Concerns and Theories on H1N1 in Ukraine

November 16, 2009

NaturalNews

By Mike Adams

Here’s what we know with some degree of certainty about the H1N1 virus in Ukraine right now: nearly 300 people have died from the viral strain, and over 65,000 people have been hospitalized (the actual numbers are increasing by the hour). The virus appears to be either a highly aggressive mutation of the globally-circulating H1N1 strain, or a combination of three different influenza strains now circulating in Ukraine. Some observers suspect this new “super flu” might be labeled viral hemorrhagic pneumonia (meaning it destroys lung tissue until your lungs bleed so much that you drown in your own fluid), but that has not been confirmed by any official sources we’re aware of.

Ukrainian President Viktor Yushchenko has issued emergency quarantine orders for nine of the country’s regions and ordered the deployment of mobile military hospitals. He announced that the nation had been simultaneously hit with two different seasonal flu strains plus H1N1 — and then hinted that all three might have recombined into the deadly new Ukrainian super flu.

In his own words, as reported by Daily Mail, “Unlike similar epidemics in other countries, three causes of serious viral infections came together simultaneously in Ukraine: two seasonal flus and the Californian flu. Virologists conclude that this combination of infections may produce an even more aggressive new virus as a result of mutation.”

On November 6, Ukraine’s Deputy Health Minister Zinovy Mytnyk announced that over 600,000 citizens had already caught the new flu. British scientists are now conducting tests on the new viral strain to find out why it appears to be so deadly (http://www.dailymail.co.uk/news/wor…).

The mainstream media is blaming Ukraine’s poor health care system for the relatively high rates of hospitalization and death (http://www.nytimes.com/2009/11/14/w…), but they refuse to mention (yet again) the vitamin D deficiency found across this population living at high latitude in the winter, where sunlight is relatively scarce.

Here’s a useful blog for staying up to date on the Ukrainian plague:
http://ukraineplague.blogspot.com/
What we don’t know
Now here’s what we don’t know about the Ukraine outbreak:

What is the actual genetic composition of this mutated strain?

Scientists have not released any meaningful news about the genetic sequence of the Ukraine strain. For the moment, the WHO is somewhat quiet on the matter. The last WHO update was from November 3 (and the situation has become considerably worse since). (http://www.who.int/csr/don/2009_11_…).

Was this viral strain released as a bioweapon?

There are numerous reports circulating widely across the ‘net that cite aerial spraying across Kiev in the days before the new “super flu” outbreak. People are speculating that this was a bioweapon attack intentionally unleashed upon the Ukrainian population. So far, NaturalNews can find no credible information supporting this theory, but it remains a possibility to be researched further.

Does Baxter Pharmaceuticals have anything to do with the outbreak?

You may recall that earlier this year, Baxter shipped live avian flu viral material to labs in 18 countries, including one in the Ukraine. (http://www.naturalnews.com/025760.html) There is suspicion that Baxter could be tied to a planned outbreak of a weaponized virus as a population control bioweapon of some sort, but NaturalNews has not been unable to find any credible information sources supporting this theory. Lacking any better leads on this subject, as far as we can tell right now this remains an unproven conspiracy theory. (If anyone has more credible info on this, please send it our way for review.)

It is plausible that Baxter had something to do with this, but we just don’t have any convincing evidence to back it up at this point.
H1N1 vaccines likely offer little protect against the Ukraine super flu
People receiving H1N1 vaccine shots right now need to know that currently-available H1N1 vaccine shots may offer no protection whatsoever against the “Ukraine Strain.” That’s because once the virus mutates, changing it genetic structure, it can instantly render all existing vaccines obsolete.

Depending on the degree of genetic changes, there is a possibility that some level of immunity may be conferred to people who already have H1N1 antibodies, but here’s the dirty little secret the vaccine industry doesn’t want you to know: People who built their own natural immunity to H1N1 through exposure rather than vaccines have a much greater likelihood of exhibiting natural immunity to genetic variations of H1N1. In other words, people who overcame H1N1 exposure on their own, without being vaccinated, have a far stronger defense against H1N1 variations that might appear.

This is yet another reason why flu vaccines are so dangerous: The deny your immune system the important opportunity to exercise its own adaptive defenses and build stronger protections against future infections.

One possible scenario that could unfold with all this is that the Ukraine strain might spread around the world, wiping out those who got vaccinated against H1N1 because their immune systems suffer from a suppressed ability to naturally generate antibodies to a new strain. Meanwhile, drug companies will try to scramble and create a whole new batch of “super flu” vaccines, but they’re always too little, too late. Theoretically, millions of people could die around the world while waiting in line for yet another vaccine shot.

All they really need is vitamin D3, some herbal anti-virals, a healthy diet and plenty of rest, but no one is telling them that.

Even the Ukraine super flu is no match for a healthy immune system. Remember: Out of 65,000+ hospitalizations, fewer than 300 people have died so far. That’s still a very low mortality rate, even if the spread of the viral infection seems aggressive.
WHO cranking up anti-viral drug push
Meanwhile, the WHO is upping its push for anti-viral drugs, saying that drugs like Tamiflu should now be used earlier on swine flu victims (http://www.google.com/hostednews/af…).

They still won’t recommend anti-viral herbs, foods, supplements or natural remedies, of course. The WHO remains a faithful pusher of Big Pharma’s profit agenda, even while denying the People of the world the truth about how they can save their own lives with anti-viral natural remedies. To both the WHO and CDC, the swine flu pandemic has always been about pushing a pharmaceutical agenda at the expense of public health.

Had the public been informed about vitamin D and natural anti-virals like Lomatium, many lives could have already been saved. Instead, the drug pushers at the CDC and WHO have tens of millions of people standing in line waiting for vaccines instead of consuming natural supplements and remedies that could help protect them from influenza.

The profit agenda forces us to wonder: With the current H1N1 strain fizzling out — and yet billions of dollars worth of vaccines still needing to be sold — could the Ukraine strain have been engineered to scare up more demand and more sales of vaccines and anti-virals?

That’s a question that all thinking people need to be asking right now. But we also need to be careful in assessing what’s true here. Reading the postings about this on the ‘net, I’ve noticed way too many people leaping to assumptions about what’s happening in the Ukraine without any real evidence to back that up. The reports about Joseph Moshe, in particular, appear to be a complete hoax.

While it’s possible this was an engineered bioweapon of some sort, it’s not enough to just assume that’s true and then declare it to be so. More evidence is needed before NaturalNews would back a theory like that.

Click here for the full report.

Heparin Blood Thinner Drug Causes Death

October 21, 2009

Natural News

By David Gutierrez

Four people have died after receiving the popular blood-thinning medication heparin, while others have suffered severe and life-threatening allergic reactions. But when drug maker Baxter International Inc. announced that it suspects a Chinese manufacturing plant of being the source of contamination that led to the reactions, the FDA admitted that it has never inspected that particular factory.

Baxter stopped manufacturing certain varieties of heparin after receiving reports of allergic reactions that included nausea, breathing trouble, and rapid, life-threatening drops in blood pressure. All the reports were associated with the high initial doses given to patients about to undergo procedures such as dialysis or heart surgery.

In addition, four people taking the medicine have also died this year, out of a total of 350 adverse reactions to the drug. According to the FDA, the deaths do not appear related to the recent allergic reactions, because they did not happen after high initial doses.

Heparin is already known to have dangerous side effects including blood clotting and bleeding, and long-term use can even lead to hair loss and osteoporosis. In 2006, three premature infants were killed when a hospital accidentally gave them a lethal dose of the drug.

The Chinese manufacturing plant that makes heparin’s active ingredient, an enzyme found in pig intestines, is being investigated as a possible source of the allergies, although Baxter was careful to note that it is still unclear whether the plant or even the active ingredient are responsible for the reactions. The company said that it had inspected the Chinese plant less than six months ago, and that it always tests the active ingredients of its drugs as part of the manufacturing process.

“We are aggressively investigating the cause of the increase in adverse reactions,” a company spokesperson said.

But while Baxter has inspected the plant, which has been shipping the drug to the United States since 2004, the FDA admits that it has never done so.

“While no inspection of the facility has been conducted to date, preparations are being made to perform an inspection as soon as possible,” the agency said. “We have already requested expedited access to the facility, facilitated through a recently assigned agreement with the Chinese State Food and Drug Administration.”

The FDA noted that it would be investigating why it had failed to inspect the Chinese plant before this. It said that one factor appeared to be the fact that the plant’s name, Changzhou SPL, was similar to the name of a different drug manufacturer that the agency had already inspected.

China is the world’s largest manufacturer of active drug ingredients, and a major exporter to the United States of all kinds of products. But recent safety recalls of Chinese toy and food imports have drawn attention to the need for tighter inspections.

The FDA has come under increasing fire recently for its failure to regularly inspect foreign drug manufacturing plants. According to a report by the Government Accountability Office, the FDA only inspects about 7 percent of foreign drug factories each year. In 2007, the agency inspected only 11 Chinese facilities out of a total of 170 foreign inspects conducted.

In a letter to the FDA, Rep. John D. Dingell of Michigan blasted the agency for the “disastrous state of your agency’s foreign inspection program related to pharmaceuticals.” Sen. Charles Grassley of Iowa also wrote to the agency, noting that the 2007 inspection of 11 Chinese plants was actually a drop from the 2004 high of 18 inspections.

There is no legal requirement that the FDA inspect drug manufacturing plants that are not located in the United States.

Click here for the full report.

German Soldiers Get Mercury Free Swine Flu Vaccine

October 13, 2009

PrisonPlanet.com

By Paul Joseph Watson

According to a report out of Germany, German soldiers have been given an additive-free swine flu shot that doesn’t contain mercury, squalene, or any of the other dangerous adjuvants associated with the vaccine, raising questions as to why this version of the shot has not been made available to the general population.

An article that when translated is entitled, German soldiers gets non poisonous vaccine, explains how 250,000 German troops have been given a “friendly” vaccine made by Baxter that does not contain “controversial mercury-containing additives or preservatives”.

It appears that there are two versions of the swine flu shot, one for those in the know and another for the general population who trust the government to shoot them up with dangerous toxins that have been linked to autism and other neurological disorders.

Despite concerns about thimerosal and mercury, thimerosal is an ingredient of the swine flu vaccine which is currently being rolled out globally.

“Some of the vaccine will be stored in multi-dose vials containing thimerosal, an antibacterial additive that contains mercury,” reported the Washington Post in an article about which groups will receive the swine flu vaccine first.

Indeed, the swine flu vaccine contains no less than 25,000 per cent the amount of mercury considered safe.

Mercury is classified by The Department of Defense as a hazardous material that could cause death if swallowed, inhaled or absorbed through the skin, and the EPA is now limiting mercury emissions from factories because the toxin “can damage the brain and nervous system and is especially dangerous to fetuses and small children,” but according to the CDC it’s perfectly safe to inject into your child’s bloodstream.

As we previously highlighted, many people are choosing to take the nasal spray version of the vaccine in the false assumption that it is safer than the injectable version. In reality, the nasal spray contains live H1N1 virus, which has led many doctors and health professionals to express concerns that it could spread the swine flu virus amongst those with weakened immune systems.

“It has been documented that the live viruses from the vaccine can be shed (and potentially spread into the community) from recipient children for up to 21 days, and even longer from adults. Viral shedding also puts breastfeeding infants at risk if the mother has been given FluMist,” writes Dr. Sherri Tenpenny, one of the most outspoken physicians in the country on the hazards of vaccines and vaccination.

FluMist’s own package insert reads as follows, “FluMist® recipients should avoid close contact with immunocompromised individuals for at least 21 days.”

“The warning is specifically directed toward those living in the same household with an immunocompromised person, but the on-going release of live viruses throughout the community may be a significant risk to everyone who has a weak, or weakened, immune system,” writes Tenpenny, pointing out that if one takes into account a plethora of health conditions that could be classified as contributing to immunodeficiency, as much as 60% of the entire population could be considered to be “chemically immunosuppressed.”

One of the pharmaceutical companies developing nasal spray vaccines is Baxter International, who were caught earlier this year releasing batches of vaccines from a lab in Austria that were contaminated live bird flu virus, otherwise known as H5N1.

Click here for the full report.

Drug Firms Can Make H1N1 Vaccine for Half Planet: WHO

September 24, 2009

Reuters

By Stephanie Nebehay

Drug makers can only produce enough H1N1 vaccine each year for half the planet because they lack factory capacity, the World Health Organization said on Thursday.

The H1N1 vaccine looks to be as safe as the regular flu shot, the WHO said in a statement, adding that drug makers worldwide can produce an estimated 3 billion doses per year and a single dose should be enough to give immunity to healthy adults and older children.

But it said companies had “limited, inadequate and not readily augmented” capacity to increase output to cover the planet’s 6.8 billion population.

The WHO’s previous projection last May was that global production capacity would be close to 5 billion doses, but its new estimate was made on the basis of results from clinical trials and confidential data provided to the U.N. agency.

“There is not enough production capacity worldwide to vaccinate everyone,” WHO spokesman Gregory Hartl told Reuters.

“New production capacity takes a long time to come on line. Any new single plant for vaccine production takes about five years to build, test and get approval,” he added.

It was not immediately clear whether the WHO’s new estimate of 3 billion doses per year implied switching all production from seasonal flu vaccine to H1N1 pandemic vaccine.

Marie-Paule Kieny, director of WHO’s initiative for vaccine research, is due to give a teleconference at 1500 GMT on Thursday.

“Outcomes of trials completed to date suggest that pandemic vaccines are as safe as seasonal influenza vaccines,” WHO said.

“However, even very large clinical trials will not be able to identify possible rare events that can occur when pandemic vaccines are administered to many millions of people,” it said.

Pandemic vaccines are most effective as a preventive strategy when given before or near the peak incidence of cases in an outbreak, it said.

The WHO advised countries to closely monitor the vaccine’s safety and report “adverse events.” This was vital to determine whether changes in vaccination policies were needed.

Side effects are expected to be similar to those with seasonal flu vaccines, including soreness or swelling at the point of injection and possible fever, headache, muscle or joint aches, according to the United Nations agency.

In almost all people, these symptoms should be mild and last 1-2 days, it said.

Most rich nations have contracts with drug makers to obtain enough vaccine to cover their entire populations, it said.

But most low- and middle-income countries lack the financial resources to compete for an early share of limited supplies, which in such countries would depend mainly on donations.

The WHO said it would begin an initial distribution of some 300 million doses of vaccine donated by rich nations to more than 90 developing countries from November.

Leading flu vaccine makers include Sanofi-Aventis, Novartis, Baxter, GlaxoSmithKline and Solvay.

Regulatory authorities have licensed pandemic vaccines in Australia, China, Hungary and the United States, soon to be followed by Japan and several countries in Europe, the WHO said.

Click here for the full report from Reuters

Vaccines Far More Deadly Than The Swine Flu

July 28, 2009

Institute of Science in Society

The vaccines far more deadly than the swine flu; mass vaccinations a recipe for disaster Dr. Mae-Wan Ho and Prof. Joe Cummins

This report has been submitted to Sir Liam Donaldson, Chief Medical Officer of the UK, and to the US Food and Drugs Administration

Please circulate widely, with all the hyperlinks included, to your elected representatives, wherever you are

A swine flu outbreak occurred in Mexico and the United States in April 2009 and spread rapidly around the world by human-to human transmission. The new type A H1N1 influenza virus is unlike any that had been previously isolated [1, 2], judging from the first data released in May. It is a messy combination of sequences from bird, human and swine flu virus lineages from North America and Eurasia. A senior virologist based in Canberra, Australia, told the press he thought that the virus could have been created in the laboratory and released by accident [3]. Some even suggest it was made intentionally as a bioweapon [4], while others blame the intensive livestock industry and extensive trafficking of love animals over long distances, which provide plenty of opportunity for generating exotic recombinants [5]. But what worries the public most is the mass vaccination programmes governments are putting in place to combat the emerging pandemic, which could well be worse than the pandemic itself.

Watchdog opposes fast-track vaccine for school children

The US government is intending to vaccinate all children in September when school re-opens, and the country’s vaccine watchdog National Vaccine Information Center (NVIC)  has called on the Obama Administration and all state Governors to provide evidence that the move is [6] “necessary and safe”, demanding “strong mechanisms for vaccine safety screening, recording, monitoring, reporting and vaccine injury compensation.”

The US Departments of Health and Homeland Security had declared a national public health emergency in April soon after the swine flu outbreak. As a result, some schools were closed, people quarantined, and drug companies were given contracts worth $7billon to make vaccines that are being fast tracked by the Food and Drugs Administration [7]. That means they will only be tested for a few weeks on several hundred children and adult volunteers before being given to all school children this fall.

Furthermore, under federal legislation passed by Congress since 2001, an Emergency Use Authorization allows drug companies, health officials and anyone administering experimental vaccines to Americans during a declared public health emergency to be protected from liability if people get injured. US Secretary of Health and Human Services Kathleen Sebelius has granted vaccine makers total legal immunity from any lawsuits that may result from any new swine flu vaccine. And some states may make the vaccination mandatory by law.

The NVIC is asking whether the states are prepared to obey vaccine safety provisions in the 1986 National Childhood Vaccine Injury Act, which include: 1. Giving parents written information about vaccine benefits and risks before children are vaccinated; 2. Keeping a record of which vaccines the children get, including the manufacturer’s name and lot number; 3. Recording which vaccines were given in the child’s medical record; and 4. Recording serious health problems that develop after vaccination in the child’s medical record and immediately making a report to the federal Vaccine Adverse Event Reporting System.

NVIC also wants to know if the states are prepared to provide financial compensation to children injured by the swine flu vaccines, whether parents will be given “complete, truthful information about swine flu vaccine risks”, and have the right to say “no” to vaccination.

Co-founder and president of NVIC Barbara Loe Fisher said [6]: “Parents and legislators should be asking themselves right now: Why are children the first to get experimental swine flu vaccines? Are schools equipped to get signed informed consent from parents before vaccination, keep accurate vaccination records and screen out children biologically at high risk for suffering vaccine reactions? Will people giving these vaccines know how to monitor children afterwards and immediately record, report and treat serious health problems that develop? And will states have the financial resources to compensate children who are injured?”

WHO and mass vaccination fever

The mass vaccination order has come from the World Health Organization (WHO) [8].  In early July 2009, a group of vaccination experts concluded that the pandemic is unstoppable, and Marie-Paul Kieny, WHO director on vaccine research said all nations will need access to vaccines, and that a vaccine should be available as early as September.

Critics point out that the ‘vaccination experts’ are dominated by the vaccine makers standing to gain from the enormously lucrative vaccine and antiviral contracts awarded by governments. But the decisive argument against mass vaccinations is that flu shots simply don’t work and are dangerous [9].

Flu shots ineffective and increase risks of asthma

There are widely acknowledged reasons why flu vaccines won’t work, as already pointed out with regard to the much touted vaccines against the ‘pandemic bird flu’ that has yet to materialize [10] (How to Stop Bird Flu Instead, SiS 35). The flu virus changes quickly – even without the help of genetic engineering in the laboratory, and especially with the help of the intensive livestock industry – whereas the vaccines target specific strains. Furthermore, flu vaccination does not give permanent protection, and must be repeated annually; the vaccines are difficult to mass-produce, and some strains won’t grow at all under laboratory conditions.

Numerous studies have documented that flu shots give little or no protection against infection and illness, and there is no reason to believe that swine flu vaccines will be different.

A review of 51 separate studies in 2006 concluded that flu vaccines worked no better than a placebo in 260 000 children ranging in age from six months to 23 months [11]. A report published in 2008 found flu vaccines in young children made no difference in the number of flu-related doctor and hospital visits [12].

On the other hand, a study of 800 children with asthma found that those receiving a flu vaccine had a significantly increased risk of asthma-related doctor and emergency room visits [13]; the odds ratios were 3.4 and 1.9 respectively. This was confirmed in a report published in 2009, which showed children with asthma who received FluMist had a 3-fold increased risk of hospitalization [14]

Flu vaccines are equally useless for adults, including the elderly, giving little or no protection against infection or illnesses including pneumonia (see [9]).

Toxic adjuvants in flu vaccines

Vaccines themselves can be dangerous, especially live, attenuated viral vaccines or the new recombinant nucleic acid vaccines [10], they have the potential to generate virulent viruses by recombination and the recombinant nucleic acids could cause autoimmune diseases.

A further major source of toxicity in the case of the flu vaccines are the adjuvants, substances added in order to boost the immunogenicity of the vaccines. There is a large literature on the toxicities of adjuvants.  Most flu vaccines contain dangerous levels of mercury in the form of thimerosal, a deadly preservative 50 times more toxic than mercury itself [9]. At high enough doses, it can cause long-term immune, sensory, neurological, motor, and behavioural dysfunctions. Also associated with mercury poisoning are autism, attention deficit disorder, multiple sclerosis, and speech and language deficiencies. The Institute of Medicine has warned that infants, children, and pregnant women should not be injected with thimerosal, yet the majority of flu shots contain 25 micrograms of it.

Another common adjuvant is alum or aluminium hydroxide, which can cause vaccine allergy, anaphylaxis, and macrophage myofascitis, a chronic inflammation syndrome, In cats, alum also gives rise to fibrosarcomas at the site of injection [15]. Numerous new adjuvants are no better, and could be worse. According to a recent review in a science and business pharmaceutical publication [15], most newer adjuvants including MF59, ISCOMS, QS21, AS02, and AS04 have “substantially higher local reactogenicity and systemic toxicity than alum.”

Current status of swine flu vaccines

Five different companies have been contracted to produce vaccines worldwide: Baxter International, GlaxoSmithKline, Novartis and Sanofi-Aventis and AstroZeneca [16]. Already stretched beyond capacity, there is every intention to make smaller vaccine doses go further with a range of new adjuvants [17], with the blessing of the WHO (see later).

Flu vaccines are traditionally produced from non-virulent (attenuated or weakened) influenza viruses (see Box for a description of the viruses). To be effective, the genes of the non- virulent virus used must match those of the viral strain spreading in the population. Activation of the immune system by exposure to the non pathogenic form of the circulating pathogenic strain leads to the production of antibodies that will confer protection against the pathogenic strain. Producing the non-virulent virus involves first identifying and then recreating the subtypes of two of the virus’s surface proteins, haemagglutinin (H) and neuraminidase (N), which determine the strain’s virulence and ability to spread, and are also the target proteins for vaccine production.

Seed viruses are first made to provide the starting material for large scale production of live non-virulent flu viruses. The seed viruses are approved by the WHO or the United States Food and Drug Administration (USFDA). The usual method of seed virus production is reassortment (see Box). Fertilized chicken eggs are injected with both a standard non-pathogenic influenza strain known to grow well in eggs and the strain that carries the genes expressing the desired vaccine H and N protein subtypes. The two viruses multiply, and their eight genome segments reassort with 256 possible combinations. The resulting recombinant viruses are then screened for the desired virus with the six genome segments that allow the standard strain to grow so well in eggs and the H and N genes from the circulating strain. The seed virus is then injected into millions of eggs for mass production of vaccine. This conventional method of seed stock production takes about one to two months to complete [20].

Cell culture systems may eventually replace chicken eggs. Baxter International applied for a patent on a process using cell culture to produce quantities of infecting virus, which are harvested, inactivated with formaldehyde and ultraviolet light, and then detergent [21].  Baxter has produced H5N1 whole virus vaccines in a Vero cell line derived from the kidney of an African green monkey, and conducted phase 1 and 2 clinical trials with and without aluminium hydroxide as adjuvant [22, 23]. The main finding was that the toxic adjuvant did not increase neutralising antibodies against the vaccine strain. Baxter has agreed to ship H1N1 vaccine by the end of July or early August 2009 but details of the production of that vaccine have not yet been released to the public [16].
In December, a Baxter facility in Austria sent a human flu vaccine contaminated with the deadly H5N1 live avian flu virus to 18 countries, including the Czech Republic, where testing showed it killed the ferrets inoculated [24]. Czech newspapers questioned whether Baxter was involved in a deliberate attempt to start a pandemic.

Norvatis, another big pharma, announced on 13 June that it, too, has produced a swine flu vaccine using cell-based technology and the proprietary adjuvant MF59®. The MF59® adjuvant is oil based and contains Tween80, Span85, and squalene [25]. In studies of oil-based adjuvants in rats, the animals were rendered crippled and paralyzed. Squalene brought on severe arthritis symptoms in rats, and studies in humans given from 10 to 20 ppb (parts per billion) of squalene showed severe immune system impact and development of autoimmune disorders [26].

Novartis was in the news in 2008 for a clinical trial of a H5N1 vaccine in Poland. The trial was administered by local nurses and doctors who gave the vaccine to 350 homeless people, leaving 21 died; and were prosecuted by the Polish police [27, 28]. Novartis claimed the deaths were unrelated to the H5N1 vaccine [29], which had been “tested on 3500 other people without any deaths.”

GlaxoSmithKline’s vaccine will be made up of antigens of the recently isolated influenza strain, and also contains its own proprietary adjuvant system AS03 that has been approved in the EU along with its H5N1 bird flu vaccine in 2008. According to the European Public Assessment Report [30], AS03 adjuvant is composed of squalene (10.68 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.85 milligrams). The H5N1 vaccine also contains 5 micrograms thiomersal, as well as Polysorbate 80, Octoxynol 10, and various inorganic salts. The company is aggressively promoting various adjuvant systems as its ‘adjuvant advantage’ that reduces the dose of vaccines [31].

A recent WHO survey of primary vaccine producers concluded that the potential output of 4.9 Billion doses of H1N1 vaccine per year is a best-case scenario, assuming among other factors that the most dose-sparing formulation (that will include toxic adjuvants) be selected by each manufacturer and that production will take place at full capacity. WHO Director-General, Dr .Margaret Chan,  and the United Nations Secretary-General, Mr Ban Ki-moon, met with senior officials of vaccine manufacturers on 19 May and asked  them to reserve part of their production capacity for poor countries that would otherwise have no or little access to vaccine in the case of a pandemic [32].

The last mass-vaccination in the US was a disaster. In 1976, cases of swine flu were found in soldiers at Fort Dix, New Jersey, and one of them died, most likely of physical overexertion rather than from the infection [7]. This led to the launch of a mass vaccination of 40 million against a pandemic that never materialized. Thousands filed claims for injury. At least 25 died and 500 developed paralyzing Guillain-Barre syndrome [33, 34].

Swine flu syndromes mostly mild

As of 22 July 2009, the CDC listed a total of 40 617 cases in the US, with 319 fatalities, giving a fatalites/case ratio of 0.8 percent [35]; though the real death rate – among all cases of infection including the mild ones that go unreported – is probably much lower. Experts estimate that only 1 out of 20 cases are reported [36].

The UK is the worst affected European country, and the pandemic is in the headlines everyday in July. A new telephone helpline was set up on 23 July to let people get advice and tamiflu without seeing a doctor. In that week, there has been a record rise in cases to 100 000 and a total of 30 deaths so far [37], giving a fatalities/case ratio of 0.03 percent, a more accurate reflection of the actual death rate.

UK’s chief medical officer Sir Liam Donaldson has ordered the NHS to plan for as many as 65 000 deaths, with 350 a day at the peak [38]. There has been no plan as yet for mass vaccination; but the UK government has advance orders for 195 million doses of vaccine with GlaxoSmithKline (GSK).

The vaccine that GSK is developing will be tested on a limited number of people as the UK drug company reportedly [39] “weighs the pandemic danger against the risks of an unsafe shot.” This was criticized as “risky” by Prof. Hugh Pennington, a retired microbiologist at the University of Aberdeen, Scotland. “By limiting clinical trials, Glaxo raises the danger that the vaccine dose isn’t properly calibrated, and could lead to shots that don’t protect people from the virus or at worse are unsafe,” Pennington said.

Pennington added that the shot’s ability to trigger the body’s defences is crucial and requires tests to determine the best dose and whether an adjuvant is needed to bolster the immunity. (As we know, GSK is definitely promoting its new range of toxic adjuvants.) He also referred to the Fort Dix incident in 1976 (see earlier).

France has ordered vaccines from Sanofi, GSK and Novartis, but sees no reason to ask vaccine makers to shorten or skip clinical trials [16]. Sanofi-Aventis, the French drug maker developing its own swine flu vaccine will begin testing the product in early August, and estimates it will need as much as two and a half months of tests before having a shot that’s “both safe and protective”, according to Albert Garcia, speaking for the company’s vaccine unit, “the vaccine will be ready in November or December, he said.

Baxter, however, will produce a vaccine by early August for clinical tests.

Glaxo also said it is developing a face mask coated with antivirals to prevent infection and boosting production of its Relenza drug for patients already suffering from swine flu.

There are obviously safer and more effective ways to combat the pandemic than mass vaccinations: washing hands often, sneezing into a tissue that can be safely disposed of, avoiding unnecessary gatherings, and delay opening schools – all advised by governments – and we would add, eating healthily, exercise, and getting enough vitamin D to boost your natural immunity [10].

Click here for the full report and links from the Institute of Science in Society.

Drug Groups to Reap Swine-Flu Billions

July 20, 2009

Financial Times

by Andrew Jack

Some of the world’s leading pharmaceutical companies are reaping billions of dollars in extra revenue amid global concern about the spread of swine flu.

Analysts expect to see a boost in sales from GlaxoSmithKline, Roche and Sanofi-Aventis when the companies report first-half earnings lifted by government contracts for flu vaccines and antiviral medicines.

The fresh sales – on top of strong results from Novartis of Switzerland and Baxter of the US, which both also produce vaccines – come as the latest tallies show that more than 740 people have died from the H1N1 virus, and millions have been affected around the world.

GlaxoSmithKline of the UK confirmed it had sold 150m doses of a pandemic flu vaccine – equivalent to its normal sales of seasonal flu vaccine – to countries including the UK, the US, France and Belgium, and was gearing up to boost production.

GSK also produces Relenza, an antiviral medicine that reduces the length and severity of the infection, and is preparing to increase manufacturing towards 60m annual doses. The UK placed an order for 10m treatments this year.

One beneficiary of the fears about the pandemic has been Roche of Switzerland, which sells Tamiflu, the leading antiviral drug, and has seen a sharp rise in orders from private companies as well as governments.

A report last week from JPMorgan, the investment bank, estimated that governments had ordered nearly 600m doses of pandemic vaccine and adjuvant – a chemical that boosts its efficacy – worth $4.3bn (€3bn, £2.6bn) in sales, and there was potential for 342m more doses worth $2.6bn.

It forecast that fresh antiviral sales could boost sales for GSK and Roche by another $1.8bn in the developed world, and potentially up to $1.2bn from the developing world.

But there were also uncertainties for the pharmaceutical manufacturers. With demand likely to outstrip supply, and initial production suggesting that the yield for the pandemic vaccine is relatively low, they may face difficult choices in determining how much to supply to the countries seeking orders.

They are also under pressure to provide more drugs and vaccines for free, or extremely cheaply, to the developing world.

Click here for the full report from FT.com

New Flu “Unstoppable”, WHO says, Calls for Vaccine

July 13, 2009

Reuters

By Maggie Fox

WASHINGTON (Reuters) – Saying the new H1N1 virus is “unstoppable”, the World Health Organization gave drug makers a full go-ahead to manufacture vaccines against the pandemic influenza strain on Monday and said healthcare workers should be the first to get one.

Every country will need to vaccinate citizens against the swine flu virus and must choose who else would get priority after nurses, doctors and technicians, said Dr. Marie-Paule Kieny, WHO director of the Initiative for Vaccine Research.

Several reports showed the new virus attacks people differently than seasonal flu — affecting younger people, the severely obese and seemingly healthy adults, and causing disease deep in the lungs.

Kieny briefed reporters on the findings of the WHO’s Strategic Advisory Group of Experts on Immunization, or SAGE. “The committee recognized that the H1N1 pandemic … is unstoppable and therefore that all countries need access to vaccine,” Kieney said.

“The SAGE recognized first that healthcare workers should be immunized in all countries in order to retain a functional health system as the virus evolves,” she added.

After that, each country should decide who is next in line, based on the virus’s unusual behavior.

Seasonal influenza is deadly enough — each year it is involved in 250,000 to 500,000 deaths globally. But most are the elderly or those with some kind of chronic disease that makes them more vulnerable to flu, such as asthma.

ELDERLY ADVANTAGE

The elderly seem to have some extra immunity to this new H1N1, which is a mixture of two swine viruses, one of which also contains genetic material from birds and humans. It is a very distant cousin of the H1N1 virus that caused the 1918 pandemic that killed 50 million to 100 million people.

A study published in the journal Nature on Monday confirmed that the blood of people born before 1920 carries antibodies to the 1918 strain, suggesting their immune systems remember a childhood infection.

The work by Dr. Yoshihiro Kawaoka also supports other studies that this new H1N1 strain does not stay in the nose and throat, as do most seasonal viruses.

“The H1N1 virus replicates significantly better in the lungs,” Kawaoka said. Other studies have also shown it can cause gastrointestinal effects, and that it targets people not usually thought of as being at high risk.

“Obesity has been observed to be one of the risk factors for more severe reaction to H1N1″ — something never before seen, Kieny added. It is not clear if obese people may have undiagnosed health problems that make them susceptible, or if obesity in and of itself is a risk.

On Friday, a team at the U.S. Centers for Disease Control and Prevention and the University of Michigan reported that nine out of 10 patients treated in an intensive care unit there were obese. They also had unusual symptoms such as blood clots in the lungs and multiple organ failure.

None have recovered and three died.

The CDC estimates at least a million people are infected in the United States alone and clinics everywhere are advised not to test each and every patient, so keeping an accurate count of cases will be impossible. The United States has documented 211 deaths and WHO counted 429 early last week.

Kieny said WHO would also work to get better viruses for companies from which to make vaccines. She said the strains that had been distributed did not grow very well in chicken eggs — used to make all flu vaccines.

One exception — AstraZeneca’s MedImmune unit makes a live virus vaccine that is squirted up the nose and it is easier to produce, Kieny said.

WHO said countries should continue with their normal vaccination programs against seasonal flu. Kieny said the seasonal H3N2 strain was also very active now in the southern hemisphere’s winter.

Sanofi-Aventis, Novartis, Baxter, Schering-Plough’s Nobilon, GlaxoSmithKline, Solvay, CSL and AstraZeneca’s MedImmune are among those working on flu vaccines.

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U.S. to Spend Another $1 Billion on Flu Vaccine

July 12, 2009

Reuters

The United States will spend another $1 billion on ingredients for an H1N1 vaccine, U.S. Health and Human Services Secretary Kathleen Sebelius said on Sunday.

“There’ll be another $1 billion worth of orders placed to get the bulk ingredients for an H1N1 vaccination. Congress has agreed with the president that this is the number one priority, keeping Americans safe and secure,” Sebelius said on CNN.

Sebelius has said plans were on track for a mid-October vaccination program, although it was not certain Americans would be offered the vaccine for the so-called swine flu.

“We are aggressively working on, first of all, testing the virus strains to get a vaccination ready. It needs to be safe so testing and clinical trials will start this month. We’ll know a lot more by the end of the summer and it needs to be effective,” she said.

The World Health Organization may issue guidance as soon as Monday on whether an H1N1 swine flu vaccine will be offered alongside the seasonal flu vaccine.

Vaccine makers Sanofi-Aventis, Novartis, Baxter, GlaxoSmithKline, Solvay and AstraZeneca’s MedImmune subsidiary have finished making seasonal flu vaccines for this year.

The U.S. Food and Drug Administration has scheduled a July 23 advisory panel meeting to discuss clinical trials of the vaccines against the H1N1 influenza virus and the U.S. Advisory Committee on Immunization Practice wills meet July 29.

“FDA is working with the scientists at NIH (National Institutes of Health) to make sure that we have a safe and effective strain and then we’re getting ready to make sure that we have a vaccination program,” Sebelius said.

Health experts estimate at least 1 million people have been infected with H1N1 in the United States, and the U.S. Centers for Disease Control and Prevention has confirmed 211 deaths. It often takes weeks or months to collect data on flu deaths.

About 36,000 people die each year from the seasonal flu in the United States alone, and 250,000 to 500,000 die globally.

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