At least one million people in the United States are infected with the novel H1N1 flu virus, far more than the official case count, the U.S. Centers for Disease Control and Prevention said yesterday. The startling statistic is based on epidemiologic modeling, CDC’s Lyn Finelli told the Advisory Committee For Immunization Practices, a group that advises the U.S. government on vaccine use. ACIP has met for the past 3 days in Atlanta to discuss, among other things, ways to contain the pandemic.

The pandemic flu vaccine isn’t ready yet, nor are recommendations on who should get it. But states and cities should already start planning for a massive vaccination campaign this fall. Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases, told journalists during a press conference following the ACIP meeting. She said they should think about how to get the vaccine to those at the highest risk for severe illness: “We want states and communities and health care providers to be thinking about how they would be able to vaccinate younger people, pregnant women, people who have underlying health conditions like diabetes and asthma.”

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The A(H1N1) swine flu virus has struck a pig farm in Buenos Aires province in Argentina—the second known instance of the pandemic virus infecting pigs. The outbreak was announced in a statement by Argentina’s food safety agency SENASA on Wednesday;…

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Oculus Innovative Sciences, Inc. (NASDAQ:OCLS), a healthcare company that develops, manufactures and markets a family of products based upon the Microcyn® Technology platform, which includes new formulations intended to reduce the use of antibiotics by preventing or treating infections including those caused by bacteria and viruses, has confirmed the effectiveness of Microcyn® Technology at inactivating the H1NI Swine Influenza A. In a virucidal time-kill suspension test conducted by an independent laboratory, BioScience Laboratories, Inc., the specific Microcyn Technology formulation reduced infectivity of the swine flu virus by 4.00log10 (99.99%) reduction after just 30-seconds exposure. BioScience Laboratories, working in cooperation with the U.S. Department of Agriculture, received formal approval to acquire, house and evaluate the specific swine influenza virus in April 2009.

Oculus is preparing the study data for submission to both the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) to help accelerate global awareness of Microcyn Technology’s ability to effectively and safely reduce the incidence of transmission of this pandemic virus. However, specific product formulations of the Microcyn Technology have not yet been reviewed or approved by any regulatory body for a specific swine flu indication.

“We experienced increased consumer use of our Microcyn-based products in April and May when the swine flu first hit in Mexico,” says Sergio Caleti, sales director of Oculus Innovative Sciences of Mexico. “This resulted in an uptick in product sales along with a corresponding increase in market awareness of the Microcyn Technology in Mexico. We are leveraging this increased name recognition with the introduction this year of a family of Mexican consumer products including a new pediatric skin treatment and smaller consumer packaging for the Microcyn-based wound care products.”

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CEL-SCI CORPORATION (NYSE AMEX: CVM) announced that it has filed a provisional U.S. patent application covering its L.E.A.P.S.(TM) immune therapy drugs (vaccines) for the prevention/treatment of H1N1, swine, bird flu, Influenza A and/or evolving mutants or variants of these viruses. Some experts believe that by the next flu season the swine flu virus will have evolved and/or combined with other viruses to create a much more lethal new virus. That is what happened in the case of the Spanish flu pandemic. CEL-SCI’s efforts to fight this virus are focused on using conserved epitopes from essential proteins to be found in the A influenza virus for H1N1, H1N5, swine, bird flu and Spanish influenza to create an effective vaccine/treatment that could potentially fight such a mutant virus.

Geert Kersten, Chief Executive Officer of CEL-SCI said, “By filing this provisional patent in the U.S., we are preserving our rights to file patents on these inventions and for their use world-wide either as an injected vaccine before a person is infected or exposed or as a therapeutic vaccine for treatment.”

Experimental work has been initiated on these various methods of use and applications for the A influenza vaccines. These L.E.A.P.S. vaccines, when used individually or together, are expected to induce antigen specific immune response(s) which, based on other L.E.A.P.S. animal tests in multiple disease models will hopefully lead to a protective immune response.

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Novavax, Inc. (Nasdaq: NVAX) announced publication of the preclinical study results that supported the clinical development of the company’s investigational VLP vaccine against the H3N2, H1N1 and B influenza strains. The study, which was conducted by scientists from the University of Pittsburgh, Center for Vaccine Research and Novavax, was published in the June 24, 2009 online issue of PLoS ONE. The vaccine contains three VLPs mixed together in a single formulation; each made up of the hemagglutinin (HA), neuraminidase (NA) and matrix 1 (M1) proteins from the representative strains. These proteins are important for broad protection against influenza, which is responsible for nearly 200,000 hospitalizations and 36,000 deaths in the U.S. each year. The vaccine is currently in Phase 2 clinical testing.

In this study, mice and ferrets received intramuscular injections of VLP vaccine which induced HAI antibodies against all three influenza strains represented in the vaccine and against a variety of drifted strains. All of the ferrets who received a vaccine dose of 15 mcg/strain, the dose used for currently licensed vaccines, developed HAI titers greater than or equal to 1:40. This level of antibody has been shown to be important for protection against flu in human studies of influenza vaccines. In addition, approximately 50% of ferrets developed HAI titers greater than or equal to 1:40 against drifted H3N2 strains from the 1999, 2002, and 2005 influenza seasons. The vaccine was also protective, reducing the amount of influenza virus in the nose of ferrets that were challenged with the H3N2 strain from the 2005-6 season.

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The HHS on Tuesday announced its decision to award a $35 million contract to a U.S. company using “insect cell technology” to develop flu vaccines, AFP/Google.com reports (AFP/Google.com, 6/23). CQ HealthBeat reports: “If the Food and Drug Administration approves the new technology [to be safe and effective], Connecticut-based Protein Sciences Corp. will establish the capability to produce a finished vaccine within 12 weeks of a pandemic’s onset and manufacture at least 50 million doses in the following six months.”

Unlike the conventional method of using chicken eggs to grow flu vaccines – a process that can take four to six months – “[t]he new technology, known as recombinant influenza vaccine, places a gene from a flu virus into an insect virus that can multiply quickly in insect cells, which are then purified for use in a human vaccine,” according to CQ HealthBeat. “The cells can be frozen, which would facilitate rapid production of large quantities of vaccine for use against both seasonal and pandemic flu” (Stephenson, CQ HealthBeat, 6/23).

“The technology has advanced in recent years to a point that we believe it could help meet a surge in demand for U.S.-based vaccine for seasonal and pandemic flu,” HHS Secretary Kathleen Sebelius said in a written statement. “We want to use the technology to help our nation respond to emerging infectious diseases” (HHS release, 6/23).

HHS’ announcement came one day after creditors filed a petition to force Protein Sciences into involuntary “bankruptcy and liquidation, saying they were owed $11.7 million,” the New York Times reports. The article continues, “The series of events raises questions about whether the government is entrusting part of the nation’s influenza defense to a financially shaky or untrustworthy company” (Pollack, New York Times, 6/23).

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Genómica, a company of the Zeltia Group (ZEL.MC) leader in molecular diagnostic products, is developing an updated version of its product CLART® PneumoVir for the specific and urgent detection of the New A/H1N1 Influenza. For the development of this test, Genómica is collaborating with various Spanish and international hospitals. Over the past two months a great number of suspicious samples have been analyzed. Positive and negative cases were confirmed in all the tests and the results have been validated by the different Spanish and international centres of reference.

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Senate Passes Bill Including Flu Funds The U.S. Senate on Thursday passed a $105.9 billion war-funding bill that “includes $7.7 billion to prepare for pandemic flu,” the Washington Post reports (Bacon, Washington Post, 6/19).

South Africa Confirms First Case of H1N1

Also on Thursday, South Africa’s Department of Health confirmed the country’s first H1N1 case, Reuters reports. The department released a written statement saying, “The patient, a 12-year-old who flew in from the U.S. on Sunday, was admitted to hospital on Monday and was kept in isolation,” Reuters writes. He has since been released from the hospital (Bosch, Reuters, 6/18).

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Amarillo Biosciences, Inc. (ABI) (OTCBB: AMAR) announced that the screening of volunteers for inclusion in a Phase 2 clinical study of the company’s oral interferon product at the University of Western Australia is now complete. The investigators met their target of screening at least 200 healthy adults for participation in the trial. A total of 215 volunteers were evaluated and 134 of them have been enrolled into the study to date. About 90% of the screened subjects have been found to qualify for the study, so additional enrollments are expected over the next 2 weeks to bring the total number of study participants up to or above the targeted 160 subjects.

The double-blind, placebo-controlled Phase 2 clinical trial is being conducted by Dr. Manfred Beilharz and colleagues. The study is expected to show that lozenges containing a low dose of interferon-alpha can prevent infection or reduce the severity of infection with influenza and other common respiratory viruses when taken once a day during a typical winter cold/flu season.

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GP groups and Aboriginal community controlled health services from around the country have called on the Government to quickly engage with general practices and Aboriginal community controlled health services in preparation for the rollout of a Swine Flu vaccine.

In a letter to Health Minister Nicola Roxon, United General Practice Australia (UGPA) and the National Aboriginal Community Controlled Health Organisation (NACCHO) called on Government to start planning for the roll out now.

A Swine Flu vaccine is currently undergoing clinical trials and is expected to be available within months.

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