Possible Swine Flu Mutations

Norway and Britain may have some troubling news regarding the Swine Flu.

A National Emergency of the Swine flu may be improving, at least for now.

Obviously, the Swine flu is far from over. A peak may be seen in America and in Western Europe. The wave of infections seems to be increasing in Eastern Europe and Asia.

Over 6,700 deaths worldwide have been recorded as a direct result of the Swine Flu.

Though, it has been argued, cases may increase in January and several peaks could be seen in the typical single flu season whether human flu or H1N1.

There are “early signs of a peak in disease activity in some areas of the northern hemisphere,” the WHO said in a statement.

Drug-Resistant Swine Flu

The real concern or next phase of concern may be moving to a possible drug resistance by the swine flu virus in certain countries.  The spread of this strain may be occurring in Great Britain.

Importantly, this does not mean a resistance to the vaccine!!

5 individuals in Wales were found to be resistant to the antiviral drug “Tami-flu” from companies Roche AG and Gilead Sciences Inc

These patients did have success with a different antiviral from other companies GlaxoSmithKline and Biota Inc’s “Relenza”.

Each of these patients also had serious immune problems that may have given the strain an opportunity to develop resistance.

Another outbreak is being investigated in Norway where a strain of H1N1 may have mutated causing symptoms that were worse than expected and rather severe.

Recently the Norwegian Institute of Public Health reported that the virus may be able to go deeper into the respiratory system as a result, the symptoms were more serious.

The virus mutation was found on autopsy of two individuals that had died from the Swine flu.

Norway has seen a larger number of deaths per population when compared to other European countries.

Swine Flu Available Vaccines

World production continues to move forward when it comes to the  H1N1 vaccinations.   But truthfully, the world population and the number of vaccines available is quite large.  It is unlikely that a bridge will be able to connect the two sides any time soon.

The United States and several other countries are far behind where they would like to be.  Some countries report a shortage in the vaccine production.   Currently 44 million doses have been shipped so far.    This is only 30% of the anticipated amount.

Plateau

Several countries including the Untied States and Western Europe have experienced a decrease in number of new cases of the Swine flu within the past few weeks.

The question is whether this is a shift or a plateau.  Eastern European countries and Asia have seen an increase in cases.

The next few weeks will be telling for the projection of Swine Flu cases in the New year.

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.

Let Human Testing Begin!!!

August 10th, 2009

Swine flu vaccines are now beginning the trial stages. It is time for volunteers to step into line.

The Swine flu Swine flu also referred to as H1N1 has been classified as a pandemic situation. Several bio-pharmaceutical companies have been creating a vaccine . Emory University’s Hope Clinic appears to be starting human testing today.

Approximately 25 volunteers will be seen and evaluated today. Each will receive an injection of the vaccine. This will continue for the next 5 days. Another 25 volunteers will be seen each of the additional 5 days.

The goal is to test the safety of this vaccine. They will also be concerned regarding the number of doses needed. Full immunity is the goal of this trial.

Many researchers and medical providers are concerned that the Swine flu will return this fall with increased resistance and swiftness of illness. This alarming concern has many willing to be ready to accept the Swine flu vaccine.

Sanofi Pasteur and others

French drug maker Sanofi Pasteur will begin testing on 2,000 individuals this week in the United States. This will make them the third company initiating testing.

Novartis AGwill be starting their testing this week as well in Great Britain, Germany and in the United States. They will be testing around 6,000 volunteers

CSL from Australia stared testing its vaccine last month

Adjuvants will be added to dosing from Sanofi Pasteur and Novartis

Aethlon Medical

Is a medical company that will be initiating testing on a medical device called the Hemopurifer
This device will apparently absorb viruses and toxins from the blood stream. Currently this device has been used capturing a reconstructed Spanish Flu virus and the avian influenza virus (Bird flu)

CDC guidelines

Last week – the Centers for Disease Control and Prevention (CDC) issued a warning or
guideline for school closures and cleaning

It appears that the CDC would like to focus on cleaning and prevention of the Swine flu rather then complete school closures. An although this may be an option for some schools it appear that it will not be the standard. But when a child does become sick they should miss school and they should be allowed to return to class as early as 24 hours following the absence of a fever.

August 7th numbers

In the United States – at least 6500 hospitalizations from Swine flu

436 deaths attributed to the Swine flu

Over 1 million Americans have been affected with the disease

The Future

Many believe that a large amount of new cases will be seen starting this fall. The hopes are that a new mutation won’t be seen but it appears to early to tell.

Medical providers and such appear to be in line for the first available approved vaccine.

Originally posted at InterActive Health

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