Tag Archives: H1N1

New flu drug may resist mutations: researchers

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New flu drug may resist mutations: researchers

A new type of experimental flu drug that stops the virus from infecting cells appears to stop it from mutating into drug-resistant forms, researchers reported on Sunday.

Tests in mice and in lab dishes show that NexBio Inc.’s drug Fludase can stop the seasonal influenza virus from infecting cells and can fight strains of virus that have evolved resistance to Tamiflu, Roche AG’s popular influenza drug, the company said.

“Extensive, prolonged nonclinical influenza studies have not shown the development of any meaningful resistance,” the company said in a statement released at the Interscience Conference on Antimicrobial Agents and Chemotherapy in San Francisco.

Privately held NexBio Inc. said tests showed that Fludase, also known as DAS181, worked against the new H1N1 swine flu virus too.

Influenza viruses very quickly change to put up a strong defense against antiviral drugs. Last year the seasonal H1N1 virus developed strong resistance to Tamiflu. Two older flu drugs, amantadine and rimantadine, now have very little effect against influenza viruses.

Tamiflu and a similar drug, GlaxoSmithKline’s Relenza, affect a compound in the flu virus called neuraminadase — which gives flu viruses like H1N1 the “N” in their names.

Fludase affects the human cells that influenza infects, not the virus itself and that should make it less likely to cause the virus to develop resistance, company spokesman Dr. David Wurtman said.

It affects the sialic acid receptor — the molecular doorway that flu viruses use to attach to cells, he said.

“It makes it impossible to spread, so it can’t infect neighboring cells,” Wurtman said in a telephone interview.

Teams at the U.S. Centers for Disease Control and Prevention, University of Hong Kong and Saint Louis University in Missouri ran the experiments, the company said.

“Based on these encouraging data, we are moving forward with our ongoing clinical development of DAS181, and we will continue to work closely with FDA (the U.S. Food and Drug Administration), CDC and NIH (the National Institutes of Health) on this clinical program during the current pandemic,” Dr. Ronald Moss of NexBio, who presented the study, said in a statement.

Health experts predict that new drugs to fight flu will soon be needed, as the virus is mutation prone. Many are in development — furthest along is BioCryst’s peramivir, which would be made and sold in partnership with Japan’s Shionogi.

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Studies show one dose of H1N1 vaccine may be enough

in.reuters.com

Studies show one dose of H1N1 vaccine may be enough

Two studies published on Thursday confirmed that a single dose of swine flu vaccine can protect people from the new pandemic H1N1 virus — welcome news to global health officials who had worried that people might need two doses.

Australian vaccine maker CSL Inc. released new data showing its vaccine got what would be considered a protective immune response with a singe dose, and Swiss drug maker Novartis presented a study confirming a report from last week showing its vaccine worked at an even lower dose when boosted with an immune system compound called an adjuvant.

Both studies, published in the New England Journal of Medicine, may lay to rest fears about the logistical nightmare of trying to vaccinate hundreds of millions of people globally with two doses of H1N1 vaccine — given a month apart — in addition to a single recommended dose of seasonal influenza vaccine.

Last week China’s Sinovac also reported its vaccine protected patients with a single dose.

The new H1N1 strain of flu, declared a pandemic in June, could eventually infect one third of the world’s population, or 2 billion people, according to the World Health Organization.

Because it is a new strain, infectious disease experts had said people would likely need two doses to get full immunity against the virus. They are rushing to put in place vaccine programs as the weather cools in the Northern Hemisphere and the traditional flu season starts.

About 20 pharmaceutical companies including Sanofi-Aventis, GlaxoSmithKline and AstraZeneca’s MedImmune unit are also racing to develop H1N1 vaccine as governments scramble to secure supplies.

The United States hopes to vaccinate 160 million Americans by the beginning of December.

NASAL SPRAY READY

Also on Thursday, MedImmune said its inhaled vaccine against the pandemic H1N1 virus could be ready to start shipping to the U.S. government by the end of September.

MedImmune’s Dr. Raburn Mallory said the company has submitted safety data for its nasal spray swine flu vaccine to the U.S. Food and Drug Administration.

“There are no red flags there. We think we can have 5 million doses ready to distribute at the end of September,” Mallory said in an interview. U.S. officials had not expected vaccination to begin until mid-October.

The company has 5 million doses in spray devices now, a company spokeswoman said, adding that a more conservative estimate would be that 3.5 million doses could be sent out by the end of September.

U.S. health officials said they started testing swine flu vaccines in pregnant women this week and were scheduled on Friday to report on results of some of the tests being done on various swine flu vaccines for the U.S. market.

The U.S. Food and Drug Administration is licensing H1N1 vaccines as if they are a simple reformulation of the seasonal flu vaccine. This does not require clinical tests, but the National Institutes of Health is running clinical tests anyway, to be sure it is safe and to find the best dose.

Governments in Europe have started to take delivery of H1N1 swine flu vaccines but are awaiting a license from European authorities before they can start mass vaccinations.

“The immune response to all these vaccines is a very high response, whatever type of vaccine it is, whether it is adjuvanted or non-adjuvanted,” Thomas Lonngren, executive director of the European Medicines Agency or EMEA, told a news briefing.

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Eggs for making H1N1 vaccine meet world standards

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Eggs for making H1N1 vaccine meet world standards

An egg is a round or oval body laid by the female of any number of different species, consisting of an ovum surrounded by layers of membranes and an outer casing, which acts to nourish and protect a developing embryo and its nutrient reserves. Most edible eggs, including bird eggs and turtle eggs, consist of a protective, oval eggshell, the albumen (egg white), the vitellus (egg yolk), and various thin membranes. Every part is edible, although the eggshell is generally discarded. Eggs are considered a good source of protein and choline. Because of this, the egg falls in the Meats category under the Food Guide Pyramid.

Roe and caviar are edible eggs produced by fish.

The eggs provided by two local companies to be used in the manufacture of H1N1 vaccine by Adimmune Corp. meet both world and local standards, the Central Epidemic Command Center under the Cabinet-level Department of Health (DOH) said Wednesday.”The eggs being used by Adimmune to produce HINI vaccine scrupulously meet the international standards set forth by the World Health Organization (WHO) and by Good Manufacturing Practice (GMP) criteria imposed by the DOH for high-quality food, ” the center said in response to a report by Next Magazine that questioned the safety of the eggs used by Taiwan’s sole human vaccine manufacturer.

Chen Hui-fang, director-general of the Bureau of Pharmaceutical Affairs under the DOH, said that in line with WHO guidelines, embryo eggs used to make vaccine must come from healthy chickens of adequate maturity and that such eggs supplied by two local providers fully meet the WHO regulations.

Eggs produced by chickens in the two enclosed farms are being raised in a fully automated and safe environment with round-the-clock monitoring, Chen said.

According to Chen, the bureau dispatched officials to inspect the production operations for the embryo eggs late last month, and no bacteria or residue from antibiotics or hormones were detected.

A day earlier, an Adimmune executive said the company’s vaccine production had entered the “filling stage,” which means that the dose of the vaccine has largely been established.

The executive added that the company is expected to launch human clinical trials in two weeks, to be conducted at the National Taiwan University (NTU) Hospital, the Tri-Service General Hospital and the Taipei Medical University-Wan Fang Hospital.

The company is recruiting 250 adults and 150 children to take part in the trials, he noted.

Immunizations are expected to begin in late October, with healthcare workers, pregnant women and children between 6 months and 6 years selected as priority recipients.

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