Reuters examines the WHO’s battle against the H1N1 (swine flu) virus in “[d]eveloping countries, where medical care systems are weak and supplies of antivirals insufficient. In addition to “supplying countries with diagnostic kits, medicines and masks and gloves to protect health care workers and minimize the further spread of the new virus,” the WHO is continuing to distribute doses of the antiviral Tamiflu, which has been “shown to be effective so far against H1N1,” according to Reuters.

“We need to worry about the development of (drug) resistance if treatment is not done correctly, if inferior doses are used or counterfeit drugs come on the market,” David Heymann, a former senior WHO official now chairing Britain’s Health Protection Agency, said. Additionally, “In Africa, poor communities are vulnerable due to malnutrition, often compounded by respiratory diseases including tuberculosis, according to Heymann, who worked for 13 years in Africa” for the CDC, Reuters writes. “This is something that has to be watched very closely… We don’t know whether this will be exacerbated by H1N1,” Heymann said.

H1N1 Vaccine Development Moving Ahead

According to Reuters, “[t]he WHO has urged drugmakers to complete production of seasonal flu vaccine for the northern hemisphere’s next winter over the next two weeks, and then switch to production of a pandemic vaccine” (Nebehay, Reuters, 6/12). Novartis AG on Friday announced it had developed an experimental H1N1 vaccine ahead of schedule and would begin clinical trials in July (Kaiser Daily Global Health Policy Report, 6/12).

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Responding to the World Health Organisation’s recent confirmation of swine flu as a pandemic, BMJ Learning, the medical education arm of the BMJ Group, has updated and revised its guide ‘Influenza pandemics: why, what, and how to prepare’ which covers all the information doctors need to know about pandemic flu including details of the epidemiological features and a description of the viruses involved.

Three audio modules have also been published:

- ‘Swine influenza: an update’ has been produced in association with the UK Health Protection Agency. It reviews how doctors should be dealing with cases and suspected cases

- ‘Pandemic flu: an update on ethical dilemmas’ discusses the ethical dilemmas that doctors are likely to face as a pandemic worsens and answers questions about when doctors should risk their own and their families’ health to care for the sick and how to share out the available resources – drugs, ventilators, vaccines – when there’s not enough to go round

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British scientists have developed a unique air purifier, now patented in 36 jurisdictions around the world, which according to independent research can kill the viruses H1N1 Swine Flu and H5N1 Bird Flu within minutes in any room or other enclosed space. It is also effective against the MRSA ‘superbug’ and other airborne bacteria and viruses: Tri-Air Developments

The technology is not a filtration process: the unit uniquely combines three different methods of decontamination to simulate the natural purification properties of fresh air, creating the cleansing hydroxyl radicals that occur outdoors. The technology ‘scrubs’ the air clean of airborne viruses and bacteria, and is also effective against those on surfaces – which would help protect against hospital acquired infections and shield offices, homes and public spaces from flu virus.

The technology has been tested by the UK’s Health Protection Agency for its ability to kill both airborne and surface bacteria and viruses, and was shown to be 99.999 per cent effective in killing an airborne test Staphylococcus of the same genus as MRSA in less than two minutes. It significantly reduces airborne spores similar to C. difficile in one hour (reference: UK HPA Centre for Emergency Preparedness and Response, Porton Down, Sep 24, 2007).

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The U.S. Food and Drug Administration is enforcing the laws that protect consumers from illegal products marketed through the Internet that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 flu virus. On May 1, 2009, the FDA warned consumers regarding products related to the 2009 H1N1 flu virus offered on the Internet. The products involved are those that are promoted and marketed to diagnose, mitigate, prevent, treat, or cure the 2009 H1N1 flu virus but are not approved, cleared, or authorized by the FDA. The agency advised operators of offending Web sites that they must take immediate action to ensure that they are not marketing products intended to diagnose, mitigate, prevent, treat, or cure the 2009 H1N1 flu virus that have not been cleared, approved, or authorized by the FDA.

Since then, the FDA has issued more than 50 warning letters to offending Web sites and as a result, more than 66 percent of these Web sites have removed the offending claims and/or products.

“We are committed to aggressively pursuing those who attempt to take advantage of a public health emergency by promoting and marketing unapproved, uncleared, or unauthorized products,” said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs. “We have achieved some success and will remain vigilant in our efforts to protect consumers from these fraudulent, potentially dangerous products.”

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With the H1N1 flu outbreak now elevated to pandemic level, a new article http://www.cmaj.ca/cgi/rapidpdf/cmaj.090866 in CMAJ (Canadian Medical Association Journal) reports that oseltamivir (Tamiflu®) and zanamivir (Relenza®) are relatively safe drugs for use in pregnant and breast-feeding women.

Pregnant women, especially those in the third trimester, are at high risk of serious complications from the H1N1 A influenza virus.

The study was conducted by researchers from the Motherisk Program at The Hospital for Sick Children (SickKids) in Toronto and the Japan Drug Information Institute in Pregnancy in Tokyo, Japan.

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Governments and drug companies are struggling with efforts to prepare for a possible resurgence of swine flu in the fall as well as questioning who should receive swine flu vaccines as they ramp up production. The Boston Globe reports on low stockpiles as disease trackers prepare for the fall to see how the swine strain develops. The paper reports: “The arrival of swine flu in the United States exposed gaps in the supply chain that delivers medication, masks, and even testing swabs to hospitals and doctors’ offices – shortcomings that could prove vastly more worrisome if a deadlier strain returns in the fall, officials say. In Massachusetts, where the state health agency had to tap its emergency cache of flu-relief pills to supplement dwindling private supplies, the administration of Governor Deval Patrick is asking the Legislature to spend $1 million more to bolster the state stockpile, a request that is pending.” The paper also notes: “The experience with swine flu has underscored how the agencies responsible for corralling dangerous germs often have no way of assuring whether pharmaceutical and medical supply companies have stocks sufficient to satisfy demand.”

Later this month, five dozen health officers will convene in Massachusetts to analyze the handling of swine flu. Massachusetts health authorities have noted that supply shortages tended to be localized and that nation’s health system didn’t experience major upheaval. The Boston Globe also notes: “Disease specialists fear that the appearance of twin flu strains could sorely tax the nation’s healthcare system, which faced episodic supply shortages since the first cases of swine flu were diagnosed. In the early days of the epidemic, Massachusetts doctors reported that some patients had trouble getting prescriptions filled for Tamiflu – the main medication used to treat the novel virus – as drug-store reserves ran low. As a result, the state Department of Public Health distributed enough antiviral medication from its stockpile to treat the flu or prevent it in 53,000 patients. Some hospitals said shelves usually brimming with surgical masks, used to slow the virus’ transmission, turned barren – and suppliers proved unable to replenish supplies in the standard 24-hour timeframe. Hospitals sometimes found themselves in competition with each other for supply reinforcements, and there were instances when departments within the same medical center raced to get their orders in first” (Smith, 6/15).

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Sanofi Pasteur, the vaccines division of sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announces it is ready to support public health efforts to respond to the emergence of the new A(H1N1) influenza strain following the decision made by the World Health Organization (WHO) to raise the pandemic alert level from Phase 5 to Phase 6, the highest level of alert in the WHO global influenza preparedness plan.

“By committing to develop and supply a vaccine against the new influenza A(H1N1) strain, Sanofi Pasteur supports the fight against pandemic influenza led by the WHO, the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) in the United States, the European Institutions, the French Ministry of Health and other national and international health authorities around the world”, said Wayne Pisano, President and CEO of Sanofi Pasteur. “Sanofi Pasteur remains in continuous communication with these health authorities to help develop a tailored response to local public health needs”.

As the world’s largest supplier of influenza vaccine, Sanofi Pasteur is currently implementing its internal pandemic preparedness plans to ensure its continued ability to fulfill its public health mission to produce the largest number of doses of vaccine in the shortest time frame to face the threat of pandemic influenza while maintaining the production of other life-saving vaccines.

The company received the new A(H1N1) seed virus from WHO International Reference Centers, and has begun preparation of a working seed to be used for vaccine production. Sanofi Pasteur currently estimates it will have the first bulk concentrate vaccine within four to six months. This vaccine would help prevent the spread of the new influenza A (H1N1) virus strain. Its availability would be subject to regulatory approval.

Sanofi Pasteur received an order from the U.S. Department of Health and Human Services (HHS) on May 25, 2009 for the supply of an A(H1N1) influenza vaccine.

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Novartis has successfully completed the production of the first batch of influenza A(H1N1) vaccine, weeks ahead of expectations. Cell-based manufacturing technology[1] allows vaccine production to be initiated once a pandemic virus strain is identified without the need to adapt the virus strain to grow in eggs, as with traditional vaccine technologies. This advance has cut weeks off the time required to begin vaccine production. This first batch of ten liters of wild type influenza A(H1N1) vaccine monobulk will be used for pre-clinical evaluation and testing and is also being considered for use in clinical trials. It demonstrates the value of the cell-based production approach, that is also being used by Novartis with reassortant influenza A(H1N1) seed.

The Novartis state of the art cell-culture vaccine production facility is located in Marburg, Germany. As well as speed, another advantage of cell-based production is the ability to rapidly increase production, so the facility has the potential to produce millions of doses of vaccine each week. A second facility, in collaboration with the US Department of Health and Human Services, is under construction in Holly Springs, North Carolina[1].

“The speed advantages of our cell-based production approach and our unwavering commitment to address this public health emergency have resulted in our ability to provide the fastest possible response to this outbreak,” said Dr. Andrin Oswald, CEO of Novartis Vaccines and Diagnostics. “This achievement is also a testament to the technical skills and innovation of Novartis Vaccines and Diagnostics people and our partners. I believe it highlights our reputation as a leader in influenza vaccine research, development and production.”

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Waikato Times

The Government is trying to manage the inevitable spread of swine flu and stop hospitals being overloaded with flu victims.

The number of confirmed swine flu cases has increased to 99, with two confirmed cases in the Waikato. The Waikato Times can confirm one of those cases is in the King Country, and the other in Raglan.

There were four new suspected cases in the Waikato yesterday, bringing the total number of suspected cases in the region to 10. Eleven people are in isolation. Yesterday also saw the first confirmed cases in Rotorua (a 45-year-old man) and two in Tauranga (a 19-year-old woman and another unspecified person.)

The maker of anti-viral drug Tamiflu has admitted it may not be able to keep up with public demand for the drug. While the Government has a stockpile of Tamiflu, shipments are selling out at chemists the day they arrive.

District health boards said services would inevitably be cut as the pandemic spread.

Health Minister Tony Ryall said the ministry was stepping up advertising mainly around the “helping not to spread the flu” message. Authorities were trying to delay the inevitable further increase in swine flu cases. The aim was to delay the peak beyond the normal winter seasonal increase in flu cases, Mr Ryall said.

“Normally we would see about 31,000 medical admissions to hospitals a month during winter. Officials think we could end up with another 4000 or so if the swine flu peak matches the winter peak,” he said. “That is why we are working assiduously to try and prevent that from happening.”

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By Stephen Smith, The Boston Globe

Hospitals fear stockpiles too low; Mass. seeking $1 million boost

The arrival of swine flu in the United States exposed gaps in the supply chain that delivers medication, masks, and even testing swabs to hospitals and doctors’ offices – shortcomings that could prove vastly more worrisome if a deadlier strain returns in the fall, officials say.

In Massachusetts, where the state health agency had to tap its emergency cache of flu-relief pills to supplement dwindling private supplies, the administration of Governor Deval Patrick is asking the Legislature to spend $1 million more to bolster the state stockpile, a request that is pending.

And across the nation, from sprawling federal agencies to small local health departments, disease trackers are urgently evaluating their response to swine flu, with eyes trained firmly on the autumn months.

That is when specialists expect two flu strains to circulate widely: the seasonal variety, capable of killing thousands, as well as the swine strain. The specialists operate against a backdrop of unpredictability, knowing that earlier novel flu strains sometimes petered out, while others roared back in mutated, deadlier forms.

Last week, global disease authorities declared that swine flu, known by the scientif ic designation H1N1, had reached pandemic status, a reflection of how broadly it had spread rather than its virulence. Yesterday’s reported swine flu death in Scotland represented the first outside the Americas, health officials said.

The experience with swine flu has underscored how the agencies responsible for corralling dangerous germs often have no way of assuring whether pharmaceutical and medical supply companies have stocks sufficient to satisfy demand.

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