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.

Vical Pandemic Influenza Vaccine Demonstrates Cross-reactivity Against California, Texas and Mexico H1N1 Strains

Vical Incorporated (Nasdaq:VICL) announced today that the company’s DNA vaccine against A/H1N1 pandemic influenza (swine flu) has demonstrated robust immune responses in 100% of vaccinated animals against virus strains isolated from recent outbreaks in three distinct geographic locations — California, Texas and Mexico.

Vical’s plasmid DNA vaccine contains the H1 hemagglutinin gene sequence provided by the U.S. Centers for Disease Control and Prevention (CDC) for the swine-origin A/California/04/09 pandemic influenza virus, and after two doses produced immune responses well above the accepted protection threshold in 100% of vaccinated mice and rabbits using HI assays against the swine-origin A/California/07/09 x-179a, A/Texas/15/09 and A/Mexico/4108/09 influenza viruses. Hemagglutination inhibition (HI) titers were well above the protection threshold of 40, ranging from 320 to 2,560 in mice, and from 640 to 2,560 in rabbits against the California strain. Results against the Texas and Mexico strains were essentially equivalent, ranging from 640 to 2,560 in both mice and rabbits. Vical’s vaccine would also be expected to provide similar robust immune responses against other swine-origin A/H1N1 influenza virus subtypes, supporting selection of a single A/H1N1 virus strain as the basis for the vaccine.

“Cross-reactivity is consistent with previous CDC reports that circulating strains of swine-origin A/H1N1 pandemic influenza have remained antigenically homogeneous,” said Vijay B. Samant, President and Chief Executive Officer of Vical, “but future viral changes are unpredictable and could be far more substantial. The inherent speed of our DNA vaccine platform both in initial development and manufacturing could be extremely important in addressing the potential shortfalls of conventional vaccine approaches.”

Vical has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Naval Medical Research Center (NMRC), a biomedical research organization within the U.S. Navy, to develop a vaccine against H1N1 influenza.

“We are working with the U.S. Navy to secure funding to advance our H1 vaccine into human clinical testing,” added Mr. Samant. “Based on the sustained threat from the ongoing H1N1 pandemic, we have initiated critical-path manufacturing activities to allow initiation of a Phase 1 trial in as little as four to six weeks after funding is secured.”

About Vical

Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company’s DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at www.vical.com.

The Vical Incorporated logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5768

This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about Vical’s vaccine technologies and their potential application in a vaccine against H1N1 influenza, potential human clinical testing of such a vaccine, the Vical/NMRC CRADA, potential changes in circulating strains of influenza, potential government regulatory and procurement activities, as well as the company’s focus, collaborative partners, and product candidates. Risks and uncertainties include whether the company’s technologies will be successfully applied for the development of an H1 DNA vaccine; whether such vaccine will advance to clinical testing quickly, if at all; whether funding will be secured to support a Phase 1 trial; whether Vical, NMRC or others will continue development of any influenza DNA vaccine candidates; whether Vical and/or NMRC will terminate the CRADA before achievement of its objectives; whether the company’s DNA vaccine candidate will be effective in protecting humans against H1N1 or any other strains of influenza; whether H1N1 pandemic influenza will undergo substantial strain changes; whether Vical’s pandemic influenza vaccine will advance sufficiently to be considered for licensure during future pandemics; whether results in animal testing will be predictive of results in human testing; whether any product candidates will be shown to be safe and effective; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; whether Vical or its collaborative partners will succeed in marketing any product candidates; and additional risks set forth in the company’s filings with the Securities and Exchange Commission. These forward-looking statements represent the company’s judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.

CONTACT: Vical Incorporated
         Alan R. Engbring
         (858) 646-1127
         www.vical.com

©2012 An Inconvenient Woman. All Rights Reserved.

With two new swine flu vaccines approved for use and five million doses scheduled for delivery this month, China is set to become the first country to begin a mass vaccination campaign against the H1N1 pandemic. But officials with the World Health Organization say that there are some concerns about potential side effects.

Sinovac Biotech wasted little time in testing and gaining official approval of its new swine flu vaccine. Now some of the 200,000 people expected to show up in Beijing beginning October 1 for the 60th anniversary of the founding of the country’s communist government will be first in line for the jab. After that the country plans top inoculate students, pregnant women, healthcare workers and China’s police and other key workers.

China has to be selective. Going all out it can expect to inoculate 65 million people by the end of the year – only a fraction of the country’s population of 1.3 billion. Health officials the world over will be watching China’s experience closely. If the Chinese begin to report side effects, it could have a big impact on how people in the rest of the world view these new vaccines. There’s considerable built-in resistance to noval vaccines, particularly among health workers.

Shares of Sinovac Biotech (NYSE: SVA) are higher on reports from Reuters, China approved the company for H1N1 vaccine production and the company raised their sales guidance. The stock is up 19%.

CEO Yin Weidong said, “At the beginning of this year, we forecast our sales would rise by 20 percent. H1N1 has given us an opportunity, so the rise should be more than 20 percent.”

Sinovac says patients needs only one 15 microgram dose of the vaccine to be effective. Novartis (NYSE: NVS) also said its vaccine gave a strong immune response after one dose in a pilot trial.

Review The Street Insider Report

- read the CNN report

©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.

Below is the most recent World Health Organization Press Release concerning the ongoing concerns about the safety of the H1N1 vaccines currently being developed and tested by Pharmaceutical Companies.  I can’t honestly say that this WHO release answers all of my questions, or for that matter changes my opinion, but I wanted my Inconvenient Woman readers to have access to the latest official WHO information.

GENEVA — WHO is aware of some media reports that have expressed concern about the safety of vaccines for pandemic influenza. The public needs to be reassured that regulatory procedures in place for the licensing of pandemic vaccines, including procedures for expediting regulatory approval, are rigorous and do not compromise safety or quality controls.

Vaccines are among the most important medical interventions for reducing illness and deaths during a pandemic. However, to have the greatest impact, pandemic vaccines need to be available quickly and in large quantities.

During the 1957 and 1968 pandemics, vaccines arrived too late to be used as an effective mitigation tool during the more severe phases of the pandemics. Influenza vaccines had not yet been developed when the 1918 pandemic swept around the world, eventually killing an estimated 50 million people.

In 2007, as part of preparedness for an influenza pandemic, WHO worked together with health officials, regulatory authorities, and vaccine manufacturers to explore a broad range of issues surrounding the regulatory approval of pandemic vaccines. [1]

Ways were sought to shorten the time between the emergence of a pandemic virus and the availability of safe and effective vaccines. Different regulatory pathways were assessed, and precautions needed to ensure quality, safety, and effectiveness were set out in detail.

Fast-track procedures for approval

Regulatory authorities have shown great flexibility in developing procedures for fast-tracking the approval and licensing of pandemic vaccines.

In some cases, pandemic vaccines are not regarded by regulatory authorities as entirely “new” vaccines, as they build on the technology used to produce vaccines for seasonal influenza, established procedures for testing and regulatory control, and an extensive body of safety data.

In such cases, approval procedures are similar to those applied to “strain changes” made each year when seasonal vaccines are modified to match circulating viruses in the Northern and Southern Hemispheres.

Specific regulatory procedures have been devised to expedite the approval of pandemic vaccines. In the USA, for example, fewer data are required when the manufacturer already has a licensed influenza vaccine and intends to use the same manufacturing process for its pandemic vaccine.

In the European Union, the European Medicines Agency uses a rolling review procedure whereby manufacturers can submit sets of data for regulatory review as they become available, without having to wait until all data can be submitted together in a single formal application.

Also in Europe, some manufacturers have conducted advance studies using a so-called “mock-up” vaccine. Mock-up vaccines contain an active ingredient for an influenza virus that has not circulated recently in human populations and thus mimics the novelty of a pandemic virus. Such advance studies can greatly expedite regulatory approval.

Special safety concerns

Influenza vaccines have been used for more than 60 years and have an established record of safety in all age groups. While some serious adverse events have been reported, these have been rare.

Nonetheless, special safety issues will inevitably arise during a pandemic when vaccine is administered on a massive scale. For example, adverse events too rare to show up even in a large clinical trial may become apparent when very large numbers of people receive a pandemic vaccine.

Some adverse events will be coincidental – that is, associated in time with vaccine administration, yet not directly caused by the vaccine. Genuine adverse events directly caused by the vaccine may also occur, but cannot be predicted in advance. Given the safety record of seasonal vaccines, such events are expected to be rare.

Time constraints mean that clinical data at the time when pandemic vaccines are first administered will inevitably be limited. Further testing of safety and effectiveness will need to take place after administration of the vaccine has begun.

For these reasons, WHO advises all countries administering pandemic vaccines to conduct intensive monitoring for safety and efficacy, and many countries have plans in place for doing so. On the positive side, mass vaccination campaigns can generate significant safety data within a few weeks.

International sharing of data from such post-marketing surveillance will be vital in guiding risk-benefit assessments and determining whether changes in vaccination policies are needed. WHO has developed standardized protocols for data collection and reporting in real-time, and will communicate findings to the international community via its web site.

[1] Regulatory preparedness for human pandemic influenza vaccines. Report of a WHO Expert Committee on Biological Standardization. Geneva: World Health Organization, 2007 [pdf 625kb]

Related links

Pandemic influenza vaccine manufacturing process and timeline

©2012 An Inconvenient Woman. All Rights Reserved.

Fears about swine flu have spurred more than 3,000 people so far to volunteer to take part in upcoming clinical trials of a new vaccine. That’s already more than the number scientists will need at eight different sites around the U.S.

“We don’t generally ever get a response like this,” Dr. Lisa Jackson, the principal researcher in charge of the clinical trials being readied at Seattle-based Group Health Cooperative, which fielded more than a thousand calls from people in two days.
U.S. government officials, meanwhile, say they plan to start vaccinating people in October, after researchers have a chance to review the data from trials that should wrap in September. And the Advisory Committee on Immunization Practices is reviewing how a new vaccine for A/H1N1 should be provided to people just as the fall seasonal flu vax campaign gets underway. The U.S. has placed orders for 200 million doses with MedImmune, CSL, GlaxoSmithKline, Novartis and Sanofi-Aventis. But health officials haven’t ruled out a national vaccination campaign that would require up to 600 million doses.

Altogether more than 50 governments have placed orders for a huge supply of swine flu vaccine, providing a bonanza for the big manufacturers in the field. And smaller biotech companies are benefiting as well. Early this week shares of Vical, Novavax and BioCryst Pharmaceuticals all shot up as investors scouted the industry for companies likely to get a boost from the pandemic.

New research has highlighted the need to provide vaccinations to pregnant women first, who are among the most vulnerable to the swine flu. Pregnant women are also being advised to take an antiviral like Tamiflu now if they come down with the flu. A new study in the Lancet concludes that while it’s still unknown just how the drugs could affect the fetus, the likely benefits outweigh the risks.

- check out the report from MSNBC
- read the story from the Guardian
- read the story from Reuters

©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.