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-Pasteur which 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.
Post was originally seen at interactive health
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
