Marie-Paule Kieny, WHO director of the Initiative for Vaccine Research, said manufacturers had initially reported poor yields in making vaccine, leading to worries about supplies, but this was now improving.
"We are on track in development," Kieny told reporters.
First results from clinical trials are expected early next month and these tests will show whether one or two doses are needed to provide immunity -- another big swing factor in determining how many people can be vaccinated.
Once initial clinical trial results are in, regulators will be able to approve the vaccines from next month, Kieny added.
The H1N1 flu outbreak, declared a pandemic on June 11, has spread around the world and could eventually affect 2 billion people, according to WHO estimates.
Fears the strain could become resistant to the anti-viral drug Tamiflu have underscored the need to get vaccines to market quickly. The H1N1 vaccines would be given separately from regular seasonal flu shots.
Leading flu vaccine makers include Sanofi-Aventis, GlaxoSmithKline, Novartis, Baxter, CSL and Solvay.
WHO Director-General Margaret Chan has said the H1N1 virus is stable and there were no signs of it mixing with other more dangerous types of influenza such as the deadly H5N1 bird flu strain.
At present, patients with mild symptoms generally do not need any medicines to recover, and Chan has stressed hospital visits are not necessary unless those infected with flu have certain warning signs.
These include long-lasting high fever in adults and a lack of alertness in children. Pregnant women and people with health problems including diabetes are also vulnerable to more severe effects from the new flu strain.
(Reporting by Jonathan Lynn and Laura MacInnis; writing by Ben Hirschler)
A U.S. plan to rely on swine flu vaccines without ingredients to stretch the supply would reduce the number of available shots just when other countries need them most, the British journal Lancet said in an editorial.
The ingredients, called adjuvants, have never been approved for flu vaccines in the U.S. and are controversial because some studies show they cause immune disorders in mice. The World Health Organization recommended on July 7 that adjuvants be used to boost global amounts of vaccine, and the Lancet criticized the U.S. for plans to rely exclusively on standard formulations.
The desired immune response to vaccines is the production of antibodies, and this is enhanced by adding certain substances to the vaccines. These are called adjuvants (from the Latin adjuvare, meaning "to help").
The chemical nature of adjuvants, their mode of action and their reactions (side effect) are highly variable. According to Gupta et al. (1993), some of the side effects can be ascribed to an unintentional stimulation of different mechanisms of the immune system.
Chemically, the adjuvants are a highly heterogenous group of compounds with only one thing in common: their ability to enhance the immune response—their adjuvanticity. They are highly variable in terms of how they affect the immune system and how serious their adverse effects are due to the resultant hyperactivation of the immune system.
The choice of any of adjuvant reflects a compromise between a requirement for adjuvanticity and an acceptable low level of adverse reactions.
The use of adjuvants enables the use of less antigen to achieve the desired immune response, and this reduces vaccine production costs. With a few exceptions, adjuvants are foreign to the body and cause adverse reactions.
The U.S. government has contracts with several drug companies to develop and produce swine flu vaccines. At least two of those companies, Novartis and GlaxoSmithKline, are using an adjuvant in their H1N1 vaccines.
The adjuvant? Squalene.
According to Meryl Nass, M.D., an authority on the anthrax vaccine,
“A novel feature of the two H1N1 vaccines being developed by companies Novartis and GlaxoSmithKline is the addition of squalene-containing adjuvants to boost immunogenicity and dramatically reduce the amount of viral antigen needed. This translates to much faster production of desired vaccine quantities.”
Novartis’s proprietary squalene adjuvant for their H1N1 vaccine is MF59. Glaxo’s is ASO3. MF59 has yet to be approved by the FDA for use in any U.S. vaccine, despite its history of use in other countries.
Per Dr. Nass, there are only three vaccines in existence using an approved squalene adjuvant. None of the three are approved for use in the U.S.
What Squalene Does to Rats
Oil-based vaccination adjuvants like squalene have been proved to generate concentrated, unremitting immune responses over long periods of time.
A 2000 study published in the American Journal of Pathology demonstrated a single injection of the adjuvant squalene into rats triggered “chronic, immune-mediated joint-specific inflammation,” also known as rheumatoid arthritis.
The researchers concluded the study raised questions about the role of adjuvants in chronic inflammatory diseases.
What Squalene Does to Humans
Your immune system recognizes squalene as an oil molecule native to your body. It is found throughout your nervous system and brain. In fact, you can consume squalene in olive oil and not only will your immune system recognize it, you will also reap the benefits of its antioxidant properties.
The difference between “good” and “bad” squalene is the route by which it enters your body. Injection is an abnormal route of entry which incites your immune system to attack all the squalene in your body, not just the vaccine adjuvant.
Your immune system will attempt to destroy the molecule wherever it finds it, including in places where it occurs naturally, and where it is vital to the health of your nervous system.
Gulf War veterans with Gulf War Syndrome (GWS) received anthrax vaccines which contained squalene. MF59 (the Novartis squalene adjuvant) was an unapproved ingredient in experimental anthrax vaccines and has since been linked to the devastating autoimmune diseases suffered by countless Gulf War vets.
The symptoms of gulf war syndrome included arthritis, fibromyalgia, lymphadenopathy, rashes, photosensitive rashes, malar rashes, chronic fatigue, chronic headaches, abnormal body hair loss, non-healing skin lesions, aphthous ulcers, dizziness, weakness, memory loss, seizures, mood changes, neuropsychiatric problems, anti-thyroid effects, anaemia, elevated ESR (erythrocyte sedimentation rate), systemic lupus erythematosus, multiple sclerosis, ALS (amyotrophic lateral sclerosis), Raynaud’s phenomenon, Sjorgren’s syndrome, chronic diarrhoea, night sweats and low-grade fevers.”
There is also limited or no data on the safety and effectiveness of vaccines with adjuvants in children under 3 and pregnant women - two of the most vulnerable groups in a pandemic.
http://www.whale.to/v/squalene.html
http://en.wikipedia.org/wiki/Squalene
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