Swine Flu – Heating Up or Exploding??

The Swine Flu discussion is beginning to heat up again today in Beijing with the World Health Organization indicating that they fear an “explosion” of Swine flu cases in the next few months.

This rhetoric appears to be nothing new from the hundreds of stories regarding Swine flu over the past few weeks to months. The projected timeline includes a modest increase in Swine flu cases over the next few weeks, then a sharp increase – a doubling of cases each day for several weeks and then a peak of cases in the colder months later this year and into early next year.

The current belief is that the Swine flu influenza virus is a rather resistant virus. This is backed up by the fact that the seasonal flu influenza virus typically disappears during the warm months. The Swine flu has diminished in the Northern Hemisphere but is has not disappeared. A better understanding to the pandemic outcome because of this resistance will be seen in the upcoming months.

The symposium held today wanted to address the prognosis and the current situation of the H1N1 influenza or more commonly referred to as the Swine flu.

They reported that over 1,800 deaths can be attributed to the Swine flu and that it is currently classified as a pandemic.

In the United States currently 520+ deaths are Swine flu related/caused

They believe that up to 30% of the entire world population will be exposed or infected by the Swine flu over the next few years.

While others attest that the Swine flu may be no more serious than the annual flu season that is experienced year in and year out.

Worldwide – between 200,000 and 500,000 deaths are attributed every season to the seasonal flu.

The Pacific director of the Western branch of WHO is Shin Young-Soo and he indicated a concern for developing countries. Shin indicates “…it is in developing countries that the accelerated spread of swine flu poses the greatest threat as it places under-equipped and underfunded health systems under severe strain.”

Others believe the most challenging aspect will be the significant demand for vaccine and the high emergency room numbers in both the developed and undeveloped countries. It is believed that many will be overburdened due to fear and potential outbreak.

Swine Flu Vaccine

Many are concerned over the current projected release of the Swine flu vaccine. It is anticipated to begin between the months of September and December.

Most of the vaccine rations will be given to more economically sound countries.

There is a report of two drug makers that have pledge to donate 150 million doses of the vaccine to poorer countries by the later part of the year. It is unknown the price tag on the vaccines donated.

Vaccine Timeline

Currently it is believed that the Swine flu vaccine will be available at the end of the year – or sometime sooner.

Clinical trials Clinical trials began and the results should be known by mid to late September.

Some believe that 50 million doses will be available by late October and over 200 million doses ready by December. This projection is less than half of the original expectation and has taken some by surprise. Initially it was anticipated that some 120 million doses would be ready by October.

Currently no serious side effects have been seen in the initial batch of clinical trials

Initially Adults were tested and just within the last few days – children began testing as early as 6 months of age.

More controversially pregnant women will begin testing sometime next month.

Distribution of the vaccine will be closely discussed and monitored. Currently the U.S. Centers for Disease Control and Prevention is creating a plan for distribution.

Adjuvants will also be tested more fully over the next few months.

Additional modifications to timeline and expectations will be seen over the next few weeks and months.

Swine Flu Vaccine Awarded First Contract

Immunization for the swine flu is big money.. Just ask Protein Science, a biopharmaceutical company who was apparently awarded 35 million dollars for bringing out the first 100,000 doses of the Swine flu vaccine.

But are state health sites or the government ready to open a neighborhood clinics to start giving out a swine flu shot today. Of course not, they are at least a few months from that point. The current doses in circulation have not yet been tested and are only in the development stages. Clinical trials await in the extremely near future.

The U.S. Department of Health and Human Services announced last week the contract with Protein Sciences. The contract includes this year and may include an additional 5 years. The total contract may be worth 147 million dollars.

Caterpillar cells were infected by Protein Science with a virus that had been enhanced with a specific gene called a “hemagluttinin“. This gene is often found on the surface of the influenza virus. This new technology is comparatively different than the traditional mode of vaccine development.

Protein Science’s ability to make this vaccine quicker results from insect use, rather than the traditional route of a “seed strain“. Seed strains are typically done by creating a Hybrid virus. In the case of the Swine flu, the hybrid contains the H1 and N1 aspects of the influenza virus. The incubator is chicken eggs. Typically the process is highly involved with seven rounds of engineering the virus into an egg for harvesting.

Creation of a vaccine for H1n1 – Swine flu will not fall only on Protein Science. Another company Sanofi-Pasteurwhich has received a seed strain and has also begun development. Sanofi is the largest producer of the flu vaccine currently. Several other companies continue in the development of H1N1 vaccine that will enter into the testing stages. The race is not over yet.

Qld uni from Australia has reported its initial 1,000 doses that will only be used for research with the expectation that a working drug may be ready by the end of the year.

Are we moving too fast??

It is expected that the clinical stage may test the vaccine with to shots with 2 or 3 or even 4 week cycle. This will allow a subject to be monitored and their immune system enough time to develop immunity. It will be necessary to determine the human safety involved, the immunological response of antibodies, and the side effects of the vaccine. Even at the 4 weeks we may be pushing too hard.

But what would happen if the pandemic suddenly becomes worse. Would a company or government be inclined to speed up the process. Maybe wait only 1 week or less. It could reasonably take weeks to months to adequately test the vaccine in a manner relatively safe.

Several major questions:

1.)    Who should be the first to get the vaccine? [hospital workers or extremely sick patients]

2.)   Which states first?

3.)   Do we base it on population size or ratio of Swine flu cases??

4.)   Should we plan on vaccinating all 300 million Americans

5.)   What is the groundwork plan in states and counties?

6.)   Which countries should be included?

7.)   Cost?

8.)   What’s the effectiveness of the vaccine?

9.)   Should adjuvants be used?

10.)   Will there be another wave of swine flu?

Adjuvants

Are immune potentiators or immunomodulators that are added to vaccines with the hope to improve the immune response. It has been argued that these products can improve, enhance, accelerate, and even prolong the response of the vaccine.

The severity and amount of the vaccine may force many pharmaceutical companies to adding an adjuvant to the vaccine. This would allow the vaccine to be shared with several other countries.

Examples of adjuvants include: salts, oils, lipids, microbial derivatives, human immunomodulators (cytokines), gold particles and others.

Adjuvants have been seen to act along with the vaccine to allow and improve the desired effect.

Ajuvants may be used in the Swine flu. GlaxoSmithKline Inc. which has received Canada’s pandemic vaccine contract has indicated that they will strongly consider using an adjuvant in their vaccines. In addition to the action of the vaccine it may also speed up the time it takes for the company to produce enough vaccine for the entire county.

However – some argue that once the process has begun the adjuvants may become essential – but the time for the initial production of the vaccine might double or more.

Bankruptcy a possibility??

In concerning news regarding Protein Sciences – just a day prior to receiving the contract – Creditors for Protein Sciences Corporation filed a petition to force them into bankruptcy and liquidation. This calls into concern the stability of the company that has been given the company who has been awarded the contract for production of the Swine flu vaccine.

It does appear that the government has done several internal audits into the company and it was determine that Protein Sciences are financially stable enough to continue in the development of the vaccine.

Originally seen at: Swine Flu Vaccine Awarded First Contract

Several additional stories:

http://www.proteinsciences.com/aboutus/aboutus_news.htm

http://www.abc.net.au/news/stories/2009/06/29/2611426.htm

http://www.tehrantimes.com/index_View.asp?code=197637

http://www.nytimes.com/2009/06/24/business/24vaccine.html

http://www.theglobeandmail.com/life/tall-hurdles-in-race-for-a-swine-flu-vaccine/article1197368

Pandemic WHO – Updated with new related deaths

 

As of June 11th 2009

The World Health Organization (WHO) officially declared a 2009 swine flu pandemic. This is the first such update in over 40 years – The severity of the virus world wide is rather moderate but the reason for the classification to pandemic is related to how quickly the virus has spread and will spread.

What to expect from here?

World wide awareness will continue to rise and the number of cases may double in the next few months. Some countries may devote an increased amount of funds to prepare and protect against the Swine flu.

Travel bans are unlikely and the hope is that fear does not cause rash panic.

Some countries have seen a deluge of individuals flooding emergency rooms and health clinics. Many countries will prepare for a potential second wave.

Check out http://www.cdc.gov/H1N1FLU/

Update: June 17th 2009

Utah has had an increase in the number of deaths related to Swine Flu – and recently reported in the Salt Lake Tribune that the death toll has reached 8. http://www.sltrib.com/news/ci_12607907

New York continues to have a high number of deaths and is currently reporting 23 deaths which is the highest in the nation. http://www.newsday.com/news/printedition/longisland/ny-nyswin1712885390jun16,0,179533.story

Other states with deaths include: Arizona, California, Connecticut, Illinois, Michigan, Missouri, Oregon, Pennsylvania, Texas, Virgina, Washington, and Wisconsin.

Sanofi Aventis indicated and promised that they would donate more than 100 million doses of the vaccine to help fight against the Swine Flu. It will take time to get the vaccine synthesized, but the it is anticipated to be used to help protect against the H1N1 swine flu.

“”Exceptional times require exceptional responses. We need to act responsibly and we all have to play our part,” spoke CEO Christopher Viehbacher in a statement that was released by the Pacific Health Summit in Seattle.

Currently there is no recommendation for vaccination at this time. It is unknown the possible advantage or rather disadvantage that this specific virus will cause for pharmaceutical companies. Since this is a new virus it is speculation regarding the ease of making a new vaccine. It is anticipated that several companies will begin working on the vaccine within the next few weeks to months.

Other companies that make flu vaccine include Novartis AG, Baxter International Inc, GlaxoSmithKline and Solvay.

For more details:

http://www.newsday.com/news/printedition/longisland/ny-nyswin1712885390jun16,0,179533.story

http://www.reuters.com/article/GCA-SwineFlu/idUSTRE55G51X20090617

Pandemic WHO

 

While the U.N. Health Officials met in Geneva on Thursday to discuss the H1N1 virus the World Health Organization (WHO) officially declared a 2009 Swine flu pandemic. This is the first such update in over 40 years – 41 years to be exact. The severity of the virus world wide is rather moderate but the reason for the classification to pandemic is related to how quickly the virus has spread.

The Swine Flu was first diagnosed in Mexico in late April. It soon spread to neighboring countries and is now found in more then 70 countries and has affected more than 30,000 people. The decision to update the classification does not appear to have been difficult and many feel that the U.S health officials have been acting as if a pandemic level has been around for weeks.

Fear continues to be a driving factor. Although the virus appears to be mild, there is much speculation and fear that the virus will become much more dangerous and a mutation, although unlikely, is still plauseable. A second fear is that the current state of of this virus attack is only in round 1 and a second wave may be possible in mid summer or possibly as late as August.

WHO chief Dr. Margaret Chan said “The World is moving into the early days of its first influenza pandemic in the 21st century“.

A total of 140 people have died as a direct result of the Swine flu. The seasonal flu may result 36,000 deaths in the United States and around 250,000 world wide. Recently Australia and Chile noted a large increase in symptomatic individuals. The Swine flu has spread rapidly across Europe and Japan.

A Current Gamble

A current recommendation to initiate a vaccine for the swine flu will now be taken to pharmaceutical companies. The decision to make a vaccine for swine flu may be at the expense of the regular seasonal flu. One company is typically unable to make both vaccines and therefore a gambling choice will be made.

Level 6

This is the level that caused the pandemic status to be initiated. Pandemic is classified as an epidemic of sufficient level and has become global. The last pandemic was seen in 1968 in Hong Kong.

What to expect from here?

World wide awareness will continue to rise and the number of cases may double in the next few months. Some countries may devote an increased amount of funds to prepare and protect against the Swine flu.

Travel bans are unlikely and the hope is that fear does not cause rash panic.

Some countries have seen a deluge of individuals flooding emergency rooms and health clinics. Many countries will prepare for a potential second wave.

Check out http://www.cdc.gov/H1N1FLU/

Update: June 17th 2009

Utah has had an increase in the number of deaths related to Swine Flu – and recently seen in the Salt Lake Tribune that an overall 8 individuals have died as a result. http://www.sltrib.com/news/ci_12607907

New York continues to have a high number of deaths and are currently at 23 http://www.newsday.com/news/printedition/longisland/ny-nyswin1712885390jun16,0,179533.story

Other states with deaths include: Arizona, California, Connecticut, Illinois, Michigan, Missouri, Oregon, Pennsylvania, Texas, Virgina, Washington, and Wisconsin.

Originally seen at iahealth issues