November 30th, 2011
Dana-Farber Cancer Institute and the Sanford-Burnham Medical Investigation Institute have signed a license agreement with Genentech, a wholly owned member of the Roche group, and Roche, that grants the companies exclusive rights to manufacture, develop and market human monoclonal antibodies to treat and protect against group 1 influenza viruses. These viruses include the strains for the current seasonal and H1N1 influenzas. Genentech and Roche also have a non-exclusive right to manufacture, develop and market diagnostic tests for group 1 influenza.
The discovery of the antibodies was first reported by Wayne A. Marasco, MD, PhD, associate professor of medicine at Dana-Farber and Harvard Medical School; Robert Liddington, PhD, professor and director, Infectious and Inflammatory Disease Center at Sanford-Burnham; and Ruben Donis, PhD, chief of the Molecular Virology and Vaccines Branch in the Centers for Disease Control and Prevention, in Nature Structural and Molecular Biology in February 2009.
They demonstrated that the newly identified antibodies attach to the stem region of the viral proteins (hemagglutinin), rather than to the head region, the standard target of current influenza vaccines. Binding to the very conserved stem region prevents changes within the protein that are necessary for viral entry into the host cell, thereby inhibiting further infection of host cells along with the rise of escape mutants. Standard influenza vaccines that consist of an attenuated, or killed, virus typically stimulate antibodies against the protein’s head. These vaccines are less effective as the head region is prone to change, leading towards the rise of forms of the virus that will evade neutralizing antibodies.
Complete terms of the agreement are not public, but Dana-Farber and Sanford-Burnham will receive license fees and may possibly receive milestone payments and royalties.
Source
Dana-Farber Cancer Institute
Sanford-Burnham Medical Analysis Institute
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November 30th, 2011
4.5 (2 votes)
A new study published in BJOG: An International Journal of Obstetrics and Gynaecology examines how the swine flu virus, Influenza A H1N1 (2009), affects pregnant women.
Clinicians in the KK Women’s and Children’s Hospital in Singapore treated 211 confirmed circumstances of pregnant women with swine flu in between 26 May possibly 2009 and 14 September 2009. These were women who had fever and/or acute respiratory illness at presentation and a positive diagnosis of having swine flu by way of a throat swab.
Most of these patients reported having fever at home but only 62.2% had a fever when they arrived at hospital. Cough was the most prevalent symptom, occurring in 90.5%. Other recorded symptoms had been: runny nose (62.1%), sore throat (58.8%), muscle ache (32.2%), headache (18%), and breathlessness (13.3%). Co-morbidities included: asthma (12.8%), hypertension (0.5%) and gestational diabetes (1.9%). There had been two cases of pneumonia, one requiring admission to intensive care. Each recovered.
The average time among the onset of acute respiratory illness and presentation at hospital was two days and the average time among onset and commencement of treatment was also two days. The average length of stay in hospital was four days (range: 1 to 6 days) during the containment phase and two (range: 1 to 13 days) within the mitigation phase.
Antiviral treatment was given to 208 women (three declined treatment as there was a perceived improvement in their wellness). They had been all treated with Tamiflu except 1 who requested Relenza.
29.4% had been admitted to hospital, mostly because of breathlessness, sore throat and high temperature. Women admitted were four times much more most likely to be breathless (a symptom of pulmonary complications) and 3 times more most likely to have co-morbidities, after allowing for all other symptoms.
There had been relatively few pregnancy complications; severe morning sickness (2 situations), first trimester miscarriage (three instances), preterm labour (2 circumstances), hypertension (1 case) and a suspicious recording of fetal heart rate (1 case). All patients had a complete recovery from their infection.
The authors commented that the effects of the swine flu infection were relatively mild. Moreover, Singapore’s previous experience of severe acute respiratory syndrome (SARS) in 2003 meant that it had the infrastructure and systems in place to respond towards the outbreak of flu quickly and efficiently. Surveillance, isolation and quarantine of suspected cases assisted in early diagnosis and treatment; supported by nationwide public awareness campaigns. These measures led to early presentation as well as the subsequent treatment of H1N1-positive pregnant women which may possibly have contributed to the prevention of disease progression.
Author Dr May Li Lim, from the Department of Maternal-Fetal Medicine at KK Women’s and Children’s Hospital stated “This is a largest observational study of pregnant women with a H1N1 (2009) infection published so far. Although we had two instances of respiratory complication (both of whom made a full recovery), the majority of the 211 women recovered without any adverse events from the infection.
“Admission to hospital for monitoring and treatment was much more most likely to be needed if the women presented with breathlessness and/or concurrent medical illnesses like asthma and diabetes. Notable features in our cohort included early presentation, early diagnosis and early treatment which could account for the relatively mild disease observed.
“Our observations suggest that H1N1 (2009) infection in pregnancy might be a relatively benign disease, particularly if diagnosed and treated early. Nonetheless, our knowledge of the infection is rather limited currently. It truly is thus prudent to have a cautious strategy when managing an obstetric patient using the infection.”
Professor Philip Steer, BJOG editor-in-chief stated “This is the largest study on swine flu in pregnancy to date and shows there are benefits to prompt and decisive action within the treatment of confirmed situations. The case of Singapore is interesting as it demonstrates how the wellness services in another country coped using the disease and there may be lessons to learn from this example. We will have a better understanding of the H1N1 flu disease as more such studies are published.”
Notes
BJOG: An International Journal of Obstetrics and Gynaecology is owned by the Royal College of Obstetricians and Gynaecologists (RCOG) but is editorially independent and published monthly by Wiley-Blackwell. The journal features original, peer-reviewed, high-quality medical study in all areas of obstetrics and gynaecology worldwide. Please quote ‘BJOG’ or ‘BJOG: An International Journal of Obstetrics and Gynaecology’ when referring towards the journal and include the site: www.bjog.org as a hidden link online.
Reference
“Influenza A/H1N1 (2009) infection in pregnancy-an Asian perspective.”
Lim M, Chong C, Tee W, Lim W, Chee J.
BJOG 2010; DOI: 10.1111/j.1471-0528.2010.02522.x.
Source
Royal College of Obstetricians and Gynaecologists
View drug info on Relenza; Tamiflu capsule.
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November 30th, 2011
3 (1 votes)
Social interaction among neighbours, function colleagues and other communities and social groups makes voluntary vaccination programs for epidemics including Swine Flu, SARS or Bird Flu a surprisingly effective method of disease control.
New research published today, Thursday 11 February, in New Journal of Physics (co-owned by the Institute of Physics and German Physical Society), shows that contact with others can positively influence people to choose voluntary vaccination when considering the pros and cons.
The group of Chinese researchers found that in scale-free networks – social networks with an uneven distribution of connectedness such as neighbourhoods, function places or gyms – the so-called hub nodes, folks with numerous social connections, tend to choose to vaccinate themselves as they are at higher risk of infection from others, thus containing the spread of epidemics.
Based on their studies, the researchers have observed that in the beginning of an epidemic, when levels of infection are high, a large number of individuals will gradually take vaccination. As the effects of the temporary vaccination wear off, a second wave of outbreak will occur, even so on a less severe level due to the number of people with nonetheless effective immunisation.
This is why outbreaks of disease and voluntary vaccination occur periodically, eventually settling down to a stable state. People having a large social network play a crucial role in this cycle as, given info on the spread of the disease is freely available, the majority of them will choose voluntary vaccination.
In order to set up an effective vaccination strategy it is therefore crucial to affect the hub nodes’ willingness to vaccinate, which can potentially be negatively influenced by factors including the risk of infection, the coverage of disease as well as the cost of vaccination.
As the researchers write, “Sometimes the high costs of vaccination or misunderstanding the side effect of vaccinations can reduce the enthusiasm for taking vaccination. In this case the external incentives for example subsidy of vaccination cost would be helpful in enhancing the vaccination inclination of the hub nodes.”
The researchers’ paper can be downloaded free at http://www.iop.org/EJ/abstract/1367-2630/12/2/023015
Source:
Joseph Winters
Institute of Physics
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November 30th, 2011
One quarter of Ontario hospitals surveyed in a Queen’s University-led study do not have an influenza pandemic plan and few plans that do exist have been tested. In addition, key players were not involved in developing the plans, and funding for pandemic preparedness was inadequate.
“It’s not good enough just to have a plan, you have to test it. You have to know how properly it will work in an emergency,” says Dick Zoutman, Queen’s professor of Community Wellness and Epidemiology and lead researcher on the study. “The number should be 100 per cent tested. I’m surprised and concerned we aren’t there already inside the face of SARS and bird flu.”
The study’s findings are published in the February issue of the American Journal of Infection Control.
Small and rural hospitals surveyed are much less likely to have tested their pandemic plans because staff members already have many duties and may possibly not have pandemic expertise.
“Planning for a pandemic is a complicated and enormous task,” says Dr. Zoutman.
“More funding should be made available to these smaller hospitals.”
“You have to appear at staffing levels, supply chain – everything from the basement towards the ceiling,” he adds. “It’s like planning a wedding, except you don’t know the date, who the bride and groom are, what is to be served at dinner and you have to keep the flowers fresh for when the big day happens.”
Other members of the study team are Douglas Ford, Kingston General Hospital Infection Control Analysis Unit, Brian Schwartz of the Ontario Agency for Wellness Protection and Kingston consultant Matt Melinyshyn.
The project was funded by The Change Foundation (TCF), an independent charitable foundation established by the Ontario Hospital Association
Source:
Michael Onesi
Queen’s University
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November 30th, 2011
A campaign that makes seasonal flu vaccinations for hospital staff free, convenient, ubiquitous and hard to ignore succeeds fairly well in moving care providers closer to a state of “herd” immunity and protecting patients from possible infection transmitted by wellness care workers, based on results of a survey at the Johns Hopkins Hospital.
In a report published inside the Feb. 1 edition of the journal Infection Control and Hospital Epidemiology, researchers say the rate of seasonal flu vaccination for the 2008-2009 season amongst health care workers in the Johns Hopkins East Baltimore medical campus, including The Johns Hopkins Hospital, was double the national average. They attribute the results to a persistent campaign that made it easy to get vaccinated and also towards the wider availability of free community-based vaccination opportunities.
The 2008 survey, conducted by the Johns Hopkins University School of Medicine’s Division of Occupational Medicine, showed that 71.three percent of the 10,763 hospital staff, such as medical school faculty, nurses, researchers and students, received the so-called flu shot. Staff got the vaccine either as a nasal mist or by injection among September 2008 and January 2009, when men and women are most most likely to come into contact using the highly contagious virus.
For workers who came into direct contact with patients on a daily basis, the number was even higher, at 82.8 percent. Experts say that achieving a 100 percent population vaccination rate is the only way to prevent even sporadic transmission, but that herd immunity can, at the least, prevent outbreaks from sweeping across whole sections of the hospital.
Preliminary numbers for the 2009-2010 season show even further progress for The Johns Hopkins Hospital, with an estimated 25 percent jump in vaccinations (or 1,500 more inoculated staff), an increase the experts attribute to the emergence of H1N1 last year and heightened public awareness concerning the dangers posed from all kinds of influenza.
The 2008 survey also showed that a lot more than a quarter of staff who offer direct patient care at Johns Hopkins got last year’s seasonal flu vaccination somewhere other than at the hospital, boosting the actual seasonal flu vaccination rate at the start of the 2008-2009 season from an original estimate of 72 percent.
Senior study investigator Edward Bernacki, M.D., M.P.H., who as director of occupational well being, safety and environment at Johns Hopkins monitors the hospital’s vaccination program, says his group was surprised to find that so many staff chose to get vaccinated elsewhere, which includes neighborhood drugstores and supermarkets, which have recently started offering the annual vaccination at no charge to customers, or for free at other hospitals where they hold second jobs.
“It was promising to learn that so many staff had been getting vaccinated elsewhere, as opposed to what we had been thinking, which was that they had been not getting vaccinated at all,” says Bernacki, an associate professor at Johns Hopkins.
Another factor in the higher vaccination rate, he says, may have already been the hospital’s policy requiring employees working in patient clinics who chose not to get vaccinated to wear a face mask at function. Seasonal flu vaccination is not mandatory in the vast majority of academic medical center inside the United States, such as Johns Hopkins.
“We implemented this policy to protect our patients, but it also had an added benefit of encouraging staff to do what was right and to get vaccinated,” says Bernacki, who points out that making progress in upping vaccination rates is not just good policy, it truly is also the law.
In 2009, each the city of Baltimore along with the state of Maryland began requiring all hospitals to report their yearly progress in vaccinating staff. “That is why it really is critical to track the numbers,” says Bernacki. “If all medical centers took similar steps to promote vaccination and also monitored their progress, the risk of transmitting the influenza virus to patients would prove to be far much less.”
Bernacki and his team at Baltimore’s largest wellness employer say that getting as many as possible of its well being care workers vaccinated is essential to shielding patients from achievable infection during hospital stays. Hospital patients are often elderly or already have weakened immune systems, making them vulnerable to flu and its complications, such as death. Some 36,000 Americans die annually from seasonal influenza, leading to a lot more than three.1 million patient days spent in hospital and over 34 million outpatient visits.
Since 2006, the U.S. Centers for Disease Control and Prevention has recommended vaccination for all well being care workers, but most nationwide still do not comply. Previous hospital surveys have shown that barely a quarter of all hospital workers get vaccinated, with somewhat better outcomes, 42 percent, for those providing direct patient care.
To track vaccination rates at Johns Hopkins, Bernacki’s team combined info from employee wellness records kept in the hospital and cross-checked them with outcomes obtained from questionnaires and telephone interviews from a random sampling of hospital and university employees who work at the medical campus.
A random sampling, some 10 percent of all employees, yielded 1,084 employee names, of which 650 had been already recorded in hospital databases as either having been vaccinated on site or elsewhere, or having declined the flu vaccination. The remaining 434 were followed up with by mail and phone surveys to find who got vaccinated and where, and who did not. Results showed that 132 had undergone vaccination elsewhere. Only 18 individuals on the call list could not be reached, a number so low that it did not skew the researcher’s outcomes.
According to the study’s lead investigator, biostatician and epidemiologist Xuguang (Grant) Tao, M.D., Ph.D., the one-in-10 sampling method, combined with the follow-up survey offered a practical and effective means of accurately tracking who was and was not vaccinated on the medical campus.
“Hospitals have struggled with how to monitor compliance with the CDC’s recommendation, and now we think we have a reliable tracking tool that any medical center can readily use,” says Tao.
Bernacki says patients should be comfortable going to any hospital knowing that they are in the lowest possible risk of catching the flu from an infected wellness care worker. “Now, we have the means of telling them exactly what level of protection is being offered. Having this info publicly available can only lead to higher compliance rates and a win-win for each patients and staff.”
Source
Johns Hopkins Medicine
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November 30th, 2011
5 (1 votes)
A campaign that makes seasonal flu vaccinations for hospital staff free, convenient, ubiquitous and hard to ignore succeeds fairly well in moving care providers closer to a state of “herd” immunity and protecting patients from feasible infection transmitted by health care workers, based on outcomes of a survey at the Johns Hopkins Hospital.
In a report published within the Feb. 1 edition of the journal Infection Control and Hospital Epidemiology, researchers say the rate of seasonal flu vaccination for the 2008-2009 season among health care workers in the Johns Hopkins East Baltimore medical campus, including The Johns Hopkins Hospital, was double the national average. They attribute the outcomes to a persistent campaign that made it easy to get vaccinated and also towards the wider availability of free community-based vaccination opportunities.
The 2008 survey, conducted by the Johns Hopkins University School of Medicine’s Division of Occupational Medicine, showed that 71.3 percent of the 10,763 hospital staff, including medical school faculty, nurses, researchers and students, received the so-called flu shot. Staff got the vaccine either as a nasal mist or by injection between September 2008 and January 2009, when people are most most likely to come into contact using the highly contagious virus.
For workers who came into direct contact with patients on a daily basis, the number was even higher, at 82.8 percent. Experts say that achieving a 100 percent population vaccination rate is the only way to prevent even sporadic transmission, but that herd immunity can, at the very least, prevent outbreaks from sweeping across whole sections of the hospital.
Preliminary numbers for the 2009-2010 season show even further progress for The Johns Hopkins Hospital, with an estimated 25 percent jump in vaccinations (or 1,500 more inoculated staff), an increase the experts attribute to the emergence of H1N1 last year and heightened public awareness about the dangers posed from all kinds of influenza.
The 2008 survey also showed that much more than a quarter of staff who offer direct patient care at Johns Hopkins got last year’s seasonal flu vaccination somewhere other than at the hospital, boosting the actual seasonal flu vaccination rate in the start of the 2008-2009 season from an original estimate of 72 percent.
Senior study investigator Edward Bernacki, M.D., M.P.H., who as director of occupational wellness, safety and environment at Johns Hopkins monitors the hospital’s vaccination program, says his group was surprised to find that so many staff chose to get vaccinated elsewhere, which includes neighborhood drugstores and supermarkets, which have recently started offering the annual vaccination at no charge to customers, or for free at other hospitals where they hold second jobs.
“It was promising to learn that so many staff had been getting vaccinated elsewhere, as opposed to what we had been thinking, which was that they were not getting vaccinated at all,” says Bernacki, an associate professor at Johns Hopkins.
Another factor inside the higher vaccination rate, he says, may have already been the hospital’s policy requiring employees working in patient clinics who chose not to get vaccinated to wear a face mask at function. Seasonal flu vaccination is not mandatory in the vast majority of academic medical center in the United States, which includes Johns Hopkins.
“We implemented this policy to protect our patients, but it also had an added benefit of encouraging staff to do what was right and to get vaccinated,” says Bernacki, who points out that making progress in upping vaccination rates is not just good policy, it really is also the law.
In 2009, each the city of Baltimore as well as the state of Maryland began requiring all hospitals to report their yearly progress in vaccinating staff. “That is why it truly is critical to track the numbers,” says Bernacki. “If all medical centers took similar steps to promote vaccination and also monitored their progress, the risk of transmitting the influenza virus to patients would prove to be far less.”
Bernacki and his team at Baltimore’s largest wellness employer say that getting as many as possible of its wellness care workers vaccinated is critical to shielding patients from doable infection during hospital stays. Hospital patients are often elderly or already have weakened immune systems, making them vulnerable to flu and its complications, which includes death. Some 36,000 Americans die annually from seasonal influenza, leading to far more than 3.1 million patient days spent in hospital and over 34 million outpatient visits.
Since 2006, the U.S. Centers for Disease Control and Prevention has recommended vaccination for all well being care workers, but most nationwide still do not comply. Previous hospital surveys have shown that barely a quarter of all hospital workers get vaccinated, with somewhat better outcomes, 42 percent, for those providing direct patient care.
To track vaccination rates at Johns Hopkins, Bernacki’s team combined details from employee well being records kept in the hospital and cross-checked them with results obtained from questionnaires and telephone interviews from a random sampling of hospital and university employees who function in the medical campus.
A random sampling, some 10 percent of all employees, yielded 1,084 employee names, of which 650 had been already recorded in hospital databases as either having been vaccinated on site or elsewhere, or having declined the flu vaccination. The remaining 434 had been followed up with by mail and phone surveys to find who got vaccinated and where, and who did not. Outcomes showed that 132 had undergone vaccination elsewhere. Only 18 people on the call list could not be reached, a number so low that it did not skew the researcher’s outcomes.
According to the study’s lead investigator, biostatician and epidemiologist Xuguang (Grant) Tao, M.D., Ph.D., the one-in-10 sampling method, combined using the follow-up survey offered a practical and effective means of accurately tracking who was and was not vaccinated on the medical campus.
“Hospitals have struggled with how to monitor compliance with the CDC’s recommendation, and now we think we have a reliable tracking tool that any medical center can readily use,” says Tao.
Bernacki says patients should be comfortable going to any hospital knowing that they are in the lowest feasible risk of catching the flu from an infected well being care worker. “Now, we have the means of telling them exactly what level of protection is being offered. Having this info publicly available can only lead to higher compliance rates and a win-win for both patients and staff.”
Source:
David March
Johns Hopkins Medical Institutions
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November 29th, 2011
Key points:
- The clinical consultation rate for influenza – not necessarily swine flu – in Wales during the week ending 7 February increased to 5.8 situations of flu-like illness diagnosed by GPs out of every 100,000 people in Wales. It was 3.five per 100,000 in the previous week. Existing levels of flu in Wales are below the usual level for this time of year.
- Based on the latest data available from the Public Well being Wales daily GP surveillance scheme, as at 9 February, the influenza consultation rate in Wales as a whole was 9.4 instances of flu-like illness diagnosed by GPs in the previous seven days out of every 100,000 men and women in Wales. This is the equivalent of 282 folks contacting their GPs in the last seven days with flu-like symptoms.
- As at noon on 10 February, 660 laboratory confirmed circumstances of swine flu have already been reported by Public Health Wales Wellness Protection Teams in Wales since the start of the outbreak. Two new cases have already been reported within the past week.
- A total of 447 folks with laboratory confirmed swine flu in Wales have been admitted to hospital since the start of the outbreak.
- As at 10 February, the total number of swine flu-related deaths in Wales is 28, with no deaths reported within the past week.
- Latest figures show that the percentage of total calls to NHS Direct Wales which were flu-related increased to 16.2 per cent from 14.five per cent in the previous week.
- The figure below shows the daily consultation rate of influenza across Wales since 1 Could 2009 using the Audit+ system.
Source
Welsh Assembly Government
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November 29th, 2011
The WHO will convene a meeting of its emergency committee later this month to assess whether H1N1 (swine flu) has peaked, Keiji Fukuda, the special adviser towards the WHO’s director general for pandemic influenza, said Thursday, Bloomberg reports. “While the flu continues to spread in parts of the world, notably northern Africa, eastern Europe and eastern Asia, infection activity is declining, [Fukuda] stated,” according to Bloomberg (Serafino, 2/11).
Fukuda explained that the committee, which advises WHO Director-General Margaret Chan “on the state of a pandemic,” will decide whether the pandemic “had entered a post-peak or transition phase,” Reuters reports. “Designating a transition phase in this way – indicating that the pandemic is continuing but the overall trend is back toward seasonal patterns of influenza – would help national wellness authorities appear towards the future, he said” (Kelland, 2/11).
“What we are hoping for is the fact that the worst is behind us,” Fukuda stated Thursday during a news briefing, Agence France-Presse reports. Since the virus was first uncovered in Mexico and the U.S. last April, there have been more than 15,000 lab confirmed deaths from H1N1, according to the WHO (2/11). Fukuda indicated that “the real toll is likely to be much higher, although that will not be established for a year or two,” Reuters writes (2/11). Fukuda also cautioned that declaring the end of a pandemic would not happen abruptly because H1N1 activity varies in different countries, CIDRAP News reports (Schnirring, 2/11).
CBC News reports that Fukuda said a group of flu experts are scheduled to meet next week to discuss which flu strains should be included within the northern hemisphere’s next seasonal flu vaccine. “Since H1N1 continues to be the main influenza virus circulating, it might be included, Fukuda stated.” The groups’ recommendations will be announced on Feb. 18 (2/11).
In related news, NPR’s “On the Media” examines the media’s role in the public’s perception of H1N1. The program includes comments by New York Times wellness reporter Donald McNeil, sociologist Eric Klinenberg, and Glen Nowak, of the CDC (2/5).
This info was reprinted from globalhealth.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Wellness Policy Report, search the archives and sign up for email delivery at globalhealth.kff.org.
? Henry J. Kaiser Family Foundation. All rights reserved.
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November 29th, 2011
five (1 votes)four (1 votes)
A rapid influenza diagnostic test (RIDT) can offer a diagnosis of flu within 30 minutes -speeding the delivery of antiviral medication if needed – but studies have shown these tests often give false negative results.
A new study, “Sensitivity of Rapid Influenza Diagnostic Testing for Swine-Origin 2009 A (H1N1) Influenza Virus in Children,” published within the March issue of Pediatrics (appearing online February 15), examined RIDTs in a large pediatric cohort and found the tests might be a lot more effective at diagnosing influenza in children than in adults.
A total of 820 children with influenza-like illness had been tested for respiratory viruses over two flu seasons – 2007-2008 and 2008-2009. Study authors found RIDTs had been far more sensitive in children ages five and younger and in patients who were tested within 2 days of symptom onset. The authors suggest that RIDTs may possibly have a role in diagnosing 2009 H1N1 influenza in this population, who are far more likely to develop influenza-related complications, far more most likely to transmit influenza, and far more most likely to benefit from antiviral therapy.
Source
American Academy of Pediatrics
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November 29th, 2011
The European Medicines Agency and Swissmedic will from now on be able to exchange confidential details concerning the authorisation and safety of medicines used in the context of the H1N1 pandemic influenza.
The confidentiality arrangement was agreed among the European Medicines Agency on the 1 side and also the Swiss Agency for Therapeutic Products, Swissmedic, on the other side, on 12 February 2010.
The partners will be able to exchange confidential scientific and technical info to ensure the safety, quality, efficacy and post-authorisation follow-up of medicines used inside the context of the pandemic.
This closer co-operation will supply the two authorities earlier access to info on the basis for their respective recommendations on pandemic medicines and complete the overall view on their safety. It will also generate the opportunity to exchange experience regarding ‘lessons learned’ during the H1N1 pandemic.
The new confidentiality arrangement will allow exchange of details in between the parties as part of their regulatory and scientific processes, each ahead of and after a medicine has been approved.
Notes
1. The confidentiality arrangement is valid for one year and is established by an exchange of letters which can be found here: Letter from the European Medicines Agency; Letter from Swissmedic.
2. The confidentiality arrangement covers human medicinal products used within the context of the H1N1 pandemic influenza and subject to the evaluation or authorised below the centralised authorisation procedure as well as medicinal products authorised at national level by the European Union Member States that are subject to official European arbitration and referrals.
3. The scope of products covered in Switzerland contains those used within the context of the H1N1 pandemic influenza and approved or under evaluation in accordance using the Federal Act of December 15, 2000, on Therapeutic Products (CC 812.21).
4. This arrangement complements ongoing activities inside the area of quality and manufacturing below the Mutual Recognition Agreement in between the European Union and Switzerland: see here.
Source
European Medicines Agency
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November 29th, 2011
Amarillo Biosciences, Inc. (ABI) (OTCBB: AMAR) announced additional preliminary outcomes from the recently completed Phase 2 clinical trial conducted in Perth, Australia at the University of Western Australia with Professors David Smith and Manfred Beilharz as principal investigators.
The Firm previously reported results of a post-hoc analysis, which found that subjects given interferon who had received seasonal influenza vaccine prior to enrollment had a significantly lower incidence of influenza-like illness during the study, compared to subjects within the placebo group who had been vaccinated. Further exploratory analyses have discovered that the incidence of influenza-like illness, the primary study endpoint, was significantly reduced from 60% to 24% in subjects 55 years of age or older who received interferon, compared to subjects in the placebo group who had been at the very least 55 years old at the start of the study.
Similar to what has been observed in studies of other human diseases, preliminary analysis indicates that low-dose oral interferon therapy was safe in this study. No important differences were found between the groups within the number or severity of adverse events reported. Placebo subjects reported an average of 1.4 adverse events, compared to an average of 1.3 adverse events reported per interferon-treated subject.
A total of 200 healthy human volunteers had been enrolled in this study to take a once daily dose of oral interferon or placebo for 16 weeks as prevention of influenza-like illness during the 2009 Australian cold and flu season. The H1N1 (2009) influenza virus was the major circulating virus in Perth during the duration of the trial and was estimated to account for at the least 90% of influenza viruses, according to the Australian Department of Wellness of Western Australia. Blood samples were collected in the beginning as well as the end of the study for serological analysis. Once available, these serology information will help identify those subjects who had an increase in antibodies to particular cold and flu viruses, including the H1N1 (2009) influenza virus.
Separately, ABI announced that Oromucosal Administration of Interferon to Humans, a review post authored by Manfred W. Beilharz and others, was published in Pharmaceuticals. The article may possibly be viewed here.
Source
Amarillo Biosciences
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November 29th, 2011
five (1 votes)
Evidence for the safety and efficacy of influenza vaccines inside the more than 65s is poor, despite the truth that vaccination has been recommended for the prevention of influenza in older individuals for the past 40 years. These are the conclusions of a new Cochrane Systematic Review.
Adults aged 65 and over are some of the most vulnerable during influenza season and a priority for vaccination programmes. Nevertheless, very few systematic reviews of the effectiveness of vaccines in this group have ever been carried out.
The researchers conducted a thorough search of studies based on previous vaccine trials. Randomised controlled trials (RCTs) are often considered the “gold standard”, but of the 75 studies included in their review, the researchers were only able to identify one recent RCT with “real” outcomes. In other words, this was the only RCT that used influenza circumstances as an outcome, as opposed to surrogate outcomes for example measurements of influenza antibodies inside the blood. All the other studies included inside the review were deemed of low quality and open to bias.
Limited reliable evidence from the studies suggests that the effectiveness of influenza vaccines is modest at best. “Our estimates are consistently below those usually quoted by economists and in decision making,” says lead researcher Tom Jefferson of the Cochrane Collaboration in Rome, Italy. “But until we have all available evidence, it’s hard to reach any clear conclusions concerning the effectiveness of influenza vaccines in older people.”
“As the evidence is so scarce in the moment, we should be looking at other strategies to complement vaccinations. Some of these are very simple things like personal hygiene, and adequate food and water,” says Jefferson. “Meanwhile, we need to undertake a high quality, publicly funded trial that runs more than several seasons to try to resolve some of the uncertainties we’re currently facing.”
Jefferson is also one of the authors of a second review publishing this week, which focuses on the efficacy of influenza vaccinations in healthcare workers who function using the elderly. The results are also inconclusive, with every of the four trials included within the review being of inadequate quality and reaching implausible conclusions. The researchers had been unable to draw any conclusions about whether vaccinating healthcare workers helps to prevent influenza symptoms and death in folks aged over 60.
Source:
Jennifer Beal
Wiley-Blackwell
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