H1N1 flu victim collapsed on way to hospital [Latest H1N1 updates downthread]

Within minutes, six-year-old Rubjit Thindal went from happily chatting in the back seat of the car to collapsing and dying in her father's arms.

"If we had known it was so serious, we would have called 911,'' Kuldip Thindal, Rubjit's distraught mother, said in Punjabi yesterday. "She just had a stomach ache -- she wasn't even crying.''

Rubjit was pronounced dead at hospital barely 24 hours after showing signs of a fever. Later, doctors told her parents she had the H1N1 influenza virus. She is believed to be the youngest person in Canada with the virus to have died.

“Healthy” 22-year-old dies from swine flu

By Anna Scott

Published: Thursday, July 16, 2009 at 1:21 p.m.
Last Modified: Thursday, July 16, 2009 at 1:21 p.m.

http://www.heraldtribune.com/article/20090716/breaking/907169959

The 22-year-old Sarasota man who died of swine flu was “healthy” according to the doctor overseeing Sarasota County’s health department.

“As far as we’re aware he was a healthy individual otherwise and that’s certainly of concern,” said Dr. William Heymann. “We know other illnessness can lead to increased morbidity and illness with swine flu, but this is an example of one where to our knowledge this isn’t the case.”

The man’s illness was prolonged and he received medical treatment, according to county health officials.

His death marks the first swine flu death in the county and the 13th in the state. It was first annouced by county health officials earlier today. They would not disclose his name, the date of his death, or any other personal details. He died “several days ago,” health officials said.

A source told the Herald-Tribune the man died in Tampa, but health officials could not confirm that. Also, authorities are looking into another possible death from swine flu: a patient recently died at Sarasota Memorial from complications from the flu, according to a hospital spokesperson. The hospital is waiting for state labs to confirm whether it was swine flu. No more details are available about that patient.

UK:

Swine flu to hit 12 per cent of NHS staff at one time

16 July, 2009 | By Dave West
http://www.hsj.co.uk/news/acute-care/swine-flu-to-hit-12-per-cent-of-nhs-staff-at-one-time/5004139.article?referrer=RSS

The health service has been told to prepare for up to 8 per cent of the population suffering from swine flu at any one time - and up to 12 per cent of the NHS workforce.

Thirty per cent of the population could have had the infection by the end of the first wave – expected to be around the end of the winter.

Two per cent of those would have been hospitalised, according to “reasonable worst case” assumptions issued by the government today.

Chief medical officer Sir Liam Donaldson said up to 12 per cent of the workforce could be absent at any one time.

He said the NHS needed to prepare for between 0.1 - 0.35 per cent of those affected dying – giving a maximum, worst case of 65,000 total deaths from the first wave.

Sir Liam announced the national pandemic flu service, to prescribe antivirals by phone and on the internet, would be launched for England next week to take pressure off services.

Sir Liam said in “hotspots” GPs were being “completely overwhelmed”.

He said: “As a result of the pressure the NHS has been facing, and coping with very well, we are getting advice that they [the NHS] want us to move to the national pandemic flu service.”

National director for NHS flu resilience Ian Dalton said NHS organisations should be using the Department of Health’s new planning assumptions to develop their existing plans.

Particularly he said they should be ready to provide “surge capacity” in critical care, and consider the impact of staff absence.

He said: “Clearly there are huge discussions to be had which are under way with trade unions and front line staff about how we keep services going.”

Legal immunity set for swine flu vaccine makers

ATLANTA — The last time the government embarked on a major vaccine campaign against a new swine flu, thousands filed claims contending they suffered side effects from the shots. This time, the government has already taken steps to head that off.

Vaccine makers and federal officials will be immune from lawsuits that result from any new swine flu vaccine, under a document signed by Secretary of Health and Human Services Kathleen Sebelius, government health officials said Friday.

Since the 1980s, the government has protected vaccine makers against lawsuits over the use of childhood vaccines. Instead, a federal court handles claims and decides who will be paid from a special fund.

The document signed by Sebelius last month grants immunity to those making a swine flu vaccine, under the provisions of a 2006 law for public health emergencies. It allows for a compensation fund, if needed.

The government takes such steps to encourage drug companies to make vaccines, and it’s worked. Federal officials have contracted with five manufacturers to make a swine flu vaccine. First identified in April, swine flu has so far caused about 263 deaths, according to numbers released by the Centers for Disease Control and Prevention on Friday.

The CDC said more than 40,000 Americans have had confirmed or probable cases, but those are people who sought health care. It’s likely that more than 1 million Americans have been sickened by the flu, many with mild cases.

The virus hits younger people harder that seasonal flu, but so far hasn’t been much more deadly than the strains seen every fall and winter. But health officials believe the virus could mutate to a more dangerous form, or at least contribute to a potentially heavier flu season than usual.
“We do expect there to be an increase in influenza this fall,” with a bump in cases perhaps beginning earlier than normal, said Dr. Anne Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases.

On Friday, the Food and Drug Administration approved the regular winter flu vaccine, a final step before shipments to clinics and other vaccination sites could begin.

The last time the government faced a new swine flu virus was in 1976. Cases of swine flu in soldiers at Fort Dix, N.J., including one death, made health officials worried they might be facing a deadly pandemic like the one that killed millions around the world in 1918 and 1919.

Federal officials vaccinated 40 million Americans during a national campaign. A pandemic never materialized, but thousands who got the shots filed injury claims, saying they suffered a paralyzing condition called Guillain-Barre Syndrome or other side effects.

“The government paid out quite a bit of money,” said Stephen Sugarman, a law professor who specializes in product liability at the University of California at Berkeley.
Vaccines aren’t as profitable as other drugs for manufacturers, and without protection against lawsuits “they’re saying, ‘Do we need this?’” Sugarman said.

The move to protect makers of a swine flu didn’t go over well with Paul Pennock, a prominent New York plaintiffs attorney on medical liability cases. The government will likely call on millions of Americans to get the vaccinations to prevent the disease from spreading, he noted.

“If you’re going to ask people to do this for the common good, then let’s make sure for the common good that these people will be taken care of if something goes wrong,” Pennock said.

AP Medical Writer Lauran Neergaard contributed to this report from Washington.
On the Net:
CDC: http://www.cdc.gov/H1N1flu/

http://www.google.com/hostednews/ap/article/ALeqM5hjdCHrP82YTFser5vD6CzTK1az6wD99GH8580

Flu disproportionately targets the young and healthy
Caroline Alphonso and Gloria Galloway
Friday, Jul. 17, 2009 10:41PM EDT

The median age of Canadians infected with pandemic influenza is only 18 and, among those hospitalized, is 21 years old, according to newly released government figures that paint a picture of just how disproportionately the H1N1 virus affects young adults.

While answers are still lacking as to why youth have been affected by the H1N1 virus, health officials are considering the possibility that while young people have been exposed to other flu strains, they don’t respond as well to H1N1 as older people whose first experience was with this strain.

“This kind of data pinpoints the ones that are going to have the most disease, and will also be incubators of disease to pass on to others,” said Donald Low, chief microbiologist at Toronto’s Mount Sinai Hospital. “It really targets who is at greatest risk, because when a vaccine becomes available, if it becomes available in limited amounts, I think we have to identify high-risk categories.”

The pandemic virus, which slipped into a place where no one was looking for it, in a form that no one expected and swept the globe with unprecedented speed, has challenged all assumptions on what a pandemic would look like – including the age group it would primarily infect.

Health officials have been astounded to see the ferocity with which the virus has attacked the young and healthy, pregnant women and the aboriginal population.

Data released Friday by the Public Health Agency of Canada showed that the median age of the First Nations population infected with H1N1 (19 years old) was similar to the rest of Canada. But Inuit cases were much younger with a median age of nine years. That’s likely because Nunavut, which is 85 per cent Inuit, has a younger population compared with the rest of Canada, the agency said.

Canada completed its 500-page pandemic plan in 2006, a document created during years of debate about the deadly potential of avian influenza. But, when the virus finally arrived in April, it was swine flu and not the “bird flu” that had been predicted throughout the plan.

“This thing has not followed any of the rules. It obviously didn’t read the pandemic plan that we had formulated,” Dr. Low said.

The pandemic influenza was supposed to turn up in a small village in Indonesia. The World Health Organization would quickly discover that there was a new virus being transmitted from person-to-person. The international community would respond by bringing in antiviral agents and dispending them to everyone in the area in an effort to contain the disease. One infected person would slip beyond the ring, bringing the virus to the rest the world.

In Canada, it would first take hold in British Columbia, giving Ontario, Quebec and the east coast months to prepare by distributing antivirals to the highest risk groups.

It would take its greatest toll on the elderly. The health-care system would be stretched to the limit, between 20 to 30 per cent of the population would be infected, and large parts of the workforce would be felled.

“But it would be over in about 12 weeks,” Dr. Low said. “And then we would get back to normal, we would have a post-pandemic reassessment time, we would look at how well we did knowing that in about six months it might come back again and that we would be even better prepared.”

None of which came to fruition.

The virus was first discovered in a small town in Mexico. By the time health authorities understood its pandemic potential, it was circulating freely through Mexican villages, United States, and there were probably even unrecognized cases in Canada.

“We had absolutely no hope of containment,” Dr. Low said. “The good news was that it was a relatively mild virus, it continues to be a relatively mild virus.”

David Butler-Jones, Canada’s chief medical officer of health, said the biggest surprise for him was that the virus that turned pandemic was an H1N1 – the same type that killed as many as 50 million people worldwide in 1918. The H1N1 virus was recently seen in 1976, when army recruits at Fort Dix, Md., fell ill with influenza caused by a swine flu virus.

Most experts had predicted the next pandemic would be something unlike anything seen before – an H7 or an H8 perhaps.

“Rounding back to an H1 that is sufficiently different for most of us [to not have developed immunity] was not highly expected,” said Dr. Butler-Jones.

Still, the pandemic planning hasn’t been thrown out the window.

“There are still some areas of commonality that are serving us well,” said Danuta Skowronski, an epidemiologist with the B.C. Centre for Disease Control. “For instance, even just the guiding principle: be prepared for the unexpected, don’t let your guard down, interrogate this virus.”

The planning told doctors to monitor for serious outcomes, watch for the possibility of antiviral resistance, be alert for changes in the virus, and be aware that the age groups that are most affected may not be those that are seen with seasonal influenza, she said.

Dr. Butler-Jones said Friday that the federal government is now doing a weekly analysis – as opposed to releasing numbers three times a week – to capture unusual activities, such as increased hospitalization.

“The goal of surveillance is to assess the impact of the H1N1 flu virus on our communities, so that we can adapt our planned responses to the situation at hand,” he said.

“If we start seeing increases, then that may indicate that in fact we’re into the next wave.”

http://www.theglobeandmail.com/news/national/flu-disproportionately-targets-the-young-and-healthy/article1223109/

UK:

Swine flu: pregnant women told to stay home

Steven Swinford
July 19, 2009
http://www.timesonline.co.uk/tol/life_and_style/health/article6719356.ece

PREGNANT women and parents with babies will be advised to avoid crowds and unnecessary journeys on public transport in an attempt to limit the effects of the swine flu virus on the most vulnerable.

The Department of Health will publish new guidelines on the National Health Service website today that emphasise the risk to pregnant women and young children.

The Royal College of Midwives and the Royal College of Obstetricians and Gynaecologists are recommending changes in lifestyle, including staying indoors when practical. Expectant mothers should also limit the movements of their other children so they do not bring the virus home.

Pregnant women are advised to avoid crowds where possible: “If they normally travel on the Tube or on crowded trains in rush hour they might want to leave later or earlier,” Sue Macdonald from the Royal College of Midwives said. “This is about being sensible and being aware of the risks.”

The government will not advise women to delay pregnancy until the swine flu pandemic has passed, as is recommended by the National Childbirth Trust. The latter was accused of scaremongering by the Royal College of General Practitioners.

More than 700 people have been taken to hospital with the virus and, of the 29 who have died, four were young children and two were mothers who had recently given birth. It also emerged this weekend that:

- Hospitals face a potential crisis over the limited number of intensive-care beds. In the worst-case scenario, seriously ill patients could have to make way for swine flu victims.

- The manufacturers of the new swine flu vaccine are to be given legal indemnity amid concerns over any side effects. Regulators are due to fast-track its approval.

- Some patients, whatever their illness, face waits of up to 11 hours before getting a call back from weekend and evening GPs’ services. Calls are running at double the normal rate.

- Security guards are to protect NHS supplies of Tamiflu when the drug is handed out at temporary distribution centres, such as community buildings.

British holidaymakers suspected of suffering from swine flu are being prevented from boarding flights. Check-in staff at Heathrow and other main British airports are vetting passengers for possible infection and turning away those suspected of being having the disease.

Some countries, including Thailand, Egypt, Turkey and China, have installed thermal body scanners to identify passengers with fever.

British Airways and Virgin Atlantic confirmed this weekend that its staff were not allowing suspected sufferers to travel. A BA spokesman said some passengers had been turned away at check-in because they had flu symptoms.

Passengers who are suffering from swine flu but are not spotted at check-in may find themselves quarantined on their arrival overseas. A group of 52 British children and teachers is being held in quarantine in a hotel in China after four pupils were diagnosed with swine flu on arrival in the country on Tuesday and sent to hospital. The trip was organised by the Specialist Schools and Academies Trust and involves schoolchildren from around the country.

Among pupils affected are some from Cheltenham ladies college, Gloucestershire. “The Chinese authorities are taking a very cautious approach to the flu and have quarantined the group and hospitalised some eight children who are showing symptoms,” the headmistress, Vicky Tuck, said.

UK:

Telegraph: Swine flu alert for pregnant women and babies

19 July 2009 | 03:54
FOCUS News Agency
http://www.focus-fen.net/?id=n188057

London. Urgent swine flu advice is to be issued to pregnant women and new parents in an attempt to limit the spread of the virus among the most vulnerable. Expectant mothers will be urged to avoid unnecessary journeys and crowds, with experts suggesting that they do not travel on trains and the London Underground at peak times. Parents will be advised to keep babies away from crowds, while pregnant women will also be encouraged to limit the movements of their other children, so they do not bring the virus home. The warnings come amid increasing concern that pregnant women and young children are among the groups most at risk from swine flu.

So far, more than 650 people have been taken to hospital with the virus in England, including more than 200 children. Under-fives have been three times more likely than older patients to be taken to hospital. In Scotland, 44 people have been taken to hospital, while 11 have been treated in Welsh hospitals. At least 146 cases have been recorded in Ireland. Officially, there have been 29 British deaths involving swine flu, including four children and two mothers who died shortly after giving birth. All except one – six-year-old Chloe Buckley, who died 10 days ago in west London — were known to have been suffering from underlying health problems.

Pregnant women are at increased risk of contracting any infection because their immunity is suppressed to ensure that their body does not reject their baby. Experts believe that most cases of swine flu would not harm the mother or foetus, but rare cases could lead to premature labour or miscarriage or cause birth defects. In Australia, where 11 expectant women with swine flu are in intensive care, pregnant women have been urged to stay at home when possible, and to wear face masks when they do go out. Mask-wearing is not part of Britain’s strategy because it is thought to do little to reduce the spread of disease and encourages complacency against more useful measures, such as regular hand-washing.

The new guidance, to be published on the National Health Service website, www.nhs.uk, and circulated via parenting forums, will alert parents and pregnant women to recommendations that have been drawn up by the Royal College of Midwives and the Royal College of Obstetricians and Gynaecologists. Senior figures from both organisations said that while significant changes in lifestyle, to avoid crowds and public transport, might not be realistic for all pregnant women and parents with babies, individuals should be made aware of the risks.

Sue Macdonald, from the Royal College of Midwives, said: “Pregnant women have got a strong instinct to protect their baby, but we have to be realistic about the kinds of adjustments people can make. If they normally have to travel on the Tube or on crowded trains in rush hour they might be better to come in later or earlier, but of course it is difficult to avoid crowds entirely. This is about being sensible and being aware of the risks.”

The advice states that the simplest way to reduce the risk of contracting swine flu is regular hand-washing, especially after journeys. In separate guidance, pregnant GPs and community nurses have been told that they should not see patients with suspected swine flu. The Government has decided against advising women to delay pregnancy until the swine flu pandemic has passed, even though such a recommendation was contained in previous plans.

The number of people off work with symptoms of flu more than doubled last week, according to figures compiled for The Sunday Telegraph. On Friday , about 177,000 people were absent with flu-like symptoms, compared with 80,000 the week before. Aaron Ross, the chief executive of FirstCare, an absence management company that carried out the survey of 1,000 companies, said businesses should offer home working to staff who are most vulnerable to swine flu.

Flu expert: ‘More will die’ if strike drags on
http://mobile.thestar.com/mobile/NEWS/article/668321

July 18, 2009 04:07:00
Theresa Boyle
HEALTH REPORTER

Toronto will see more deaths from the global H1N1 pandemic because of the civic workers’ strike, warns the head of infection control at Mount Sinai Hospital.

“The bottom line is more people will die,” microbiologist Dr. Allison McGeer, a respected authority on pandemic planning who has consulted for all three levels of government on the issue, said yesterday.

On the picket line are as many as 1,800 unionized employees from the Toronto Public Health Unit, which is supposed to be playing a critical role in the battle against the H1N1 influenza virus, particularly in planning for the second wave, which is feared to hit North America in September with a vengeance.

“We are already in trouble. Now we’ve got 26 days of work that hasn’t been done,” McGeer said.

Instead of being on the picket line, public health nurses, doctors, epidemiologists and other health unit staff should be providing pandemic management advice to school boards, long-term care facilities, jails, the Toronto Police Service, Toronto Fire Services and other essential services, she said.

They should be tracking the spread and severity of the virus, following up on cases where people have tested positive, and making plans for the establishment of vaccination clinics and flu assessment centres.

They should be organizing ways to help the homeless, shelter residents and people who don’t have family doctors. And they should be ensuring that plans are in place to quickly communicate updated pandemic response instructions to the general public and to health-care providers.

“We are expecting them to have spent the summer doing this. ... They are the experts in pandemic planning,” McGeer said.

“None of those things are getting done and the longer the strike goes on, the less likely they are going to get done,” she warned.

But Toronto’s medical officer of health, Dr. David McKeown, insists the strike has had no bearing on the city’s response.

“Planning for a pandemic in the context of the current H1N1 outbreak is something we identified as a critical service to be maintained during the strike, so non-union staff have been continuing with our planning efforts,” McKeown said last night.

Asked if the same level of service is currently being provided as would have been provided were there no strike, he responded: “I think we’re doing what we need to be doing at this point.”

McGeer said managers are doing their best, but it’s impossible to fill the vacuum.

As for front-line workers, she said: “I’m sure that the people who are out on strike are really unhappy about recognizing that they can’t be doing what they know needs to be done.”

Privately, senior officials at the city who are not on strike have agreed with McGeer’s assessment, expressing concern about the fall when a second wave of H1N1 is expected to hit. Managers are getting burned out, they say.

The health unit is now staffed by about 200 non-union employees and managers. They are also contending with health issues arising from piling-up garbage.

Sources say restaurant inspections are being done only on a complaint basis.

Ontario’s pandemic plan calls for the province’s 36 public health units to play a central role in containing spread of the virus and minimizing illness.

With Toronto’s health unit hobbled by the strike, not only will the city see more deaths, but there will also be more infections and hospitalizations, McGeer said.

“The whole goal of the (pandemic) plan is that fewer people die. It’s very simple,” she said.

Public health should be declared an essential service, like police and fire, so that employees are not able to strike, McGeer argued.

“I really struggle with our Toronto Public Health not being an essential service,” she said.

Her comments come days after the World Health Organization warned that the virus is spreading faster than any other pandemic in history, that production of a vaccine has been delayed and that one may not be ready until the end of the year.

Of all the province’s public health units, Toronto’s has by far seen the most H1N1 activity. Latest numbers show that there have been six related deaths and 85 hospitalizations.

What the second wave of the pandemic will bring is still a big question mark. At the very least, it’s expected to surpass the impact of regular seasonal flu, which has a role in 50 to 70 deaths in Toronto annually.

But there is a fear it could mimic the 1918 Spanish flu, which infected one-third of the world and contributed to the deaths of more than 50 million.

McGeer said the public health unit was already behind the eight ball before the strike.

Public health, in general, is woefully underfunded and under-resourced, she said, noting that the H1N1 outbreak was a challenge to deal with even with the full complement of staff.

“In terms of pandemic planning, it’s causing a terrible problem because we know that the amount of pandemic planning that the Toronto Public Health Department can do when it’s on strike is very, very limited,” McGeer said.

She pointed out that five royal commissions in the past 12 years have warned that public health is substantially underfunded.

“When I have been part of stakeholder groups and focus groups about what our goals should be for a pandemic and what we are aiming to do in Canada ... Canadians tend to talk about being sure that we have protected the most vulnerable people.

“That we can have that sense as a society and not fund pubic health is a complete mystery to me,” she said.

The future of flu vaccine production
18/Jul/09

If a more deadly form of mutated swine flu virus strikes the northern hemisphere this coming winter, governments want to be as prepared as possible. Orders for an as-yet non-existent vaccine have been pouring in to major producers in the last few months. The methods still used to produce most of the world’s flu vaccine stocks however have remained largely unaltered for decades. The A(H1N1) seed viruses the WHO provided to manufacturers at the end of May were planted in huge numbers of 11-day-old fertilised eggs, and it will take an additional 5-6 weeks to adapt a fast-growing strain for production in ‘high-growth’ cycles. It takes between one and two eggs to produce a single dose of vaccine, yet most producers are betting on the slow but reliable method in the current pandemic. But swine flu could also prove to be the spark that lights the fire of next-step technology – scalable cell-based vaccines.

A week after the World Health Organisation declared a pandemic in mid-June, 32 flu vaccine producers began preparing to accelerate production of the A(H1N1) seed virus that had been distributed at the end of May. The first wave of the disease has proven fairly moderate, with mild symptoms and few deaths (the official mortality rate at the beginning of July was just 0.49%). “But that’s also what happened in the last two flu pandemics in 1956/57 and 1968/69,” warned Dr. Susanne Stöcker from Germany’s Paul Ehrlich Institute, the country’s regulatory authority for vaccines. A mutated, more deadly version of the virus sparked a second wave of infections in both cases, killing more than a million people. Although some have questioned whether it makes economic sense to mass-produce a vaccine for what is after all still a mild disease, the latest statistics could now change a few minds. According to Germany’s Robert Koch Institute, a deadly mutated virus would possess a unique combination of characteristics that could make it particularly tricky to diagnose: 70% of those infected in the country so far have been under the age of thirty, and 20% showed no signs of fever. In the southern hemisphere, H1N1 is beginning to displace other seasonal influenzas as the most common form of the disease.

Major vaccine producers have reacted promptly. In mid-June, scarcely a day went by without press release assurances from the big manufacturers about possible production start dates. That’s unsurprising, given that the business provided by a looming pandemic will come in addition to an already booming market for the seasonal trivalent vaccines, which target antigens in virus types H1N1, H3N2 and the varying influenza B-virus.

Vaccines = Big Business

According to analysts, the last few years have seen strong growth in the areas of seasonal vaccines. The seven most important pharma markets for example saw around US$1.8bn in turnover in 2005, according figures provided by Datamonitor. Three years later that number had climbed by around a third to US$2.5bn. The market leaders are Sanofi-Pasteur, GlaxoSmithKline and Solvay, which together have around 70% of total sales. The increase can be traced back to the more comprehensive policies and programmes headed by the WHO and national agencies, which are no longer directed at just the old and infirm. In the US, there are plans in place to vaccinate around 85% of the population against seasonal flu, which experts say would have meant continued strong growth in the sector even in the absence of a swine flu threat.

Estimating market volume for pandemic vaccines is a tricky business, because important parameters for setting prices remain vague. It is still unclear for example how much antigen per egg will be produced per dose. The market for a pandemic vaccine can also be expected to follow different rules than those that dictate conditions for seasonal vaccines. However, most deal options were closed between governments and manufactuers back during the bird flu epidemic, and were ready for activation at the end of June. The big six – Sanofi-Pasteur, Novartis, GlaxoSmithKline, Baxter, AstraZeneca’s MedImmune and Australian vaccine producer CSL – all landed contracts or preliminary agreements.

First on the market – scalable cell-based vaccines

If vaccine producer Baxter is able to back up its claims, then the most advanced pandemic vaccine against the A(H1N1) virus will come from the field of biotech. The company’s spokeswoman Jutta Brenn-Vogt claimed that Baxter is “expecting the vaccine to be available sometime in July.” Pre-series testing and evaluation are already complete, she said, and mass production in Vero cells is underway at Baxter’s facility in the Czech Republic. If all goes according to plan, the commercial release will be a record-breaker in terms of time to market.

Baxters’ only competitor Novartis, which produces in MDCK cells at its Marburg site, has just begun a Phase III clinical trial, and hopes to receive approval from the regulatory authorites for its pandemic flu vaccine by October. Because of the authorisation procedure, the first vaccine doses could only be delivered at the earliest by the end of the year.
All other major producers still rely on the classic method of breeding a weakened and reassorted version of the virus in millions of fertilised chicken eggs – a slower process, but a tried and trusted one. GSK, Sanofi-Aventis and MedImmune will only be able to deliver vaccine doses by October at the earliest. Only CSL, which like Baxter began working from a CDC-isolate before the release of the seed viruses at the end of May, has said that it will be able to deliver doses by mid-August in an emergency situation.

That is an ambitious plan, as the egg-based production of vaccines generally takes around 6 months from virus isolation to market. But although the cell-based vaccine made by Baxter might be produced more quickly, experts also expect it to be more expensive. In spite of that drawback, most analysts consider the method very promising for another reason – it could provide the means for a much shorter lag in the time it takes to respond to an outbreak with a vaccine. According to Brenn-Vogt, scalable cell-based vaccine production systems are able to cut roll-out times in half because the company is able to work immediately with an unaltered version of the isolated virus. In the classic procedure, seed virus strains have to be tweaked to cope with replication conditions inside the egg. Additionally, egg-based production cannot be performed in the BSL3 safety environment required for production of highly pathogenic viruses – and the cell-based method can.

Acceptance will depend on price

Because they offer the ability to react more quickly to the fast-moving demographics of modern pandemics, scalable cell-based vaccines seem destined to replace egg-based production in the long run. To reach the end-user in time, the logistics of seasonal vaccines have to be planned around two years in advance. Optimistic WHO predictions that between one and two billion doses of swine flu vaccine could be available by this fall do not take into account the impact that production will have on the manufacture of seasonal flu vaccines. A major drawback at the moment is price. It isn’t clear exactly how much more expensive vaccines grown with the new method will cost, but if the price difference is dramatic, it could prolong the life of the outdated egg-production alternative for years. Analysts say that vaccine production based on insect-cell or bacteria is the next step.

However, many vaccine experts doubt that most cell-based processes could fully replace the traditional production method. “The current yield in cell-based methods is significantly lower – by a factor of 4-5 – than with egg-based production,” Dr. Rodney Carbis, Head of Vaccine Development at the International Vaccine Institute (Seoul, South Korea) told EuroBiotechNews at the 5th European Downstream Technology Forum (Göttingen) in mid-June. That view was confirmed by European vaccine experts at the European Centers for Disease Control and Prevention (ECDC) in Stockholm: “Growing influenza virus in egg-based culture usually results in significantly higher virus yield than in cell-culture, meaning more vaccine doses are produced in the end.” Carbis believes that there are good reasons to change production from egg-based to cell-based systems, among them allergenicity against egg proteins, time to market, scalability and safety in case of a bird flu pandemic. “But we have yet to develop the right cell lines to do it.” According to Carbis, it could take a decade before cell-based production displaces the traditional method.

http://www.eurobiotechnews.eu/service/start-page/top-news/?no_cache=1&tx_ttnews[tt_news]=10330&tx_ttnews[backPid]=12&cHash=5e7dfea015

A fatal flaw
A shortage of beds and ventilators is about to strike Canada as the H1N1 pandemic intensifies — we should have been ready

By Jaro Kotalik, Citizen SpecialJuly 16, 2009
http://www.ottawacitizen.com/health/fatal+flaw/1795251/story.html

While we continue to observe a daily increase in the number of swine flu cases across the country, we take comfort in the fact that our country has been preparing for a pandemic for years. It is true that we have an elaborate, expertly produced national pandemic plan, which in turn gave rise to provincial, territorial, regional and local plans. Canada has even been called a world leader in pandemic preparedness by the World Health Organization.

But there is an inherent weakness in our pandemic planning, a weakness which greatly undermines all the effort put into this enterprise, a weakness which may in the end be fatal.

In 2004, a Canadian pandemic plan was released that did not say a word about the amount of material and human resources that would be required for each of the hundreds of proposed pandemic measures nor about who would provide these resources. When you stop to think about it, it’s almost unbelievable: the largest public health program ever proposed in our national history was launched without any budget or allocation of funds.

Those who disagree will cite that in 2006 the federal budget earmarked $1 billion over five years for this cause. Three years into this budget, we know that the federal government purchased stocks of the antiviral drug Tamiflu and contracted for the production of a vaccine. However, these actions, while important and laudable, are far from meeting all the essential requirements. To date, none of the budgeted money seems to have made its way to the front lines and trenches where the real war against the pandemic will largely be fought, such as the hospitals I am associated with.

This economic blind eye approach has resulted in our lack of readiness to care for those sick with the flu. The sudden emergence of an enormous number of sick people is the hallmark of a pandemic. The national plan for a moderate pandemic estimates that of 4.9 million people who will become ill, 109,000 people, about two per cent, will need to be admitted to a hospital. The plan does not suggest how these additional patients could be accommodated given the fact that in Canada we have just over 100,000 beds and that they are 90 per cent full all the time.

Furthermore, it now appears that the demand for hospital beds may be much higher than what our planning experts had predicted. On June 12, the Public Health Agency of Canada reported that not two per cent, but five per cent of confirmed cases of pandemic flu had to be hospitalized. And not any kind of hospital bed will suffice.

Because the most frequent serious complication of any flu is pneumonia, and in some cases the inability to breathe, these flu patients will require mechanical ventilation in an intensive care unit in order to survive. This fact was foreseeable, and it is well known that these beds (with ventilators) are constantly in short supply, yet no provisions were made to at least partially remedy the shortage.

To their credit, the Ontario pandemic planners went as far as to estimate the required number of beds with ventilators. As the situation stands, it appears that at the peak of demand, pandemic flu patients may need almost twice as many beds with ventilators as are currently being used across the province for all patients. To date, no relief of the shortage has been proposed.

It appears that when hospitals exceed their “surge capacity,” that is, have more patients than they can treat, the province will declare “mass emergency care.” In this case, physicians will be expected to decide who will get a ventilator and who will only receive comfort measures.

A recent situation in Winnipeg highlighted how ill-prepared our hospitals are. In mid-June, at the very beginning of the H1N1 flu outbreak, when the province had only 119 confirmed cases, 31 of them needed ventilators. Winnipeg hospitals were forced to cancel non-urgent surgery, discharge other patients earlier and order 15 additional ventilators.

The fact is that the health care delivery system in Canada is stretched to its limits. As you read this article, wherever you are, at this very moment there is probably a “discharge planner” going around your local hospital trying to determine which patients could be sent home, not necessarily because it would be best for the person, but because unless someone is discharged, it is not possible to get a bed for any of the patients waiting for admission in the overcrowded emergency room. Under these circumstances, how can hospitals, pressed to avoid deficits, and having no dedicated funding for a pandemic even now when a pandemic is here, engage in serious preparation for increased demand?

So all of us are closing our eyes to the unpleasant, unmanageable reality and hoping that, somehow, we will get through this. This is of course not the stuff of press releases, and so the public is largely kept in the dark.

As someone who has promoted for years the idea that the hospital is a moral community, which has an ethical responsibility to our patients, our staff and also the people in the region we serve, I find it impossible to stay silent. The issue is just too big to be confined to the hospital. There is a need for evidence-based political decisions.

I have recommended to our hospital that we should determine what resources we need to provide care at the height of the pandemic to all patients who can be reasonably expected to rely on us. We should then notify our funding agency and include an estimate of the potential human cost of not having the necessary resources. If funding is not received, our hospital has an obligation to inform the public about the lack of resources, which may result in our inability to provide adequate care.

If we fail to do this we will have an ethical responsibility for the harm or deaths which could have been prevented. I appreciate that our funding authority, considering all the needs, may not be able to provide the resources, and may be able to justify that. What I suggest is not a pressure tactic, but a process which is necessary if we wish to respect the values of accountability, inclusiveness and transparency — the values of the Ontario pandemic planning ethical framework.

If given a choice, would Canadians want our health care system to go through the pandemic, the largest threat to the health and life of Canadians in many decades, with no additional resources, scaling down care to what the regular budget provides? Or would they be prepared to pay for the best possible care, knowing that the deaths which will occur were humanly unavoidable?

Swine flu infection threatens Swede’s life
20 Jul 09
http://www.thelocal.se/20792/20090720/

Doctors at Vrinnevi hospital in Norrköping in eastern Sweden fear for the life of the 22-year-old Swede being treated for a swine flu infection after he failed to respond to treatment.

The condition of the man, who became ill with the AH1N1 virus after returning from a holiday in southern Europe, is reported to have worsened overnight and is now described as life-threatening.

Chief physician at Vrinnevi hospital, Christer Liedgren, told newspaper Dagens Nyheter (DN) on Monday morning that treatment of the 22-year-old with a respirator had not worked and he is now going to be put on a heart-lung machine, so-called ECMO treatment.

“The patient’s lungs are not working as they should. The treatment needs to begin today,” Liedgren told DN.

ECMO treatment, which stands for extracorporeal membrane oxygenation, is however only available in Stockholm and it is as yet unclear if the patient will be offered immediate treatment.

The 22-year-old’s treatment is being managed by Karolinska University hospital in Solna and staff from the hospital will travel to Norrköping to oversee the procedure.

It is neither known why the man’s condition had worsened over night and Liedgren confirmed to the newspaper that there had been no complications.

The 22-year-old man became ill on July 11th and was prescribed the anti-flu drug Tamiflu. The patient, while no longer contagious, developed pneumonia as a result of the infection.

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