FDA PRESS RELEASE

The U.S. Food and Drug Administration (FDA) has approved four vaccines for use against the 2009 H1N1 influenza virus.

The vaccines—made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc.—will be distributed nationally after the initial lots become available. This is expected to occur within the next four weeks.

Commissioner of Food and Drugs Margaret A. Hamburg, M.D., says the approval is good news for the nation’s response to the 2009 H1N1 influenza virus. “The vaccine will help protect individuals from serious illness and death from influenza,” she says.

Vaccines against three seasonal virus strains are already available and should be used. However, they do not protect against the 2009 H1N1 virus.

What have studies of the H1N1 vaccines shown?
Based on preliminary data, the approved vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine.

Clinical studies under way will provide more information about the optimal dose in children. Recommendations for dosing will be updated if indicated by findings from those studies. The findings are expected in the near future.

What are the warnings and potential side effects?
In the ongoing clinical studies, the 2009 H1N1 vaccines have been well tolerated. However, consumers need to be aware of the following:

• People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.

• Potential side effects of the H1N1 vaccines are expected to be similar to those of seasonal flu vaccines. For the injected vaccine, the most common side effect is soreness at the injection site. Other side effects may include mild fever, body aches, and fatigue for a few days after the inoculation. For the nasal spray vaccine, the most common side effects include runny nose or nasal congestion for all ages, sore throats in adults, and—in children 2 to 6 years old—fever. (Also see seasonal flu information in the “For More Information” section below.)

• As with any medical product, unexpected or rare serious adverse events may occur.

FDA is working closely with other agencies to enhance adverse-event monitoring, information sharing, and analysis during and after the 2009 H1N1 vaccination program. In the U.S. Department of Health and Human Services, these agencies include the Centers for Disease Control and Prevention (CDC).

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

FDA Date Posted: September 16, 2009

©2012 An Inconvenient Woman. All Rights Reserved.

“It’s a complex issue which needs to be thrashed out publicly. We’d encourage the key bodies involved to have that debate, to provide that information. Consumers want to know the facts.”

— Carol Bennett, the head of the Consumers Health Forum of Australia

The Australian government’s impending programme of vaccination against H1N1 flu has been criticised by some professional groups that have raised concerns about potential risks.

The Australian Infection Control Association this week warned the government against proceeding with the programme, saying that the planned use of multidose vials (used to vaccinate several people) posed a “significant potential risk to patient safety.”

The association’s president, Claire Boardman, said that use of multidose vials would contravene national infection control guidelines (www.safetyandquality.gov.au/internet/safety/publishing.nsf/Content/02A94EEE98D72244CA25740F00251B98/$File/NationalInfectionControlGuidelines.pdf) and that numerous adverse events related to their use had been well documented.

Ms Boardman said there was no justification for using multidose vials, as “the occurrence and distribution of H1N1 in 2009 within Australia does not constitute an emergency.”

She added, “We advise strongly against the use of multidose vials and do not support this mechanism for dissemination of the vaccine,” and warned that the “high risk of failure” of the pandemic vaccination campaign could compromise future programmes and also risked causing poor uptake of seasonal flu vaccination next year.

The association’s comments follow similar concerns raised by the Australasian Society of Infectious Diseases in a letter to the government’s chief medical officer, Jim Bishop, widely reported in the media (www.abc.net.au/pm/content/2008/s2662248.htm).

However, some experts involved in trials of an H1N1 vaccine being developed by the vaccine manufacturer CSL Limited believe that any potential risks are minimal and are being blown out of proportion.

Robert Booy, professor of paediatrics and child health at the Children’s Hospital, Westmead, Sydney, and the coauthor of a blog defending the vaccine’s safety (www.aussmc.org/ScienceBlog.php), told the BMJ: “There is considerable and emerging evidence for safety of multidose vials, especially in the hands of trained nurses. Being stalled by this controversy may make us a laughing stock to the rest of the world.”

CSL has repeatedly said that the multidose vials are safe.

But Peter Collignon, an infectious diseases physician and microbiologist at the Australian National University, said it was hard to see why Australia should abandon its usual practice of using mainly single dose, preloaded syringes.

“The only reason to use multidose vials is to save money or else because there is a rapidly evolving emergency with a high death rate,” Professor Collignon said. “Neither of these conditions is currently present in Australia. We passed the peak of this epidemic in most states in Australia in mid-July.“

However, Professor Bishop said that this view overlooked the possibility of another wave of infections before next winter.

“The World Health Organization has said this virus is unpredictable; past pandemics have told us that pandemics don’t run in seasons,” he said.

Professor Bishop said that multidose vials would be used in all H1N1 vaccination programmes that he knew of around the world and that they were also used in the United States for vaccination against seasonal flu. Vaccination providers would be trained in use of multidose vials to maximise infection control and minimise wastage.

“In order to get vaccines out in a reasonable quantity and logistically, the multidose vial has many advantages,” he said.

He said he expected that vaccine supplies would start to become available this week and that the vaccine would initially be given to high risk groups, with the eventual aim of having at least 40% of the population protected.

Julie Leask, a University of Sydney social scientist who researches public acceptance of vaccines, said that the poor image of swine flu vaccination among the public meant that there may be “underwhelming demand” and that “full transparency from the authorities” would be needed to ensure public confidence.

The public would need to know the data the government was using to assess the vaccine and the risks of swine flu in Australia and that systems for reporting adverse events were in place, she said.

Carol Bennett, the head of the Consumers Health Forum of Australia, said it was important that the potential benefits and risks of flu vaccination were openly discussed.

“It’s a complex issue which needs to be thrashed out publicly,” she said. “We’d encourage the key bodies involved to have that debate, to provide that information. Consumers want to know the facts.”

Free Article Reprinted with permission in the public interest

BMJ NEWS: Reported by Melissa Sweet, Sydney AU

Published 8 September 2009, doi:10.1136/bmj.b3656
Cite this as: BMJ 2009;339:b3656

©2012 An Inconvenient Woman. All Rights Reserved.

As manufacturers work furiously to make a vaccine to protect against 2009 influenza A (H1N1) virus, a Rice University bioengineer is trying to improve the process for future flu seasons.

In a paper published this summer in the journal Protein Engineering, Design & Selection, Rice researchers described a new method to predict the efficacy of H1N1 vaccines.

Michael Deem, Rice’s John W. Cox Professor in Biochemical and Genetic Engineering and professor of physics and astronomy, and his group are using a formula they developed several years ago to more accurately predict which vaccines can halt ever-evolving strains of the flu, including the novel H1N1 variety that the World Health Organization has tagged as a pandemic virus.

Deem has identified the dominant epitope regions of hemagglutinin, a part of the virus that the immune system recognizes, as the best candidates for comparison by the formula. Epitopes are antigens, short for antibody generators. They’re bits of viral protein the body recognizes when the flu attacks, and they prompt the immune system to make antibodies, destroy the virus and be on guard against future infection by the same microorganism.

Deem’s technique compares amino-acid sequences of the epitope regions of two strains of H1N1 — or any other influenza A virus — and marks the differences. The fewer the differences, the more likely it is that one strain engineered into a vaccine will help prevent the other from infecting a person.

Vaccines work by introducing weak versions of live or inactivated viruses into the body and give the immune system fair warning that a flu virus with a particular epitope may attack. If a vaccine’s epitopes are a perfect match to those of the virus, it should be effective in stopping the flu.

That does not always happen.

Vaccines typically contain protection against what scientists consider the three most likely strains of influenza A and influenza B to hit during flu season. But the flu is a master of disguise and can evolve between the spring, when such decisions are made, and the fall, when shots are administered.

“The virus mutates quite a bit,” Deem said. “Normally, when we’re doing rational drug design, we’re trying to do it against a target protein that is not changing, and we’re trying to find something that fits very nicely in the pocket of that protein.

“For the flu, these epitopes change. So rational drug design against one strain of the flu virus would only be useful for that one year, and then the virus would mutate the next year.”

Deem wants to cut the amount of time between the analysis of flu strains and the manufacture of vaccines to fight them. He and graduate student Keyao Pan can predict the efficacy of H1N1 vaccines by estimating the antigenic “distance” — the degree of difference between the epitopes — for any two strains of virus.

Deem’s technique assigns a numerical value to the antigenic distance between two strains. That tells researchers just how effective a virus might be. But it also offers a tipping point: If a value of zero is the perfect H1N1 vaccine, a value above roughly 0.4 indicates a vaccine that offers no protection at all.

That means there’s a real incentive to formulating the vaccine as close to flu season as possible. It also means choosing strains of the virus that can be produced in high quantities but which are also as close as possible to the virus strain expected to hit. The current process is time-consuming: The novel H1N1 vaccines are incubating in hens’ eggs — the traditional method — right now, and the United States expects to have 40 million doses in hand by mid-October, with 20 million doses arriving weekly thereafter, said Deem.

His calculations provide incentive to refine cell-based approaches that could shorten manufacture time. “In the United States government, this has been recognized, and there’s investment now in new technologies,” he said.

“I think modeling has already had an impact on the World Health Organization, and this type of modeling — and our model in particular — will have an impact.”

©2012 An Inconvenient Woman. All Rights Reserved.

BioSante’s vaccine adjuvant, BioVant^TM, increases the protective effect of vaccines for multiple flu strains

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced today’s presentation of H1N1 vaccine results at the Immunotherapeutics & Vaccine Summit in Providence, RI. BioSante’s vaccine adjuvant, BioVant^TM, increased the protective effect of vaccines for multiple flu strains, including a potential new vaccine against H1N1 (swine flu), which resulted in 100 percent protection from symptoms of illness, including weight loss, and death in animal studies.

The BioSante presentation, “BioVant Calcium Phosphate (CaP) Nanoparticles: An Effective & Safe Adjuvant for Influenza Vaccines including H1N1 and H5N1,” showed that BioVant-adjuvant effectively enhanced the natural immune response to the swine flu, using a BioVant-adjuvanted matrix protein M1 vaccine, and to H5N1 (bird flu), using a BioVant-adjuvanted H5N1 vaccine delivered via intranasal administration.

The studies concluded that swine and bird flu vaccines using BioSante’s BioVant may allow for availability of a greater number of lower-dose vaccines, due to its dose sparing characteristics, and intranasal administration could provide more convenient and wider distribution during a flu pandemic.

“The results of the BioVant-influenza studies suggest that BioVant can increase the efficacy of a potential adjuvant-enhanced H1N1 vaccine,” said Michael Snabes, BioSante’s vice president of clinical development. “The exciting prospect is that BioVant also may allow use of lower doses of H1N1 swine flu vaccines in order to stretch potentially limited vaccine supplies.”

An adjuvant is a substance that, when added to a vaccine, increases the vaccine’s effectiveness by enhancing the body’s immune response. In multiple studies, BioVant has been shown to be safe and cause minimal dose-dependent inflammation at the injection site, and has been shown both to prevent the manifestation of allergic response, and, to effectively ‘switch off’ established Th2-T-cell-associated allergic reactions and potentially to be delivered via alternative routes of administration, e.g. intranasally.

About BioSante Pharmaceuticals, Inc.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism. BioSante’s lead products include LibiGel^® (transdermal testosterone gel) in Phase III clinical development by BioSante under a U.S. Food and Drug Administration (FDA) SPA (Special Protocol Assessment) for the treatment of female sexual dysfunction (FSD), and Elestrin^TM (estradiol gel) developed through FDA approval by BioSante, indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, currently marketed in the U.S. Also in development are Bio-T-Gel^TM, a testosterone gel for male hypogonadism, and an oral contraceptive in Phase II clinical development using BioSante patented technology. The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion and for oral contraceptives approximately $3 billion. The company also is developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook^TM), as a vaccine adjuvant, including for an H1N1 (swine flu) vaccine, and drug delivery.

Additional information is available online at: www.biosantepharma.com.

©2012 An Inconvenient Woman. All Rights Reserved.

Anyone who still thinks that AstraZeneca paid too much when it offered a hefty premium for MedImmune’s shares should check out a new report from Jefferies International, which estimates that the global swine flu windfall will be worth around $2.3 billion in new sales for the Maryland manufacturer in 2009 and 2010 reports FierceVaccines.

MedImmune is putting its FluMist nasal spray technology to the test against swine flu. FluMist, which got off to a shaky start in the U.S., brought in only $104 million last year, a fraction of what the big global manufacturers have been able to earn with their flu shots. But all those naysayers who scorned the terms of the MedImmune buyout in the face of such weak performance could well be silenced by the rewards available when a pandemic hits. AstraZeneca plans to make 200 million doses of swine flu vaccine by next spring.

“This puts MedImmune in a better light and helps pay back some of that $15 billion,” Jefferies analyst Jeffrey Holford told Bloomberg in an interview. “This is the first positive surprise that’s tangible.”

MedImmune has already started recruiting for human trials, saying it will test the vaccine in children aged 3 to 17 and adults aged 18 to 49. Preliminary data may be available in a matter of weeks.

- Read  more about MedImmune in this  Bloomberg feature

©2012 An Inconvenient Woman. All Rights Reserved.

Melbourne, Australia – 29/06/2009

CSL Limited, Australia’s leading biopharmaceutical company, will shortly be commencing a clinical trial of a candidate vaccine against Novel H1N1 ‘Swine’ Flu. The trial will be undertaken in partnership with Clinical Research Organisation CMAX and the Royal Adelaide Hospital in South Australia.

Healthy adults aged between 18 and 64 years are being sought to participate, and must be available to meet four appointments in Adelaide over a 6 month period.

The trial will involve participants receiving two injections of the vaccine, three weeks apart, and will compare a standard with an increased dosage of vaccine. Volunteers will need to submit to blood tests to check that they are generating an appropriate immune response to the virus.

“We understand flu vaccines very well from our long experience with yearly seasonal strains, as well as research into novel flu vaccines.” Global Director of Clinical Development at CSL, Dr Russell Basser said today.

“We appreciate that new influenza strains like the ‘swine flu’ can surprise us with properties that mean they might require higher dosing and two injections rather than one to provoke the desired level of immune response in humans.”

“CSL will be addressing these questions in the trial to ensure we know the optimum way for the vaccine to be given to protect against this strain of flu.”

It is anticipated that participants in the trial will commence being vaccinated in mid-July. This trial is being conducted with view to fulfilling a commitment to the Australian Department of Health and Ageing to supply up to 10 million people with a vaccine against Novel H1N1 ‘

©2012 An Inconvenient Woman. All Rights Reserved.

With the swine flu pandemic grabbing headlines and scaring countries the world over, GlaxoSmithKline says that it expects to reap up to $2.1 billion next year from the sale of a new H1N1 vaccine. And it’s already tripling its capacity to supply the antiviral Relenza as it dickers with about 50 countries over their plans to buy stockpiles of meds to fight the flu.

Glaxo projected $573 million in Relenza sales by the end of this year. And Glaxo says that the demand for flu meds should keep swelling its revenue stream for several years to come.

“In these last three months, governments have rapidly strengthened their pandemic stockpile and prevention strategies,” said GlaxoSmithKline’s chief executive, Andrew Witty. In some cases the talks are at a “very advanced stage. While we are currently seeing a heightened period of demand, it is likely that we will see a sustained level of orders for pandemic products over the next few years.”

Like other vaccine manufacturers, GlaxoSmithKline says that it’s work on a new vaccine has been slowed due to low yields of antigen. But Glaxo says that it should be able to supply governments with what they need by early 2010.

Analysts note that the pandemic couldn’t have come at a better time for Glaxo, one of the world’s largest vaccine makers. Generics have been steadily eating into the company’s margins, leaving Glaxo looking for new products to make up the shortfall.

- read the story from Forbes
- read the report from the Philadelphia Inquirer

©2012 An Inconvenient Woman. All Rights Reserved.

An additional $884 million in funding has been allocated to buy more ingredients an antigen and an adjuvant for swine flu vaccines. This is in addition to the $1 billion The Department of Health and Human Services committed to fighting the Swine Flu in May.

Novartis will get the bulk of the $884 million. The drugmaker has landed $690.1 million to produce bulk vaccine antigen as well as other ingredients. GlaxoSmithKline is being furnished with $71.4 million for bulk oil and water adjuvant, while Sanofi Pasteur will receive $61.4 million to produce ingredients.

Washington Business Journal writer, Vandana Sinha  reported that one month after (H1N1) swine flu was declared a global pandemic, MedImmune has been awarded additional $61 million contract from the U.S. Department of Health and Human Services, six weeks after it accepted a $90 million contract from the agency to manufacture ingredients for a potential vaccine for the H1N1 virus to fight the predicted Swine Flu outbreak.

MedImmune, now the Gaithersburg subsidiary of the London-based AstraZeneca PLC, is using the funding to produce and test the flu-fighting technology it uses in its seasonal FluMist product (nasal spray) as a viable treatment for the for the H1N1 virus.

The World Health Organization (WHO) has raised the H1N1 (Swine) Flu to the highest warning levels on the pandemic scale.

The follow-up awards were given to four of five pharmaceuticals that the federal government has been contracting with to produce potential vaccine materials — Sanofi Pasteur SA, GlaxoSmithKline PLC, Novartis AG, CSL Ltd. and MedImmune.

In all, the agency has spent nearly $1.9 billion to date on these contracts., MedImmune’s combined $150 million in awards have been the smallest so far of those companies.

Read Full Washington Business Journal Article
Read AP Story

©2012 An Inconvenient Woman. All Rights Reserved.

San Diego-based Vical, a firm who is developing an H1N1 vaccine under an agreement with the U.S. Navy saw company shares climb 45 cents,  to $2.65 on positive clinical trial news this week.  Vical researches and develops biopharmaceutical products based on thier patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Vical’s stock shot up 20 percent on the news that their swine flu jab sailed through an animal study with positive results. Vical’s H1N1 vaccine is now ready for a human study — marching into the clinic in record time.

Financial analysts are noticing uptick for successful H1N1 Vaccine manufactures

Reni Benjamin, analyst with Rodman & Renshaw (a leading investment banking firm to the capital intensive biotechnology sector, that includes specialty pharmaceutical, medical device and other life science companies) noted speed of the H1N1 vaccine’s development. Vical  received a sample of swine flu from the Centers for Disease Control and Prevention on April 30, shortly after the H1N1 strain emerged. In a recent report he wrote, “These results provide additional validation for Vical’s technology platform, demonstrating not only efficacy and but also speed in generating a vaccine to an influenza strain that emerged in April 2009.”

All the rabbits and mice injected with the H1N1 vaccine were protected in the preclinical study and three out of four hit a key protection mark after a single dose. Those were the numbers Vical needed to get a human study underway, and the company says it’s ready to start large scale manufacturing needed to produce a vaccine for clinical trials.

Researchers at vaccine developers have been racing to get a new flu vaccine ready for mass production in anticipation that the worldwide demand for a new H1N1vaccin is likely to be overwhelming. Vical is only one of many vaccine manufactures racing to cash in on the World Health Organization declared Swine Flu Pandemic. Protected from adverse reaction liabilities by the mandated H1N1 influenza immunization policies of WHO and participating country’s various public health organizations, the ailing balance sheets of Big Pharma’s walking wounded are in for a big shot in the arm. (pun totally intended.)  This vaccine is on a fast track production schedule, where speed can compromise safety, in a liability-free zone. Financial analysts breathlessly report that it only took Vical two months to take a swine flu sample and jump ahead to a clinical trial. This may be great for the stockholder, but is it really good news for the folks who may be forced to line up for a mandatory injection that flew from the butt of a mouse to our shoulder in few months of intense trial, and perhaps error.

Does anyone else remember that the last time we all ran around with our hair on fire about an impending influenza pandemic?

The year was1976. 19-year-old Army Pvt. David Lewis of Ashley Falls, Mass. sudden death was attributed to Swine Flu. The same Swine flu that took over 500,000 American lives immediately after World War 1. The label, Swine Flu, was certainly enough to cause public concern. It took the Ford administration to turn that concern into a full fledged panic.

The CDC’s reaction and mass inoculation program it developed and administered would become known to some medical historians as a fiasco and to others as perhaps the finest hour of America’s public health bureaucracy. The swine flu case of 1976 forever reduced confidence in public health pronouncements from the government and helped foster cynicism about federal policy makers that continues to this day.

Only young Lewis died from the swine flu itself in 1976. But as the critics are quick to point out, hundreds of Americans were killed or seriously injured by the inoculation the government gave them to stave off the virus.

If you wish to glimpse the future simply review the past, read:
The Epidemic That Never Was: Policy-making and the swine flu scare by Richard E Neustadt;
and watch the decision processes of those public health officials and regulators who have forgotten or ignored the lessons of history.
VICAL FACTIOD:

Vical researches and develops biopharmaceutical products based on our patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases.

VAXFECTIN®

Vical’s proprietary Vaxfectin® adjuvant has demonstrated safety and effectiveness in a number of animal models. In July 2008, we announced preliminary clinical trial data demonstrating that Vaxfectin®-formulated DNA vaccines can safely achieve significant immune responses against H5N1 pandemic influenza in humans. References to published data are included in the Vaxfectin® Publications page.

©2012 An Inconvenient Woman. All Rights Reserved.

Around the world, vaccine manufactures are rushing new swine flu (H1N1) vaccines into clinic trials and booking pre-orders from worried Public Health officials, while epidemiologists are still puzzling out how the new flu works and why many young people without any health complications are often hit the hardest by H1N1.

MARINA JIMÉNEZ, Globe and Mail National reporter, cautioned Canadians against complacency regarding the new H1N1, Swine flu .Canadian Public Health experts have predicted that as many one third of Canada’s young, healthy adults could be affected. Two out of three confirmed flu patients have no underlying health conditions. Mexician physicians concluded that it was the 20-to-50 age group that was most threatened. In most cases, the flu is somewhat more serious than seasonal flu, but still quite mild. What the specialists can’t determine is why some people are killed by it.

“They are ending up on ventilators and it can last from weeks to months,” Michael Gardam, director of infectious diseases at the Ontario Agency for Health Protection and Promotion, tells the Globe and Mail. “I would like people to be concerned about H1N1, without panicking. More concerned than they are about seasonal flu.”

- read the report from the Globe and Mail

ALSO: In the U.S., health officials expect to have 50 million doses of vaccine on hand by October 15, with millions of additional doses in hand later in the season. Report

PLUS: Both China and the UK have now stopped trying to contain the pandemic and have switched strategies, focusing on individual patients. Report

©2012 An Inconvenient Woman. All Rights Reserved.