, said in the statement that the company will launch phase 2 clinical trials shortly. “Our goal is to take the vaccine to market as soon as possible,” he added. Brett Finlay, a microbiologist at the University of British Columbia whose research led to development of the vaccine, said in an Oct 27 Bioniche press release, “If we block the colonization of cows by O157, we basically decrease the number that humans are exposed to, and thus, dropping disease levels in humans.” Bioniche is also positioning itself to market the vaccine to cattle producers in the United States, according to a previous report. In February, the US Department of Agriculture (USDA) notified the company that the latest data on the vaccine met its “expectation of efficacy” standard, which allowed the company to pursue a conditional US license. The vaccine contains live attenuated bacteria developed by Edgar Boedeker, an internal medicine professor at UNM, and Chengru Zhu, formerly of UNM and now chief of environmental microbiology at the Maryland Department of Health, according to a GeneThera statement. The vaccine is designed to inhibit the carriage and shedding of enterohemorrhagic E coli such as O157:H7. ‘A missing link’Bill Clark, a nephrologist at the London Health Sciences Centre in London, Ont., said that an E coli O157:H7 vaccine isn’t a firewall against food contamination, according to an Oct 28 report from the Canadian Broadcasting Corporation (CBC). “I’m not sure any one solution will do it, and I certainly think people still have to be very careful with their food practices,” he told the CBC. Nov 3, 2008 (CIDRAP News) – Bioniche Life Sciences, based in Belleville, Ont., announced recently that it received full approval from the Canadian Food Inspection Agency (CFIA) to market the world’s first vaccine to reduce Escherichia coli O157:H7 shedding by cattle, a measure that could decrease contamination in meat and produce. E coli O157:H7 doesn’t sicken cattle but is potentially fatal to humans. It produces a toxin that causes diarrhea, often bloody, but usually no fever. Though most patients with E coli O157:H7 infections recover in 5 to 10 days, 2% to 7% develop hemolytic uremic syndrome, a potentially fatal form of kidney failure. The vaccine, called Econiche, will be produced at Bioniche’s Belleville facility, which is undergoing a $25 million expansion. The company said vaccine supplies would be limited during the expansion period. Oct 27 Bioniche press release about vaccine’s approval Oct 17 Bioniche press release about study of vaccine US company eyes cattle vaccineOn the same day Bioniche announced it had received full Canadian approval, a US company, GeneThera, Inc, based in Wheat Ridge, Colo., announced that it had signed an agreement with the University of New Mexico’s (UNM’s) technology transfer arm to license and distribute a cattle E coli vaccine developed at the UNM Health Sciences Center. Smith DR, Moxley RA, Peterson RE, et al. A two-dose regimen of a vaccine against Escherichia coli O157:H7 type III secreted proteins reduced environmental transmission of the agent in a large-scale commercial beef feedlot clinical trial. Foodborne Pathogens and Disease 2008 Oct 1;5(5):589-98 [Abstract] Kym Anthony, a specialty beef producer in Clarksburg, Ont., said in the Bioniche press release that he has been using the vaccine over the past year under a conditional Canadian permit. “We’ve been trying to do our part to be an industry leader in food safety. The E coli vaccine fits into that,” Anthony said. “It’s been a missing link in the industry so far.” See also: The company said the vaccine could also be used in livestock at petting zoos and agricultural expositions to reduce bacterial transmission to humans. However, some producers may find the cost prohibitive. Rick Holley, a professor of food safety and microbiology at the University of Manitoba, told the CBC, “So long as these organisms don’t make the animals sick, you’re not going to see a great deal of incentive to move toward prevention.” The company did not list a cost for the vaccine, but officials previously told CIDRAP News that a course of the vaccine would likely cost less than $10 per head of cattle. As approved by the CFIA, the course involves three doses, but a study published in the October issue of Foodborne Pathogens and Disease showed that a two-dose regimen reduced the probability of environmental transmission of E coli O157:H7 within a large-scale cattle feeding operation.
Jan 20, 2009 (CIDRAP News) – Animal health workers in Nepal are culling thousands of poultry in response to the country’s first outbreak of H5N1 avian influenza, as officials in India said the virus spread to another Indian state, Sikkim in the northeastern part of the country.In a Jan 16 report to the World Organization for Animal Health (OIE), government officials in Nepal said the virus struck backyard poultry in a village in Jhapa district in the southeastern corner of the country. The outbreak killed 14 of 13,000 susceptible birds in the area.Investigators have not determined the source of the outbreak, the OIE report said.Laxman Hamal, a government administrator, said more than 10,000 chickens and ducks have been culled over the past 4 days, Agence France-Presse reported today. Hamal said officials have banned the sale, transport, consumption, and farming of poultry in the outbreak area for the next 3 months to control the spread of the virus.Elsewhere, a veterinary official in India’s Sikkim state said today that tests have revealed the H5N1 in dead poultry and wild birds, Reuters reported today. Sikkim, located in northeast India, is the country’s smallest state and borders West Bengal state, as well as Nepal and China, all of which have reported recent H5N1 outbreaks.Officials plan on culling about 15,000 chickens and ducks in Sikkim, the report said.India’s health ministry has sent a rapid response team to the area to conduct surveillance in nearby residents and has shipped oseltamivir (Tamiflu), masks, and other protective equipment to the area, the Times of India reported today.India has battled sporadic H5N1 outbreaks since 2006, most recently in several districts in West Bengal and Assam states.See also:Jan 16 OIE report
In order to enrich and aesthetically valorize the construction site of the Park Hotel in Rovinj, Maistra decoratively illuminated seven cranes up to 48 meters high in the evening, which creates an interesting and different view of the city center. The cranes are reminiscent of the Pula giants, and certainly contribute to a more beautiful view of the city and try to mitigate the negative aspect due to the ongoing construction work.Also, by temporarily stopping the works on the new Maistra hotel and marina in Rovinj, direct access to the beaches and hotels of Monte Mulini, Lone and Eden is again provided by a fenced promenade. ” In order to ennoble and aesthetically valorize the construction site space, seven cranes up to 48 meters high are decoratively lit in the evening, creating a spectacular view from the city center. The new tourist attraction will be active until the resumption of works in September this year. ” stand out from Maistra.The opening of a new hotel worth 600 million kuna is planned for next summer, and the hotel will have 209 accommodation units, 6 restaurants, 3800 square meters of wellness & spa center, shopping promenade, congress hall overlooking the old town. By 2020, Maistra will invest an additional two billion kuna, which will put 95 percent of hotel capacity at the highest level of supply.Related news: MAISTRA INVESTS 2020 BILLION HRK IN THE DEVELOPMENT OF THE TOURISM BUSINESS BY 2