France begins controversial nationwide H1N1 vaccinations today

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this is Pandemrix - the injectable vaccine WITH mercury and adjuvant ASO3 - adjuvant with squalenethe one that Germans are refusing because they were only going to give the military and political leaders one without mercury and adjuvant and the masses this oneThis is also the one being used all over Europe, UK and CanadaSherihttp://www.fleshandstone.net/healthandsciencenews/1658.htmlFrance begins controversial nationwide H1N1 vaccinations todayAfter months of often ugly debate over the best way to go about vaccinating the population of France against H1N1, the program begins today in a climate of administrative confusion and widespread health sector and public skepticism.Tempers have flared over the last few months over the program, with many authoritative personalities expressing serious doubts that there should even be a program, never mind its implementation modalities. The national daily, Liberation, went so far as to conduct a “no” campaign on the issue, assimilating mass vaccination to a potentially totalitarian denial of basic human rights and freedom of choice.But the vaccination lobby has won out and the campaign has begun.French health authorities have decided to begin with key categories of hospital personnel before extending the program to the general population, and according to the official " Priority List" issued by the government at the end of September, those key categories are intensive care, neonatology and pediatrics. Next in line will be all other medical, paramedical and auxiliary nursing staff along with doctors and ambulance personnel.General population vaccinations will begin immediately after All Saints Day on November 5. Priority will be given to women who have been pregnant for over three months. They will be given a special vaccine without an adjuvant because the government contends that studies on vaccines with adjuvants and their effects on pregnant women are not yet complete.After that the effort will be concentrated on babies, young children, and anyone else with pathologies which make them more vulnerable than they would normally be. Adults considered to present no risk factors will be vaccinated last of all.The public will be informed when their turn comes by an official convocation letter, and vaccination is not obligatory. Vaccinations will be done in one of the 1,080 vaccination centers dispersed all over the country, and parallel access to seasonal inflenza vaccinations will be unrestricted.French Health Minister Roselyne Bachelot announced this morning at a press conference that the vaccine chosen for the beginning of the campaign will be a version developed by GlaxoSmithKline (GSK) which she said has been delivered to health authorities. She said 1.5 million doses have been delivered, and initial vaccination using the GSK vaccine will consist of a double injection method. Bachelot also expressed the hope that European-wide recommendations would soon permit single-dose vaccination of the GSK vaccine as that would speed up the vaccination process.So much for the official picture. On-the-ground realities show a more confused situation, with many hospital staff expressing doubts as to whether or not they would opt for vaccination even though French health authorities are presenting vaccination as a “public duty” for hospital staff, as reported by the French daily Le Figaro.Administrative glitches are being reported, and some sites are said not to have the necessary number of doses, whereas others have all the doses they need. Administrative procedures vary from hospital to hospital, with one Parisian hospital struggling to overcome major last minute IT problems which have blocked access to the internet site it created and which contains the six page inscription form that its personnel are required to fill out online. On the other hand, other hospitals organized their inscription programs weeks ago and are ready to begin.What is not known at this time is what proportion of medical personnel will choose to be vaccinated. It is well known that several pessimistic studies carried out on the vaccines' efficiency and safety during the summer have resulted in many hospital staff being unconvinced and even hostile towards the H1N1 program. Some of this reticence is suspected to be of political origin, with some staff said to be using the vaccination issue as a way of protesting against government policies in general.Bertrand Guidet, an intensive care specialist at the Saint-Antoine hospital in Paris, observed “I have seen unwillingness to vaccinate in my service, and particularly a sense of confusion with the seasonal influenza vaccine.”One particularly candid point of view was that of a management level health worker in a hospital in the south of France who declared that he was ready to take the risk of the the virus responsible for the pandemic becoming virulent. “The problem is that the vaccines have been developed in urgent circumstances." he said. "There hasn’t been any long term thinking. We hear so much about it and don’t know what to think any more. Even some scientists are reserved about it.”In the opinion of Emmanuel Hirsch, ethics professor at the Paris South-XI medical faculty, “The current controversy going on in the professional health sector is indicative of changes which are perplexing and even worrying.” He expressed surprise that in an era supposedly dominated by the logical processes of evidence-based medicine “Data validated by competent national and international bodies is the object of contestation which is often based on scientifically baseles a prioris.” Hirsche thinks that the refusal of medical staff to be vaccinated may be a symptom of a more deeply rooted dissatisfaction. “It’s as if this is a way of demonstrating defiance towards public authorities who are diffusing the message that vaccination is necessary.” The situation in hospitals is mirrored in the attitudes of the general French population. Various polls here show that between 60 and 65 percent of French people are skeptical about the vaccines and that many of them will not present themselves for vaccination. Many French people think that the dangers of H1N1 have been greatly exaggerated, and almost no one wears an anti-H1N1 mask in public.The H1N1 vaccination debate in France seems set to continue unabated and, if anything, may well become even more venomous as the program progresses.This correspondant’s morning coffee radio news catch-up consisted almost entirely of claims and counter claims concerning H1N1 vaccines. In one debate on a quality national radio station, an expert claimed that the vaccines contain “dangerously toxic substances.” He was immediately accused of “obscurantism” by those who support the vaccination program. ************http://www.theoneclickgroup.co.uk/news.php?start=2900 & end=2920 & view=yes & id=3825#newsposthttp://www.emea.europa.eu/humandocs/PDFs/EPAR/pandemrix/Pandemrix-PU-17-en.pdfGSK's proprietary adjuvant system AS03, (squalene-based oil-in-water emulsion)NOTE: The adjuvant is added to the antigen vial at the time of dispensing for immunisation. The medical professional adds the adjuvant two single doses at least 3 weeks apart. What Pandemrix contains Active substance: Split influenza virus, inactivated, containing antigen* equivalent to: A/California/7/2009 (H1N1)v-like strain (X-179A) * propagated in eggs ** expressed in microgram haemagglutinin This vaccine complies with the WHO recommendation and EU decision for the pandemic. Adjuvant: The vaccine contains an ‘adjuvant’ AS03 to stimulate a better response. This adjuvant contains squalene (10.69 milligrams), DL-á-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams). Other ingredients: The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride, water for injections http://tucksolutions.com/blog/tag/pandemic/GSK’s Pandemrix is a split-virion inactivated vaccine, produced in embryonated hens eggs. Split-virion vaccines contain virus that has been disrupted with detergent, and purified by centrifugation and diafiltration. The virus is inactivated with formaldehyde and sodium deoxycholate. In contrast to Celvapan, which contains no adjuvant, Pandemrix contains the adjuvant AS03, a squalene based oil-in-water emulsion. The vaccine is supplied in a two-vial format, one containing the antigen, the other the adjuvant. The adjuvant is added to the antigen vial at the time of dispensing for immunisation. The vaccine antigen is produced in Dresden, Germany. *************http://www.gsk.com/media/pressreleases/2009/2009_pressrelease_10089.htmPandemic (H1N1) 2009 Influenza Update: GSK’s H1N1 ‘Pandemrix’ vaccine receives positive opinion from European RegulatorsGlaxoSmithKline (GSK) announced today that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion and recommends approval of GSK’s candidate pandemic (H1N1) adjuvanted vaccine Pandemrix™. Issued: Friday 25 September 2009, London UK GlaxoSmithKline (GSK) announced today that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion and recommends approval of GSK’s candidate pandemic (H1N1) adjuvanted vaccine Pandemrix™. The indication for the vaccine is for protection against pandemic H1N1 2009 influenza.Each single dose of the vaccine will comprise 3.75ug antigen of pandemic (H1N1) 2009 influenza strain and GSK's proprietary adjuvant system AS03, which should be administered as two single doses at least 3 weeks apart. “This positive opinion means that Pandemrix will now be immediately reviewed for approval by the European Commission which is an important step closer to helping reduce the impact of the pandemic. GSK will continue to work closely with regulators, governments and health authorities around the world so that they can determine the most appropriate strategy to address the H1N1 pandemic,” said Jean Stéphenne, President GlaxoSmithKline Biologicals.The positive opinion is based on the ‘mock-up’ Pandemrix registration file using the H5N1 antigen which was approved in Europe in May 2008. The file included data from numerous clinical and pre-clinical trials which evaluated tolerability, reactogenicity, immunogenicity and cross-protection. The H5N1 vaccine was shown to be generally well tolerated and the most commonly reported side effects were headache, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (pain and redness), fever and fatigue (tiredness).Initial information collected on the tolerability and effectiveness of the vaccine using the H1N1 antigen were also submitted to the CHMP for evaluation. These included recently announced results from the first clinical trial assessing use of the pandemic (H1N1) adjuvanted vaccine, which demonstrated, that after one dose, the vaccine can provide a strong immune response which exceeds the immunogenicity criteria as defined by international licensing authorities for a pandemic influenza vaccine. The initial tolerability data after the first dose of the H1N1 vaccine indicate a similar tolerability profile as was seen in H5N1 vaccine clinical trials.GSK is conducting 16 clinical trials in over 9000 subjects including healthy adults, the elderly and children (including infants) across Europe, Canada and the US to further evaluate its pandemic (H1N1) adjuvanted vaccine. All the data from this clinical development programme will be submitted to the regulators as soon as they are available and they will also be posted on GSK’s Clinical Study Register. GSK supports the WHO’s call for post-marketing surveillance of the ‘highest possible quality’ to ensure extensive safety evaluation of all pandemic vaccines. When governments commence vaccination programmes, GSK will collect information on the safety of the vaccine while it is being used. In addition, the Company will undertake a large 9000 people post-marketing safety and effectiveness study. ************http://justthevax.blogspot.com/2009/09/20092010-h1n1-vaccines-for-us.htmlGSK's Monovalent H1N1 Injectable: The The 2009 Monovalent H1N1 Vaccine is an inactivated split-virion vaccine (most likely) manufactured on the same platform as their Pandemrix vaccine, which incorporates the same manufacturing process as Fluarix. GSK H1N1 vaccine is a split-virion influenza vaccine that will probably be formulated to contain 15 mcg hemagglutinin (HA) per 0.5-mL dose of the following virus strain: A/California/7/2009 (H1N1)v-like virus. The virus is propagated in fertilised hens’ eggs. Each 0.5-mL dose also contains 0.120 mg octoxynol-10 (TRITON® X-100), 0.1 mg -tocopheryl hydrogen succinate, and 0.380 mg polysorbate 80 (Tween 80). Each dose may also contain residual ( 0.0016 mcg) amounts of hydrocortisone, 0.15 mcg gentamicin sulfate, 1 mcg ovalbumin, 50 mcg formaldehyde, and 50 mcg sodium deoxycholate from the manufacturing process. It should be available in 0.5 mL single-dose, pre-filled syringes and contains no preservative (thimerosal). It may also be available in 5 mL multi-dose vials containing ten doses. Thimerosal (an ethylmercury derivative), is added as a preservative and each 0.5 mL dose contains 5 mcg (micrograms) of ethylmercury. Indications and Usage: GSK H1N1 Monovalent Vaccine is indicated for active immunization of adults (18 years of age and older) against influenza disease caused by pandemic (H1N1) 2009 virus. Adults 18 years of age and older should receive a single 0.5 mL intramuscular dose. Sheri Nakken, R.N., MA, Hahnemannian Homeopath Vaccination Information & Choice Network, Washington State, USAVaccines - http://www.nccn.net/~wwithin/vaccine.htm or http://www.wellwithin1.com/vaccine.htmVaccine Dangers, Childhood Disease Classes & Homeopathy Online/email courses - next classes start October 28 & 29http://www.wellwithin1.com/vaccineclass.htm or http://www.wellwithin1.com/homeo.htm