CDC paid Harvard School Public Health for Multiple Polls of swine flu uptake, though it already knew the answer/ CDC

After many polls of how many people got vaccinated, you can see that all were an unnecessary waste of taxpayer dollars by CDC, here:

The National Pandemic Influenza Plan calls for the Department of Health and Human Services (HHS) agencies, specifically the Centers for Disease Control and Prevention (CDC), to “assess vaccine coverage rates.” To meet this objective, Public Health Emergency Preparedness (PHEP) grantees are requested to track pandemic influenza vaccine doses administered and to report the associated aggregate counts to CDC. PHEP grantees (also referred to as Project Areas) include 50 states, 4 major metropolitan areas, and 8 U.S. territories. The CRA system has been enhanced to accept aggregate counts of pandemic influenza vaccine doses administered and to aid in reporting vaccine coverage rates on a state-by-state basis. Three options for submitting aggregate counts to the CDC using CRA have been developed:

OPTION 1: For Project Areas collecting data via an existing immunization information system (IIS), aggregate counts may be submitted via three standard data exchange formats.

OPTION 2: For Project Areas collecting data manually, data may be entered directly via the CRA aggregate reporting screen using a Web browser.

OPTION 3: For Project Areas using CDC’s CRA application to collect patient-level information, selected data elements will be automatically calculated and aggregated.

And here is an example of how the states require hospitals, clinics and other vaccination sites to report doses administered on a weekly basis.

Most Americans Think Swine Flu Pandemic Is Over, a Harvard Poll Finds / NY Times

Looks like the school-based swine flu vaccinations may have been a pilot program that CDC wants to become "routine." Excerpts from the NYTimes article:

Most Americans do not intend to get the swine flu vaccine, assume the pandemic is over and think the flu threat was overblown, according to a poll released Friday by the Harvard School of Public Health...

Dr. Anne Schuchat, the C.D.C.’s director of immunization and respiratory disease, who in early January urged all Americans to get shots because they had finally become plentiful, put a brave face on the low figures, saying she was “encouraged” because more children got shots than ever previously got regular flu shots and because many got them at school for the first time. If that became routine, it could lead to much wider flu protection because schoolchildren often are the vectors that infect their families... (a current hypothesis--Nass)

The Harvard polling data was of 1,419 adults, including 377 parents, and had a margin of error of three percentage points for the total response. It found that 21 percent of those polled had been vaccinated, and 15 percent intended to by the end of February. Of the parents, 40 percent had had their children vaccinated, and 13 percent intended to.

Lancet vs. Wakefield

I love the Lancet. I have my own subscription, and it isn't cheap. However, the Lancet took a cheap shot last week, when it retracted a paper on autism by Wakefield et al. immediately following a ruling by the UK's General Medical Counsel. The Lancet has been embroiled in controversy (and repeatedly tried to extract itself, but that's another story) since publishing the 1998 Wakefield et al. paper that put the issue of autism and measles vaccine on the map.

But the retraction didn't have to happen. The abstract discussed in the post just below this one shows that DHHS doctors came to a similar conclusion (that measles vaccine and neurologic damage in children should be investigated) the same year as Wakefield. Those authors were never put on trial, have retracted nothing, and Caserta is currently running the vaccine injury compensation program for swine flu vaccine.

Why is the Lancet retracting the paper now? The editors list two reasons: the children were not "consecutively referred" and the studies weren't approved by the local ethics committee. Well, after the many prior investigations of this paper, I am astonished that it took 12 years for Lancet to discover the lack of IRB approval. Sounds fishy.

Lancet is upset the children were not "consecutively referred"? Isn't that reaching a bit, editors?
Have you forgotten that JAMA recently published a paper claiming that 10% of your published papers are written by ghost authors? Maybe those papers should be retracted? Isn't faked authorship more important to root out than lack of consecutive referral, whatever that is supposed to mean?

Here is the Lancet statement:

The Lancet, Volume 375, Issue 9713, Page 445, 6 February 2010
Retraction—Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children.

Original Text

The Editors of The Lancet

Following the judgment of the UK General Medical Council's Fitness to Practise Panel on Jan 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al. are incorrect, contrary to the findings of an earlier investigation. In particular, the claims in the original paper that children were “consecutively referred” and that investigations were “approved” by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record.

And here are the major conclusions of the Wakefield paper that are being retracted, although their accuracy has not been disputed:

Wakefield AJ, Murch SH, Anthony A, et al. Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet 1998; 351: 637-641.

We did not prove an association between measles,
mumps, and rubella vaccine and the syndrome described.
Virological studies are underway that may help to resolve
this issue.

If there is a causal link between measles, mumps, and
rubella vaccine and this syndrome, a rising incidence
might be anticipated after the introduction of this vaccine
in the UK in 1988. Published evidence is inadequate to
show whether there is a change in incidence or a link
with measles, mumps, and rubella vaccine. A genetic
predisposition to autistic-spectrum disorders is suggested
by over-representation in boys and a greater concordance
rate in monozygotic than in dizygotic twins...

We have identified a chronic enterocolitis in children
that may be related to neuropsychiatric dysfunction. In
most cases, onset of symptoms was after measles,
mumps, and rubella immunisation. Further investigations
are needed to examine this syndrome and its possible
relation to this vaccine.

Measles vaccine can cause encephalopathy 8-9 days post injection/ DHHS

I was hoping to avoid joining the Andrew Wakefield/Lancet fray, but so many inaccurate statements have been published in the last few days that I had to jump in. There is clearcut evidence for a syndrome of brain injury (and sometimes death) occurring after measles vaccine (and not after rubella or mumps vaccines). Who discovered it? DHHS physicians charged with responding to vaccine injury claims for the federal government. Here is the abstract, published in the journal Pediatrics in 1998.

I'd also like to point out that many children with autism have chronic diarrhea and other gastrointestinal problems, and there can be no question that these features are part of the autism syndrome. Some children are born with neurological impairment; some develop it later; but a surprising and statistically significant number developed it 8-9 days after getting their first measles vaccine, and no amount of hand-waving can erase this fact.

UPDATE: Here is the full text.

Pediatrics. 1998 Mar;101(3 Pt 1):383-7.

Acute encephalopathy followed by permanent brain injury or death associated with further attenuated measles vaccines: a review of claims submitted to the National Vaccine Injury Compensation Program.

Weibel RE, Caserta V, Benor DE, Evans G.

Division of Vaccine Injury Compensation, National Vaccine Injury Compensation Program, Health Resources and Services Administration, Public Health Service, Rockville, Maryland 20857, USA.

OBJECTIVE: To determine if there is evidence for a causal relationship between acute encephalopathy followed by permanent brain injury or death associated with the administration of further attenuated measles vaccines (Attenuvax or Lirugen, Hoechst Marion Roussel, Kansas City, MO), mumps vaccine (Mumpsvax, Merck and Co, Inc, West Point, PA), or rubella vaccines (Meruvax or Meruvax II, Merck and Co, Inc, West Point, PA), combined measles and rubella vaccine (M-R-Vax or M-R-Vax II, Merck and Co, Inc, West Point, PA), or combined measles, mumps, and rubella vaccine (M-M-R or M-M-R II, Merck and Co, Inc, West Point, PA), the lead author reviewed claims submitted to the National Vaccine Injury Compensation Program. METHODS: The medical records of children who met the inclusion criteria of receiving the first dose of these vaccines between 1970 and 1993 and who developed such an encephalopathy with no determined cause within 15 days were identified and analyzed. RESULTS: A total of 48 children, ages 10 to 49 months, met the inclusion criteria after receiving measles vaccine, alone or in combination. Eight children died, and the remainder had mental regression and retardation, chronic seizures, motor and sensory deficits, and movement disorders. The onset of neurologic signs or symptoms occurred with a nonrandom, statistically significant distribution of cases on days 8 and 9. No cases were identified after the administration of monovalent mumps or rubella vaccine.

CONCLUSIONS: This clustering suggests that a causal relationship between measles vaccine and encephalopathy may exist as a rare complication of measles immunization.

Hard sell: If you go to the doctor for anything the doctor will be offering free swine flu vaccine

From the UK's Daily Telegraph, excerpts from a story about Australia's new push to use up its swine flu stockpile. The multidose vaccine vials need to be used within 24 hours of opening.

DOCTORS have been told to issue the swine flu vaccine throughout summer in order to deplete the Government's stockpile before millions of doses expire.

Australia's chief medical officer Professor Jim Bishop will write to doctors this week urging them to "redouble efforts" to vaccinate as many patients as possible.

But critics say there is no legitimate medical reason to mass vaccinate against a flu that has proved to be far less serious than first feared.

The federal Government is committed to buying 21 million doses of the vaccine from [Australian] manufacturer CSL, but the take-up rate has been slower than hoped.

GPs admit they are doing opportunistic vaccinations to avoid wasting the vaccine, which comes in multi-dose vials that need to be thrown out after 24 hours. Patients who present with food poisoning or for a routine blood test are leaving with a swine flu jab...

Make Adult Vaccinations as Widespread as Those for Children, Say Immunization Advocates (Sponsored by Pharma)/ Medscape

A report claiming "dangerously low" adult levels of vaccinations just came out, sponsored by Trust for America's Health (TFAH), the Robert Wood Johnson Foundation and the Infectious Diseases Society of America (IDSA). TFAH focused on "emergency preparedness" and "pandemic preparedness" as the first two subjects covered in its last 2 annual reports (2005 and 2006) available on it website. Robert Wood Johnson Foundation was funded by pharmaceutical manufacturer Johnson and Johnson. IDSA was recently sued by Connecticut's Attorney general over conflicts of interest that may have affected the content of guidelines for Lyme Disease treatment issued by the Society.

The report is correct that immunization rates in seniors for influenza and pneumococcal vaccines are far below 100%. But since the evidence to support strong benefits resulting from these two vaccinations in seniors does not exist, logic would suggest this is neither "dangerous" nor too low.

This is simply another shot across the bow-- intended to push policymakers toward mandating more adult vaccinations. More later on the varied methods being used for this purpose.

Snippets from the Medscape article:

The United States needs a national strategy to immunize adults against infectious diseases that would achieve the same success found in childhood immunization efforts, according to a report released today that characterized adult immunization rates as dangerously low.

Between 40,000 and 50,000 adults die each year from vaccine-preventable illnesses, according to the report, published by the Infectious Diseases Society of America, the Robert Wood Johnson Foundation, and the Trust for America's Health.

The report, titled "Adult Immunization: Shots to Save Lives," states that one third of adults aged 65 years and older have not been vaccinated against pneumonia, and 30.5% have not been vaccinated against the seasonal influenza.

Trust for America's Health Executive Director Jeffrey Levi, PhD, said that the 3 report sponsors wanted to capitalize on the visibility and momentum of recent efforts to immunize people against the H1N1 influenza virus.

In contrast to the adult world, efforts to vaccinate children against various diseases have been far more successful, in large measure because state laws require immunization as a condition of attending school or day care, the report stated. No such institutional mandate exists for adults, apart from those in the military or certain colleges...

And from McClatchy comes another talking point for mandating vaccinations: Failure to use the vaccines adds about $10 billion annually to the cost of heath care, according to the U.S. Centers for Disease Control and Prevention...

Only 36.1 percent of adults have been vaccinated annually for seasonal flu.

"It sort of plateaued at that level," Glen Nowack, a spokesman for the CDC, said of the seasonal flu shots. "The next groups are not as easily persuadable. They have not been in the habit of getting the influenza vaccine. They have concerns about it, or don't believe it's going to be as effective. We've been working real hard to try and persuade them."

WHO challenged at public hearing on the handling of the Swine Flu pandemic/ Council of Europe

From the Council of Europe's website:

"Are decisions on pandemics taken on the best scientific evidence only?" was the question asked today at a public hearing of PACE's Committee on Social, Health and Family Affairs into the handling of the H1N1 pandemic. The World Health Organisation's flu chief defended his organisation, saying its advice was not improperly influenced by the pharmaceutical industry. Paul Flynn (United Kingdom, SOC) will now prepare a report on this topic, for possible debate by the plenary Assembly in July or October 2010.

Extracts of statements by main speakers

Statement by Dr Wolfgang Wodarg (PDF)

Statement by Dr Keiji Fukuda, World Health Organisation (PDF)

Statement by Dr Luc Hessel, European Vaccine Manufacturers (PDF)

Statement by Prof. Dr. Ulrich Keil

Biographies of participants (PDF)

Video of the hearing

Video of the press conference

Motion by Mr Wodarg and others (PDF)

Announcement of hearing

Holy moly, it's hard getting swine flu vaccine to people who might need it overseas/ NY Times

WHO's Dr. Fukuda still isn't making sense, only now he is discussing WHO's work getting vaccine to poor nations. Swine flu cases began falling rapidly in the US in October. Countries have been trying to give away much of their vaccine stockpile since December. Yet WHO has only managed to get vaccine to two countries. Guess they don't think it's that critical.

From Donald McNeil at the NY Times:

There is now so much unused swine flu vaccine in the world that rich nations, including the United States, are trying to get rid of their surpluses. But the world’s poorest countries — a few still facing the brunt of the pandemic — are receiving very little of it.

...countries that can afford vaccines save themselves first and, when the worst has passed, transfer their leftovers to the poor, using the W.H.O. as a clearinghouse.

That transfer “turns out to be an incredibly difficult logistical action,” said Dr. Keiji Fukuda, the W.H.O.’s chief of pandemic influenza. “It’s a mammoth effort by an awful lot of people and organizations and countries but holy moly, it’s a very complex operation.”

Each country must submit a plan proving it can store refrigerated vaccine, give it to those who need it most, inject it safely and do medical follow-up. It must also sign letters exempting donors from legal liability, and the W.H.O. has to certify the vaccine as safe if the country has no regulatory agency. Even shipping adds delays. By December, Dr. Fukuda said, only five countries had even received syringes...

Vaccination Coercion: We don't have the data to show it's valuable, but some would force vaccinations nonetheless

Here's a big yawn from the Infectious Disease News: Mandatory policy increased influenza vaccine uptake among Health Care Workers.

The article claims that the program's "success" was supported by "consistent communication emphasizing patient safety and quality of care, coordinated campaigns, leadership support and medical director support to talk with any employee with concerns about the vaccine, on request.”

Hello? The "success" was not thought due to potentially losing your job? Even pregnancy was not an accepted contraindication to vaccination, unless a doctor gave you an exemption. And the Human Resources department, not physicians, was used to review exemption requests and act on them positively or negatively (by firing the employee). Fifty-one requests for exemptions were not granted. Since when does Human Resources come between employees and their medical care? I hope this process gets litigated.

Remember the poem by Martin Niemoller?

First they came for the communists, and I did not speak out—because I was not a communist;
Then they came for the trade unionists, and I did not speak out—because I was not a trade unionist;
Then they came for the Jews, and I did not speak out—because I was not a Jew;
Then they came for me—and there was no one left to speak out.

A human body that has not received its yearly flu booster and all other vaccines can be seen as an untapped revenue source. Remember: first they came for the schoolkids, then they came for the healthcare workers...

Is WHO's pandemic plan the problem?

From PharmaTech comes the following paragraph, which implies that once a pandemic is identified, the WHO's Pandemic Plan goes into effect. An evaluation of severity is missing from this scenario. Somehow, the assumption seems to be that pandemics (all pandemics, especially those associated with influenza viruses) are dire events with high mortality rates. Yet the word pandemic only means "widespread."

"WHO’s 2009 pandemic-preparedness plan was an updated version of its first such document, which the organization drafted in 1999. Stressing the effort WHO put into the plan, Fukuda said that the plan included contributions from more than 135 public-health scientists from 48 countries. A request for public comments on the draft document yielded more than 600 replies."

Fukuda's protest that swine flu is a "real" pandemic is correct. Swine flu is a pandemic, and it is mild. A new type of cold virus can also cause a pandemic.

So who decides that a sufficiently severe pandemic is occurring, and therefore WHO's pandemic plan needs to be activated? Wouldn't that be Fukuda and Chen? Isn't Fukuda dodging discussion of what is really relevant?

Somebody at WHO has to take responsibility for the worldwide misallocation of many billion $s in public health resources. A conflicted SAGE (Strategic Advisory Group of Experts) gave WHO advice. But who at WHO flipped the switch?

World Health Organization calls swine flu critics 'irresponsible' / AP

GENEVA (AP) — The World Health Organization has rejected as "irresponsible" allegations that swine flu is a fake pandemic. WHO also dismissed claims it colluded with drug companies to bring economic benefit to the industry by playing up the danger of the new H1N1 influenza strain. WHO officials met Tuesday with the Parliamentary Assembly of the Council of Europe after the watchdog body questioned whether the U.N.'s health agency acted under undue influence.

Spokesman Gregory Hartl says WHO has always been "very measured and sober" in describing the outbreak as causing overwhelmingly mild disease. Hartl said Monday that from a scientific point of view "this is plainly a pandemic and for people to not describe it as a pandemic is irresponsible."

How many Americans were REALLY immunized for Swine Flu?

CDC called a few thousand random phone numbers and asked people whether they had been vaccinated. CDC said the response rate was poor. From this admittedly poor quality dataset, CDC told the world that 20% of Americans had been vaccinated against swine flu.

But CDC had a high quality dataset telling it exactly how many Americans had been vaccinated. From the immunizations program's beginning, CDC has required all centers giving swine flu immunizations to provide weekly tallies of numbers vaccinated.

So why did CDC waste taxpayer dollars dialing random phone numbers, and waste the time of people answering the phone? Early in the epidemic, over 50% of Americans who were surveyed said they planned to get the shot. It seems Americans exaggerate their willingness to be vaccinated when queried by government agencies or their proxies.

Didn't CDC like the actual percentage of vaccinated Americans that had been reported by vaccine clinics? Did CDC instead seek a result from random dialing that would make CDC appear to have been more successful at convincing Americans to be vaccinated? "From our point of view, this looks very successful," said CDC spokesman, Richard Quartarone.

According to Bloomberg, "The U.K., Ireland, Italy, Germany and France have vaccinated less than 10 percent of their populations, compared with 20 percent in Europe in a typical flu season." And in another Bloomberg article: “The willingness to be vaccinated against swine flu is much lower than what governments projected,” said Andrew Goodsall, a health-care analyst with UBS AG in Sydney. And in Texas last week, it was reported that 80% of kids who had received the first swine flu shot failed to return for the second dose.

Yet CDC has claimed that more Americans were vaccinated than in a typical flu season. I think we deserve to see the real data.

"Public health officials who want to increase vaccination rates will need to focus more attention on convincing people who most need it of its safety," Robert Blendon, director of the Harvard Opinion Research Program, said in a statement released with the poll. "Findings here—like past polls—suggest that beliefs about safety have been difficult to change for a segment of the public."

No wonder the Pharma-Government complex has been sending out feelers regarding mandatory vaccinations. Aggressive PR is failing to convince most people of the need to be vaccinated for minor annoyances. Meanwhile, who is in charge of US vaccine safety "science"? CDC.

Do you need a shot now?

Swine Flu Didn't Fly/ Truthout

From Niko Kyriakou at Truthout, excerpts:

Wow, what a year 2009 was for makers of the swine flu vaccine. CSL Limited's profits rose 63 percent above 2008 levels, while in the third quarter of 2009 - just about the time H1N1 contracts picked up steam - GlaxoSmithKine enjoyed a 30 percent jump in earnings to $2.19 billion. Roche, the maker of Tamiflu, which prevents H1N1, saw second quarter profits leap to 12 times what they were in that quarter of 2008. But in 2010, drug companies may get their comeuppance.
On Tuesday, the Council of Europe launched an investigation into whether the World Health Organization (WHO) "faked" the swine flu pandemic to boost profits for vaccine manufacturers. The inquiry, held in Strasbourg, France, vindicates a worldwide movement of insiders, experts and elected officials who accuse the United Nations organization of misleading the world into buying millions of unnecessary vaccines...

Food and drug agencies in Canada, the UK, France, the US, and elsewhere guaranteed vaccine manufacturers that they would be shielded from any lawsuits connected to the vaccines. This enabled companies to fast track the testing process, reducing some trials to as little as five days.

The Anthrax Attacks Remain Unsolved/ Wall Street Journal

The Jan. 24 WSJ ran an Op-Ed on the anthrax letters investigation and meaning of 1.4% silicon in the letter anthrax, by Edward Jay Epstein. Subtitled "The FBI disproved its main theory about how the spores were weaponized," excerpts from the article follow:

The investigation of the 2001 anthrax attacks ended as far as the public knew on July 29, 2008, with the death of Bruce Ivins, a senior biodefense researcher at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) in Fort Detrick, Md. The cause of death was an overdose of the painkiller Tylenol. No autopsy was performed, and there was no suicide note...

Consequently, Ivins, who was assisting the FBI with its investigation, as well as all the scientists who had access to the anthrax, became suspects in the investigation. They were intensely questioned, given polygraph examinations, and played off against one another in variations of the prisoner's dilemma game. Their labs, computers, phones, homes and personal effects were scrutinized for possible clues...

Livermore scientists had tried 56 times to replicate the high silicon content without any success. Even though they added increasingly high amounts of silicon to the media, they never even came close to the 1.4% in the attack anthrax. Most results were an order of magnitude lower, with some as low as .001%.

What these tests inadvertently demonstrated is that the anthrax spores could not have been accidently contaminated by the nutrients in the media. "If there is that much silicon, it had to have been added," Jeffrey Adamovicz, who supervised Ivins's work at Fort Detrick, wrote to me last month. He added that the silicon in the attack anthrax could have been added via a large fermentor—which Battelle and other labs use" but "we did not use a fermentor to grow anthrax at USAMRIID . . . We did not have the capability to add silicon compounds to anthrax spores."

...even though the public may be under the impression that the anthrax case had been closed in 2008, the FBI investigation is still open—and, unless it can refute the Livermore findings on the silicon, it is back to square one.

David Kelly post mortem to be kept secret for 70 years as doctors accuse Lord Hutton of concealing vital information / Daily Mail

The Chilcot Inquiry into the facts surrounding the decision for Great Briitain to enter the Iraq War has now been lobbed a ball it probably can't duck.

A group of physicians have asked for release of data--including autopsy reports--on the death of David Kelly. Kelly, a WMD expert, told the BBC that Blair's government had "sexed up" a report on Iraq's WMD: that there was no evidence for the claim that nuclear weapons could be sent overseas by Saddam Hussein within 45 minutes. Shortly thereafter he was found dead in the woods near his home.

His death was not explained satisfactorily. Now it turns out that Lord Hutton, who convened an earlier inquiry into Kelly's death that many regard as a cover-up, sealed all the records for 70 years. This new fact seems to clinch Hutton as a cover-upper.

Now the Chilcot hearing will almost certainly need to delve into the circumstances of Kelly's death, and behind all that is the role Labor Party leaders may have had in it. So far, Chilcot has dodged the entire issue of Kelly.

UPDATE: The TimesOnline (and other UK media) have reported that Lord Hutton will be making classified documents available to the 5 doctors investigating Kelly's death. The Times site has a nice clickable summary of the witnesses' testimony at the Chilcott hearing, where Tony Blair dodged and prevaricated on Jan. 29.

Swiss warn on flu vaccine with autoimmune disease/ Reuters

ZURICH (from Jan. 20, 2010: Reuters) -

Switzerland's medical regulator recommended patients with serious
autoimmune diseases should not use an H1N1 flu vaccine from
Novartis, saying there were no studies assessing the innoculation in that
population.

Swissmedic said on Wednesday it could not be ruled out that either or both
the adjuvant -- which can enhance the immune response -- and/or the antigen, or less active ingredient, could lead to an intensifying of autoimmune diseases.

Autoimmune diseases, like rheumatoid arthritis, are caused by an overly
active immune system attacking its own body, targeting substances which are
normally present.

Novartis was not immediately available to comment.

Instead, Novartis was busy flogging its MF59 adjuvant in the US for BIRD FLU. The only problem is that enhanced immune responses are dangerous in people who have autoimmune diseases, or a genetic predisposition to them. And from another of today's Reuters articles:

A vaccine additive made by Novartis (NOVN.VX) and used in its European influenza shots can boost the body's immune response to a wide range of viruses, U.S. researchers reported on Wednesday.

Tests in the laboratory suggested the so-called adjuvant, called MF59, helped the immune system counteract not only the H5N1 virus in the current experimental bird flu vaccine, but mutant viruses as well. The U.S. Food and Drug Administration study, published in the journal Science Translational Medicine, suggests using vaccines with adjuvants may protect patients against even more types of flu viruses than they are being vaccinated against. Adjuvants are widely used in European flu vaccines as well as in Canada. But are not widely used in the United States -- even though the federal government has spent nearly $700 million buying them.

The reason? People might not trust them.

Other studies have shown adjuvants can stretch the supply of flu vaccine, because
shots using them require much less of the actual vaccine antigen.

"Adjuvanted vaccines produce higher immune response than unadjuvanted vaccines particularly in the elderly and young children," Dr. Vas Narasimhan, president of Novartis Vaccines USA, told a U.S. Congressional hearing last November.

WHO examines claims over exaggerating swine flu danger / Deutsche World

Snippets from Deutsche World online:

Amid criticism that it exaggerated the dangers of swine flu, the World Health Organization (WHO) has begun a week long meeting in Geneva. Critics accuse the organization of having been too quick to proclaim a pandemic.

British member of parliament Paul Flynn wants an investigation into exactly how the pandemic was handled. "We want to know who decided the level of risk," he said. "Was it decided on medical and health grounds or was it decided to meet the priorities of making profits of the pharmaceutical organizations. The great danger is that having cried 'wolf' on avian flu and on swine flu, nobody is going to trust the World Health Organisation if they come out with another threat, with another scare story in the future."

In Norway the ministry of health announced a deal with GSK identical to one the pharmaceutical giant signed with Germany and Belgium, allowing the country to save around 24.6 million euros ($35.4 million).

The Greek government cancelled 12.3 million of its flu vaccine orders, from a total of 16 million originally destined for the 11 million Greek population, while Norway had ordered 9.4 million vaccinations from GSK, foreseeing two doses for each of its 4.8 million citizens, in accordance with the recommendations at the time from health authorities.

A total of 97 people have died in Greece for reasons linked to swine flu and in Norway 29 people have died from the virus.

But this is a debate that won't go away – next week in Strasbourg, the council of Europe is set to hold an emergency debate on the swine flu pandemic – WHO officials and executives from the vaccine producers will be required to attend.

2 Studies Question the Effectiveness of Flu Vaccines/NY Times

From the NY Times, Sept. 21, 2005 -

Just as governments around the world are stockpiling millions of doses of flu vaccine and antiviral drugs in anticipation of a potential influenza pandemic, two new research papers published today have found that such treatments are far less effective than previously thought.

"The studies published today reinforce the shortcomings of our efforts to control influenza," wrote Dr. Guan Yi, a virologist at the University of Hong Kong, in an editorial that accompanied the papers...
In one paper, international researchers analyzed all the data from patient studies on the flu vaccine performed worldwide in the past 37 years and discovered that vaccines showed at best a "modest" ability to prevent influenza or its complications in elderly people.

The current bird flu virus does not spread easily - if at all - from human to human, and so has little potential to become a worldwide human scourge. But the World Health Organization has warned that it could acquire that potential through a couple of common biological processes, and that countries should prepare for a possible wave of serious influenza...

In people over 65, the vaccines "are apparently ineffective" in the prevention of influenza, pneumonia and hospital admissions, although they did reduce deaths from pneumonia by "up to 30 per cent."

Why not a US investigation of the swine flu response?/ Alliance for Human Research Protection

The Alliance for Human Research Protection (AHRP) calls for an investigation of
conflicts of interest at Federal Agencies which spearheaded the excessive,
expensive, and unjustifiable federal expenditure in response to the false Swine
Flu "pandemic" in the U.S. Indeed, "off the record", CDC even stage-managed media coverage of the epidemic.

Issues requiring investigation:

1. BARDA (the Biomedical Advanced Research Development Authority) is a new federal agency that has been charged with procuring countermeasures for attacks by weapons of mass destruction. BARDA had no expertise obtaining drugs in common usage. Why then was it made the lead federal agency to procure vaccines and drugs for a nonexistent Bird Flu outbreak, and for this year's Swine Flu pandemic?

BARDA contracted for enormous quantities of new drug and vaccine products which had not
been tested in the field. It is unknown if any of these new entities will work as desired. Indeed, as reported in the BMJ on December 8, 2009, no reliable evidence supports the usefulness of Tamiflu in treating the flu, which was purchased in huge amounts.

2. Why were the manufacturers of all five Swine Flu vaccines and the two antiviral drugs (Tamiflu and Relenza) issued blanket liability waivers--as were "government program planners" at BARDA and other agencies who had approved and exhorted their use?

DHHS Secretaries under George W. Bush and Barack Obama approved these liability
waivers under the Public Readiness and Emergency Preparedness Act (PREP).

However, neither the Bush nor Obama administration made any attempt to inform Americans that in the event that they suffered a drug or vaccine-caused injury, they were prohibited from accessing the US legal system to seek damages. Discussion of the PREP law which enabled this can be found here.

3. AHRP would like to know why the US treasury, and worldwide health budgets, have come to resemble Big Pharma's cookie jar?

With a reported 36,000 U.S. deaths annually from seasonal flu, and (at most) 10,000 deaths from swine flu, we believe that President Obama's declaration (in October 2009) that swine flu presents a national emergency was as ill-advised as it is preposterous.

And with the pandemic over, declaring the week of January 10 "National Influenza Vaccination Week" to push more vaccinations... is a cynical ploy to provide cover for officials who wasted $ billions ordering excessive vaccine. How long does vaccine protection last? Could we use the excess supply to add to seasonal flu vaccine next winter, as already planned?

Or does next year's supply require spending more billions?

Is Avian Flu vaccine next for selected groups?/ WHO

WHO's Strategic Group of Experts Working Group on Avian Flu (H5N1) Vaccine is working on "evidence-based recommendations" for using up stockpiles of avian flu vaccine that are reaching their expiration date. From WHO's website:

"Facilitate a SAGE review and decision on potential evidence-based recommendations on the use during the current inter-pandemic period of:

• H5N1 influenza vaccines in persons at high-risk of infection with H5N1 avian influenza virus and/or and in certain priority groups (as identified by country plans) or in the general population
• WHO stockpiled H5N1 influenza vaccines reaching the end of their shelf life."

Could this be why WHO's Director General starting warning about Bird Flu two weeks ago? "The world is not ready for a pandemic to be caused by H5N1," she chirped.

Like her deputy Dr. Fukuda, Dr. Chan has personal experience responding to both bird flu and SARS while serving as Hong Kong's health director. This shared experience likely skewed their priority setting at WHO.

How can WHO's sages make any recommendations based on evidence when there never has been a bird flu pandemic and bird flu viruses have never caused an epidemic through person to person spread? Get real, WHO, and stop hiding a universe of uncertainty behind pretty verbiage and scare tactics.

The issue at hand is whether you are going to recommend using expiring vaccines in humans, whose safety and efficacy are unknown, for a disease epidemic that does not exist. And the advantage to doing so is the theoretical hope that if the disease ever surfaced, the vaccine might provide a soupçon [French: a suspicion, hint or drop] of protection. Presumably the real reason to use it is to enable WHO and national health departments to purchase more, newer bird flu vaccines, thereby increasing Pharma profits while expanding the concept of appropriate vaccine uses.

Investing in snake oil (excuse me, bird oil) is great business, especially if the World Health Organization is behind you.

CDC Conflicts of Interest

CDC does not just award grants, it also obtains research grants from other federal agencies and industry. Here is one grant CDC got from an Australian biotech company to advance research on the company's pandemic flu vaccine. How might such relationships affect CDC's impartiality in fulfilling its mission to recommend vaccines for general use in the US?

Furthermore, CDC created the CDC Foundation to enable it to accept corporate (and other) gifts. It appears that corporations can use CDC to advance their own interests by, for example, "creat[ing] health education campaigns" and "invest[ing] in specific programmatic areas." For example:

Businesses and Corporations

Restricted Support: Some corporations wish to invest in a specific programmatic area within CDC. These gifts typically help defray all or some of the costs of carrying out a scientific study, health education campaign, training program or other public health program. Often funding partners become engaged early on in a project to clearly understand its objectives or participate in the program design. Several partners may jointly fund a program to provide adequate resources to ensure its successful completion. Read more about CDC Foundation partnerships that help corporations and CDC achieve common goals. To find out about contributing to a particular program, call the Advancement Office at 404-653-0790 or e-mail jsmith@cdcfoundation.org.

Annual Alliance: The CDC Foundation's Annual Alliance campaign provides companies of all sizes the opportunity to align themselves with the public health objectives of CDC, while providing unrestricted support to the CDC Foundation. Learn More

Swine flu vaccine is safe, they say: but I am seeing nasty coincidences

Real data is important, and anecdotes are just anecdotal. Yet during the past 3 weeks I have been personally involved with 3 events that have me concerned. I am a doctor on an island of 13,000 people, where hundreds received swine flu vaccine.

Coincidence 1: several hours after getting the swine flu vaccine, a man "looked gray" to his wife and then had vague chest pain. I sent him for a cath, and he had a near-complete stenosis of a large coronary artery.

Coincidence 2: one week after the vaccine, a man I treated developed Bell's Palsy.

Coincidence 3: one day after receiving injected swine flu vaccine, a child I was consulted on had new onset of a facial tic.

The possibility that one or more of these cases may be adverse effects of the vaccine (and the second two probably are) means that detailed data on adverse events needs to be made public NOW. The epidemic is nearly over, but there is a big push to VACCINATE NOW, during National Influenza Vaccination Week (Jan 10-16).

The vaccines have been in use for 3 months. Sixty million Americans have used them, according to a small CDC poll. Enhanced electronic data collection is said to be a feature of the US vaccine program. While we continue to push the vaccine, let's have transparency about what the existing data show.

WHO, investigated for swine flu mismanagement, says it will investigate itself

The BBC today notes that:

The Council of Europe is planning an investigation, to begin later this month, into whether pharmaceutical companies influenced public health officials to spend money unnecessarily.

In Geneva, a WHO spokeswoman acknowledged there were questions to be answered.

She said the review of its management of the pandemic would be conducted with independent experts, and the results would be made public.

However, the review will not begin until the pandemic itself is declared over - and that could still be months away.

UPDATE: The Washington Post reported Jan 14 on statements by Keiji Fukuda, Assistant Director-General for the World Health Organization, who denied WHO had changed the pandemic flu definition in anything but its usual manner of modifying definitions, and said that all conflicts of interest at WHO had to be disclosed and were taken very seriously. [See earlier blogs for discussion of how 80% of WHO's budget does not come from member states, and how the WHO pandemic definition was changed. Here is a 2004 WHO definition:

An influenza pandemic occurs when a new influenza virus appears against which the human population has no immunity, resulting in several, simultaneous epidemics worldwide with enormous numbers of deaths and illness.

and here (May 26, 2009 at Science blogs) you can see that the definition was a moving target last spring, which ultimately did not change, after a 2006 change that extracted disease severity from the pandemic definition:

WHO earlier had defined phase 6 as sustained community spread of the virus in two regions of the world but last week put that definition on ice, following pressure from member countries that criticized the phasing system for not taking into account disease severity. Fukuda said in the next few weeks that WHO hopes to hold a videoconference with prominent scientists and public health specialists who have “a wide range of opinions” about how to define phases in influenza outbreaks. “We’re trying to see what kind of adjustments might be made to make sure that the definitions really meet the situation,” said Fukuda.

Fukuda himself is a former US CDC official who has worked on avian flu for the past 12 years, and participated in responses to small avian flu outbreaks in China, Hong Kong and Vietnam.

How the world's response to swine flu came to mirror the planned response to a future, widespread avian flu epidemic could be related to Fukuda's experience and expertise. I wonder what he can tell us about this aspect of WHO's swine flu actions?

Keiji Fukuda is assistant director general of the WHO. (Anja Niedringhaus - AP)

Meanwhile, the Guardian discusses the Council of Europe investigation:

European health chiefs are to hold emergency talks about whether pharmaceutical giants have unduly influenced governments into squandering public money on vast stockpiles of unnecessary swine flu drugs...

The text of the resolution proposed by Wodarg (who is Chair of the Health Subcommittee of the Council of Europe) calling for an inquiry states that "in order to promote their patented drugs and vaccines against flu, pharmaceutical companies influenced scientists and official agencies responsible for public health standards to alarm governments worldwide and make them squander tight health resources for inefficient vaccine strategies, and needlessly expose millions of healthy people to the risk of an unknown amount of side-effects of insufficiently-tested vaccines."

The total bill for fighting swine flu in the UK was put at £1bn in a parliamentary question back in September. It is expected to have risen since then.

Seasonal Flu Vaccine or Else! Workers Fired/W Va Gazette

Let's draw a stupid line in the sand. Let's fire employees who refuse a seasonal flu vaccine made up of antigens for 3 strains of flu that do not happen to be circulating in the US right now, and may never circulate. Check out the CDC's graph detailing the flu strains found in the US every week, below. The seasonal flu vaccine contains antigens for the red, blue and a green strain. No one seems to be testing positive for any of them.




Why impose vaccinations? Because it is "better for patients and everyone else."

Everyone else surely includes the vaccine manufacturers, who (in citations from previous posts) are including efforts to push mandatory vaccinations in their business plans. Merck did this with its Gardasil marketing. In 2007 Texas Governor Rick Perry issued an Executive Order mandating Gardasil vaccinations for Texas' young girls. His decree was later overturned by the legislature, when it was revealed his former chief of staff was a Merck lobbyist and Merck had funded his campaign and that of other Texas legislators.

Presumably one reason to hire ex-CDC director Gerberding as president of Merck Vaccines is to marshall CDC's help expanding vaccine mandates. According to Reuters:

She [Gerberding] may be charged with reigniting flagging sales of Merck's Gardasil vaccine to prevent cervical cancer by protecting against human papillomavirus or HPV. After an encouraging launch Gardasil sales have been falling and were down 22 percent in the third quarter at $311 million.

One result of vaccine mandates will be more disabled employees. The January 10 Express (U.K.) discussed the plight of

up to 200 [disabled] frontline health workers, social workers, prison officers and binmen, who have to be vaccinated against hepatitis B as a condition of their employment.

This is to protect them from contracting potentially fatal conditions from infected blood through needle injuries or physical assaults. Although they are not legally forced to have the vaccinations, without them they are not allowed to work. [Is that an oxymoron, or what?--Nass]

Experts believe the injections caused the health problems, which include chronic fatigue, muscle pain, weakness and cognitive problems, because illnesses developed soon after vaccination.

It's never been made clear whether more people are saved from chronic illness from hepatitis B through vaccination, or whether more people are made chronically ill by the vaccinations in a country like the US, where the disease is not rampant. [Yes, I know this is a bad disease--my grandfather died from a rare case of fulminant Hep B, and I have had my shots--but I have also treated people whose health and vitality disappeared after vaccination. We need to be able to weigh risk and benefit.]

However, if you pretend almost nobody gets sick from vaccines, it appears entirely reasonable to force an increasing number of vaccinations on the public, using mandates based on school enrollment, place of employment, type of employment, place of residence... or some other arbitrary category identified as susceptible to a mandate.

It seems reasonable to force kids to be vaccinated, then to force healthcare workers, social workers, garbagemen, etc. But the ultimate goal of some public health leaders is required vaccinations for everyone, regardless of individual need and individual risk.

And because no institution performs active surveillance in a large enough population for long enough after vaccinations are given, we may never know how the net benefit and net harm of each vaccine compare.

What we do know, however, is that there appears to be a hereditary component in the risk of vaccine injuries, and some families are more prone to this problem than others. (See story on mitochondrial disorders and vaccine injury in Scientific American.) So potential harms from vaccine mandates are not shared proportionately.

Vaccines enjoy renaissance in pharma industry/ SwissInfo

I told readers in November that I would be discussing the expanding vaccine industry at more length. Fortunately, the media have obliged with excellent articles explaining the financial forces driving development of increasing types and numbers of vaccines. Articles like the one below also hint at why physicians are being pressured to vaccinate more and more people. Here are snippets from SwissInfo:

“The market has almost tripled over the last eight to ten years,” Carsten Mantel, a medical officer in the World Health Organization’s Expanded Programme on Immunisation, told swissinfo.ch... Growth is probably more than twice as fast as the therapeutic drugs market.”

“There are five players in the world, including [Switzerland’s] Novartis that have jumped on the train to make vaccines because it also fits well into modern thinking about health care reforms,” explained Zurich Cantonal Bank senior analyst Michael Nawrath.

The thinking goes that if you can prevent a disease, you are saving exponential costs such as going to a doctor or a hospital stay. Nawrath also believes that more and more doctors will be urged by health authorities to carry out vaccinations based on the cost reduction, even though prices for vaccines might be considered high at present...

Europe seeks to offload flu vaccines

From SwissInfo:

... Western European countries, including Switzerland, are queuing up to shift surplus stocks of the H1N1 flu vaccine after low public demand.

... Sales of H1N1 vaccines have been a windfall for pharmaceutical companies. GSK is expected to be the single biggest beneficiary with anticipated sales of SFr3.7 billion by the end of the first quarter of 2010, according to analysts. Sanofi and Novartis have been forecast to earn an estimated SFr1.1 billion and SFr628 million, respectively...

"Extravant Fiasco"

The French government move came after intense criticism from politicians and scientists. The French opposition Socialist Party described the national campaign as an “extravagant fiasco” and demanded a parliamentary investigation.

Elsewhere, Council of Europe member states are considering whether to launch an inquiry into pharmaceutical companies’ influence on the global swine flu campaign.

The WHO's "false pandemic" flu campaign was "one of the greatest medicine scandals of the century," said German doctor Wolfgang Wodarg, chairman of the Council of Europe Parliamentary Assembly (Pace) Health Committee, who tabled the motion to be debated on January 25.

Was Swine Flu A False Pandemic?/ Pharmalot

From the famous Pharmalot blog by Ed Silverman (formerly a reporter at the Newark Star Ledger):

That’s the contention by more than a dozen members of the Parliamentary Assembly of the Council of Europe, which reportedly plans to conduct an inquiry into the influence that drugmakers may have had on the World Health Organization, scientists and governments. A resolution was introduced last month by Wolfgang Wodarg, a member of Germany’s Social Democratic Party who chairs the PACE health committee, and it reads:

“In order to promote their patented drugs and vaccines against flu, pharmaceutical companies have influenced scientists and official agencies, responsible for public health standards, to alarm governments worldwide. They have made them squander tight health care resources for inefficient vaccine strategies and needlessly exposed millions of healthy people to the risk of unknown side-effects of insufficiently tested vaccines. The birds flu campaign (2005-06) combined with the swine flu campaign seem to have caused a great deal of damage not only to some vaccinated patients and to public health budgets, but also to the credibility and accountability of important international health agencies. The definition of an alarming pandemic must not be under the influence of drugsellers.”

Wodarg contends that WHO standards forced governments to react by signing contracts and, consequently, taking almost all responsibility thereafter. “In this way, the producers of vaccines are sure of enormous gains without having any financial risks. So they just wait until WHO says ‘pandemic’ and activate the contracts,” Wodarg, who intends to hold an emergency debate this month, tells PharmaTimes. “The victims among millions of needlessly vaccinated people must be protected by their states, and independent scientific clarification should provide evidence and transparency for national and, if necessary, European courts.”

France sells off surplus swine flu vaccine/ BBC

from the BBC:

Germany and The Netherlands announced similar sales late last year...

The government bought 94 million swine flu vaccine doses - more than one for every French person - and started vaccinating in October.

Only about five million people are recorded as having been vaccinated in France so far, AFP reports...

WHO: Acute respiratory (including swine flu) disease prevalence around the world

The map I previously posted disappeared off this website. However, WHO updates the map weekly. To see the current week's map (and you may click to compare it with previous weeks) please go to the WHO site.


African Drum Anthrax: 80 advised to take anti-anthrax medicine/ Union-Leader

According to Dan Tuohy at the Manchester, New Hampshire Union-Leader,

The state is encouraging more than 80 people to take antibiotics and anthrax vaccine after an environmental sample at the United Campus Ministry in Durham tested positive for anthrax.

The announcement today comes after a young woman remains in critical condition with gastrointestinal anthrax. She attended a drum circle at the ministry building, which the state ordered closed until further notice.

However, many questions remain about the vaccine's efficacy and safety. Whether vaccination is appropriate in the current setting is another question, since anthrax vaccine has not been FDA-approved for this purpose, and provided no additional benefit for persons who took antibiotics after anthrax exposure in 2001. When CDC offered the vaccine for post-exposure prophylaxis in 2001, it failed to make a positive recommendation for the vaccine's use, since no data supported a presumption of benefit from the vaccine then, and none support it now. In fact, the New Hampshire department of health rightly points out that, "The vaccine is not effective in prevention of the disease after someone has been exposed." Although CDC's Advisory Committee on Immunization Practices recently voted in favor of post-exposure anthrax vaccination, the recommendation is provisional and has not been approved by CDC's director or DHHS.

Weeks (or months) after an exposure, one's risk of developing anthrax drops toward zero. The likelihood of another case developing in New Hampshire is extraordinarily low.

If anthrax vaccine was perfectly safe, people who might have been exposed to anthrax would do well to use it as extra insurance against the disease. But there are troubling safety questions. The GAO (the investigative arm of Congress) reported in 2007 that, "Officials from the VHC Network and CDC estimate that between 1 and 2 percent of immunized individuals may experience severe adverse events, which could result in disability or death." I discussed this earlier here.

Below is a table from the largest trial of Biothrax anthrax vaccine conducted in humans, by CDC, published in the October 1, 2008 Journal of the American Medical Association. A total of 1564 people were entered in the study, and 1300 received anthrax vaccine. In the 1564 subjects, 229 serious adverse events occurred during the 43 month trial. A listing of all the adverse events, comparing the vaccine and placebo groups, has yet to be published--but study authors reported that the following 7 serious adverse events (including two people with new breast cancers) were possibly related to the vaccine:

Table 7. Serious Adverse Events Rated as Possibly Associated With the Study Agent (anthrax vaccine) Since Study Initiation

A Latin phrase encapsulates the anthrax vaccination issue, for those civilians in a position to choose whether to take it: Caveat Emptor (or in English, Let the Buyer Beware).

Flu Inc.: How vaccines became big business/ Globe and Mail

Paul Waldie and Grant Robertson of the Globe and Mail, Canada have published a detailed investigative piece on how vaccines have been transformed into a huge industry in the space of a few years. Thirty-two percent growth per year has followed the expanding use of yearly flu vaccines (and the expanding population groups for whom it is advised). This article is a must-read explanation of the vaccine industry and the strategies it is employing. Snippets follow:

... H5N1 (avian or bird flu virus) would alter government approaches to pandemic planning. But it would also create a new and unprecedented opportunity for the global pharmaceutical industry. It was, as Dr. Ossi recalls, “an obvious commercial opportunity” for the drug companies – one that is reshaping their businesses.

In a matter of a few years, flu shots have gone from being a marginal, money-losing business to a massive profit generator for a small number of global companies, as
governments and the public hasten to protect themselves from getting sick.
Between 2004 and 2007, vaccine sales across the industry soared an average
of 32 per cent each year, with flu vaccine leading the way. That is roughly four
times faster than any other pharmaceutical product.

This is the story of how that happened – how Flu Inc. grew out of nowhere, transforming a once struggling business characterized by lab closures and lawsuits into a high-profit industry in less than a decade, and of the steps the pharmaceutical industry has taken to ensure the dollars keep flowing.

The change is driven by a new way of thinking in government about how to approach future threats of a flu pandemic. Health officials have begun to see merit in pursuing a strategy of stockpiling vaccines, even at a much higher cost per dose than they paid in the past...

The problem with making vaccines

For years, scientists had tried to find a faster way to make vaccines. They chased a variety of theories, including isolating the DNA of a virus, which many researchers believed would unlock new ways to fight infections. But at its main vaccine facility in Rixensart, Belgium, Glaxo had found a way to make vaccines more potent using another kind of technology: adjuvants...

Adjuvants are like superchargers for vaccines. They are mild contaminants that cause the body to respond with a more intense immune response. When paired with antigens, the adjuvant liquid can make the vaccine's impact stronger. This allows for more doses to be produced from less antigen...

Adjuvants allowed companies to pump out more, but it is also a higher-margin business than antigens... “The barriers to enter the market are extremely high,” said Mr. Monteyne in Belgium. “You don't become a vaccine maker over night. That's why we have a few big players, and very few only.” That meant the giants could push hard to increase prices. And they did.

...the cost of a flu shot is flexible depending on whether the buyer can pay more. “We have a tiered pricing strategy,” Mr. Monteyne said. “It is mainly based on the level of income of the country.”

...Switzerland was the first country to jump in. In October, 2006, with fear over H5N1 at fever pitch, the Swiss signed a contract with Glaxo on a stockpiling deal that called for 8 million doses of avian flu vaccine, slightly more than one shot for every citizen. This emerging business – pre-pandemic treatment – was rounding into shape. Glaxo began trade-marking the names of vaccines along those lines, registering its vaccines as Prepandrix.

... There was just one problem: the H5N1 pandemic never happened. The virus stayed mostly with animals. The Swiss were left with one of the world's largest stockpiles of unused H5N1 flu vaccine. Glaxo's sales of avian flu vaccine fell 54 per cent in 2008, as countries realized their stockpiles weren't needed.

... Once a country bought a large supply of adjuvant, it was locked in as a buyer for Glaxo's antigen for years to come. Countries were not just vaccine buyers now; they were subscribers, coming back annually to the company for more and different types of shots... In the past 12 months, the number of countries using such stockpiling methods has grown to 60 from less than 10. (See discussion of how the UK is negotiating with GSK to cancel H1N1 shots and in exchange stockpile GSK's adjuvant, here.)

... Soaring vaccine sales are also pushing companies to chase profit in other types of shots. The race is now on to develop blockbuster vaccines, defined as those that bring in more than $1-billion annually. Two recently developed vaccines – Prevnar for pneumonia and Gardasil for cervical cancer – have become blockbusters, selling close to $2-billion a year.... It's a new marketplace.

WHO Director Chan begins instilling fear of bird flu/ BBC

From the BBC:

Dr Margaret Chan says avian flu is more of a problem than swine flu

The head of the World Health Organisation (WHO) has warned the global swine flu pandemic is not yet over and the virus could still mutate....

However she admitted she had not yet had a vaccine but said she would have it soon.

She said that although countries are now better prepared to cope with a global disease outbreak, people still had to be aware of the dangers of bird flu (H5N1).

She said this was more toxic and deadly than swine flu and that many countries remained ill-prepared for mass outbreaks of this virus.

"The world is not ready for a pandemic to be caused by H5N1," she said.

You read it here first on October 25: bird flu vaccinations may be next.

And old bird flu vaccine trial data were substituted to license European swine flu vaccines (a neat way to distribute swine flu vaccine before there is any data on it).

Might the 97 partnerships and collaborative arrangements with WHO, which supply about 80% of WHO's budget, or simply channeling money have influenced the way WHO weakened the criteria for a pandemic last spring, and/or influenced WHO's support for billions of doses of unnecessary vaccine for swine flu?

Initial data on swine flu adverse event reporting/ MMWR

Per CDC's MMWR, as of November 24, VAERS data indicated 82 adverse event reports per 1 million H1N1 vaccine doses distributed, compared with 47 reports per 1 million seasonal influenza vaccine doses distributed.

Adverse events designated serious were 50% higher (based on doses distributed, not doses used) for swine flu compared to seasonal flu. Monitoring will continue over a longer duration and for more vaccine doses. For 13 deaths reported following vaccination:

"No patterns in age, sex, or type of underlying medical condition were observed that might lead investigators to suspect a causal link with vaccination."

Is bird flu losing virulence?/ CIDRAP

Egypt's health ministry has confirmed an H5N1 avian influenza infection in a 21-year-old woman, the country's third case since late September, the World Health Organization (WHO) reported today. She received Tamiflu.

An investigation into the source of her infection revealed that the woman had close contact with dead poultry and had helped slaughter sick birds.

Egypt's latest case confirmation raises the global H5N1 tally to 447 cases, of which 263 have been fatal (a 59% fatality rate--Nass).

The country so far has recorded more H5N1 cases in 2009 than any other. Of 52 cases reported internationally, 39 were from Egypt. Of those Egyptians who were infected in 2009, only four died (a 10% fatality rate. This makes you wonder whether cases have been primarily diagnosed posthumously, and that cases who survive are being missed...after all, what country wants to advertise rising numbers of humans with avian flu, since tourism will be affected, and it doesn't help other businesses--Nass )

UPDATE: Science covered the story of asymptomatic individuals who were antibody positive for avian (bird) flu in 2005, suggesting the mortality rate could be considerably less than expected.

Novartis' MF59 swine flu vaccines "Prequalified" by WHO/Novartis press release

December 21, 2009 07:15 CET/ Novartis press release: Basel, Switzerland

All three Novartis A(H1N1) 2009 influenza vaccines prequalified (read that as untested or inadequately tested for third world distribution) by World Health Organization (WHO) for use in developing world

· First prequalification from WHO for multiple influenza A(H1N1) 2009 vaccines from a single company: Celtura^® and Focetria^®, both with the Novartis adjuvant MF59^®, as well as unadjuvanted A(H1N1) vaccine from the Fluvirin^® platform

· WHO prequalification of two MF59 adjuvanted vaccines highlights Novartis adjuvant’s antigen sparing potential as means to enhance global supply of pandemic vaccines

· More than 80 million doses of Novartis influenza A(H1N1) vaccine shipped to 21 countries around the world

Vaccine industry is being revived: New technology, greater funding and higher profits are a shot in the arm for advances/ LA Times

I will be talking more about how the H1N1 pandemic was exploited to greatly expand the use of vaccines, in the near future. This January 28, 2007 article by Daniel Costello in the LA Times provides important background on this whole issue, and begins to unravel the interconnected roles of large charitable organizations and big Pharma to make this happen.

Breakthroughs in technology, increased funding and higher profits are spurring a boom in vaccine discovery and development that could save or improve the lives of millions of people by attacking such scourges as cancer and malaria.

Three new vaccines arrived on the market in 2006, the most in a single year. They include vaccines for the human papillomavirus, linked to cervical cancer, and for rotavirus, which causes severe diarrhea and kills 600,000 children globally each year. Another prevents shingles in the elderly.

As early as the end of the decade, scientists say, there may be new immunizationsagainst herpes simplex and rheumatoid arthritis and a better seasonal influenza vaccine.

Researchers also are talking about a potential vaccine within five years to fight malaria -- long one of mankind's deadliest and most elusive adversaries.

Other scientists are making progress with what are known as therapeutic vaccines, which fight already diagnosed diseases or conditions, including cancer and Alzheimer's, or addictions to substances such as nicotine, by "teaching" the body to fight back. They're further down the road but hold the potential to transform medical care, experts say.

"It may turn out we have a perfect storm here of several different things coming together at the right time. This is a tremendous time of opportunity for both the developed and the developing world," said David Fleming, director of the Bill & Melinda Gates Foundation's global health strategies program, which has made vaccine development and access a cornerstone of its mission.

"It's clear there is a renaissance going on around vaccines," said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases. "We have made more progress with some [vaccines] in the past few years than we have in the past 30."

The current immunization boom could rival or even surpass the Golden Age of vaccine development between the late 1940s and early 1960s, experts say, when scientists such as Jonas Salk discovered inoculations for polio, flu, mumps and measles. But relatively few vaccines were found in the decades that followed, partly due to lack of profitability for drug companies and reduced vaccine research funding.

Perhaps the best evidence of a vaccine revival is that the pharmaceutical industry is returning to the market.

... Jean Stephenne, president of GlaxoSmithKline Biologicals, expects his company to have five new vaccines in the next five years and that its vaccine business will grow from 6% of the company's sales this year to 14% by 2010.

Overall, the number of vaccines in development has risen from 285 in 1996 to 450 today.

Drug executives say they can charge considerably more for today's vaccines -- up to several hundred dollars or more -- versus a few dollars for older vaccines.

... But Greene said major recent advances in vaccine technology had made finds considered unattainable a decade ago look possible. [Although the term is never used in this article, what is really meant by "recent advances" is the potential use of novel adjuvants, which have been around for awhile but never looked close to widespread usage before the carefully orchestrated pandemic response of 2009.--Nass]

Building Markets, Avoiding Liability: a 2004 Example of Pandemic-Mongering/ Science

Here is a typical piece of industry hype on the dangers of a future pandemic, the need to build a bigger industrial base for vaccine production and the need to stockpile Tamiflu. But it didn't appear in an industry publication; instead it was published in Science, the US's premier scientific journal. The title is INFLUENZA: GIRDING FOR DISASTER. Facing Down Pandemic Flu, the World's Defense are Weak, by Jocelyn Kaiser.

The article pounds the drum regarding the need to protect manufacturers from liability, repeats the "millions of deaths" mantra, and no doubt helped push along billions in funding for Tamiflu and H5N1 vaccine development and stockpiling.

Can someone please tell me how you can assure adequate safety testing when manufacturer liability is waived? Unless manufacturers have tested enough to know about their products' problems, millions of people will be at risk from using medical products rushed into use. Yet US law says that manufacturers can only be liable for damages if they know about problems and choose to ignore them. Thus manufacturers are incentivized to perform the most minimal testing allowed. Is that why millions of doses of vaccine from 2 manufacturers were recalled for potency problems in the past 2 weeks?

In 2004 10 Tamiflu pills cost $10 wholesale. The retail price in my neighborhood this year was $100. Pandemic mongering is great for business. And as the BMJ pointed out 3 weeks ago, there is no reliable evidence it works. Excerpts from this piece follow; reading it will help you understand how the response to this year's swine flu epidemic was decided years ago, and had almost nothing to do with the characteristics of this year's virus.

... If Asia's potent H5N1 bird flu assumes a form transmitted between humans, this drug, oseltamivir, would be the world's only initial defense against a pandemic that could kill millions of people. But oseltamivir, sold as Tamiflu, is made by only one company, Roche, at a single plant in Switzerland. "We are living in a brave new world where we only have one drug," says flu expert Arnold Monto of the University of Michigan, Ann Arbor, who spoke before the working group meeting of the G7+ Global Health Security Action Group.

That grim assessment is one indicator of the world's vulnerability to pandemic influenza. Most virologists say a pandemic is a virtual certainty within the next few decades, if not from H5N1 then from another avian flu strain (see p. 392). When that happens, public health officials will have two tools to battle the disease: antiviral drugs and vaccines. But although research has produced effective new antivirals, they are expensive, and global supply falls far short of need. And a promising genetically engineered vaccine against H5N1 is still an experimental product only just now being tested in people.

After years of warning from flu experts, governments are finally beginning to respond. Some countries are starting to stockpile antivirals.

... However the vaccine is made, countries would need to pass legislation to shield companies from liability should the vaccine cause serious side effects, as did the swine flu vaccine. Some believe these problems will quickly be solved if a pandemic arrives. "What happens in a crisis is, a lot of the roadblocks get moved," says virologist Maria Zambon of the U.K.'s Health Protection Agency.

In Holland, the Public Face of Flu Takes a Hit/ Science

From Martin Enserink in the Oct. 16 Science, excerpts regarding claims of financial conflict of interest and fear-mongering on the part of Holland's leading flu scientist, Albert Osterhaus:

... fellow scientists have accused Osterhaus of fear-mongering. Luc Bonneux, an epidemiologist at the Netherlands Interdisciplinary Demographic Institute, says Osterhaus is part of a "flu mafia" and that he's hyping the threats of both avian and swine flu. Miquel Ekkelenkamp, a microbiologist at University Medical Center Utrecht, called Osterhaus a "panic virologist" in a recent op-ed, adding that he "should be banned from television permanently."

... Bonneux has also taken aim at the European Scientific Working Group on Influenza (ESWI), an industry-supported group that Osterhaus has chaired since 2000. ESWI organizes meetings, promotes awareness about flu, and tries to raise vaccination levels. Bonneux says the group—which receives a 40,000 contribution from each of 10 companies annually—is little more than a lobby club that gives "trumped-up, sensational stories a scientific seal of approval."

And last July, it was pointed out that the UK's appointee (Sir Roy Anderson) to the WHO Strategic Group of Experts (that helps make decisions about the approach to pandemics) received 116,000 pounds from GlaxoSmithKline as a director last year. That is $185,000 US dollars. Glaxo sells Relenza for swine flu treatment. Sir Roy took over as Rector of Imperial College, London last year, where he earns up to £400,000 a year in additional compensation.

Officials recall more swine flu vaccine/ SF Chronicle

Millions more doses of swine flu vaccine were recalled this week after routine tests found they weren't strong enough to meet minimum public health standards for protection against the virus.

In a previous post, I cited literature that showed the nasal vaccine had been only 29% effective in adults in a previous year, even when fully 'potent.'

How Merck Created a New Disease (Osteopenia) to Sell its New Drug, FOSAMAX/ NPR

MUST_READ from NPR (thanks to Marc Crispin Miller)

... armed with the firm conviction that he was about to do good in the world, and coincidentally sell a ton of drugs for Merck, Jeremy Allen set out to completely rework the way that bone was measured in America.

Now, to do this, he figured, the first thing he needed was an institution, an entity whose mission was not to sell drugs, but to serve the public good. So he decided to create one. In 1995, Allen convinced Merck to establish a nonprofit called the Bone Measurement Institute. On its board were six of the most respected osteoporosis researchers in the country. But the institute itself had a rather slim staff: Allen, you see, was its only employee.

Mr. ALLEN: There was no payroll, there was no building, there was no office with the name Bone Measurement Institute...

... Jeremy Allen says that to encourage other companies to take seriously Merck's goal of dropping the price of measuring machines, Merck actually purchased a bone measurement business.

Mr. ALLEN: We bought one of the companies and showed how low the price could become purely to get everybody's attention. And we got everybody's attention. And subsequently, when everybody else moved, we let it go, and the company closed. And we cheered its demise...

Flu vaccines for every American, every year/ CIDRAP

From 3/2008 CIDRAP:

Until now, the Centers for Disease Control and Prevention (CDC), which is advised by the ACIP, recommended flu vaccination for children from 6 through 59 months old. The new ACIP recommendation expands the target groups to include children from ages 5 through 18 years. That adds about 30 million children to the groups targeted for flu shots, the CDC estimates.

[Dr.] Wexler [executive director of the Immunization Action Coalition, an industry-sponsored vaccine advocacy group--Nass] observed that the ACIP recommendation pushes the country closer to embracing universal flu vaccination. Previously, flu immunization recommendations covered groups constituting about 74% of the US population, she said. Now, "it's probably up to 90%, or at least up to 85%."

In light of those numbers, she said, "I think it would be better to recommend vaccination for everyone. It's much simpler. . . . It's going to save clinicians a lot of time, instead of having to wade through and figure out who's supposed to be vaccinated. It'll be much easier for [insurance] coverage to be ascertained. . . . And I think it'll reduce influenza in circulation."[Why bother making an informed vaccination risk-benefit determination for each patient when it's so much easier to ignore their underlying conditions and recommend that every American get a flu shot, every year--Nass]

See also:

Feb 27 CIDRAP News story "ACIP recommends flu shots for all school children"

Merck Hires Ex-CDC Chief Gerberding To Run Vaccines Unit/ NPR

verbatim from National Public Radio:

... [Gerberding] came to the CDC in 1998, and was credited with smoothly handling the media after the mysterious anthrax attacks that followed the World Trade Center attack.

Merck is one of the largest vaccine makers in the world; Gerberding will be overseeing a $5-billion-a-year business starting in late January...

Gerberding, a long-time advocate for vaccines, has some potholes ahead of her. Merck has caught flack for aggressively pushing its new and expensive Gardasil vaccine... Sales of the vaccine have slipped recently--falling 22 percent to $311 million during the third quarter.

Earlier this year she was attacked for encouraging people to get vaccinated against the new H1N1 virus at the same time she was a consultant for Edelman, a public relations firm with lots of Big Pharma clients, including Merck. [No wonder she ignored illegal conflicts of interest in CDC's vaccine experts--Nass] And Merck itself has come under criticism from within the public health community for pushing its expensive new HPV vaccine for children...

As head of the agency from 2002 to 2009, Gerberding oversaw a not-so-popular reorganization of CDC management, and led the agency through some high-profile crises, including SARS and several food-borne outbreaks.

And from the Atlanta Journal-Constitution on Gerberding:

Gerberding’s six years leading one of the nation’s most trusted institutions were marked by numerous controversies, from allegations that she allowed politics to interfere with science to concerns that her strategic decisions incapacitated the agency’s ability to respond in a public health crisis.

... for much of her tenure, many CDC employees lacked confidence in her vision for the agency. Just 48 percent of CDC staff said they had a high level of respect for the agency’s senior leaders, according to results released last year of a federal survey of government employees.

Last year, congressional investigators concluded the CDC failed “in almost every respect” to protect Hurricane Katrina’s victims from dangerous formaldehyde fumes in government-provided trailers. And Gerberding was accused of playing politics by refusing to reappoint the director of the agency’s worker safety division —- a man widely respected by business leaders, labor unions and lawmakers.

Gerberding drew fire from Democratic lawmakers in 2007 when she delivered testimony to Congress about the health effects of climate change that had been censored by the White House.

In 2003, Gerberding launched a massive reorganization of the CDC that many employees say plunged the nation’s 911 system for public health into turmoil and caused an exodus of key scientific staff.

In December 2005, five former CDC directors sent Gerberding a highly unusual joint letter warning that the agency was in trouble in the wake of her reorganization. They were alarmed by the departures of critical staff...

Pushing vaccines, hiding adverse effects: Flu pandemic may change US flu approach forever/ Reuters

photo of Julie Gerberding, Reuters

From Reuters' Maggie Fox, we learn that the swine flu "pandemic" has opened avenues for increasing vaccine uptake in the US... by grabbing children in schools, which might reduce the impact of seasonal influenza. (Let's experiment on tens of millions of American children to find out.)

The vaccine spin doctors know how to take every bit of news and turn it into an opportunity to increase Pharma profits. Let's spend a billion bucks and vaccinate 75 million children (yearly) to prevent 75 pediatric deaths (most of which occur in children with severe chronic illnesses)--and that is a best case scenario, occuring only if the vaccine strains are perfect matches to the flu viruses, and if efficacy is 100%.

The swine flu pandemic may have changed the U.S. approach to handling influenza forever, and for the better, U.S. officials said on Thursday.

While they said years of work were needed before vaccine production was up to the desired standard, some experiments such as vaccinating children in schools might work to help control seasonal influenza.

Yet in a 2006 New England Journal article on school-based vaccine programs, researchers found the results of the study were paradoxical: in families of children who attended schools that had vaccine programs, there were more adults and children who were hospitalized than in families of children from control schools that did not vaccinate. And vaccinated children had no fewer hospitalizations than unvaccinated children. So what do our public health policymakers suggest? Expand the experiment to all our children. Hello!?

As long as we continue to fail to perform active side effect surveillance for a meaningful duration, we'll never know how many cases of Bell's Palsy, Guillain Barre Syndrome, Crohn's Disease, Asthma, Diabetes, Lupus, Developmental Disorders, etc. are due to the vaccines. Instead, we can posit air pollution as the cause of autism (for example), as some "expert" did last week, or suggest that any other byproduct of modern society is the reason so many Americans are developing neurologic and autoimmune disorders, compared to years past.

Ever wonder why Julie Gerberding, former CDC director, moved the vaccine safety group into the Office of the Director at CDC? Could it be to maintain control over how aggressively they looked for side effects? She starts work next month as president of Merck Vaccines. A fitting reward for her success at keeeping the lid on vaccine injuries. Here's one method she used:

According to the NY Times' Gardiner Harris,

A new report finds that the Centers for Disease Control and Prevention did a poor job of screening medical experts for financial conflicts when it hired them to advise the agency on vaccine safety, officials said Thursday... the inspector general of the Department of Health and Human Services, found that the centers failed nearly every time to ensure that the experts adequately filled out forms confirming they were not being paid by companies with an interest in their decisions.

The report found that 64 percent of the advisers had potential conflicts of interest that were never identified or were left unresolved by the centers.

... little attention has been paid to the potential conflicts of advisers to the C.D.C., even though that agency’s committees have significant influence over what vaccines are sold in the United States.

Thanks, Julie. I'm sure you'll do a great job promoting school-based vaccine programs for many Merck vaccines, including blockbuster Gardasil. After all, you wouldn't want a 9 year old boy to get a case of genital warts, would you? (Yes, believe it or not, genital warts is the indication for boys aged nine and up to get this vaccine.)

More vaccine but fewer takers, H1N1 surveys indicate/ WaPo

According to David Brown, 111 million doses of swine flu vaccine have been released to the cities and states by now. CDC estimated that in the second week of December 46 million Americans had received the vaccine.

And I saw a new case of Bell's palsy this week in someone a week after receiving both seasonal and swine vaccines. Is it coincidence or causation? Likely we will never know. But there were many cases of Bell's palsy reported after anthrax vaccinations, which led me to ask about vaccinations.

Flu activity is only "widespread" in 11 states per CDC. But how widespread could it be when less than 2% of tests for flu are now coming up positive?

Doctor to sue DOH over vaccinated son’s death/Taipei Times

Does Taiwan allow law suits against the government for possible swine flu-related deaths? US law does not. Nor can you sue the manufacturer. Instead, you must apply to DHHS and only if a medical officer employed by DHHS says the vaccine caused the death can you be compensated by DHHS. About $300,000 is the maximal award for a death, with no compensation allowed to pay attorneys or experts.

This report points up the difficulty linking an injury to a vaccine. Taiwan's CDC Director-General said, "There is also no evidence at present to link the boy’s death to the vaccine.” Apparently all reported deaths were determined by the Department of Health to be unrelated to the vaccine, even though the doctor's son appeared to die from an autoimmune reaction:

After preliminary discussions, the experts concluded that the boy’s death
was unrelated to the vaccination, Kuo said, adding that an immune system problem was a possible cause of death.“The boy’s parents are welcome to request an investigation into the case to allow experts to make a more comprehensive, independent judgment,” Kuo said.

Problems and side effects that have been reported so far from the vaccine
include deaths among elderly recipients and dizziness among
students. These have dissuaded some from getting vaccinated.Health officials
said the reports of dizziness caused some parents, to withdraw their permission
for their children to receive the shots.“A total of 331 cases of side effects
from the vaccines has been reported, but all the symptoms were
temporary,” Kuo said. “These cases will not affect our vaccination
policy.”

Spain and Germany want to return excess swine flu vaccine/ Reuters

According to Reuters via the One Click Group, alternatively these countries could resell vaccine to other countries if manufacturers will not accept vaccine back.

"... The Geneva-based WHO is coordinating efforts to encourage rich countries to
share vaccines with poorer nations who had little or no access to supplies.
Fukuda said six manufacturers and 12 countries had so far pledged some 180
million doses of vaccines to be distributed to around 95 countries.
Officials at the drug companies had no immediate comments on the German and Spanish government moves."

EUROPEAN PARLIAMENT TO INVESTIGATE WHO IN JANUARY 2010

Thanks to website "The Flu Case" we have a story in English derived from reports in two German newspapers, Zeit and Tages Spiegel:

Wolfgang Wodarg , former SPD member of parliament, and chairman of the European parliament’s health committee, initiated the inquiry. The motion was passed unanimously by his colleagues in the European parliament‘s health committee.

Wodarg has criticised the measures taken against the swine flu as "one of the biggest medical scandals of the century.“

He said the influence of the the pharmaceutical industry on scientists and government officials has resulted in "millions of healthy people being exposed unnecessarily to the risks of an inadequately tested vaccine.“ That even though the swine flu virus is "much less harmful“ than last year’s seasonal flu, causing "not even a tenth of the usual deaths associated with flu.“

Wodarg has also criticised the way pharmaceutical companies have made gigantic profits at the expense of taxpayers.

He accused vaccine manufacturers of being willing even to inflict bodily harm in their pursuit of profits, noting that the adjuvants in the swine flu jab have hardly been tested. In addtion,the vaccine‘s side effects including dangerous paralysis have not been adequately recorded.

Wodarg has said that the role of the WHO and its pandemic emergency declaration in June needs to be the special focus of a European parliamentary inquiry. For the first time the criteria for a pandemic was made not the actual risk of a disease, but the number of cases of the disease.

By classifying the swine flu as pandemic, nations were compelled to implement pandemic plans and also to purchase swine flu vaccines.

Because WHO is not subject to any parliamentary control, Wodarg argued it is necessary for governments to insist on accountability.

Panflu Vaccine: Europeans Can't Be Bothered/ National Public Radio

from NPR:

... In the U.K., under two percent of the population has stepped up, and only 17 percent of those at special risk of flu complications, according to Bloomberg News...

Ah, but look at the Scandinavians. They are Europe's model citizens when it comes to doing what public health officials want. According to Andrea Gerlin of Bloomberg, Norway has managed to vaccinate all 1.2 million people in high-risk groups. At least a third of Swedes have gotten swine flu shots.

Health bosses accused of flu-mongering

From Theresa Boyle at Healthzone, Canada:

Public health officials are misleading Canadians by continuing to
characterize the H1N1 virus as a threat in the hopes of unloading millions of
doses of unused vaccine, charges Ontario's former chief medical officer of
health.

They are trying to save face because of an expensive overreaction, Dr.
Richard Schabas said Thursday as lineups for the vaccine continued to
dwindle.

He made his comments the day after the Public Health Agency of Canada
unveiled a new advertising campaign aimed at encouraging Canadians to get
vaccinated...

Is swine flu vaccine safe in pregnancy?/ FDA

According to FDA,

"while no safety concerns have been identified to date, a project will be initiated this fall to focus on the safety of the pandemic (H1N1) influenza vaccine and of antiviral medicines for pregnant women and their newborns..." [a.k.a. the 'Shoot first, answer questions later' principle--Nass] "FDA is collaborating with CDC, HHS, private partners and other government agencies to enhance adverse event safety monitoring during and after the Influenza A (H1N1) 2009 vaccination program in all populations, including pregnant women."

"Influenza vaccines, both seasonal and the recently licensed Influenza A (H1N1) 2009 monovalent vaccines, are not contraindicated for use in pregnancy. [Beware the use of a double negative--Nass] As with many other vaccine products, the manufacturers did not conduct clinical studies specifically to evaluate the influenza vaccines in pregnant women prior to approval of these vaccines."