Studies performed in three animal models confirmed the safety and intensive immunogenicity of a new type of intranasal H5N1 influenza vaccine, according to the latest preclinical study data announced today by the Vienna based firm, Avir Green Hills Biotechnology. The study data was just published in PloS One, the Public Library of Science. “The intranasal immunization with our vaccine has proven itself capable of generating a strong immune response against H5N1 viruses. The technology, with which we produce the vaccine, once again has proven itself an especially successful path for future vaccines,” reports Dr. Thomas Muster, founder, CEO and CSO of Avir Green Hills Biotechnology. In addition to the intensive immune response, the tests in the animal models also showed long sustainable protection against different varieties of the virus. “Our approach is an attractive alternative to conventional influenza vaccines. Clinical evaluations of our pandemic and seasonal vaccine candidates are already in progress.”

Innovative technology for production and application

The process developed by Avir Green Hills Biotechnology for the creation of a vaccine against different influenza strains has several unique features compared to conventional flu vaccines:

- The application as nasal spray instead of injection into the muscle has an advantage in that the immunization protection is stimulated directly at the virus’ portal of entry. The simple practicability of such a spray is enormously advantageous, particularly in the case of pandemics in which circumstances might necessitate the inoculation of numerous people simultaneously.

- The novel vaccine can produce an effective immune reaction against the most distinct varieties of influenza viruses – something only conditionally possible with conventional vaccines. This so-called cross-protection also enables the warding-off of distantly related and already mutated strains of influenza viruses.

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Two elite flu reporters, Helen Branswell (Canadian Press) and Declan Butler (Nature), both noted yesterday the dearth of clinic information on the serious and fatal swine flu cases. First Butler:

Clinical researchers have been slow to respond to the 2009 flu pandemic, lament researchers writing in today’s Lancet. “Public health officials, virologists, epidemiologists, and policy makers have done well in responding to a rapidly emerging and complex problem. By contrast, the clinical research community’s response has been delayed and modest, ” writes Jeremy Farrar, a researcher in Ho Chi Minh City, Vietnam and colleagues from Vietnam, the US and Mexico.

They deplore the “lack of information” on the pathogenesis and clinical aspects of those with severe illness, and argue that trials and other clinical research are urgently needed to better understand the disease, and learn of necessary tweaks to treatment regimes. What research is being done isn’t being published fast enough, add Farrar et al., contrasting this with the speedy publication by researchers in other disciplines who have published in fast-tracked journal articles, or shared on public wikis – eg here – in advance of formal publication. Clinical researchers need to “catch up,” they conclude, “To do otherwise would be unethical.” (Declan Butler, The Great Beyond [Nature blog])

I don’t know the slowness is “unethical.” Clinicians in the midst of an outbreak have their hands full managing critically ill patients. Papers don’t write themselves. They require time, effort and spare energy, three things not so abundant in such circumstances.

Branswell offers a view what those circumstances look like and a few hospitals:

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(ChinaPost.com.tw) – The price of a planned domestically developed vaccine against the influenza A(H1N1) virus, better known as swine flu, will be competitive compared to imported vaccines, but variables still exist in the development process, Adimmune Corp. said Thursday.

While inaugurating its new plant in Taichung County, central Taiwan, the management of Adimmune Corp. — the only company in Taiwan qualified to mass produce the A(H1N1) vaccine — said the price of the domestically developed vaccine could be controlled to remain as low US$10 per dose, compared to 10 euros or US$15-US$20 per dose for counterparts quoted on the international pharmaceuticals market.

Adimmune has received vials of the virus strain for vaccine production from four World Health Organization (WHO) -authorized labs in Australia, Britain and the United States but has yet to decide which strain to use for domestic development, said Ignatius Wei, deputy CEO and president of Adimmune.

Adimmune will produce the vaccine based on chicken embryos, said Chang Chin-chuan, vice president of the company.

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The drugmaker Sanofi-Aventis will donate millions of doses of a vaccine that offers protection against the H1N1 (swine flu) virus to the WHO once the vaccine is ready, the company’s chief executive officer announced Tuesday, Reuters reports (Elsner, Reuters, 6/17). The AP/Google.com writes, “Exceptional times require exceptional responses. We need to act responsibly and we all have to play our part,” Sanofi CEO Christopher Viehbacher said in a statement released during the Pacific Health Summit in Seattle. “This flexible donation aims to help the WHO address the needs of these most vulnerable populations,” he said.

Viehbacher said Sanofi will give a total of 100 million doses of swine flu and bird flu vaccines, according to the AP/Google.com (Johnson, AP/Google.com, 6/17). “In the event that Sanofi Pasteur’s manufacturing facilities become fully committed to the production of pandemic vaccine,” the company will offer the vaccine to developing countries at a reduced rate, according to a company statement (Sanofi-Aventis release, 6/17).

As drug makers continue to work on developing a viable H1N1 vaccine, the WHO has held off on “whether people should get vaccinated against H1N1, which has spread to all regions of the world,” Reuters writes. “WHO has estimated vaccine makers could produce up to 4.9 billion pandemic flu shots a year in a best-case scenario, leaving some of the world’s 6.5 billion population unprotected, particularly if more than one dose was needed” (Reuters, 6/17).

A GlaxoSmithKline spokesman told Bloomberg the company also plans to donate 50 million doses of an H1N1 vaccine to the WHO. Bloomberg writes, “The decisions by Sanofi and Glaxo contrast with that of Novartis AG, which said this week it wouldn’t donate the vaccine,” but “may look at pricing and other ways to assure access.” The company’s resistance toward donating vaccines to developing countries stems from their belief “[d]onations won’t address the current pandemic or create sustainable access, [Novartis spokesman Eric] Althoff said.”

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Arrayit Corporation (OTCBB: ARYC), a leading manufacturer of products and services for disease prevention, treatment and cure, announced that its microarray-based diagnostic test, patented under the trade name Variation Identification Platform (VIP), is ready for manufacture and distribution. A breakthrough screening test using VIP will allow clinicians and researchers to test and detect the H1N1 swine flu virus in population wide studies.

The World Health Organization (WHO) announced on June 11, that the threat level of the H1N1 swine flu virus is now a global pandemic. This news is ideally timed with Arrayit Corporation’s release of its patented VIP screening test.

The Arrayit test will allow researchers and clinicians to detect the presence of the new H1N1 virus in mass numbers of flu patients, and to distinguish this threatening mutated strain from less harmful variants. Arrayit’s first supplies will be sent to the Centers for Disease Control (CDC) in Atlanta to be approved for use in the USA. Shortly thereafter, the H1N1 test kits will be made available for emergency use by licensed clinics, laboratories and other health care organizations worldwide.

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By sanjay tanday, Healthcare Republic

GPs should continue with containment measures to control the spread of swine flu, despite the WHO declaring a pandemic, according to the RCGP.

There has been a surge in the number of confirmed cases of swine flu in the UK and across the globe in recent weeks.
Currently, the HPA estimates that more than 800 patients in the UK have swine flu, but experts have warned that the true figure could be double this, as many cases are going undetected.

More than 1,200 people have contracted the virus in Australia, with a four-fold increase in just a week. The WHO believes that this sharp rise indicates that the pandemic level, phase 6, has been reached.

Current BMA/RCGP guidance states that once phase 6 has been reached, the focus should shift from efforts to contain or delay the spread to minimising the impact of a pandemic.

But Professor Steve Field, chairman of the RCGP, told GP that there would need to be evidence of the virus spreading across the whole of the UK before GPs moved away from the containment measures to treating patients.

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By MIKE STOBBE, Google

ATLANTA (AP) — The first study of U.S. health care workers with swine flu found that many didn’t do enough to protect themselves against the virus.

Researchers focused on 13 nurses and other health care workers who were likely infected at work in the early days of the U.S. outbreak. They found that only half always wore gloves, and even fewer routinely wore other protection around patients who might have the virus.

In late April — just as U.S. cases were first mounting — the U.S. Centers for Disease Control and Prevention said health care workers should wear gloves, gowns, eye protection and respirator masks when dealing with patients suspected of having swine flu. The CDC also advised sick workers to stay home.

To date, about 80 health care workers have been confirmed with swine flu. The study examined the 26 cases of infected workers with detailed information as of mid-May the study’s numbers are too small to generalize about what’s going on in clinics and hospitals. But they suggest that at least some health care workers aren’t doing enough to identify and isolate patients with swine flu and take precautions when treating them, said Dr. Michael Bell, a CDC official focused on infection control in health care settings.

“I think we’ve been lucky that this first wave has not been of the lethality that some people feared,” Bell said, at a news conference Thursday.

But CDC officials say many health care workers will need to improve how they deal with the flu, especially if — as some fear — the virus mutates into a deadlier form.

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Vaccine maker sanofi-aventis plans to donate 100 million doses of its A(H1N1) pandemic vaccine, currently in development, to the World Health Organization for use in developing nations that cannot afford to buy it  hemselves. The donation, which came on the heels of a similar move by GlaxoSmithKline, was announced yesterday during the opening session of the Pacific Health Summit in Seattle, Washington.

Christopher Viehbacher pledged that sanofi-aventis will donate 10% of the vaccine it produces to WHO. Robert Sebbag, the company’s vice president for access to medicines, says sanofi-aventis believes it can make at least 800 million doses the 1st year after production starts. That number could be several times higher, however, if the vaccine contains a so-called adjuvant, a compound that amplifies the host’s immune response, meaning that less viral protein is needed per shot. How well the adjuvanted vaccine will work and whether it will receive approval from regulatory authorities remains to be seen.

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The novel H1N1 swine flu virus looks like it’s going to hang out in the United States all summer, epidemiologist Dan Jernigan of the U.S. Centers for Disease Control and Prevention said at a press conference today. “Influenza season normally has ended by now, however the novel H1N1 continues in the United States,” said Jernigan. “We’re anticipating that we will see the novel H1N1 continue with activity probably all the way into our flu season in the fall and winter.”

CDC testing now shows that 89% of the influenza virus still circulating in the United States is the novel H1N1 strain. Jernigan said the northeastern part of the country continues to see increased numbers of swine flu cases, and it may be related to the cooler climate in that region and influenza’s penchant for lower temperatures. He said in the areas hardest hit by the virus, it appears to infect about 7% of the populations. “Clearly there are hundreds of thousands of cases that have occurred in the U.S.,” he said.

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Commenting on the World Health Organisation’s decision to raise its global pandemic alert level to Phase 6 due to the global spread of the novel H1N1 influenza strain, Acting Director General Michael D. Boyd of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), of which the Irish Pharmaceutical Healthcare Association (IPHA) is a member, said:

“Our members are better prepared than ever to face a pandemic influenza threat. Vaccine makers are ready to start producing novel H1N1 vaccines as soon as requested, and are discussing with WHO measures to help ensure broad access to them. In addition, antiviral manufacturers have provided WHO with stockpiles that have already been distributed to countries in need and are now replenishing those stockpiles. Looking at the broader implications of a pandemic, extensive plans have been made to ensure that companies can continue to produce and distribute essential medicines of all kinds during an influenza pandemic.”

When the novel H1N1 outbreak began, vaccine and pharmaceutical manufacturers began their own internal preparations to respond to the situation. Measures undertaken included preparing to produce a targeted novel H1N1 vaccine and increasing the manufacture of anti-virals. In addition, the IFPMA has been in close contact with the WHO to facilitate timely technical preparations for vaccine production.

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