4 (1 votes)2 (1 votes)

The Department of Public Health (DPH) is urging all Connecticut residents to obtain a flu vaccination. The flu vaccine is currently available and residents should not wait to be vaccinated.

“Influenza is really a critical disease that could result in hospitalization as well as death,” stated DPH Commissioner J. Robert Galvin, M.D., M.P.H., and M.B.A. “Flu vaccines are safe and effective.”

Vaccines are encouraged for everyone, but especially for high-risk groups, including children from 6 months to 18 years of age, women who will be pregnant throughout the flu season, folks at least 50 years old, anyone with certain chronic medical conditions and individuals who live in nursing homes or long-term care facilities.

“The single very best method to defend yourself and your loved ones is usually to get vaccinated – either by the flu nasal spray or injection,” said Dr. Galvin. “People should talk to their physician about obtaining a flu vaccination for themselves and other family members,” he stated.

The influenza season runs from September-April and people can continue to be vaccinated throughout the course of the flu season. Manufacturers expect to create a record number of influenza doses this year with practically all vaccine delivered to providers by the middle of November.

To find a flu vaccine clinic, please visit the American Lung Association’s (ALA) Flu Clinic Locator at http://flucliniclocator.org/, call the ALA flu hotline available Mon-Friday 9am-3pm at 1-888-668-6358 (1-888-NO-TO-FLU), call 2-1-1 statewide Info line 24 hour access to ALA, or check with your usual wellness care provider for distinct information on when they will receive their vaccine to vaccinate you.

To learn much more about seasonal influenza visit the DPH web site at http://www.ct.gov/dph and click “Programs and Services” then click the “Seasonal Influenza” program link, or call 509- 7994.

The Connecticut Department of Public Health may be the state’s leader in public well being policy and advocacy with a mission to shield and promote the wellness and safety of the men and women of our state. To get in touch with the department, please visit its website at http://www.ct.gov/dph or call (860) 509-7270.

The Connecticut Department of Public Health

MedImmune has announced that it will present nine abstracts at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)/46th Annual Meeting of Infectious Disease Society of America (IDSA). These abstracts advance the knowledge about respiratory syncytial virus (RSV) and influenza, providing valuable insight into infectious disease prevention and underscoring MedImmune’s leadership in this disease category.

“MedImmune is committed to conducting innovative infectious disease investigation to figure out how best to stop critical illness that can negatively impact pediatric well being, specifically during this time of year,” said Alexander A. Zukiwski, M.D., executive vice president and chief medical officer. “We believe the data being presented at this meeting will help result in essential new healthcare solutions, and our company is proud to advance our already robust investigation base to identify the very best ways to help protect children.”

MedImmune abstracts to be presented at ICAAC/IDSA on RSV include: Respiratory Syncytial Virus Therapy Utilizing Intranasally Delivered Motavizumab, a Monoclonal Antibody Against the Viral Fusion Protein (#V-4145) B. Richter, Tuesday, October 28, 2008, Hall C from 12:15 PM to 1:15 PM

BACKGROUND: A primary cause of pneumonia and bronchiolitis in young young children is RSV infection. This preclinical study examined the therapeutic effect of topically administered motavizumab.

Therapeutic Addition of Motavizumab, a Monoclonal Antibody Against Respiratory Syncytial Virus, Modulates Epithelial Cell Responses to RSV Infection (#V-4146) S. Krishnan, Tuesday, October 28, 2008, Hall C from 12:15 PM to 1:15 PM

BACKGROUND: RSV infection of epithelial cells leads to inflammatory host responses. This preclinical study tested whether or not motavizumab, a humanized monoclonal antibody against the RSV fusion (F) protein, could modulate epithelial cell immune responses to RSV. Lower and upper airway epithelial cells had been infected with RSV and motavizumab or a control antibody was subsequently administered at various points post-infection to evaluate the therapeutic addition.

Total Healthcare Costs of Preterm Infants with Medically Attended Respiratory Syncytial Virus Lower Respiratory Infection (#K-1429 ) D. Stewart, Sunday, October 26, 2008, Hall C from 12:15 PM to 1:15 PM

BACKGROUND: Although RSV lower respiratory infection (LRI) is the most widespread cause of hospitalization among infants below 1 year of age, the total healthcare costs of medically attended RSV LRI for babies of this age group is unknown. This retrospective, propensity-matched cohort assessment sought to decide first-year healthcare costs by examining premature infants born over a five-year period who were insured by a national U.S. health plan, including a subgroup analysis of babies born among 33 and 36 weeks gestation.

In Vitro Mechanism of Action Studies of the RSV-Neutralizing Monoclonal Antibodies Palivizumab and Motavizumab (#V-4146) K. Huang, Tuesday, October 28, 2008, Hall C from 12:15 PM to 1:15 PM

BACKGROUND: Synagis is the only licensed drug product available to help prevent lower respiratory tract RSV infection in premature infants, a leading cause of hospitalizations in this patient population. An affinity-optimized version of Synagis, motavizumab, has been subsequently developed. Since both Synagis and motavizumab bind the RSV fusion (F) protein, which plays a role in virus attachment and mediates the process of virus-cell fusion and cell-to-cell fusion, this study aimed to figure out exactly how the drugs neutralize RSV. Four assays were utilised, which target four distinct steps during virus replication, to identify the mechanism.

In Vitro and In Vivo Characterization of a Motavizumab-Resistant RSV A Mutant (#V-4148) F. J. Palmer-Hill, Tuesday, October 28, 2008, Hall C from 12:15 PM to 1:15 PM

BACKGROUND: This study investigated the growth characteristics – both in vitro and in vivo – of an RSV mutant that was created within the laboratory and is resistant to neutralization by motavizumab, an affinity-optimized MAb directed against the RSV fusion (F) protein. The F protein of the MAb differs from a wild type RSV F protein, so comparisons were made.

Characterization of Respiratory Syncytial Virus (RSV)Mutants Resistant to Antibody Neutralization with Novel Amino Acid Changes within the RSV Fusion Protein (#V-4149) N. K. Patel, Tuesday, October 28, 2008, Hall C from 12:15 PM to 1:15 PM

BACKGROUND: Synagis is really a MAb approved for the prevention of severe lower respiratory tract RSV infection in premature infants. Motavizumab was developed by affinity optimization of Synagis and is characterized by greater in vitro and in vivo neutralization activity against RSV. Previously, the selection of RSV mutants resistant to Synagis has been reported, characterized by amino acid changes inside the RSV fusion (F) protein. This study sought to identify the selection and characterization of additional Synagis MAb-resistant mutants, as well as a novel motavizumab MAb-resistant mutant. MedImmune abstracts to be presented at ICAAC/IDSA on influenza include: Influenza-like Illness and Employee Productivity – Results from the Child and Household Influenza-illness and Employee Function (CHIEF) (#K-4207) M. D. Rousculp, Tuesday, October 28, Room 150B from two:450 PM to 3:00 PM

BACKGROUND: This prospective cohort study of nearly two,293 U.S. households evaluated the effect of employee and household member influenza-like illness on worker productivity. The households studied were employees from three large Fortune 500 companies. All households included in the study had at least one child. Households had been surveyed monthly throughout the 2007-2008 influenza season to decide the impact of influenza-like illness on employees’ function absenteeism and decreased productivity whilst on the job.

Impact of Early and Late Influenza Vaccine Availability on In-Office Vaccination Opportunities (#G1-1208) R. Judelsohn, Sunday October 26, Hall C from 11:15 AM to 12:15 PM

BACKGROUND: The CDC now recommends all youngsters from six months to 18 years of age receive an annual influenza vaccination; however, a key barrier to implementation is the inconvenience to parents and providers around scheduling additional office visits to administer the vaccination. This study examined how numerous more vaccination opportunities exist if influenza vaccination availability were expanded beyond the typical October-to-December timeframe.

Benefits Versus Risks of Live Attenuated Influenza Vaccine (LAIV) in Young Young children (#G1-1204) G. Oster, Sunday October 26, Hall C from 11:15 AM to 12:15 PM

BACKGROUND: In September 2007, approved use of LAIV in the U.S. was expanded to include young children aged 24-59 months but with warning/precautions against use in younger young children and children 24-59 months with a history of recurrent wheezing or asthma. Since some latter kids may receive LAIV in clinical practice, its risks and benefits versus trivalent influenza vaccine (TIV) in this setting must be considered. ###

Additional information about the 2008 ICAAC/IDSA conference can be found at http://www.icaacidsa2008.org/.

About Synagis

Synagis? (palivizumab) is indicated for the prevention of severe lung infections caused by respiratory syncytial virus (RSV) in youngsters at high risk of RSV disease. Synagis is given as a shot, usually inside the thigh muscle, each and every month through the RSV season. The first dose of Synagis should be given before RSV season begins. Kids who develop an RSV infection although receiving Synagis should continue the monthly dosing schedule throughout the season. Synagis has been utilised in more than one million young children in the U.S. since its introduction in 1998.

Synagis should not be used in patients with a history of severe prior reaction to Synagis or its components. Circumstances of severe allergic reactions such as anaphylaxis and other types of hypersensitivity reactions have been reported with Synagis. These reactions could occur when any dose of Synagis is given, not just the initial 1. Another significant side effect, which may lead to unusual bruising and/or groups of pinpoint red spots found on the skin, has been reported.

Most widespread side effects with Synagis may possibly include upper respiratory tract infection, ear infection, fever, and runny nose. In kids born with heart problems, Synagis was associated with reports of low blood oxygen levels and abnormal heart rhythms. Side effects, such as, skin reactions about the area where the shot was given (like redness, swelling, warmth, or discomfort) have also been reported.

Please see accompanying full prescribing information at http://www.synagis.com/.

About FluMist

FluMist? (Influenza Virus Vaccine Live, Intranasal) is really a live attenuated influenza virus vaccine indicated for active immunization of individuals two to 49 years of age against influenza disease caused by influenza virus subtypes A and type B contained within the vaccine.

FluMist is contraindicated in individuals with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine or with life- threatening reactions to previous influenza vaccinations, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy.

Do not administer FluMist to children much less than two years of age due to an elevated risk of hospitalization and wheezing that was observed in clinical trials. FluMist should not be administered to any individual with asthma and to kids much less than 5 years of age with recurrent wheezing unless the potential benefit outweighs the potential risk. Don’t administer FluMist to people with severe asthma or active wheezing.

If Guillain-Barre syndrome has occurred with prior influenza vaccination or if an individual is immunocompromised, the decision to give FluMist should be based on careful consideration of the potential benefits and risks. FluMist should not be administered to people with underlying medical conditions predisposing them to wild-type influenza infection complications unless the potential benefit outweighs the potential risk. FluMist should be given to a pregnant woman only if clearly needed.

Most frequent adverse reactions (occurring in 10 percent or a lot more of people receiving FluMist and at a rate at least five percent higher than in those receiving placebo) are runny nose or nasal congestion in recipients of all ages, fever more than 100 degrees F in young children two to six years of age, and sore throat in adults.

FluMist might not shield all individuals receiving the vaccine. FluMist is for intranasal administration only.

Please see complete Prescribing Information for FluMist, visit http://www.flumist.com/prescribing-information.aspx for additional information.

About MedImmune

MedImmune is actually a leading innovation-focused biotechnology company whose mission would be to provide much better medicines to patients, new medical options for physicians and rewarding careers to employees. Dedicated to advancing science and medicine to help folks live far better lives, the company is focused on infection, oncology, respiratory disease and inflammation, cardiovascular/ gastrointestinal disease and neuroscience. Headquartered in Gaithersburg, Maryland, MedImmune has approximately 3,000 employees worldwide and is the wholly owned biologics business for AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information, visit MedImmune’s website at http://www.medimmune.com/.

Source: Tor Constantino
Edelman Public Relations

View drug information on FluMist; Synagis.

Vaccinating new mothers and other family members against influenza before their newborns leave the hospital creates a “cocooning effect” that could shelter unprotected young children from the flu, a virus that will be life-threatening to infants, according to researchers at Duke Children’s Hospital.

The hospital-based outreach tested in this study proved efficient at boosting immunization rates in parents – specifically new fathers – and siblings who otherwise may possibly not be vaccinated.

“The Centers for Disease Control and Prevention does not recommend vaccinating newborns for flu because they’re too young, however they’re a component of the population that is at highest risk,” explains Emmanuel (Chip) Walter, MD, a pediatric infectious disease specialist at Duke Children’s Hospital. He presented the findings of the CDC-funded study in the annual ICAAC/IDSA meeting in Washington, DC.

“Newborns have the highest rate of hospitalizations due to influenza when compared to any other age group of youngsters. Their rates of influenza-related hospitalization are similar to men and women age 80 and older. And, in some seasons the influenza-associated mortality rate is highest among infants. We want to shield the newborn by vaccinating the entire family, and send parents home with one less thing to worry about.”

The study was carried out from October 2007 to February 2008 at Durham Regional Hospital. Educational material was distributed to new mothers, and a flu vaccine clinic was set up to facilitate the vaccinations for other family members around the time of a newborn’s birth. Duke University Medical Center served as the comparison site.

Walter reported that vaccination coverage of new mothers and other family members elevated 16 percent at Durham Regional when judged against the comparison site. And, while the researchers were encouraged to learn that approximately 40 percent of pregnant women had received vaccinations – much more than previously noted – their efforts resulted in an additional 45 percent of new mothers who had not received a flu shot during pregnancy choosing to be vaccinated. Equally significant was the number of new dads and siblings who received the flu shot when compared towards the comparison site.

“Our study shows that offering the flu vaccine to new mothers throughout their baby’s stay within the hospital is an successful approach to assure that all women have the opportunity to get vaccinated and thereby shield their own health along with the well being of their baby,” says Walter. “It also proved to be a convenient, and possibly the most powerful way for fathers to be vaccinated. Protection of the newborn from the dangers of influenza is maximized when those who have the closest contact are vaccinated.”

###

Source: Debbe Geiger
Duke University Medical Center

Giving people age 65 and older a dose four times larger than the standard flu vaccine boosts the amount of antibodies in their blood to levels considered protective against the flu, far more so than the standard flu vaccine does. The findings from a study of practically 4,000 people had been presented Oct. 26 at a national meeting on infectious diseases.

The higher dose of vaccine usually resulted in approximately 30 percent to 80 percent far more antibodies against flu, lengthy considered a good measure of protection.

Ann Falsey, M.D., associate professor of medicine at the University of Rochester School of Medicine and Dentistry and an infectious diseases specialist at Rochester General Hospital, presented the results in the 48th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)/Infectious Diseases Society of America (IDSA) 46th annual meeting. The study was funded by sanofi pasteur, the vaccines division of sanofi-aventis Group, which makes Fluzone? Influenza Virus Vaccine, a licensed flu vaccine used widely within the United States and elsewhere.

The immune system typically weakens as we get older, not only leaving folks more vulnerable to infection but also reducing their ability to respond to vaccination. Although some studies have questioned the effectiveness of the flu vaccine in older adults, the nation’s leading public well being experts stress that it’s a worthwhile, even life-saving, measure. About 90 percent of the estimated 36,000 individuals who die from flu-related causes inside the United States every year are 65 and older.

“Without doubt, the influenza vaccine as it’s today is beneficial for everyone, which includes older adults, and we strongly encourage every single older person, and each and every individual with a chronic illness, to get vaccinated,” said Falsey. “However, older individuals generally don’t respond to vaccines as well as young healthy adults and as a result, there is much room for improvement. The goal is to increase immune response in older adults, since this is 1 of the populations most at risk for becoming seriously ill or dying from influenza.”

The conventional flu vaccine is really a combination of 3 circulating strains of flu, with every component consisting of 15 micrograms of material designed to evoke an immune response to safeguard a individual against a particular type of flu. Inside the study headed by Falsey and conducted at 30 sites about the country in fall 2006, physicians compared the immune response brought about from a traditional flu vaccine compared to that from a vaccine shot containing four times as much material – 60 micrograms of material known as hemagglutinin for each of the three components.

In the study of men and women age 65 and older, the larger dose was given to 2,575 participants, even though 1,262 subjects received the standard dose. Scientists checked the level of antibodies within the blood of the participants one month later. Typically, the large-dose vaccine increased the number of flu antibodies in study participants on average from about 30 to 80 percent. The level of such antibodies inside the blood has long been considered a good gauge of how protected folks are against the flu.

A greater percentage of people who received the high-dose vaccine had the typical side effects associated with the flu shot, such as redness, swelling, and discomfort in the site of the injection, but the symptoms generally didn’t last longer than three days.

One especially interesting bit of data from the study, based on Falsey, was the effect of the larger dose on folks who had no measurable antibodies against certain strains of the flu when the study began. Such individuals are considered particularly vulnerable because their body doesn’t have the “head start” that most individuals have in generating at least some protection against flu on their own, before the vaccine offers a needed boost. These people might also represent a group that does not respond well to vaccines in general.

Even in this group, the larger dose greatly elevated the number of such people who ultimately had antibody levels considered protective. For example, 51 percent of such individuals who received the standard dose had an antibody level thought to be protective against 1 of the strains, H1N1, included within the vaccine, even though 74 percent of participants who received the high dose reached the same levels. The percentages also went up for the other two strains included inside the shot, from 82 to 96 percent for the H3N2 strain and from 41 to 56 percent for the type B strain.

“These are the people in the highest risk for becoming very sick from influenza, and we saw significant improvement within the immune response in a lot of of these people,” said Falsey. “This is very encouraging.”

###

Among the study participants had been 129 in Rochester, N.Y., such as 100 folks at Rochester General Hospital and 29 people in the University of Rochester Medical Center.

Source: Tom Rickey
University of Rochester Medical Center

View drug information on Fluzone Preservative-free.

3.5 (2 votes)

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced today that an investigational high-dose influenza vaccine demonstrated elevated immune responses among adults 65 years of age and older compared with the standard influenza vaccine. The candidate high-dose intramuscular formulation of the influenza vaccine is being developed by sanofi pasteur.

The results were reported today at the 48th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)/Infectious Diseases Society of America ( IDSA ) 46th annual meeting.

According towards the U.S. Centers for Disease Control and Prevention (CDC), the currently available inactivated influenza vaccine provides public well being benefits in reducing influenza-related morbidity and mortality in older adults. Study authors explain, however, that as folks age, the immune system tends to weaken. Older adults become not only far more susceptible to infections, but also much less responsive to vaccination. When infected with the influenza virus, they’re less in a position to mount an immune response to neutralize the attack.

“Development of an influenza vaccine that will offer an improved immune response in older adults is crucial because this population has the highest rates of complications from influenza which includes hospitalization and death,” said Ann R. Falsey, MD Associate Professor of Medicine, University of Rochester School of Medicine, Rochester, NY; Infectious Diseases Unit, Rochester General Hospital. Approximately 90 percent of the 36,000 average annual influenza-associated respiratory and circulatory related deaths occur among adults 65 years of age and older.

Study Results

The Phase III study of nearly 4,000 individuals 65 years of age and older compared the high-dose influenza vaccine using the standard inactivated influenza vaccine formulated for the 2006-2007 season. The key finding is that the new high-dose vaccine elevated the immune responses to all three influenza strains compared with standard vaccine in the study population. An essential additional observation was that the increased immune response was also observed inside the potentially far more vulnerable subset of study participants who had no measurable circulating protective antibodies before receiving their annual influenza vaccine.

In the randomized double-blind study conducted at 30 centers throughout the United States , 2,575 men and women received the high-dose influenza vaccine and 1,262 received the standard influenza vaccine. The standard influenza vaccine contained 15???g of hemagglutinin (HA) of every of 3 influenza strains, along with the high-dose vaccine contained four times as much, 60???g HA per strain. Both vaccines contained two influenza type A strains (H1N1 and H3N2) and 1 influenza type B strain.

After 28 days, investigators assessed serum hemagglutination inhibition (HAI) titers in study participants, a standard measurement of the immune response to influenza vaccination. HAI titers are thought by researchers to correlate with elevated protection against illness after exposure to influenza. Statistically significant higher HAI titers against all three influenza virus strains were reported in people who received the high-dose vaccine compared with people who received the standard vaccine. Immunogenicity results met pre-defined criteria for overall superiority of the high-dose vaccine. Pre-defined criteria for overall superiority in the phase III study was based on geometric mean titers (GMT) and seroconversion, which is defined as either a rise in HAI titer from < 1:10 to a???1:40 post-vaccination or a a???4-fold increase in HAI titer post-vaccination from a pre-vaccination titer a???1:10.

In a post hoc analysis, study investigators also examined post-vaccination immune responses induced by the two vaccines among a subgroup of study participants with no protective antibodies (HAI titers less than 1:10 as measured by their pre-vaccination serum sample). This subset of the study population represents a group who may be at even greater risk for severe influenza disease and its associated complications. Among all study participants, 10 percent were seronegative for H1N1, 8 percent were seronegative for H3N2, and 21 percent had been seronegative for the B strain. Twenty-eight days after vaccination, a greater percentage of the subgroup given the high-dose vaccine developed seroprotective HAI titers of 1:40 or greater to each and every of the 3 vaccine strains compared with those given the standard vaccine. In addition, mean HAI titers for all strains had been greater inside the seronegative individuals who received the high-dose vaccine compared with those that received the standard vaccine.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided a lot more than 1.6 billion doses of vaccine in 2007, making it possible to immunize more than 500 million men and women across the globe. A globe leader in the vaccine industry, sanofi pasteur delivers the broadest range of vaccines protecting against 20 infectious diseases. The company’s heritage, to create vaccines that shield life, dates back much more than a century. Sanofi Pasteur may be the largest company entirely dedicated to vaccines. Every single day, the company invests a lot more than EUR1 million in study and development. For far more information, please visit: http://www.sanofipasteur.com or http://www.sanofipasteur.us

Forward Looking Statements

This press release contains forward-looking statements as defined inside the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are usually identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans” and similar expressions. Although sanofi-aventis’ management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are topic to various risks and uncertainties, several of which are difficult to predict and typically beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified inside the public filings with the SEC and also the AMF made by sanofi-aventis, which includes those listed below “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended December 31, 2007. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

Source
Iris D. Shaffer (for Cooney/Waters Group on behalf of sanofi pasteur)
Sanofi-aventis

4 (two votes)

Giving individuals age 65 and older a dose four times larger than the standard flu vaccine boosts the amount of antibodies in their blood to levels considered protective against the flu, far more so than the standard flu vaccine does. The findings from a study of nearly 4,000 folks were presented Oct. 26 at a national meeting on infectious diseases.

The higher dose of vaccine normally resulted in approximately 30 to 80 percent a lot more antibodies against flu, long considered a good measure of protection.

Ann Falsey, M.D., associate professor of medicine in the University of Rochester School of Medicine and Dentistry and an infectious diseases specialist at Rochester General Hospital, presented the results in the 48th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)/Infectious Diseases Society of America (IDSA) 46th annual meeting. The study was funded by sanofi pasteur, the vaccines division of sanofi-aventis Group, which makes Fluzone? Influenza Virus Vaccine, a licensed flu vaccine utilised widely within the United States and elsewhere.

The immune system typically weakens as we get older, not only leaving people a lot more vulnerable to infection but also reducing their ability to respond to vaccination. Whilst some studies have questioned the effectiveness of the flu vaccine in older adults, the nation’s leading public wellness experts stress that it’s a worthwhile, even life-saving, measure. About 90 percent of the estimated 36,000 men and women who die from flu-related causes inside the United States each year are 65 and older.

“Without doubt, the influenza vaccine as it’s today is beneficial for everyone, such as older adults, and we strongly encourage every single older person, and every person with a chronic illness, to obtain vaccinated,” said Falsey. “However, older folks generally don’t respond to vaccines as well as young healthy adults and therefore, there’s much room for improvement. The goal is to increase immune response in older adults, since this is one of the populations most at risk for becoming seriously ill or dying from influenza.”

The conventional flu vaccine is actually a combination of three circulating strains of flu, with every single component consisting of 15 micrograms of material designed to evoke an immune response to protect a individual against a particular type of flu. Inside the study headed by Falsey and conducted at 30 sites about the country in fall 2006, physicians compared the immune response brought about from a traditional flu vaccine compared to that from a vaccine shot containing four times as much material – 60 micrograms of material known as hemagglutinin for every single of the three components.

In the study of folks age 65 and older, the larger dose was given to two,575 participants, although 1,262 subjects received the standard dose. Scientists checked the level of antibodies within the blood of the participants 1 month later. Normally, the large-dose vaccine increased the number of flu antibodies in study participants on average 30 to 80 percent. The level of such antibodies in the blood has long been considered a good gauge of how protected men and women are against the flu.

A greater percentage of men and women who received the high-dose vaccine had the typical side effects associated with the flu shot, which includes redness, swelling, and discomfort in the site of the injection, but the symptoms usually did not last longer than 3 days.

One particularly interesting bit of data from the study, based on Falsey, was the effect of the larger dose on folks who had no measurable antibodies against certain strains of the flu when the study began. Such people are considered especially vulnerable because their body doesn’t have the “head start” that most men and women have in generating at least some protection against flu on their own, before the vaccine gives a needed boost. These folks might also represent a group that does not respond well to vaccines in general.

Even in this group, the larger dose greatly increased the number of such individuals who ultimately had antibody levels considered protective. For example, 51 percent of such people who received the standard dose had an antibody level thought to be protective against 1 of the strains, H1N1, included within the vaccine, whilst 74 percent of participants who received the high dose reached the same levels. The percentages also went up for the other two strains included in the shot, from 82 to 96 percent for the H3N2 strain and from 41 to 56 percent for the type B strain.

“These are the people at the highest risk for becoming really sick from influenza, and we saw significant improvement inside the immune response in a lot of of these folks,” said Falsey. “This is really encouraging.”

Among the study participants were 129 in Rochester, N.Y., including 100 individuals at Rochester General Hospital and 29 individuals in the University of Rochester Medical Center.

Source:
University of Rochester Medical Center

View drug information on Fluzone Preservative-free.

five (1 votes)4.75 (4 votes)

With the new flu season beginning, the open-access journal PLoS Medicine has released two studies related to influenza vaccination, every single showing that the population burden of the flu can be decreased overall by increasing the number of people vaccinated.

The flu vaccine is often recommended for distinct groups of folks whoare at a higher risk of spreading or suffering from influenza intargeted vaccination programs. However, in 2000, the province ofOntario, Canada began a universal immunization program, promotingvaccination and providing vaccination free of charge to all peopleover 6 months old. Jeff Kwong from the Institute for ClinicalEvaluative Sciences in Toronto and colleagues examined this program’seffects on influenza-related health outcomes.

To do this, they examined data from both national and provincialrecords among 1997 and 2004 in order to compare Ontario’s fluoutcomes before and after the introduction of the universal vaccinationprogram, as well as to compare Ontario’s outcomes to those of otherprovinces which continued their targeted vaccination programs. In theanalysis the group identified that the universal vaccination program wasassociated with reductions in influenza outcomes, such as flu-relateddeaths, hospitalizations and emergency room and physician visits.

The results also indicated that increasing immunization rates were notas clearly associated with a reduction in mortality and wellness careneed in older people, particularly older than 75 years, in comparisonwith younger men and women. Additionally, even with the far better access to freeflu vaccines in Ontario, a modest average of 38% of the overallhousehold population reported that they had received the vaccinations.This suggests that immunizing younger men and women who come in contact witholder people might nonetheless be useful in prevention of influenza-relatedoutcomes.

The second study investigated this idea mathematically, capitalizing ona concept known as herd immunity, in which immunization of a fewindividuals in the population contributes to reduce overall exposure topeople who are not immunized. Carline van den Dool and colleagues atthe University Medical Center, Utrecht, the Netherlands created amathematical model simulating the spread of influenza in nursing homes.

Specifically, they discovered that by increasing the proportion ofvaccinated well being care workers from zero to 100% in a 30 bed nursinghome department could reduce infections in patients by approximately 60%.On average, vaccinating seven health care workers prevented one patientfrom contracting influenza. Unfortunately, they found that even full health careworker vaccination does not guarantee complete herd immunity. Thissuggests that even when immunization rates are high, health careworkers should be vaccinated every year to reduce the risk to patients.

The authors point out that 1 of the major drawbacks of the study wasrandom variation which limits the abilities of small vaccine trials toassess the real relationship between vaccination and influenza. As aresult, further studies should be performed to confirm these results.

C??cile Viboud and Mark Miller of the Fogarty InternationalCenter, US National Institutes of Well being, contributed an accompanyingcomment in which they discuss the merits and drawbacks of theobservational study design for evaluation of influenza vaccination.

Watch the SciVeeVideo by Jeff Kwong Here

The effect of universal influenza immunization on mortalityand health care use.
Kwong JC, Stukel TA, Lim J, McGeer AJ, Upshur REG, et al.
PLoS Med 5(10): e211.
doi:10.1371/journal.pmed.0050211
ClickHere For Full Length Article

The effects of influenza vaccination of wellness care workers in nursinghomes: Insights from a mathematical model.
van den Dool C, Bonten MJM, Hak E, Heijne JCM, Wallinga J
PLoS Med 5(9): e200.
doi:10.1371/journal.pmed.0050200
ClickHere For Full Length Article

Health benefits of universal influenza vaccination strategy.
Viboud C, Miller M
PLoS Med five(10): e216.
doi:10.1371/journal.pmed.0050216
ClickHere For Full Length Article

Written by Anna Sophia McKenney
Copyright: Medical News Today
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5 (1 votes)

A universal flu vaccine candidate that could end the need for annual flu shots and offer protection against seasonal and pandemic flu strains was well tolerated and immunogenic in a Phase I study that was presented at the joint 48th ICAAC/46th IDSA annual meetings here today.

This initial clinical study of VaxInnate’s M2e universal flu vaccine candidate also validates the Cranbury, NJ-based biotechnology company’s novel approach to developing and producing flu vaccines, which is based upon a proprietary combination of toll-like receptor (TLR)-mediated immune enhancement and recombinant bacterial production of vaccine antigen.

“VaxInnate’s M2e universal flu vaccine candidate has passed a critical initial test,” said David Taylor, MD, Chief Medical Officer. “We’re encouraged by these data, which demonstrate that the vaccine is safe and elicits potent immune responses at doses below a microgram of vaccine antigen, and does so without the use of conventional adjuvants.”

Safety & Immunogenicity Established

The multicenter, double-blind, randomized, placebo-controlled Phase I study was designed to assess the safety and immunogenicity — a patient’s ability to generate an immune response — of four doses (0.three, 1, 3 and 10 ??g) of the vaccine candidate. The vaccine candidate is comprised of the ectodomain of the viral M2 protein (M2e) fused towards the bacterial protein flagellin.

Sixty healthy young volunteers aged 18-49 were randomized to receive the vaccine candidate in dosages of 0.three ??g (6 subjects), 1.0 ??g (18 subjects), 3.0 ??g (6 subjects), 10 ??g (14 subjects), compared to placebo (16 subjects), in two doses injected 28 days apart. Clinical and laboratory safety assessments took place 1 and 7 days after immunization; immune response to M2e and flagellin was assessed at 7, 14 and 28 days after every single dose. Seroconversion was defined as a serum IgG anti-M2e antibody (???g/ml) value a???0.174 and a four-fold rise in titer.

The 0.three and 1.0 ???g doses had been safe and well tolerated in all subjects and immunogenic in 18 (75%) of 24 vaccinees after the very first dose and 23 (96%) after the second dose. Inside the 1.0 ???g group, the geometric mean M2e antibody concentration was 0.4 ???g/ml after the initial dose and 1.7 ???g/ml after the booster dose. Immune responses to flagellin were also robust and did not appear to negatively affect M2e antibody responses from the booster dose. The two highest doses (3 and 10 ???g) were associated using the presence of flu-like symptoms in some of the subjects.

Given the strength of the antibody responses along with the absence of significant adverse reactions in the two lowest doses (0.three and 1.0 ??g), VaxInnate intends to continue development and clinical evaluation of the vaccine candidate at doses of 1.0 ??g and much less.

“In this trial, the M2e flu vaccine candidate was well tolerated and able to induce high antibody levels to M2e at 0.3 and 1.0 ??g, the two lowest doses we studied,” said primary investigator Christine Turley, MD, who is Director of Clinical Trials and Clinical Investigation at the Sealy Center for Vaccine Development, University of Texas Medical Branch (UTMB). “These results suggest that the M2e vaccine candidate could be a promising and much-needed new option for prevention or attenuation of influenza A disease.”

UTMB and VaxInnate researchers are collaborating on a manuscript for submission to a peer-reviewed journal.

The trial was conducted at study sites in Galveston, TX and Lenexa, KS. It was supported by a $9.5 million grant awarded to UTMB by the Bill & Melinda Gates Foundation, for better control of influenza epidemics in the developing world.

Universal Vaccination Challenges

A universal influenza vaccine is one that would supply protection against all strains of seasonal and pandemic influenza A without requiring annual shots. Although universal vaccination has been proposed to improve vaccination coverage and avoid disease, you will find no universal vaccines available at this time. Nor is there a means of developing and producing the volume of vaccine necessary to implement universal influenza vaccine recommendations given the inefficiency of current flu vaccine production.

In developing traditional vaccines, epidemiologists must predict months in advance which flu strains will be circulating through the next flu season in order to formulate a vaccine that targets the likeliest candidates. The selected strains are then manufactured in live, fertilized chicken eggs using a laborious process that takes 6 to 9 months.

Federally-funded alternative approaches that are now in development, such as cell-based production, wouldn’t reduce the time necessary to create vaccine and, furthermore, would require construction of large, committed manufacturing facilities.

The inefficiency of egg- or cell-based vaccine production makes it virtually impossible to respond to public health emergencies, such as the emergence of a pandemic avian flu, and impossible to reformulate vaccine if circulating strains do not match those inside the vaccine, as was the case throughout the last flu season.

VaxInnate’s Approach and M2e Flu Vaccine Candidate

VaxInnate M2e universal flu vaccine candidate represents a novel approach with respect to both vaccine design and production.

Unlike conventional flu vaccines, the M2e vaccine candidate targets the ectodomain of the M2 protein (M2e), an ion channel protein found on the surface of influenza A viruses. Because M2e may be the most highly conserved surface protein of the virus, VaxInnate’s vaccine candidate would eliminate the need to have for epidemiologists to identify and predict strain variants that emerge from year to year, and design an entirely new vaccine annually, as they must now.

Another key difference may be the elimination of eggs or cells for vaccine production. VaxInnate’s production technology is instead based upon the expression in recombinant bacteria of relevant influenza virus protein antigens fused to the bacterial protein flagellin. Flagellin interacts using the immune system’s toll-like receptors (TLRs), which function in human immune cells as sentries to detect pathogens and mount a general immune defense. This initial defense, in turn, stimulates an adaptive immune response that includes production of pathogen-specific antibodies.

VaxInnate scientists believe that their technology can make it possible to produce flu vaccine of heretofore unseen quality rapidly and inexpensively in volumes sufficient to meet national and global needs in as little as a couple of months. No other vaccine technology in use or in development today has these same potential capabilities.

In addition, VaxInnate’s use of bacterial expression for vaccine production doesn’t require costly expansion of manufacturing capacity, as do other influenza vaccine products. Due to its efficiency and transferability, VaxInnate’s flu vaccine could instead be produced in existing biotechnology facilities with microbial production capacity.

About VaxInnate

VaxInnate can be a privately-held biotechnology company in Cranbury, NJ and New Haven, CT that is pioneering breakthrough technology for use in developing novel, proprietary vaccines for seasonal and pandemic influenza. This technology has the potential to dramatically improve the potency, manufacturing capacity and cost-effectiveness of influenza vaccines.

In addition to an hemagglutinin (HA)-flagellin flu vaccine candidate in clinical development in the University of Rochester, VaxInnate is on track both to begin a Phase II study of its M2e universal influenza vaccine candidate and to advance a vaccine candidate for H5 avian influenza virus – the most likely parent of a new pandemic strain — into clinical development in 2009.

VaxInnate’s technology platform is also being investigated for development of vaccines for other diseases. For much more information about VaxInnate, please visit http://www.vaxinnate.com.

Source
Janet Skidmore
VaxInnate Corporation

1 (1 votes)

A single administration of a novel, nasally delivered influenza vaccine elicited immune responses in ferrets that were much more than 20 times higher than those generated by two injections of the currently approved vaccines, based on a study by NanoBio Corporation. The new vaccine employed only half the standard antigen dose to create this effect.

Results of the study are being presented today in the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)/Infectious Diseases Society of America (IDSA) 46th annual meeting in Washington, D.C.

The company’s nasal vaccines exert adjuvant activity without the want for pro-inflammatory materials, toxins or cytokines.

“Our nanoemulsion-based intranasal vaccine adjuvant system represents a paradigm shift in vaccinology. It can be employed to safely deliver multiple antigen types directly into the lining of the nasal mucosa, which is rich in dendritic cells that present the antigen(s) to the immune system,” said James R. Baker, Jr., M.D., founder and chairman of NanoBio Corp. “The nanoemulsion adjuvant uniquely interacts with these cells to trigger unparalleled mucosal and systemic immunity.”

Within the study, ferrets received 7.5, 15 and 45 micrograms of nanoemulsion-adjuvanted influenza vaccine (n=12 ferrets/dose). All 3 doses produced antibody responses substantially higher than those triggered by the standard intramuscular vaccine. The ferrets, which represent the most relevant influenza animal model for humans, were then challenged with live influenza virus, and all were protected.

“A large, unmet medical require still exists for protecting people from influenza infection,” Baker said. “The robust immunity and antigen-sparing capability demonstrated in this study are particularly essential for addressing this unmet want, as are the demands for a vaccine that would protect men and women within the face of a flu pandemic.”

NanoBio plans to begin a phase 1 clinical study for seasonal influenza inside the initial half of 2009 and is currently initiating preclinical studies in pandemic flu.

About NanoBio

NanoBio? Corp. is actually a privately held biopharmaceutical company focused on developing and commercializing anti-infective products and mucosal vaccines derived from its patented NanoStat? technology platform. The company’s lead clinical product candidates are treatments for herpes labialis (cold sores), onychomycosis (nail fungus), acne, cystic fibrosis and mucosal vaccines for influenza and hepatitis B. Company headquarters and laboratory facilities are located in Ann Arbor, Mich. http://www.nanobio.com

Source
John Coffey
Vice President, Business Development
http://www.nanobio.com
and
Becky Levine
MedThink Communications
http://www.medthink.com

4.8 (5 votes)

Wearing masks and using alcohol-based hand sanitizers may prevent the spread of flu symptoms by as much as 50 percent, a landmark new study suggests.

In a first-of-its-kind look in the efficacy of non-pharmaceutical interventions in controlling the spread of the flu virus in a community setting, researchers at the University of Michigan School of Public Health studied more than 1,000 student subjects from seven U-M residence halls throughout last year’s flu season.

“The first-year results (2006-2007) indicate that mask use and alcohol-based hand sanitizer help reduce influenza- like illness rates, ranging from 10 to 50 percent over the study period,” said Allison Aiello, co-principal investigator and assistant professor of epidemiology at the U-M SPH. Dr. Arnold Monto, professor of epidemiology, is also a principal investigator of the study.

Aiello stressed the very first year of the two-year project, called M-Flu, was a extremely mild flu season and only a few instances had been positive for flu, so results should be interpreted cautiously. Ongoing studies will test for other viruses that might be responsible for the influenza-like illness symptoms observed, she stated.

“Nevertheless, these initial results are encouraging since masks and hand hygiene may be effective for preventing a range of respiratory illnesses,” Aiello said.

The findings, “Mask Use Reduces Seasonal Influenza-like Illness In the Community Setting,” was presented Sunday in the Interscience Conference on Antimicrobial Agents and Chemotherapy and also the Infectious Diseases Society of America annual meeting in Washington, D.C.

At the start of flu season in the last two years, participants were randomly assigned to six weeks of wearing a standard medical procedure mask alone, mask use and hand sanitizer use, or a control group with no intervention. Researchers followed students for incidence of influenza like illness symptoms, defined as cough with at least one other characteristic symptom such as fever, chills or body aches, Monto said.

From the third week on, both the mask only and mask/hand sanitizer interventions showed a significant or nearly significant reduction in the rate of influenza-like illness symptoms in comparison to the control group. The observed reduction in rate of flu-like symptoms remained even after adjusting for gender, race/ethnicity, hand washing practices, sleep quality, and flu vaccination.

Non-pharmaceutical interventions such as hand washing and masks—especially in a pandemic flu outbreak—are critical to study because pharmaceutical interventions such as vaccinations and antivirals may not be available in sufficient quantity for preventing and controlling pandemic influenza outbreaks.

In February 2007, the Centers for Disease Control and Prevention along with the U.S. Department of Well being and Human Services in collaboration with other federal agencies, education, businesses, healthcare and private sectors developed an interim planning guide on the use of Non-Pharmaceutical Interventions (NPIs) to mitigate an influenza pandemic.

The measures include voluntary home quarantine, isolation and treatment of circumstances, social distancing, personal protection such as face masks and hand hygiene, and school dismissal.

“Although a few of these measures can be evaluated through seasonal influenza outbreaks, a lot of are difficult or impossible to evaluate in advance of a pandemic,” Monto said. “However, use of face masks and hand hygiene interventions can be evaluated now, throughout seasonal influenza outbreaks, which can provide concrete evidence for decision makers.”

Further studies are needed to confirm no matter whether mask use could be an efficient means of reducing influenza in shared living settings. Since it was not possible to blind subjects, knowledge of the intervention may have influenced influenza-like symptom reporting and for that reason the results of this study should be interpreted with caution, Aiello said.

“During year two of the study (2007-2008) a significant outbreak of influenza took place,” Aiello stated. “Forthcoming studies will examine whether results observed in the course of this a lot more severe outbreak mirror those observed throughout the milder year 1 influenza season. Influenza virus identification will also be examined as an additional outcome.”

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The M-Flu study is a collaboration between SPH, U-M Housing, and University of Michigan Heath Services. The study was funded by Centers for Disease Control and Prevention.

Co-authors include: Genevra Murray, PhD; Rebecca Coulborn, BS; Anne-Michelle Noone, all of the U-M SPH Department of Epidemiology.

For information about M-Flu, which includes video, news clips, FAQs, visit: http://www.sph.umich.edu/mflu/

For information about the U-M SPH: http://www.sph.umich.edu/

For information about Aiello: click here

For information about Monto: click here

The University of Michigan School of Public Wellness has been working to promote wellness and prevent disease since 1941, and is consistently ranked among the top 5 public well being schools in the nation. Faculty and students in the school’s five academic departments and dozens of collaborative centers and initiatives are forging new solutions to the complex well being challenges of today, including chronic disease, wellness care quality and finance, emerging genetic technologies, climate alter, socioeconomic inequalities and their impact on health, infectious disease, and also the globalization of well being.

Source: Laura Bailey
University of Michigan