FDA Issues Warning on Four Asthma Drugs

The government is taking steps to curb use of some long-acting asthma drugs taken by millions, issuing safety restrictions to lower an uncommon, but potentially life-threatening risk that asthma could worsen suddenly. The warning covers the drugs Advair, Symbicort, Foradil and Serevent.  The FDA said these drugs should only be used  by asthmatics who can’t control their disease with other drugs — and then only for the shortest time possible.

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Call For Scientific Inquiry Into The HPV Vaccine Used in The UK

The Alliance for Natural Health today is calling on all Members of Parliament in the UK to help stimulate an independent and transparent scientific inquiry on the safety of the HPV vaccine.

Press Release

For immediate release

9th October 2009

ALLIANCE FOR NATURAL HEALTH CALL FOR AN URGENT SCIENTIFIC INQUIRY INTO THE HPV VACCINE USED IN THE UK

Reports of serious and even lethal adverse reactions to the Human Papilloma Virus (HPV) vaccine, Cervarix, manufactured by GlaxoSmithKline, raises grave concern over the safety of the vaccine.  While its closely related vaccine, Gardasil, manufactured by Merck, is recognised by the US Centers for Disease Control (CDC) to trigger severe reactions, namely hospitalisation, permanent disability, life-threatening illness or death, equivalent data in the UK appears not to be publicly available.

In addition, the tragic case of 14-year-old Natalie Morton’s death just two hours following her vaccination, which was considered by the pathologist in her post mortem as being completely independent of the vaccine, has raised further questions in the minds of many about the accuracy of reporting.

The role of the HPV vaccines in the development of disabling symptoms in the cases of Stacey Jones (18), Rebecca Ramagge (13), Lisa Wickenden (13), Carly Steel (13) and Ashleigh Cave (13), appears to be unresolved and circumstantial evidence would suggest that Cervarix may have been at least a contributing factor in their respective conditions.

Dr Diane Harper of the University of Missouri, who was directly involved in clinical trials on HPV vaccines, is among a growing number of scientists who have publicly expressed their concerns over the vaccines’ safety.

Cervarix was approved for use in the European Union in September 2007 for the prevention of precancerous changes in the cervix in girls and women between the age of 10 and 25.  The vaccination programme started in September 2008 for girls aged 12 to 13, delivered in three injections over 6 months.  There is a new, accelerated catch-up programme for girls aged 15 to 18 years starting in September 2009, due to complete by end of the academic year 2010.

Given the number of girls, the lack of transparency on the frequency and type of adverse reactions, as well as the possibility of long-term effects on the reproductive system, the Alliance for Natural Health is requesting all Members of the UK Parliament to put pressure on the Government to initiate an independent and fully transparent scientific inquiry on the short and long term effect of the vaccine.

The Alliance for Natural Health is an international campaign organisation comprised of scientists, doctors, lawyers, practitioners and consumers, working to promote natural and sustainable approaches to health through the use of ‘good science’ and ‘good law’.

Executive Director of the Alliance for Natural Health, Robert Verkerk, stated: “Young girls in the UK—as well as their parents and guardians—deserve to have the full facts on the risks and benefits of this vaccine to help them make properly informed choices. The NHS position is that the vaccine is safe, but the facts would suggest otherwise.  Presently, there are no adequate data available on the comparative risks of Cervarix and Gardasil. Neither is there adequate information on the factors which may predispose certain individuals to serious adverse reactions, nor about the duration and effectiveness of immunity following single and multiple vaccinations.  It is in the public interest—and of utmost urgency—that these key questions are answered by an independent scientific review panel and are made public.”

FOR FURTHER INFORMATION, PLEASE CONTACT:

Sophie Middleton
Campaign Administrator
The Alliance for Natural Health
The Atrium
Curtis Road
Dorking
Surrey
RH4 1XA

Tel: +44 (0)1306 646 600
info@anhcampaign.org

NOTES FOR THE EDITOR:

For more information about the HPV vaccine (by ANH Medical Director, Dr Damien Downing):
http://anhcampaign.org/news/anh-feature-the-hpv-vaccine-gardasil-in-the-spotlight

For more information about cases which may be linked to the HPV vaccine:
http://anhcampaign.org/news/brain-damage-follows-hpv-vaccination-in-uk

The ANH Vaccine Choice campaign page:
http://anhcampaign.org/campaigns/vaccine-choice

About the Alliance for Natural Health:
http://www.anhcampaign.org

The Alliance for Natural Health (ANH) is an international, non-governmental organisation, based in the UK. It was founded in 2002, and works on behalf of consumers, medical doctors, complementary health practitioners and health-product suppliers worldwide, to promote natural and sustainable health, using the principles of good science and good law.

Robert Verkerk DIC PhD MSc BSc
Executive and Scientific Director
The Alliance for Natural Health
Curtis Road
Dorking
Surrey RH4 1XA
United Kingdom

tel:  +44 (0)1306 646 600
fax: +44 (0)1306 646 552
email: info@anhcampaign.org
www.anhcampaign.org

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FDA Approves Vaccines for H1N1 Influenza Virus

And So It Begins…

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FDA PRESS RELEASE

The U.S. Food and Drug Administration (FDA) has approved four vaccines for use against the 2009 H1N1 influenza virus.

The vaccines—made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc.—will be distributed nationally after the initial lots become available. This is expected to occur within the next four weeks.

Commissioner of Food and Drugs Margaret A. Hamburg, M.D., says the approval is good news for the nation’s response to the 2009 H1N1 influenza virus. “The vaccine will help protect individuals from serious illness and death from influenza,” she says.

Vaccines against three seasonal virus strains are already available and should be used. However, they do not protect against the 2009 H1N1 virus.

What have studies of the H1N1 vaccines shown?
Based on preliminary data, the approved vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine.

Clinical studies under way will provide more information about the optimal dose in children. Recommendations for dosing will be updated if indicated by findings from those studies. The findings are expected in the near future.

What are the warnings and potential side effects?
In the ongoing clinical studies, the 2009 H1N1 vaccines have been well tolerated. However, consumers need to be aware of the following:

• People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.

• Potential side effects of the H1N1 vaccines are expected to be similar to those of seasonal flu vaccines. For the injected vaccine, the most common side effect is soreness at the injection site. Other side effects may include mild fever, body aches, and fatigue for a few days after the inoculation. For the nasal spray vaccine, the most common side effects include runny nose or nasal congestion for all ages, sore throats in adults, and—in children 2 to 6 years old—fever. (Also see seasonal flu information in the “For More Information” section below.)

• As with any medical product, unexpected or rare serious adverse events may occur.

FDA is working closely with other agencies to enhance adverse-event monitoring, information sharing, and analysis during and after the 2009 H1N1 vaccination program. In the U.S. Department of Health and Human Services, these agencies include the Centers for Disease Control and Prevention (CDC).

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

FDA Date Posted: September 16, 2009

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FDA Gifts Merck’s Garasil With Broader Market Access

FDA advisory panel recommends approval of Gardasil to prevent genital warts in young men

Bonus Lobbying Victory: European regulators give Gardasil nod for use in women up to the age of 45

Last week was good to Merck’s hopes for an improved bottom line next quarter. It was a very a disappointing week for those of us who feel the HPV vaccine has the potential to do more harm than good, and continues to preempt scarce public health funds better used for more effective programs, like universal access to PAP Tests.

Merck’s FDA and European Gardasil market-expansion victory was some what muted by its potential competitor, GSK’s Cervarix own good news as it inches  closer to FDA approval. Merck has used all of its Federal regulatory lobbying influence to delay FDA approval of Cervarix for the American market.

Merck actively sought new indications for Gardasil to help combat falling sales of their human papillomavirus shot

Merck’s Garasil vaccine, promoted to prevent cervical cancer and genital warts, roared onto the market in 2006, but since then has decelerated sharply. Merck has been lobbying to increase its potential market to boys and mature women. It failed to persuade FDA to broaden use to older women–up to the age of 45–but now has convinced an agency advisory committee that Gardasil would be useful for boys and young men.

A few panelists–and at least one analyst–point out that approval for use in males doesn’t necessarily mean males will use it. The series of three shots is expensive, around $400, and will require three visits to the doctor over a six-month period…to prevent a nonfatal venereal disease. “Pretty much no healthy teen would ever do that,” Tim Anderson, analyst with Sanford C. Bernstein, told the New York Times.  (Good point Tim. The more cynical amongst those of us, who have fought use of Garasil  since the beginning, are wondering if, even now, the Merck marketing team is not trying to whip up false scare tactics that will herd fathers into take their sons in to doctor’s offices in massive numbers — after all, those catchy, cute commercials worked to move hundreds of thousands of well meaning mothers to contribute to those fat bonuses Merck Execs passed out in 2006 and 2007.)

Merck is expected to argue for vaccination of boys and young men in part to help protect girls and young women. But it remains to be seen whether that “herd immunity” argument will work on parents and insurers who have to pay for the shot.

The European approval, meanwhile, addresses cervical cancer, which is potentially fatal. [Sandi note: Merck’s phasing, not mine. Cervical cancer is potentially, but rarely fatal if women have regular PAP tests after they become sexually active.] In Europe, the vaccine is marketed by Sanofi Pasteur MSD, a joint venture between Merck and Sanofi-Aventis. European regulators gave the nod to expand use of Gardasil to women up to age 45, when previously it was only indicated for those up to age 26.

This new expansion gambit is a complete mystery. In 2006 the rational used by Merck lobbyists for vaccinating school-girls as young as age 10 was that the HPV-vaccine Gardasil was not effective once the girls were exposed to HPV via sexual activity. Hundreds of thousand of girls have been herded into doctor’s offices by mothers and State regulators on the promise of lifetime protection from cervical cancer.  As more non-marketing information became available, questions that should have been asked and answered BEFORE approval began to be discussed. Dr. Diane Harper, one of the designers of the early trials, questioned the long-term effectiveness of the vaccine and raised the possibility of booster shots needed just at the age when young women became sexually active.  Based on Merck rational for expanding Gardasil usage for women up to their mid-forties, why do we continue to put young girls at risk with a vaccine with a history of adverse effects and has been tied to the deaths of young healthy girls.

In the U.S., the FDA has asked Merck for more data on Gardasil use in women 27 to 45 years old; the company expects to provide that info by the end of this year. Mother’s need to watch this like hawks. Read the FDA rational and the Merck aguments for expansion.  The money spent enriching Merck executives is far better used expanding access to PAP tests.

Sources:

Read Full NYT story: Two Giants Vie for Billions in S.T.D. Vaccine Market:

Read Full Story from CNNHealth.com: FDA panel urges HPV vaccine be given to boys

Read Wall Street Journal article: FDA Panel Backs Cancer Vaccines

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MERCK Press Release Touting Clinical Efficacy of Gardasil for Mature Women

The product information for Gardasil® has been updated to include the clinical efficacy and safety of the vaccine for women up to 45 years of age.

– The product information of the four-type (6,11,16,18) human papillomavirus (HPV) vaccine Gardasil® has been updated to include the clinical efficacy and safety information of the vaccine for women up to 45 years of age.*,1

In a clinical study which included 3,819† women between 24 and 45 years of age, among those who were not infected with the relevant virus type at vaccination‡ and who received all three doses of the vaccine (3,351 women§, Gardasil® prevented 90.5%** of HPV 6-, 11-, 16-, or 18-related persistent infection, cervical lesions (CIN††) of any grade, adenocarcinoma in situ (AIS), cervical cancer, vulvar and vaginal lesions and genital warts.1,2

Gardasil® was generally well tolerated and demonstrated a good safety profile with fever as well as redness, swelling and pain at the injection site as the most commonly reported side effects.1,2

“Vaccination recommendations or campaigns from health authorities will continue to focus on adolescent girls. However, women may remain at risk of HPV infection and developing related diseases during their adult life. Women should be aware of the efficacy and safety of Gardasil® up to 45 years. They should make an informed decision about individual vaccination following discussion with their doctors taking into account their personal and HPV disease histories“, says Professor Xavier Bosch from the Catalan Institute of Oncology in Barcelona, Spain.

All women should continue regular screening for early detection of cervical cancer whether they have been vaccinated or not. Gardasil® is a preventive vaccine and can therefore not treat preexisting infections or disease. The vaccine cannot protect against all HPV types.

Gardasil® is the only HPV vaccine to have clinical efficacy and safety for women up to 45 years added to its product information. Gardasil® is a four-type (6,11,16,18) HPV vaccine. In addition to unsurpassed and sustained cervical cancer protection, Gardasil® can protect from cervical, vulvar and vaginal pre-cancer, and from genital warts caused by HPV types 6, 11, 16 and 18. These four types together cause the vast majority of HPV-related genital diseases.1,3,4,5

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Vical Pandemic Influenza Vaccine Shows Strong Results in H1N1 Study

Vical vax demonstrates cross-reactivity against California,Texas and Mexico H1N1 strains

Vical Pandemic Influenza Vaccine Demonstrates Cross-reactivity Against California, Texas and Mexico H1N1 Strains

Vical Incorporated (Nasdaq:VICL) announced today that the company’s DNA vaccine against A/H1N1 pandemic influenza (swine flu) has demonstrated robust immune responses in 100% of vaccinated animals against virus strains isolated from recent outbreaks in three distinct geographic locations — California, Texas and Mexico.

Vical’s plasmid DNA vaccine contains the H1 hemagglutinin gene sequence provided by the U.S. Centers for Disease Control and Prevention (CDC) for the swine-origin A/California/04/09 pandemic influenza virus, and after two doses produced immune responses well above the accepted protection threshold in 100% of vaccinated mice and rabbits using HI assays against the swine-origin A/California/07/09 x-179a, A/Texas/15/09 and A/Mexico/4108/09 influenza viruses. Hemagglutination inhibition (HI) titers were well above the protection threshold of 40, ranging from 320 to 2,560 in mice, and from 640 to 2,560 in rabbits against the California strain. Results against the Texas and Mexico strains were essentially equivalent, ranging from 640 to 2,560 in both mice and rabbits. Vical’s vaccine would also be expected to provide similar robust immune responses against other swine-origin A/H1N1 influenza virus subtypes, supporting selection of a single A/H1N1 virus strain as the basis for the vaccine.

“Cross-reactivity is consistent with previous CDC reports that circulating strains of swine-origin A/H1N1 pandemic influenza have remained antigenically homogeneous,” said Vijay B. Samant, President and Chief Executive Officer of Vical, “but future viral changes are unpredictable and could be far more substantial. The inherent speed of our DNA vaccine platform both in initial development and manufacturing could be extremely important in addressing the potential shortfalls of conventional vaccine approaches.”

Vical has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Naval Medical Research Center (NMRC), a biomedical research organization within the U.S. Navy, to develop a vaccine against H1N1 influenza.

“We are working with the U.S. Navy to secure funding to advance our H1 vaccine into human clinical testing,” added Mr. Samant. “Based on the sustained threat from the ongoing H1N1 pandemic, we have initiated critical-path manufacturing activities to allow initiation of a Phase 1 trial in as little as four to six weeks after funding is secured.”

About Vical

Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company’s DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.

The Vical Incorporated logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5768

This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about Vical’s vaccine technologies and their potential application in a vaccine against H1N1 influenza, potential human clinical testing of such a vaccine, the Vical/NMRC CRADA, potential changes in circulating strains of influenza, potential government regulatory and procurement activities, as well as the company’s focus, collaborative partners, and product candidates. Risks and uncertainties include whether the company’s technologies will be successfully applied for the development of an H1 DNA vaccine; whether such vaccine will advance to clinical testing quickly, if at all; whether funding will be secured to support a Phase 1 trial; whether Vical, NMRC or others will continue development of any influenza DNA vaccine candidates; whether Vical and/or NMRC will terminate the CRADA before achievement of its objectives; whether the company’s DNA vaccine candidate will be effective in protecting humans against H1N1 or any other strains of influenza; whether H1N1 pandemic influenza will undergo substantial strain changes; whether Vical’s pandemic influenza vaccine will advance sufficiently to be considered for licensure during future pandemics; whether results in animal testing will be predictive of results in human testing; whether any product candidates will be shown to be safe and effective; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; whether Vical or its collaborative partners will succeed in marketing any product candidates; and additional risks set forth in the company’s filings with the Securities and Exchange Commission. These forward-looking statements represent the company’s judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.

CONTACT: Vical Incorporated
         Alan R. Engbring
         (858) 646-1127
         www.vical.com
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Cervarix On Track for FDA Approval, Garasil to Have Expanded Use

FDA experts back Merck’s application to extend the use of Gardasil to males

In twin votes likely to add considerable force to U.S. marketing efforts for HPV vaccines, an FDA expert panel has voted to back GlaxoSmithKline’s long delayed application to market its HPV vaccine Cervarix to women and soon after supported Merck’s application to extend the use of Gardasil to males. Glaxo shares gain 0.5 pct, Merck shares gain 1.9 pct.

Glaxo had originally tried and failed to gain FDA approval for Cervarix back in 2007 but was thwarted by the agency’s desire to see more information on potential side effects, particularly a heightened risk of miscarriage. Since that time the pharma giant has gained approvals in more than 100 countries, while biding its time with the FDA. And while the panel concluded that the link between Cervarix and miscarriages is tenuous, the experts suggested a warning to prevent pregnant women from getting the vaccine. The panel vote makes it all but certain that Glaxo will gain final marketing approval from the FDA, opening the door to the world’s biggest drug market and finally offering Merck some competition for Gardasil. Glaxo’s shares were buoyed by the news.

Food and Drug Administration advisers, in an 11-1 vote, said Cervarix appeared safe despite miscarriages reported around the time of vaccination and a small number of autoimmune problems such as rheumatoid arthritis and lupus. Panelists urged monitoring for those issues after approval to see if there was any link to the vaccine.Merck, meanwhile, is seeking an FDA approval to use its HPV vaccine to guard against genital warts in boys and men. The panel gave Merck its support, but there was widespread agreement that the use of an HPV vaccine for males 9 to 26 offered little protection against cancer, as HPV-related penile and anal cancer cases are extremely rare. The FDA has indicated that any final approval on Gardasil’s use in males will require post-marketing safety studies.

Check out full story in  the Los Angeles Times
Read  Reuters Report

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China Readies to Launch Mass Vaccination Campaign

Plans to inoculate students, pregnant women,  China’s police, health care and other key workers

With two new swine flu vaccines approved for use and five million doses scheduled for delivery this month, China is set to become the first country to begin a mass vaccination campaign against the H1N1 pandemic. But officials with the World Health Organization say that there are some concerns about potential side effects.

Sinovac Biotech wasted little time in testing and gaining official approval of its new swine flu vaccine. Now some of the 200,000 people expected to show up in Beijing beginning October 1 for the 60th anniversary of the founding of the country’s communist government will be first in line for the jab. After that the country plans top inoculate students, pregnant women, healthcare workers and China’s police and other key workers.

China has to be selective. Going all out it can expect to inoculate 65 million people by the end of the year – only a fraction of the country’s population of 1.3 billion. Health officials the world over will be watching China’s experience closely. If the Chinese begin to report side effects, it could have a big impact on how people in the rest of the world view these new vaccines. There’s considerable built-in resistance to noval vaccines, particularly among health workers.

Shares of Sinovac Biotech (NYSE: SVA) are higher on reports from Reuters, China approved the company for H1N1 vaccine production and the company raised their sales guidance. The stock is up 19%.

CEO Yin Weidong said, “At the beginning of this year, we forecast our sales would rise by 20 percent. H1N1 has given us an opportunity, so the rise should be more than 20 percent.”

Sinovac says patients needs only one 15 microgram dose of the vaccine to be effective. Novartis (NYSE: NVS) also said its vaccine gave a strong immune response after one dose in a pilot trial.

Review The Street Insider Report

– read the CNN report

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Muscle density predicts risk of hospitalization

Muscle density is the ratio of lean tissue to fat contained within muscle

Elderly Women At Risk
Elderly Women At Risk

A study conducted at the California Pacific Medical Center Research Institute indicated that elderly with low muscle density have a higher likelihood of being hospitalized than those with a more moderate ratio and suggests it may be a better predictor of the risk of hospitalization than muscle mass or size

New research suggests exercise programs designed to increase muscle density in the elderly could help reduce rates of disability and hospitalization. Researchers  studied 3,011 healthy U.S. residents, aged 70 to 80. During about a five-year span, more than 55 percent of them were hospitalized at least once. People most likely to be hospitalized were those who scored lowest on measures of physical function, such as walking speed, ability to stand up from a chair repeatedly, grip strength and leg strength.

In a study published in the current issue of the Journal of the American Geriatrics Society, researchers also found that people with the least dense thigh muscles — meaning more fat than lean tissue — were more likely to be hospitalized than those with more dense thigh muscles.

“Our research suggests that we need to re-think the way we define sarcopenia, or age-related muscle loss,” study author Peggy Cawthon, a scientist with the California Pacific Medical Center Research Institute, said in a news release from the American Geriatrics Society. “Many definitions of sarcopenia today tend to focus on lean mass or muscle size. Our study shows that is looking at the wrong factors. We found that muscle strength or performance were much better ways of measuring function.”

The findings “suggest that interventions, such as physical exercise, that improve physical function could help keep more vulnerable seniors out of the hospital,” she said. “That would not only reduce disability but it would also reduce the huge economic burden associated with hospitalization of the elderly.”

One in five Americans older than 65 has sarcopenia. In 2000, the direct costs of treating the condition were more than $18.5 billion, according to background information in the news release.

The team analyzed more than 3,000 healthy seniors aged between 70 and 80 for an average of five years and looked at factors such as their walking speeds, ability to stand up repeatedly and leg strength. They found that the largest number of hospitalizations occurred among those with the least dense muscles.

Dr. Peggy Cawthon, the study’s lead author, says the findings are important because they suggest non-pharmacological and non-surgical approaches such as enhanced physical activity or moderate exercise may help keep vulnerable seniors out of hospital.

A high-protein diet or appropriate supplementation may also be useful for some seniors at risk of low muscle density.

Source for Additional Information:

Bone density and risk of hip fracture in men and women: cross sectional analysis

bmj.com
CEDHD Laet, BA Hout, H Burger, A Hofman, … – British Medical Journal, 1997 – bmj.com
BMJ 1997;315:221-225 (26 July) Papers. Bone density and risk of hip fracture
in men and women: cross sectional analysis. Chris EDH

Forbes: Muscle Density Linked to Disability

More information

The American Academy of Orthopaedic Surgeons has more about the physical effects of aging.

ADNFCR-1961-ID-19343380-ADNFCR

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Australia’s swine flu vaccination plans come under fire

“It’s a complex issue which needs to be thrashed out publicly. We’d encourage the key bodies involved to have that debate, to provide that information. Consumers want to know the facts.”

— Carol Bennett, the head of the Consumers Health Forum of Australia

The Australian government’s impending programme of vaccination against H1N1 flu has been criticised by some professional groups that have raised concerns about potential risks.

The Australian Infection Control Association this week warned the government against proceeding with the programme, saying that the planned use of multidose vials (used to vaccinate several people) posed a “significant potential risk to patient safety.”

The association’s president, Claire Boardman, said that use of multidose vials would contravene national infection control guidelines (www.safetyandquality.gov.au/internet/safety/publishing.nsf/Content/02A94EEE98D72244CA25740F00251B98/$File/NationalInfectionControlGuidelines.pdf) and that numerous adverse events related to their use had been well documented.

Ms Boardman said there was no justification for using multidose vials, as “the occurrence and distribution of H1N1 in 2009 within Australia does not constitute an emergency.”

She added, “We advise strongly against the use of multidose vials and do not support this mechanism for dissemination of the vaccine,” and warned that the “high risk of failure” of the pandemic vaccination campaign could compromise future programmes and also risked causing poor uptake of seasonal flu vaccination next year.

The association’s comments follow similar concerns raised by the Australasian Society of Infectious Diseases in a letter to the government’s chief medical officer, Jim Bishop, widely reported in the media (www.abc.net.au/pm/content/2008/s2662248.htm).

However, some experts involved in trials of an H1N1 vaccine being developed by the vaccine manufacturer CSL Limited believe that any potential risks are minimal and are being blown out of proportion.

Robert Booy, professor of paediatrics and child health at the Children’s Hospital, Westmead, Sydney, and the coauthor of a blog defending the vaccine’s safety (www.aussmc.org/ScienceBlog.php), told the BMJ: “There is considerable and emerging evidence for safety of multidose vials, especially in the hands of trained nurses. Being stalled by this controversy may make us a laughing stock to the rest of the world.”

CSL has repeatedly said that the multidose vials are safe.

But Peter Collignon, an infectious diseases physician and microbiologist at the Australian National University, said it was hard to see why Australia should abandon its usual practice of using mainly single dose, preloaded syringes.

“The only reason to use multidose vials is to save money or else because there is a rapidly evolving emergency with a high death rate,” Professor Collignon said. “Neither of these conditions is currently present in Australia. We passed the peak of this epidemic in most states in Australia in mid-July.

However, Professor Bishop said that this view overlooked the possibility of another wave of infections before next winter.

“The World Health Organization has said this virus is unpredictable; past pandemics have told us that pandemics don’t run in seasons,” he said.

Professor Bishop said that multidose vials would be used in all H1N1 vaccination programmes that he knew of around the world and that they were also used in the United States for vaccination against seasonal flu. Vaccination providers would be trained in use of multidose vials to maximise infection control and minimise wastage.

“In order to get vaccines out in a reasonable quantity and logistically, the multidose vial has many advantages,” he said.

He said he expected that vaccine supplies would start to become available this week and that the vaccine would initially be given to high risk groups, with the eventual aim of having at least 40% of the population protected.

Julie Leask, a University of Sydney social scientist who researches public acceptance of vaccines, said that the poor image of swine flu vaccination among the public meant that there may be “underwhelming demand” and that “full transparency from the authorities” would be needed to ensure public confidence.

The public would need to know the data the government was using to assess the vaccine and the risks of swine flu in Australia and that systems for reporting adverse events were in place, she said.

Carol Bennett, the head of the Consumers Health Forum of Australia, said it was important that the potential benefits and risks of flu vaccination were openly discussed.

“It’s a complex issue which needs to be thrashed out publicly,” she said. “We’d encourage the key bodies involved to have that debate, to provide that information. Consumers want to know the facts.”

Free Article Reprinted with permission in the public interest

BMJ NEWS: Reported by Melissa Sweet, Sydney AU

Published 8 September 2009, doi:10.1136/bmj.b3656
Cite this as: BMJ 2009;339:b3656

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