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.

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.

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.

Health and Human Services Secretary Kathleen Sebelius said she is urging school superintendents around the country to spend the summer preparing for the possibility of turning schools into swine flu vaccine clinics this fall.

“If you think about vaccinating kids, schools are the logical place,” Sebelius told The Associated Press.

The World Health Organization formally declared the swine flu a pandemic, meaning it is now spreading throughout the world unchecked.

The U.S. has not made a formal decision on how to vaccinate millions of Americans against the flu, although money is being poured into developing a vaccine for the strain.

Currently the swine flu doesn’t appear to be any more harmful than regular flu, which kills 36,000 Americans each year, although scientists do fear that the strain has the potential to develop into a much more serious flu.

According to the WHO, nearly half of the 160 people who have died from swine flu have been young and healthy.

That could mean school-age children would be the first priority to receive vaccinations, said Sebelius.

Schools have teamed up with health officials in the past to provide flu vaccinations, although the event is rare.

Last fall, 140 schools scheduled flu vaccinations for students, and some offered them to entire families.

According to Sebelius, meeting President Barack Obama’s top healthcare priority of covering the uninsured could take until 2012 to implement, even if it Congress passes legislation this fall.

Implementing the new programs is estimated to cost over $1 trillion over 10 years.

The administration also plans to eliminate health disparities between minority groups and whites.

According to Sebelius, the most severe disparities are found among American Indians

She pledged to reverse this “a historic failure of the government,” saying the U.S. must provide free health care on reservations, and give the Indian Health Service the funds it needs.

Sebelius faces the question of whether to push forward with swine flu vaccinations this fall in edition to the annual winter flu vaccination.  Communication on who needs which, or both, vaccines will be a key challenge.

She will soon call together state governors to see that the summer is used to prepare for the possibility of a severe flu season, instead of being “used as vacation months.”

“We can always sort of back off” if the new flu fades away, she said, “but we can’t wait til October hits and say, ‘Oh my heavens, what are we going to do?’”

In 1976, a mass vaccination against a different swine flu occurred, but was spoiled by reports of paralyzing vaccine side effects.

The Food and Drug Administration will thoroughly test for swine flu vaccine safety, Sebelius said.

“The worst of all worlds is to have the vaccine cause more damage than the flu potential,” she added.

©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.

Faced with the first World Health Organization (WHO)  declared pandemic in four decades, health officials arou world are rushing to order huge stock-piles of the H1N1 (Swine) Fl vaccine in what is shaping up as a multibillion-dollar windfall for the world’s biggest manufacturers.

The French government has ordered 94 million doses of swine flu vaccine–enough to vaccinate three-quarters of the country’s population. The French inked contracts–which total $1.4 billion–with Sanofi-Aventis, GlaxoSmithKline and Novartis. Sanofi Pasteur is estimating that it will have the first supplies of a new swine flu vaccine ready for delivery in four to six months.

And France is far from the only country to lay the foundation for a mass vaccination campaign as soon as supplies arrive. The UK is considering hiring private contractors to help doctors in the country’s national health service to administer theH1N1 vaccine. Peter Holden, who represents the British Medical Association, says doctors and nurses need to be ready to administer vaccines to 30 to 40 people an hour.

While far more mild than originally feared, swine flu has nevertheless roiled populations around the globe, with each new death raising fresh fears. Those fears in turn have spurred government agencies to come up with new vaccination campaigns as a new flu season in the northern hemisphere looms.

- Read Full Reuters Article
- Read Full Dow Jones Article

©2012 An Inconvenient Woman. All Rights Reserved.

Using both a traditional egg-based as well as a cell-based approach in developing a new vaccine for swine (H1N1) flu, pharma giant, Novartis says it expects to launch a clinical trial of a new jab before the end of the month as it racks up huge orders from countries around the globe.

Novartis is one of five big manufacturers preparing swine flu vaccines for the U.S. market, a CDC official says. Dr. Pascale Wortley, the CDC’s pandemic-vaccine coordinator, says that by October the U.S. expects to have between 40 million and 160 million doses of vaccine ready for use.

That could mean that this fall,  U.S. school children  may be expected to get a seasonal flu shot as well as a double dose of swine flu vaccine.

Right now no one in the U.S. government has laid out a clear plan for handling swine flu this fall. Vaccinations may initially be planned only for health care workers and other front-line emergency workers. Ultimately, some believe that the U.S. will order up to 600 million doses for the entire population to guard against a so-called second wave in the fall that could include a more lethal version of A/H1N1.

- Read Monsters and Critics Full article
- Read Seattle Times Article with CDC Swine Flu Vaccine Report

©2012 An Inconvenient Woman. All Rights Reserved.