Med Microbiol Immunol. 2009 Oct 23. [Epub ahead of print] Bhakdi S, Lackner K, Doerr HW. Institute of Medical Microbiology and Hygiene, University Medical Center, Augustusplatz, 55101, Mainz, Germany, sbhakdi@uni-mainz.de. Programs for vaccination against the new influenza A/H1N1 targeting many hundred million citizens in Europe and the USA are to be launched in the fall…

I apologize for ignoring this subject until now. Celvapan is the Baxter non-adjuvanted swine flu vaccine that is being used in many countries outside the US. It has no thimerosal. It is not grown in eggs, but instead is grown in tissue culture using Vero cells. This is a major advantage to people who have…

Here is an FDA briefing document for the Vaccines and Related Biological Products Advisory Committee meeting of July 23, 2009. It lays out the plan that has been followed since then. The plan involved very limited safety data collection before starting vaccinations, and a detailed plan for obtaining data on adverse reactions after vaccinations have…

I was asked if any other vaccines have been approved that contain ASO3. The answer is yes, and no. No licensed US vaccines have ever contained this adjuvant. I am not aware of its presence in licensed vaccines used in any other countries, prior to the H1N1 adjuvanted vaccines. However, ASO3 was approved by the…

From Jon Cohen and Martin Enserink, excerpts: For proprietary reasons, Lurie would not name the delay issues at each manufacturer, but said “one company was just really overoptimistic” in its delivery predictions to HHS. Initially, all of the makers of inactivated vaccine had trouble with the “potency assay” used to ensure that 15 micrograms of…

From Spiegel Online comes this story about how the German government and army ordered adjuvant-free vaccine for themselves, but adjuvanted Pandemrix (containing ASO3) for the rest of Germany. Excerpts follow: Damage control is the name of the game in Berlin on Monday as politicians rush to deny that they are receiving a better, safer swine…

From the Globe and Mail: Canada’s vaccine uses an adjuvant, which consists of squalene (shark liver oil), DL-alpha-tocopherol (vitamin E) and polysorbate 80 (an emulsifier also used in ice cream). An adjuvant is a chemical product that boosts the immune response. There were claims that squalene, used in the anthrax vaccine, was to blame for…

From the Globe and Mail, Canada:  Peramivir first new antiviral in years. This might be excellent:  it might be just what severely ill patients with swine flu need.  However, before using this unlicensed drug, wouldn’t you like to know what data exist on its safety and efficacy?  What do we know about iv zanamivir and…

Following issuance of a TRO last week, but possibly unrelated to it, NY State governor Patterson suspended the directive that all health care workers must receive influenza vaccinations.  The lawsuit will now be moot.

I have been waiting for cases to peak and then go away.  Maybe that is what is happening in Virginia.  It is too bad no one is collecting seroprevalence data to learn how many people have already been affected and are now immune. State health officials say that the H1N1 flu may be peaking in…

A 2200 subject trial of Chinese H1N1 vaccines (developed from the same CDC virus as vaccines developed by western manufacturers) was published in the NEJM.  Four strengths of antigen were used in 4 age groups, with and without an aluminum phosphate (not a novel) adjuvant. Of interest:  15 mcg of antigen was sufficient.  (This is…

ASO3 is the GlaxoSmithKline adjuvant being used in some swine flu vaccines. It is not being used in the United States. It does contain squalene. It is being used in Canada and Europe. The presence of novel adjuvants in swine flu vaccines has become very controversial in some countries. WHO recommended that countries use the…

Ha’aretz tells us that Israel only has adjuvanted vaccine available currently, and The Health Ministry has decided to hold off on giving the swine flu vaccine to pregnant women and chronically ill children because vaccine stocks now in Israel contain a substance whose safety and effectiveness in pregnant women has not been fully substantiated.  They…

As I’ve said previously, before the 2009 swine flu came along, public health officials knew that vaccinations sometimes led to small increases in cases of GBS.  GBS cases (above baseline incidence levels) were not limited to the 1976 swine flu vaccine, but have occurred after other vaccines, although less commonly. During the 1992-3 flu season,…

Adjuvants stimulate increased, nonspecific immunity and are included in many “killed” vaccines. Until October 16, all adjuvants in licensed vaccines in the US were aluminum salts. They are included in tetanus, Hepatitis A and B, anthrax and other killed vaccines. Thimerosal is a compound composed of 50% mercury which has been included in many killed…

Despite data showing twice the rate of miscarriages in women who received Cervarix, FDA approved this new HPV vaccine from GlaxoSmithKline for the US market: the first-ever vaccine licensed in the US with a novel adjuvant, named ASO4. According to a GSK press release, “In clinical trials, the most common side effects after vaccination with…

Children under 5 years of age are at relatively low risk from Swine Flu, while teens are at relatively greater risk.  CDC finally acknowledged this on October 17, although CDC’s data, published August 21, showed it then. What’s also surprising, Schuchat said, is that about half of the children who have died since the end…

from the NY Times: A temporary restraining order has been issued for mandatory vaccinations in New York state. In response, “the State Department of Health vowed to fight the restraining order, saying that the authorities “have clear legal authority” to require vaccinations, and noted that state courts had upheld mandatory vaccinations of health care workers…

Dr. Paul Offit, head of pediatric infectious diseases at Children’s Hospital, Philadelphia PA, and originator of a licensed Rotavirus vaccine recommended for all children, is an inveterate vaccine booster.  In his Oct 11 NYTimes Op-ed, he makes four claims about the new swine flu vaccine.  I’ll briefly comment on each. 1.  The vaccine is safe because…

From The Local, an English-language German newspaper, comes this report.  Interesting.

The presentation discussed the legal framework for scientific misconduct, other questionable practices in science that are not legally prohibited, and how such practices were employed to create a body of literature that falsely proclaims anthrax vaccine’s safety.  Also discussed was the role of anthrax vaccine in bioterrorism, its history since 1970, and the new laws…

From Reuters: A U.S. government media event to promote H1N1 school vaccinations on Friday included VIPs, cute kids and a phalanx of television cameras — but only one in five children at the school had proper parental consent to get immunized. . . But the small numbers also underscored the challenge facing the U.S. government’s…

Senator Joe McCarthy has been dead over 50 years, but the loyalty oaths that became notorious after his fall are alive and well in America today. Loyalty oaths? Perhaps you haven’t seen any.  But perhaps you’ve simply missed what was right before your eyes. There are different kinds of loyalty oaths.  Some require you to…

French physician and pharmacoepidemiologist Marc Girard has written a valuable piece on swine flu vaccines, their risk assessment and their rushed approval, contrasting this with what should ordinarily take place before a drug or vaccine enters the market.

From the Washington Post: According to the Post, 19 of the 76 deaths occurred during the past week. But according to CDC, the 19 deaths actually occurred between July 19 and October 3.  They were reported last week. So far, approximately one in a million US children have died from swine flu-associated causes.  But only…

According to the CDC, US deaths from influenza and pneumonia were significantly greater in 2008 than  they have been in 2009, despite all the hoopla about pandemic swine influenza.  Here is CDC’s own data.  CDC also tells us, on the same website, that 60 children have died from swine flu in the US in the…

My friend Mark Crispin Miller has urged me to be more specific about why I am concerned about the safety of swine flu vaccines in the US. In a nutshell: 1. Newness I am always concerned about new drugs and vaccines. A former FDA Commissioner, Dr. Jane Henney, once said she did not use drugs…

This Wall Street Journal article provides a fascinating glimpse into what I will call, for lack of a better term, scientific xenophobia.  It suggests an unwillingness to grapple with important data originating from another nation, perhaps because the data suggest US public health professionals should consider veering from the federal flu vaccine strategy being followed….

The CDC Advisory Committee on Immunization Practices posted its new but provisional recommendations for anthrax vaccine on October 5.  Post-exposure use is recommended, although this is not an approved indication per FDA.  Therefore, the ACIP recommends that anthrax vaccine be administered under an Investigational New Drug (IND) application or an Emergency Use Authorization (EUA). The…

There are only two questions you need to ask about any drug or vaccine.  Does it work?  Is it safe? Efficacy is commonly measured by a rise in antibody titer.  However, the antibody being measured has not always been a good surrogate for level of protection.  What one really needs to do is measure the…

Interesting take by the Associated Press on how Cuba plans to deal with a swine flu epidemic–sans vaccine.  Excerpts: As the U.S. prepares an extensive health survey for side affects from its massive inoculation plans, Cuba’s No. 2 health official says relying on a shot to contain a world pandemic is risky as best —…

Excerpts from the Washington Post: As the federal government launches the most ambitious inoculation campaign in U.S. history, several surveys indicate the public is decidedly ambivalent. “Safety is our top priority,” said Anne Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases. “What I want people to know is that no corners…

Who’s calling the shots? This WaPo article includes a surprisingly frank assessment of military vaccinations: …”Because I can compel people to get the shots, larger numbers will have the vaccine,” General Renuart said. “They will, as a percentage of the population, be vaccinated more rapidly than many of us. So we may see some objective…

Coverage from USA Today and CBS News.

Article by Patrick White: A “perplexing” Canadian study linking H1N1 to seasonal flu shots is throwing national influenza plans into disarray and testing public faith in the government agencies responsible for protecting the nation’s health.  Distributed for peer review last week, the study confounded infectious-disease experts in suggesting that people vaccinated against seasonal flu are…

From the LATimes: In a poll of 1,678 U.S. parents conducted by the University of Michigan’s C.S. Mott Children’s Hospital, 40% said they would get their children immunized against the H1N1 virus — even as 54% indicated they would get their kids vaccinated against regular seasonal flu.

A domino effect is cascading through the country, as officials rush to impose vaccination mandates on citizens (Massachusetts) and health care employees (New York), as well as mandate influenza (seasonal +/-swine) vaccinations in many other healthcare systems and hospitals.  Many state laws are written such that in a declared emergency, vaccination or, alternatively, quarantine are…

Important article by Gardiner Harris about the new, improving FDA: The Food and Drug Administration said Thursday that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting… The agency has never…

From Jefferson T et al. in this week’s BMJ:    The disparity in effectiveness between the high profile of influenza vaccines and antivirals and the low profile of physical interventions is striking. Public health recommendations are almost completely based on the use of vaccines and antivirals despite the lack of strong evidence.1 Vaccines work best…

by Australian Infectious Diseases professor Peter Collignon at the ANU: In 1976, a small group of soldiers at Fort Dix in the US were infected with a swine flu virus. It had an apparent high mortality rate and was deemed similar to the virus responsible for the great 1918-19 worldwide flu pandemic. The US government…

From the Sept. 21 Newsday: Dozens of Long Island nurses – many from Stony Brook University Medical Center – plan to rally with health care workers from across the state next week in Albany to protest a state regulation that mandates they be vaccinated for swine flu or lose their jobs. The New York State…

With respect to squalene-containing (a.k.a. oil-in-water emulsion) adjuvants, the September 21 New York Times’ Andrew Pollack has done some excellent reporting:  …“These are products that potentially can be given to millions of healthy people,” said Dr. Jesse Goodman, chief scientist at the Food and Drug Administration. “There is not a known, specific safety danger or…

From the NY Times: “This is just not the right flu season to take this on,” said Dr. Frieden, who previously was the New York City health commissioner.[He was responding to questions about mandatory flu vaccinations–Nass] …Over all, virologists say, of every 100 people who faithfully get flu shots, only about 70 are fully protected…

from the Canadian Press: Researchers from Melbourne, Australia tested pregnant patients with life-threatening swine flu infections for levels of antibody in different antibody subclasses.  This test is rarely done, but is used to investigate possible immune deficiencies.  Serendipitously, the researchers and treating physicians found that one class of antibody (IgG2) was low in most of…

APIC is the Association for Professionals in Infection Control and Epidemiology.  Its President and most officers are RNs, but no particular qualifications are required for membership, apart from a $175 annual fee.  An August 31, 2009 APIC announcement says, “The association’s more than 12,000 members direct infection control programs that save lives and improve the…

A notice was issued in December 2007 regarding the process for seeking compensation under the 2006 Public Readiness and Emergency Preparedness Act  (PREPA).  The DHHS Secretary Sibelius has designated the Health Resources and Services Administration (HRSA) to address adverse vaccine reactions.  HRSA created a Countermeasures Injury Compensation Program, modeled on the VICP, with the potential…

Everybody knows some things are good for health and some things are bad.  Yet one rarely learns the magnitude of the positive or negative effect, making it impossible to take the logical approach, which is to balance risks and benefits as we make all sorts of choices. For example, how much benefit will I receive…

Over and over, I have seen media reports that claim, regarding the 1976 flu vaccine and Guillain Barre Syndrome (GBS): “scientists never proved whether that link was real or coincidence”–as reported in Lauran Neergard’s Associated Press article Sept. 15 and again by her on September 27.  Or by Maggie Fox (Reuters) on Sept. 17: “Guillain-Barre…

An FDA Press Release today notes that vaccines made by MedImmune (the nasal spray attenuated live virus vaccine) and killed vaccines from CSL (Commonwealth Scientific Laboratories, Australia), Novartis and Sanofi Pasteur have been approved for use (licensed). These are the vaccines made without novel adjuvants.  Based on FDA’s statement that, “All four firms manufacture the…

The UK head of immunization, Dr. David Salisbury, wrote today to the Guardian that the decision had been taken to add adjuvants to the H1N1 vaccine, if the virus mutates.  Salisbury claims this would offer cross-protection. It might, but it might not.  Until the virus mutates you won’t know. Salisbury contends that, “the UK has…

On December 2-3, 2008, FDA with joint NIAID sponsorship held a public workshop “for academics, government researchers, government regulators, vaccine clinical trial experts and industry representatives. The purpose of this workshop is to assess the scientific knowledge base regarding vaccine adjuvants and to facilitate the development of a research agenda to improve the safety and…

With 45 million doses expected October 15, and 20 million vaccine doses available weekly thereafter, 85 million high-risk Americans will be able to receive their single needed swine flu vaccination during October.  By the end of November, another 80 million (lower risk) Americans could be vaccinated. That will probably cover everyone who wants to be…

Associated Press In accord with what we’ve learned from the mortality data, the G-7 plus Mexico group chose to omit children, but include pregnant women, in the group most at risk of death or severe illness from swine flu infection: those who should be offered vaccination first. Wedded to its earlier pronouncements, however, CDC continues…

If you convene an expert group to issue a set of recommendations, they will be issued.  What the groups’ report may omit is an explanation of the sufficiency of the data.  Nor will their report provide an idea of how statistically likely the conclusions are to be right or wrong.  Historically, the experts usually issue…

From the Associated Press: Roughly half of health workers skip the immunizations, raising two concerns: If doctors and nurses get sick, who will treat what could be millions of Americans reeling from seasonal or swine flu? And could infected health workers make things worse by spreading flu to patients? New York, the first state to…

Thanks to Merrill Goozner: FDA’s Vaccines and Related Biological Products Advisory Committee meets on Tuesday, September 9. It will consider the safety and efficacy of an HPV vaccine for girls from GlaxoSmithKline called Cervarix.  In an earlier post, I noted that the safety of Cervarix (which includes the squalene-containing adjuvant ASO4) was controversial.  No US…

Finally, a series of logical experiments were done by Drs. Nareen Abboud and Arturo Casadevall to see what small peptides might stimulate immunity to anthrax.  Two were found:  one is five and the other six amino acids long.   Each is immunogenic and protected macrophages from anthrax toxin. Their efficacy and safety in other models is…

The Lancet’s H1N1 Flu Resource Center includes this interesting article on the provenance of the swine flu virus.  CDC submitted a first set of completed coding sequences (8 gene segments) for the 2009 swine flu virus to GenBank on April 27, 2009. Drs. Hong Zhang and Ling Chen of Zunyi Medical College, China, compared the…

I think I have had influenza twice, based on my symptom pattern and the fact I was exposed to flu cases.  But every winter I care for flu patients, so I have probably been exposed to flu viruses repeatedly each season.  But I generally stay well.  Why? For each infectious disease, an “infectious dose” has…

Xinhua, September 5, 2009: Total US swine flu deaths are at 593; this is confirmed by CDC.  Total US hospitalizations are 9,079.  California has had 144 deaths. New cases at 165 US universities totalled 1,640 last week.  No college students have died. WHO reported total global deaths of 2,837. The MMWR mortality in children report…

The Atlanta Journal Constitution tells us that Atlanta’s large public hospital, Grady Memorial, is requiring that seasonal flu shots be given to all employees. “Several factors led Emory officials to make taking the seasonal flu vaccine mandatory — protecting patients and providing a safe environment for workers; the fact that the seasonal flu and swine…

The BBC reports:  The UK has lowered its worst-case scenario estimate of possible swine flu-related deaths from 65,000 to 19,000.  Seventy people have died so far in the UK, while 6,000 to 8,000 die yearly from seasonal flu.    Advisors have now agreed that the swine flu death rate is lower than previously thought, likely to…

From the LA Times blog: Since the outbreak this spring of the novel H1N1, public health officials have treated the new so-called swine flu as if it were a replay of the devastating 1918 Spanish flu, which claimed tens of millions of victims and was particularly devastating to people who were otherwise young and healthy……

From today’s Bloomberg News Kudos to Dr. Frieden, who said, perhaps in response to front page news that Novartis’ (squalene-adjuvanted) swine flu vaccine would require only one dose (after initial testing in 100 subjects): “We don’t anticipate that we’ll be using adjuvanted vaccine in most of the scenarios that we anticipate now, though that could…

It’s September.  Kids are back in school.  A federal panel predicted a worst-case scenario of 90,000 Americans dead from complications of swine flu ten days ago. CDC’s Clinician Guidance:  Identifying and Caring for Patients is still dated May 4 and fails to provide any guidance based on study of the pandemic’s characteristics. It still says,…

Spokane’s Spokesman-Review reported on a local meeting held by CDC on Aug. 29 (one of ten held throughout the US) to elicit comments on the upcoming swine flu vaccination program.   The campaign to immunize children and other vulnerable people against the fast-spreading H1N1 influenza virus should be moderate – perhaps even passive – a panel…

The French performed a meta-analysis of the effectiveness and safety of flu vaccines containing MF59 for elderly recipients. Local and systemic adverse reactions were higher with vaccines containing MF59, but mortality rates were unimproved. Here is the abstract: Prescrire Int. 2004 Dec;13(74):206-8. Influenza vaccine with squalene adjuvant: new preparation. No better than available products. [No…

One third of the Italian supply of swine flu vaccine (8 million doses) will be distributed mid November to mid-December. The other two thirds will be distributed after January 31, 2010. Italy is taking a Christmas vaccine break. They don’t feel the need to get everyone vaccinated by Halloween or Thanksgiving, thank goodness. How civilized….

Article By MARIA CHENG (AP) LONDON — About half of Hong Kong’s health workers would refuse the swine flu vaccine, new research says, a trend that experts say would likely apply worldwide. In a study that polled 2,255 Hong Kong health workers this year, researchers found even during the height of global swine flu panic…

According to the Guardian, “Several studies suggest up to 60% of GPs would oppose being immunised because they are concerned the safety trials will be rushed.. The biggest reason given by those who said they would not have it was concern that the safety trials would not be adequate: 71.3% said they were “concerned that…

The Washington Post’s Rob Stein updates us on the current thinking about availability of swine flu vaccine and its voluntary nature. He does not cover liability issues nor how care will be delivered for illnesses that attend vaccination. Excerpts: “There’s little doubt we’re going to vaccinate people,” said Anthony S. Fauci of the National Institute…

The Daily Mail reported on letters sent to 600 neurologists in the UK by its Health Protection Agency, asking them to be observant for, and immediately report, cases of Guillain-Barre Syndrome [GBS]. The letter is a tacit acknowledgment of the risk of using an untested vaccine with novel ingredients. But it also indicates that the…

Excerpts from this Aug 15, 2009 story from the AP: In Europe, Glaxo is testing vaccines with an adjuvant, a chemical compound used to stretch a vaccine’s active ingredient and boost the body’s immune response. In Canada and the United States, Glaxo is testing vaccines both with and without adjuvants. Neither country has ever licensed…

DHHS’s National Vaccine Advisory Committee (NVAC) met February 5-6, 2009. Here is a section of the NVAC minutes that dealt with the concept of vaccinating the public for a “Bird Flu” H5N1 pandemic–vaccinating before an epidemic appeared.  Remember that Bird Flu, though deadly, has not spread from one person to another, but only from a…

[You heard about the lack of crucial, clinical information here first. CDC’s skimpy information for clinicians on managing H1N1 cases is still dated May 4, 2009! I complained about this gross failure of the public health system to share information on June 22, 2009, yet the information, and the public servants who should be offering…

[After breaking client-therapist confidentiality, and filing for a “Peace Order,” with an FBI agent accompanying her to court, Ms. Duley hasn’t been seen or heard from since–Nass] http://www.fredericknewspost.com/sections/opinion/display_columnist.htm?StoryID=93767Katherine HeerbrandtA shocking mockeryAugust 12, 2009 With the anniversary of Bruce Ivins’ death and subsequent character assassination by the FBI and Department of Justice, comes “new” information supporting…

Review of prior epidemics refutes theory that virus gets more severe Fauci’s staff publish paper doubting serious epidemic to come: TUESDAY, Aug. 11 (HealthDay News) — The theory that a relatively mild outbreak of a new flu virus in the spring predicts a more severe, deadly outbreak in the fall isn’t borne out by a…

Joseph Brownstein of ABC News wrote a useful article today with plenty of content. Thanks! “Killed” vaccines contain one or more antigens (molecules that resembles part of the microbe you are protecting against), and usually also preservatives and antimicrobial products like formaldehyde and thimerosal (50% mercury). Most contain an aluminum adjuvant, which strengthens their effectiveness…but…

Per the AP: “…To increase the global supply of swine flu vaccines, WHO recommends that countries use ones containing adjuvants, a component that stretches the vaccine’s active ingredient and boosts the body’s immune response. Adjuvants are commonly used in flu vaccines in Europe, [only in those over 65, and only in some countries–Nass] but there…

Now here is a very surprising editorial from the Aug. 7 Australian. It was penned by Lawrence O. Gostin, now a visiting professor at the University of Sydney. Gostin authored the Model State Emergency Health Powers Act, on contract to CDC. Versions (or parts) of the Act have been passed so far in 38 states….

1. The US government is using laws designed for dealing with a very deadly pandemic, or bioterrorism, to bring about a mass vaccination program for swine flu, beginning with the Public Readiness and Emergency Preparedness Act 0f 2006. http://www.hhs.gov/disasters/emergency/manmadedisasters/bioterorism/medication-vaccine-qa.html 2. This law removes liability from the manufacturer, medical practitioners who use the product, and from…

The story comes from the Peoples Daily/Xinhua press release, and there does not appear to be independent reporting. The BBC has reported for two days on cases of pneumonic plague in a remote area of western China, said to be inhabited primarily by Tibetans. Although plague can be transmitted to humans via insect bites (due…

From the Aug 1, 2009 Lancet online: Last week, Australia and the USA announced that they would begin trials of an H1N1 vaccine. Vaccination against H1N1 will be an important development in controlling the impact of the pandemic. However, several thorny issues exist around vaccine manufacture and approval. All countries will require the vaccine but…

The Frederick News Post covered the first meeting of the NAS panel to validate the FBI microbial forensics work. The panel was addressed by Rep. Rush Holt and key scientist Claire Fraser-Liggett, among others. Excerpts: “If the technical and scientific procedures are as flawed as the nontechnical procedures, they certainly deserve a look,” said Rep….

Excerpts from the Editorial: The FBI’s case against Ivins is almost wholly circumstantial. It includes his strained behavior while under suspicion and surveillance by the FBI, which he was aware of before apparently committing suicide in July 2008. While the NAS study may well validate the scientific protocols used by the FBI in its investigation,…

Excerpts from article by Joby Warrick and Carrie Johnson exactly one year after the death of Bruce Ivins was made public: “Our government — and specifically, the FBI — suffers from a credibility gap on this issue,” Rep. Rush D. Holt (D-N.J.) told an expert panel that convened in Washington this week to begin reviewing…

At the 12/2008 FDA-NIH meeting on how to study novel adjuvants, Novartis scientist (Novartis owns the MF59 adjuvant) Dr. Novicki made the following statement: “Carcinogenicity–we have done no testing for the carcinogenicity of MF59 adjuvant or any of our preventive vaccines. We haven’t done it and we don’t plan to.” (See page 391.) And if…

HHS Purchases Additional H1N1 Vaccine Ingredients–July 13, 2009 (Thanks to Bloomberg News) Manufacturer Bulk Vaccine Antigen Bulk Virus Concentrate/FFF Bulk Oil and Water Adjuvant Sanofi Pasteur $61,425,000 0 0 GSK $0 0 $71,400,000 Novartis $346,334,450 0 $343,810,470 CSL $0 0 0 MedImmune $0 $61,020,000 0 TOTAL $407,759,450 $61,020,000 $415,210,470 That means the Department of Health…

The 1978 National Academy of Sciences (NAS) report on the 1976 Swine Flu Vaccination Program points out that a large number of assumptions going into the program were never acknowledged or critically examined. For example, the report lists the following assumptions that were made when the program was conceived: high-yield eggs, one dose per person,…

AP Medical Writer Mike Stobbe got a swine flu vaccine scoop–yet the news is four weeks old. It turns out that DHHS Secretary Sibelius has not only given immunity to the makers of Tamiflu and Relenza for injuries stemming from their use against swine flu. She also granted immunity to future swine flu vaccines and…

There are many federal advisory panels, often comprised of those with vested interests. This panel did as expected, calling for precipitous vaccine approval. The Wall Street Journal reports: In the U.S., a federal advisory panel said the FDA should move ahead to approve or license the new H1N1 vaccine without waiting to receive data from…

This HHS chart indicates that vaccine will be distributed in early November, after which “monitoring effectiveness and safety” begins. Here is an excellent H1N1 swine flu links page from the National Library of Medicine. This DHHS/DHS document explains the plan for priority targeting of (pandemic) influenza vaccinations. According to FDA: Through an Emergency Use Authorization…

US DHHS Orders for Bulk Supply of 2009 H1N1 Influenza Vaccine Antigens and Squalene-containing Adjuvants Manufacturer Bulk Vaccine Antigen Oil-In-Water Bulk Adjuvant Novartis $150 million $139 million GlaxoSmithKline $ 38 million $144 million Sanofi Pasteur $191 million CSL Biotherapies $180 million MedImmune $ 90 million Total $649 million $283 million

I am aware of two very useful sources of information on the 1976 swine flu vaccine fiasco. Both are available in full on-line. The first is a short article published in the Journal of the American Medical Association in 1996, written by Maurice Hilleman, PhD. Hilleman was America’s pre-eminent vaccinologist until his death 5 years…

The LA Times’ Rosie Mestel wrote about the timeline for swine flu vaccine production July 20: Five companies are at work producing the H1N1 vaccine right now. Testing is starting this month–and by month’s end, an advisory committee will meet to decide who in the U.S. is likely to be first in line for a…

Q: How virulent is this virus?A: It appears to be about as deadly as usual flu viruses–but with the major caveat that younger people are hardest hit. CDC reports 263 deaths and 40,000 confirmed cases in the US, but expects that over 1 million have been infected. The UK reported its 15th death on July…

Deaths in the under 18 age group from flu-associated illness, per CDC: The following table presents the total number of deaths in children in the United States associated with influenza infections for the past four years: Year _____ Deaths2008-9 _____ 92007-8 _____ 892006-7 _____ 772005-6 _____ 46

Useful facts regarding the standard (non-swine) flu vaccine: advice from CDC: 84% of the population is now advised annual vaccinations All children 6 months through 18 years of age are advised annual vaccinations Vaccination is recommended for “All persons who want to reduce the risk of becoming ill with influenza or of transmitting it to…

While CDC has not committed to a strategy beyond Tamiflu (to which some viral strains in Hong Kong have resistance), Australia faces a major H1N1 outbreak, as the southern hemisphere winter just began. But mathematical modelling suggests the US has already experienced 1 million H1N1 cases. On May 17, Australia moved to a new national…

The US government has contracted with at least 5 pharmaceutical manufacturers to develop and produce H1N1 vaccines, using a variety of platforms and manufacturing methods. This is an excellent approach, since at this point no one knows which will succeed and how long it will take to obtain desired quantities of vaccine. A novel feature…