WHO: World H1N1 Deaths Now at Least 11,516

GENEVA —  At least 11,516 people around the globe have died from the H1N1 flu virus since the pandemic emerged in April, the World Health Organization (WHO) reported on Wednesday.

But in its weekly update, which showed an increase in officially reported deaths of nearly 1,000 since its last report, it said the disease appeared to have peaked or plateaued in Western Europe and North America while transmission was declining in parts of Asia.
In the United States and Canada, the virus remained geographically widespread but overall levels of flu-like illnesses had declined substantially and hospitalizations and deaths were dropping, the WHO said.


In Europe, active transmission of the virus was still widespread across the continent but in a majority of countries its activity appeared to have peaked — although it was increasing in central and eastern parts of the continent.
In an earlier report on Tuesday, the United Nations agency said the pandemic remained moderate but continued to infect and sometimes kill much younger people than traditional seasonal flu.
But although it gives figures of confirmed deaths from H1N1, sometimes known as swine flu, officials at the WHO say comparing mortality numbers from the two types of flu is complicated and can be misleading.

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H1N1 Deadlier in Children Than Seasonal Flu

BOSTON —  H1N1 swine flu can kill children at a much higher rate than seasonal flu, and the elevated risk for pregnant women extends as long as two weeks after they give birth, researchers reported.
The findings show that the H1N1 pandemic, while overall no more deadly than seasonal flu, is capable of hitting vulnerable women and children far harder than regular flu usually does.
"Pediatric 2009 H1N1 influenza was associated with pediatric death rates that were 10 times the rates for seasonal influenza than in previous years," Dr. Romina Libster of Hospital Posadas in Buenos Aires and colleagues wrote in the New England Journal of Medicine.
They said hospitalization rates for children with H1N1 were twice those of the 2008 rate for seasonal influenza.
H1N1 flu has killed more than 10,000 people in the United States alone, infected nearly 50 million and put 200,000 into the hospital. Pregnant women and children were known to be at higher risk and had already been given priority for the vaccine.
The results show that prompt treatment is important, Dr. Fernando Pollack of Vanderbilt University in Tennessee said in a telephone interview. Roche AG's Tamiflu and GlaxoSmithKline's Relenza can help ease symptoms if given quickly.
"We cannot chase this disease from behind. Once it gets going, it is very difficult to treat. All our fatal cases had not been treated within 48 hours of the development of symptoms," he said.
"Patients with lung problems or neurologic problems are at serious risk of not only having serious disease, but dying of swine flu," Pollack added. "They should not only be targets for vaccination, but for treatment."
Of 251 children hospitalized with H1N1 at six pediatric centers in Buenos Aires through July, 19 percent ended up in the intensive care unit and most of them required mechanical ventilation.
The death rate was 5 percent. Nearly one third had no pre-existing health problems, and the risk was highest among children less than 1 year old.
In contrast, none of the youngsters hospitalized for seasonal influenza required intensive care.
A second study, involving 94 pregnant women who became ill with H1N1 before Aug. 11 in California, found that those who delayed treatment were four times more likely to end up in the intensive care unit or die compared to those who received antiviral therapy no later than two days after symptoms appeared.



"Although pregnant women frequently presented with mild or moderate symptoms, many had a rapid clinical progression and deterioration," Dr. Janice Louie of the California Department of Public Health and colleagues wrote.
Eight women who were hospitalized for H1N1 flu had given birth less than two weeks earlier, four required intensive care and two died, "highlighting the continued high risk immediately after pregnancy," the researchers said.
That result was surprising, Louie said in a telephone interview. She did not know why women continue to be vulnerable after giving birth.

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Guidance for expanded use of oseltamivir (Tamiflu®) in children under one year of age in the context of Pandemic (H1N1) 2009

The following guidance should be read in conjunction with relevant provincial and territorial guidance documents. The Public Health Agency of Canada will be posting regular updates and related documents at www.phac-aspc.gc.ca.

ntroduction

This guidance document has been prepared by the Public Health Agency of Canada to assist clinicians in the management of children under one year of age presenting with influenza-like-illness (ILI) in the context of the pandemic (H1N1) 2009 (pH1N1).  This guidance has been updated based on current scientific evidence, expert opinion and the Interim Order, issued by the Federal Minister of Health, permitting the expanded use of oseltamivir for the influenza A H1N1 virus in children under 1 year of age.Although there are limited data regarding the use of Tamiflu® in children under one, there continues to be a need for recommendations to treat this population, given their increased risk for morbidity and mortality from influenza.   Similar actions have also been taken internationally by the US FDA and the EMEA .  This guidance is subject to review and change as new information becomes available.  These guidelines should be used in conjunction with guidance contained in the Clinical recommendations for patients presenting with respiratory symptoms during the 2009-2010 influenza season, H1N1 PHAC Guidelines for health professionals, Annex E and Annex G of the Canadian Pandemic Influenza Plan.

Influenza and children

Healthy children under 24 months and children with certain chronic health conditions are at increased risk of influenza-related complications and hospitalization from seasonal influenza⁶ .  Recent Canadian epidemiological data for pH1N1 indicates higher rates of hospitalization and ICU admissions in children under 1 year of age compared with all pH1N1 cases in Canada.  In children under the age of 2 years, greater than 90% have presented with fever when infected with pH1N1. Children may have higher fevers and may have febrile seizures. Atypical presentations are most common in infants, the elderly and immunocompromised persons. Unexplained fever may be the only manifestation of the disease in infants.  In infants less than 2 months old, the condition can progress rapidly to severe illness.  Younger children may experience nausea, vomiting, diarrhea and abdominal pain⁷ .  Infants may also present with neurologic symptoms suggestive of meningitis or encephalitis, although the data for pH1N1 indicates these symptoms have occurred in < 5% of cases. *
* Public Health Agency of Canada. Unpublished data. 

CLINICAL MANAGEMENT of children under 1 year of age

Antivirals can reduce complications and mortality from influenza. Currently, the pH1N1 virus is susceptible to oseltamivir (Tamiflu®) and zanamivir (Relenza®), but resistant to amantadine.  Relenza® is indicated only in children 7 years or older.  The Interim Order issued by the Federal Minister of Health, pursuant to her authority under the Food and Drugs Act, permits the expanded use of oseltamivir as a treatment or prophylaxis for children under 1 year of age, for infection caused by the pH1N1 virus¹. Adverse event data regarding use in children over 1 year of age is available in the Product Monograph⁸
Clinical recommendations for the management of children under 1 year of age presenting with suspected, probable or confirmed pH1N1 infection, include early antiviral treatment (within 48 hours of symptom onset) and close follow-up, as they are at high risk for complications of influenza. When pH1N1 is known to be circulating in the community, clinicians should not wait for laboratory confirmation prior to initiating treatment. The parents or guardian should be informed that this is exceptional use. A recent review of the available clinical safety data indicates that there are no new safety signals for this age group and that the safety profile remains similar to that seen in children over one year of age. Currently available pharmacokinetic data supports updating Canadian recommendations for oseltamivir dosing. If oseltamivir is prescribed, the following dosing is recommended:
A) Treatment

Age	Recommended Dose (weight-based), 1, 2
1 month to < 12 months	3mg/kg/dose twice daily for 5 days
< 1 month	2 mg/kg/dose twice daily for 5 days
1 Not to exceed 30 mg twice daily, in accord with recommended dosing for patients > 1 year of age 2 Weight-based dosing is preferred, however, if weight is not known, dosing by age for full-term infants may be necessary as follows: 0-<3 months =  12 mg twice daily; 3-<6 months =  20 mg twice daily; 6 -<12 months = 25 mg twice daily

The Health Canada recommended dosing for infants under the age of 1 year is not intended for premature infants (those < 37 weeks gestational age at birth who have not reached their expected due date), and may result in high drug concentrations in this age group. Very limited data from a cohort of premature infants receiving a mean dose of 1.7 mg/kg BID demonstrated drug concentrations higher than those observed in term infants given a dose of 3 mg/kg BID. Insufficient data is available at this time to make specific recommendations for premature infants. It is recommended that clinicians consult with an infectious disease specialist and/or pharmacist when considering antiviral treatment of pre-term infants. In addition, an important consideration in the treatment of infants with lower body weight is the significant difference between weight-based dosing and age-based dosing; therefore it is important to get an accurate weight and use weight-based dosages as soon as possible.
Commercially manufactured Tamiflu for Oral Suspension should be used if available; if not, refer to the instructions found in “Emergency Compounding of an oral suspension from Tamiflu® capsules” on page 16 of the Tamiflu® product monograph⁸ .
Children under 1 year of age with influenza should be treated in hospital.  If during the H1N1 pandemic demands on hospital resources become too great, hospitalization is still indicated in children less than 3 months, due to their increased risk of progressing rapidly to severe disease.  Treatment should be started as soon as possible as the benefit wanes if treatment is initiated after 48 hours of the onset of symptoms. 
B) Prophylaxis



At phase 6 of the pandemic, prophylactic use of antivirals is recommended only for outbreak control in closed health care settings or other closed facilities where high risk persons reside. If after a careful risk/benefit assessment this is thought to be clinically indicated for a particular patient, the following dosing with oseltamivir is recommended: 

Age	Recommended Dose (weight-based), 1, 2
3 month to < 12 months	3mg/kg/dose twice daily for 10 days 3
< 3 month	Not recommended at this time4
1 Not to exceed 30 mg once daily, in accord with recommended dosing for patients > 1 year of age 2 Weight-based dosing is preferred, however, if weight is not known, dosing by age for full-term infants may be necessary as follows: 3-<6  months =  20 mg once daily; 6-<12 months = 25 mg once daily 3 In children and the elderly, viral shedding may continue for up to 14 days after the onset of influenza illness. Therefore, if the index case is a child or an elderly person, prophylaxis with TAMIFLU may continue for up to 14 days. 4 Based on the available data, prevention of influenza in infants under 3 months of age is not recommended at this time unless there has been significant exposure and/or the risk of severe illness is considered to be high.

Adverse Reaction Reporting
Reports of adverse reactions to antiviral medications are important as this information will be used to guide their safe and effective use, particularly in certain populations where there may only be limited safety data available, for example pregnant women and children .
The Interim Order regarding the expanded use of Tamiflu® for children under one year of age applies to all strengths and formulations:

DIN#02304848, 30mg capsule
DIN#02304856, 45mg capsule
DIN#02241472, 75mg capsule
DIN#02245549, 12mg/ml (reconstituted) oral suspension

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WHO use of advisory bodies in responding to the influenza pandemic

Pandemic (H1N1) 2009 briefing note 19

3 DECEMBER 2009 | GENEVA -- WHO is aware of some concerns, expressed in the media, that ties with the pharmaceutical industry among experts on the Organization’s advisory bodies may influence policy decisions, especially those relating to the influenza pandemic.
WHO has historically collaborated with the pharmaceutical industry for legitimate reasons. Efforts to improve health depend on better access to high-quality and affordable medicines, vaccines, and diagnostics. Medical interventions, including antiviral drugs, vaccines, and diagnostic tests, have long been recognized for their role in mitigating the health impact of an influenza pandemic. Pharmaceutical companies play an essential role in this regard and WHO has engaged with them to pursue its public health objectives.

Conflicts of interest: safeguards in place

Potential conflicts of interest are inherent in any relationship between a normative and health development agency, like WHO, and a profit-driven industry. Similar considerations apply when experts advising the Organization have professional links with pharmaceutical companies. Numerous safeguards are in place to manage possible conflicts of interest or their perception.
External experts who advise WHO are required to provide a declaration of interests that details professional or financial interests that could compromise the impartiality of their advice. Procedures are in place for identifying, investigating and assessing potential conflicts of interest, disclosing them, and taking appropriate action such as excluding an expert from participating in a meeting.

International Health Regulations

The influenza pandemic is providing the first major test of the revised International Health Regulations, which were approved by WHO Member States in 2005 and came into legal force in 2007. The Regulations provide an orderly, rules-based mechanism for coordinating the response to public health emergencies of international concern, such as that caused by the H1N1 pandemic virus.
Apart from protecting public health against the international spread of disease, the Regulations contain provisions for avoiding unnecessary interference with international travel and trade.
Under the provisions of the revised Regulations, an Emergency Committee advises the WHO Director-General on matters such as declaring a public health emergency of international concern, the need to raise the level of pandemic alert following spread of the H1N1 virus, and the need to introduce temporary measures, such as restrictions on travel or trade. Final decisions are made by the Director-General, as guided by the Committee’s advice.
All members of the Emergency Committee sign a confidentiality agreement, provide a declaration of interests, and agree to give their consultative time freely, without compensation. Members of the Committee are drawn from a roster of about 160 experts covering a range of public health areas. The framework for membership is set out in the International Health Regulations. Each State Party to the Regulations is entitled to nominate one member of the roster and additional experts are appointed by the Director-General. Recommendations of the Emergency Committee are immediately made public on the WHO web site together with the relevant decisions of the Director-General.

Strategic Advisory Group of Experts on Immunization

In responding to the pandemic, WHO has also drawn on advice from a standing body of experts, the Strategic Advisory Group of Experts on Immunization (SAGE), which advises WHO on vaccine use. Members of SAGE are likewise required to declare all professional and financial interests, including funding received from pharmaceutical companies or consultancies or other forms of professional engagement with pharmaceutical companies. The names and affiliations of members of SAGE and of SAGE working groups are published on the WHO web site, together with meeting reports and declarations of interest submitted by the experts.
Allegations of undeclared conflicts of interest are taken very seriously by WHO, and are immediately investigated.

Criticisms: understandable but unfounded

Public perceptions about the current H1N1 influenza pandemic, as well as national preparedness plans, were strongly influenced by a five-year close watch over the highly lethal H5N1 avian influenza virus, which was widely regarded as the virus most likely to ignite the next influenza pandemic. A pandemic caused by a virus that kills more than 60% of the people it infects is strikingly, and fortunately, very different from the reality of the current pandemic.
Adjusting public perceptions to suit a far less lethal virus has been problematic. Given the discrepancy between what was expected and what has happened, a search for ulterior motives on the part of WHO and its scientific advisers is understandable, though without justification.
WHO has consistently assessed the impact of the current influenza pandemic as moderate. WHO has consistently reminded the medical community, public, and media that the overwhelming majority of patients experience mild influenza-like illness and recover fully within a week, even without any form of medical treatment. WHO has consistently advised against any restrictions on travel or trade. Although influenza viruses are notoriously unpredictable, it is hoped that this moderate impact will continue throughout the duration of the pandemic.

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H1N1 immunization starts next week in Nova Scotia

With the announcement of federal authorization of the pandemic H1N1 vaccine, Nova Scotia is set to begin its biggest immunization campaign yet, Dr. Robert Strang, the province's chief public health officer, announced on Wednesday, Oct. 21.

Immunizations will get underway in this province next week.

The federal authorization order for H1N1 vaccine means the government of Canada is satisfied the vaccine is safe and effective.

Specifics of the Nova Scotia plan include:

•H1N1 vaccine will be available for free to all Nova Scotians who want it;

•People in high-risk groups for seasonal flu can get seasonal flu and H1N1 shots at the same time;

•H1N1 vaccine will be available through community clinics, some doctor offices and workplace clinics;

•Community clinics will begin across Nova Scotia over the next two weeks.

"I have every confidence that the H1N1 vaccine is safe and effective for Nova Scotians," said Dr. Strang. "I urge all Nova Scotians to get the H1N1 vaccine. It is the best way to protect yourself and your community."

Nova Scotia has ordered 1.4 million doses of the vaccine. The first shipment, 52,000 doses, arrived on Oct. 19. The province will pay about $4.5 million for the vaccine.

District health authorities are organizing community immunization clinics. Doctors will also have the option to offer the vaccine in their offices. Private nursing agencies can also get the vaccine for workplace clinics. H1N1 vaccine is also being provided to hospitals and long-term care facilities to immunize staff.

Each district health authority will organize its immunization program, including clinic dates and times. Nova Scotians should check with local district health authorities for dates and times.

"Every Nova Scotian who wants the H1N1 vaccine will be able to receive it," Dr. Strang said. "Our priority is to ensure that all Nova Scotians have the opportunity to receive the vaccine in a timely manner."

If Nova Scotians have questions about the vaccination, they can go to www.gov.ns.ca , call their local public health unit or call HealthLink 811.

Groups at high risk for seasonal flu can receive that vaccine at the same time.

"In the weeks past, we were recommending that only people above the age of 65 and those in long-term care facilities get the seasonal flu vaccine," said Dr. Strang. "Our decision was based on the best information we had available to us at that time.

"New data indicates that we can offer the vaccines concurrently. In an effort to make it easier for Nova Scotians, both the H1N1 vaccine and seasonal flu vaccine will be offered at the mass immunization clinics."

As in previous years, the seasonal flu vaccine will also be available through doctors' offices.

Signs of H1N1 activity are now starting to be seen in Nova Scotia. There have been 17 confirmed cases of H1N1 in the province since Aug. 29. There has been one death in Nova Scotia associated with the virus.

Dr. Strang continues to advise Nova Scotians to make every effort to minimize the spread of the virus. The most important step is to stay home if sick with flu-like symptoms, which are fever and/or cough with unusual tiredness, head/muscle/joint aches or sore throat.

Along with immunization, people are also encouraged to take the following precautions to prevent illness:



•Wash hands often with soap and water, especially after a sneeze or cough. When soap and water are not handy, alcohol-based hand sanitizers are an acceptable alternative.

•Cough and sneeze into elbow or sleeve.

•If using tissues, dispose of them appropriately and wash hands.

•Limit touching eyes, nose and mouth.

•Do not share drinking glasses, water bottles, mouth guards, cosmetics or eating utensils.

•If concerned that medical advice or care is needed, contact HealthLink 811. Like any illness, should symptoms worsen, visit a doctor or walk-in clinic.

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