FDA approves H1N1 vaccine applications

ATLANTA, Georgia (CNN) -- The Food and Drug Administration has approved applications from four manufacturers to make H1N1 flu vaccine, the secretary of the Department of Health and Human Services said Tuesday.

"We will have enough vaccine available for everyone," Kathleen Sebelius told the House Energy and Commerce Committee.

The plan is to begin the large-scale vaccination program in mid-October in as many as 90,000 sites, though limited amounts of the vaccine are expected to be available a week to 10 days earlier, she said.

Monday, the director of the nation's top disease agency told CNN the vaccine will be available earlier than had been expected.

"We think the first doses of some of the vaccine forms should be available in about three weeks," said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention.

Previously, the CDC had been predicting the vaccine would not be available before middle or late October.

Frieden said that the vaccines appear to confer protection from the virus eight to 10 days after they are administered.

The news about the vaccine against H1N1, also called swine flu, comes a week after researchers concluded that a single injection would suffice to protect against the virus.

Health officials are urging that pregnant women, school-age children and anyone with underlying health conditions, like diabetes, heart disease or lung disease, get the swine flu shot.  See which states are showing the greatest swine flu activity »

Frieden said it appears that health workers will be able to administer the H1N1 vaccine at the same time that they administer the shot against seasonal flu.

The symptoms of seasonal flu are similar to those of swine flu, and patients and their caregivers need not know which one they have, he said.

"The key messages are the same in either case: If you're sick, stay home," he said. "If you're severely ill -- and that means you have trouble breathing, you have severe illness, your fever comes back or you have one of those underlying conditions like diabetes or people with special health care problems, like children with disabilities, that make it difficult for them to breathe -- then see your doctor right away."

The timing is important because 11 states already are reporting widespread flu activity. "We wish we had the vaccine today," Frieden said.

He said flu vaccines have a good safety record. "Literally, hundreds of millions of people have gotten the flu vaccine, and certainly my kids will be getting the H1N1 vaccine when it becomes available for everybody."

Frieden's two children are ages 5 and 15.

http://edition.cnn.com/2009/HEALTH/09/15/h1n1.flu.vaccine/index.html

FDA NEWS RELEASE

For Immediate Release: Sept. 15, 2009

Media Inquiries: Pat El-Hinnawy, 301-796-4763, patricia.el-hinnawy@fda.hhs.gov; Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 1-888-INFO-FDA

FDA Approves Vaccines for 2009 H1N1 Influenza Virus 
Approval Provides Important Tool to Fight Pandemic

The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.

“Today's approval is good news for our nation's response to the 2009 H1N1 influenza virus,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “This vaccine will help protect individuals from serious illness and death from influenza.”

The vaccines are made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc. All four firms manufacture the H1N1 vaccines using the same processes, which have a long record of producing safe seasonal influenza vaccines.

”The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines,” said Jesse Goodman, M.D., FDA acting chief scientist.

Based on preliminary data from adults participating in multiple clinical studies, the 2009 H1N1 vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine.   

Clinical studies under way will provide additional information about the optimal dose in children. The recommendations for dosing will be updated if indicated by findings from those studies. The findings are expected in the near future.

As with the seasonal influenza vaccines, the 2009 H1N1 vaccines are being produced in formulations that contain thimerosal, a mercury-containing preservative, and in formulations that do not contain thimerosal.   

People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.

In the ongoing clinical studies, the vaccines have been well tolerated. Potential side effects of the H1N1 vaccines are expected to be similar to those of seasonal flu vaccines.

For the injected vaccine, the most common side effect is soreness at the injection site. Other side effects may include mild fever, body aches, and fatigue for a few days after the inoculation. For the nasal spray vaccine, the most common side effects include runny nose or nasal congestion for all ages, sore throats in adults, and -- in children 2 to 6 years old -- fever.

As with any medical product, unexpected or rare serious adverse events may occur. The FDA is working closely with governmental and nongovernmental organizations to enhance the capacity for adverse event monitoring, information sharing and analysis during and after the 2009 H1N1 vaccination program. In the U.S. Department of Health and Human Services, these agencies include the Centers for Disease Control and Prevention.

Vaccines against three seasonal virus strains are already available and should be used (see information on the seasonal flu). However, they do not protect against the 2009 H1N1 virus (see information on H1N1 flu).

#

Additional Information
Influenza A (H1N1) 2009 Monovalent

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182399.htm

Docs say NO to vaccine in pregnancy

Influenza Vaccination During Pregnancy:

A Critical Assessment of the Recommendations of the Advisory Committee on Immunization Practices (ACIP)

Influenza vaccination during all trimesters of pregnancy is now universally recommended in the United States. We critically reviewed the influenza vaccination policy of the CDCs Advisory Committee on Immunization Practice (ACIP) and the citations that were used to support their recommendations. The ACIPs citations and the current literature indicate that
influenza infection is rarely a threat to a normal pregnancy. There is no convincing evidence of the effectiveness of influenza vaccination during this critical period. No studies have adequately assessed the risk of influenza vaccination during pregnancy, and animal safety testing is lacking.

Thimerosal, a mercury-based preservative present in most inactivated formulations of the vaccine, has been implicated in human neurodevelopment disorders, including autism, and a
broad range of animal and experimental reproductive toxicities including teratogenicity, mutagenicity, and fetal death. Thimerosal is classified as a human teratogen.
The ACIP policy recommendation of routinely administering influenza vaccine during pregnancy is ill-advised and unsupported by current scientific literature, and it should be withdrawn.
Use of thimerosal during pregnancy should be contraindicated.

On May 28, 2004, the Advisory Committee on Immunization Practice (ACIP) of the Centers for Disease Control and Prevention (CDC) published its annual report on its current policy for prevention of influenza. The recommendation to vaccinate all pregnant women regardless of trimester was the most aggressive in a series of policy changes that began in 1995. Previously, influenza vaccine was advised only for women with preexisting medical conditions. The latest ACIP recommendation was promptly endorsed by the
American College of Obstetricians and Gynecologists (ACOG) and theAmericanAcademy of Pediatrics (AAP).

This investigation critically assesses the current ACIP recommendations, reviews the clinical research that supported them, and evaluates the risk-benefit analysis of administering
inactivated influenza vaccine during pregnancy.

http://www.jpands.org/vol11no2/ayoub.pdf

German Swine Flu Vaccine Trial Participant Coughs Up Blood

A participant in German swine flu vaccine trials has come forward with startling allegations that he experienced serious adverse side effects after taking the swine flu vaccine - including coughing up blood. The 40 year old German businessman named Axel described to a German publication exactly what happened after he was vaccinated on August 10th: "I felt totally beat. On the third day, my kidneys and head were aching and I got a fever. I then had a coughing fit - and the wash basin was suddenly red - it was blood!"

You can find the original German article containing Axel's story here (it is in German though):

http://www.merkur-online.de/nachrichten/muenchen/schweinegrippe-impfung-testpatient-packt-meta-451084.html

German medical researcher Frank von Sonnenburg, who is in charge of the swine flu vaccine trials there does not believe that Axel's account is credible. He told the German publication doing the story that Axel's symptoms could not possibly be related to the vaccine.

Axel, however, insists that what happened to him was most definitely a result of taking the vaccine: "Surely it is no coincidence that they occurred directly after the vaccination."

Considering what happened in 1976, one would think that reports such as these would give health authorities reason to do more testing at least.

But that is not going to happen. In fact, in the United States the swine flu vaccine is going to be rolled out even earlier.

U.S. Health and Human Services Secretary Kathleen Sebelius recently told ABC's George Stephanopoulos that the swine flu vaccine will be available in the United States by the first week of October, 2 weeks earlier than has been previously expected.

So instead of delaying the swine flu vaccine in order to do proper testing, U.S. authorities have decided to rush it out as fast as they can possibly get their hands on it.

Just listen to how reckless Sebelius sounds in the following quote....

"We are on track to have an ample supply rolling out by mid October, but we may have some early vaccine as early as the first full week in October. And we plan to get the vaccine rolling out the door as fast as it hits the production line."

Should Americans be thanking Sebelius and the Obama administration for rushing out the door an untested, potentially dangerous vaccine "as fast as it hits the production line"? 

How negligent can the U.S. government possibly be?

At least some health authorities are trying to warn the public about this potential disaster.  Dr. Marc Girard, a very highly respected authority on the side effects of drugs and a medical expert commissioned by French courts, has actually said on French television that the swine flu vaccine could cause as many as 60,000 deaths in France - especially among young children and pregnant women.

A YouTube video of Dr. Girard being interviewed on French television about this is below, but unless you know French you will not be able to understand it.  For those that don't speak French, the following is a translation of the most pertinent portion of his remarks:

A vaccine is being developed in conditions of amateurism such as I have never seen. Lets take the pessimistic hypothesis: one death among every 1000 patients. There are plans to vaccinate 60 million people, and you so you already have 60,000 deaths, and this time, young people, children, pregnant women.

All of this news is very, very disturbing.  A swine flu vaccine is being rushed out to the public that some health experts are warning could kill tens of thousands of people and that is causing very serious side effects in some patients during trials. 

What if 60,000 people do die from the swine flu vaccine as the French doctor is suggesting? 

Will the reckless health authorities that have rushed out this vaccine be held accountable?

If you know of any additional swine flu news that should be brought to our attention, please post a message in the comments field below.  We could be heading for a complete and total worldwide health disaster if an unsafe, untested vaccine is rushed out to millions of people around the globe.  It will be important for all of us to pay attention and to get important swine flu news items out to our family and friends as quickly as possible in the days ahead.  Their lives may depend upon it.

Doctor says FLU VACCINE will cause 60,000 deaths in France alone ( SEE INFO BOX )

http://thebirdflupandemic.com/archives/german-swine-flu-vaccine-trial-participant-coughs-up-blood


Also check this out ~

3 People In Egypt Suspected Of Being Infected With H1N1 Swine Flu And H5N1 Bird Flu

http://thebirdflupandemic.com/archives/3-people-in-egypt-suspected-of-being-infected-with-h1n1-swine-flu-and-h5n1-bird-flu

H1N1 Vaccines Safe, Immunogenic in Single Dose

By Michael Smith, North American Correspondent, MedPage Today
Published: September 10, 2009

Two investigational vaccines against the pandemic H1N1 flu appear to be safe and to yield a robust immune response with a single dose.

Those findings -- contained in two preliminary reports published online today in the New England Journal of Medicine -- are reassuring, experts said.

Among other things, vaccines that can produce an immune response with a single dose will stretch what is predicted to be a short supply of the drugs, according to Kathleen Neuzil, MD, of the University of Washington in Seattle.

Also, she wrote in an editorial accompanying the papers, immunity will appear more quickly -- soon after vaccination rather than after two doses at least three weeks apart.

The reports are "welcome and reassuring," Neuzil said, especially since a third online paper reported that few people currently have any immunity to the new H1N1 strain.

The first of the preliminary reports published today is from a continuing study in Australia, where researchers are testing an inactivated H1N1 vaccine in a cohort of 240 volunteers, randomized to get either 15 or 30 micrograms of the drug.

Three weeks after vaccination more than 90% of volunteers had a robust immune response, according to Michael Greenberg, MD, of CSL, the vaccine's manufacturer.

Volunteers -- 175 adults, ages 18 to 50 -- were randomly assigned to receive:

• Two intramuscular injections of adjuvanted vaccine containing 7.5 micrograms of hemagglutinin on day zero in each arm
• Or one injection on day zero and the other on either day seven, 14, or 21
• Or two 3.75-microgram doses of adjuvanted vaccine 21 days apart
• Or 7.5 micrograms or 15 micrograms of non-adjuvanted vaccine, again given 21 days apart

The researchers are reporting data from 100 volunteers -- those who got the 7.5-microgram dose of the adjuvanted vaccine. (The manufacturer earlier gave some details of the findings. See Novartis Says Swine Flu Vaccine Works Quickly)

In that cohort, Stephenson and colleagues found, 86% of the volunteers reported adverse reactions after one or both doses -- primarily injection site pain and muscle aches. The reactions were generally mild or moderate and resolved after 72 hours, the researchers said.

For those who got two doses, the researchers said, more than 90% achieved "seroprotection" by day 21 -- defined as an antibody titer of 1:40 or more -- regardless of the dosing schedule.

"Generally, I think the results are good news," said John Treanor, MD, a vaccine expert at the University of Rochester in Rochester, N.Y.

He noted that the vaccine recently approved in China reportedly had good results with a single dose and other studies are still under way that should have data available soon.

"The overall impression I think, is that for adults, a single dose of vaccine will be sufficient," Treanor said.

One thing to consider, he said, is that the Australian study took place during the epidemic in that country, so that prevaccination antibody levels were higher than expected.

But the level of protection the researchers found is high enough that it seems likely the conclusion will stand up, he added.

The vaccines thus far have been given to healthy adults, so immunization of other groups may produce different antibody responses.

Richard E. Besser, MD, a former CDC deputy director who is now senior health and medical editor at ABC News, was also enthusiastic -- especially about the possibility that a single dose could produce immunity.

"This is very exciting news. It has many implications. It could double the number of adults who could be vaccinated. It will greatly simplify vaccination programs by no longer needing to track people between the first and second dose. It will greatly reduce the costs of vaccination programs," Besser said.

The results of the British study are also encouraging, Treanor said, although it's still too early to say what role the oil-in-water adjuvant is playing.

John Bartlett, MD, of Johns Hopkins Medical Institution, in Baltimore, agrees that the findings are encouraging. "The good news is that it suggests a single dose may be adequate," he said.

That's important for logistical reasons, as well as to stretch an available vaccine as far as it will go, said Robert Field, JD, PhD, of Drexel University in Philadelphia.

"It is dramatically easier to administer one shot than two," he said. "With a two-dose regimen, many people will neglect to get the second shot" -- sometimes for the simple reason that they don't know where to get the second shot.

"For instance," Field said, "if someone gets the first one at a supermarket, do they have to return there, can they get it at another supermarket, can they go to their physician's office, or can they go elsewhere?"

The Australian study was supported by CSL and the Department of Health and Aging of the Australian government. All authors report being employees of CSL and several report having an equity interest in the company.

The British study was supported by University Hospitals Leicester and Novartis. Stephenson reported financial links with Novartis Vaccines, Sanofi Pasteur, Baxter Vaccines, Hoffmann–La Roche, and GlaxoSmithKline.

The CDC study was supported by the CDC. Katz reported research support from GlaxoSmithKline.

The editorial author reported no conflicts.

Seeing who paid for the trials i wouldnt be putting too much faith in them - they have all been known to falsify reports in the past :/

Possible link between El Nino & Flu Pandemics

Texas A&M researcher shows possible link between 1918 El Niño and flu pandemic

Research conducted at Texas A&M University casts doubts on the notion that El Niño has been getting stronger because of global warming and raises interesting questions about the relationship between El Niño and a severe flu pandemic 91 years ago. The findings are based on analysis of the 1918 El Niño, which the new research shows to be one of the strongest of the 20th century.

El Niño occurs when unusually warm surface waters form over vast stretches of the eastern Pacific Ocean and can affect weather systems worldwide. Using advanced computer models, Benjamin Giese, a professor of oceanography who specializes in ocean modeling, and his co-authors conducted a simulation of the global oceans for the first half of the 20th century and they find that, in contrast with prior descriptions, the 1918-19 El Niño was one of the strongest of the century.

Giese says there were few measurements of the tropical Pacific Ocean in 1918, the last year of World War I, and the few observations that are available from 1918 are mostly along the coast of South America. “But the model results show that the El Niño of 1918 was stronger in the central Pacific, with a weaker signature near the coast,” Giese explains. “Thus the limited measurements likely missed detecting the 1918 El Niño.”

Giese adds, “The most commonly used indicator of El Niño is the ocean temperature anomaly in the central Pacific Ocean. By that standard, the 1918-19 El Niño is as strong as the events in 1982-83 and 1997-98, considered to be two of the strongest events on record, causing some researchers to conclude that El Niño has been getting stronger because of global warming. Since the 1918-19 El Niño occurred before significant warming from greenhouse gasses, it makes it difficult to argue that El Niño s have been getting stronger.”

The El Niño of 1918 coincided with one of the worst droughts in India, he adds. “It is well known that there is a connection between El Niño and the failure of the Indian monsoon, just as there is a well-established connection between El Niño and Atlantic hurricane intensity,” Giese says. In addition to drought in India and Australia, 1918 was also a year in which there were few Atlantic hurricanes.


The research also raises questions about El Niño and mortality from the influenza pandemic of 1918. By mid-1918, a flu outbreak – which we now know was the H1N1 strain that is of great concern today – was sweeping the world, and the resulting fatalities were catastrophic: At least 25 million people died worldwide, with some estimates as high as 100 million deaths. India was particularly hard hit by the influenza.

“We know that there is a connection between El Niño and drought in India,” Giese notes.

“It seems probable that mortality from influenza was high in India because of famine associated with drought, so it is likely that El Niño contributed to the high mortality from influenza in India.”

The flu epidemic of 1918, commonly called the “Spanish Flu,” is believed to be the greatest medical holocaust in history. It lasted from March of 1918 to June of 1920, and about 500 million people worldwide became infected, with the disease killing between 25 million to 100 million, most of them young adults. An estimated 17 million died in India, between 500,000 to 675,000 died in the U.S. and another 400,000 died in Japan.

Could the events of 1918 be a harbinger of what might occur in 2009?

Giese says there are some interesting parallels. The winter and spring in 1918 were unusually cold throughout North America, just at the time influenza started to spread in the central U.S. That was followed by a strengthening El Niño and subsequent drought in India. As the El Niño matured in the fall of 1918, the influenza became a pandemic.

With a moderate to strong El Niño now forming in the Pacific and the H1N1 flu strain apparently making a vigorous comeback, the concerns today are obvious, Giese adds.

Giese’s work will be published in the current “Bulletin of the American Meteorological Society,” and the research project was funded by NOAA (National Oceanic and Atmospheric Administration) and the National Science Foundation.

http://www.youtube.com/watch?v=Mp1yR2NL1v4

A(H1N1) gets more virulent

HYDERABAD, September 15, 2009

The A(H1N1) virus is showing signs of getting ‘mutated’ into a more virulent form.

Clinical observation of experts in the State capital indicate that the genetic make up of A(H1N1) virus has ‘changed’ and is now more ‘potent’ after coming into contact with the local existing viral forms.

‘Second wave’

This is the ‘second wave’ of swine flu virus, coinciding with the rainy season, which is still active. There is a possibility of onset of a third and more virulent form in the upcoming winter season. The virus is getting more ‘time’ to stay in the atmosphere because of low temperatures, experts opine.

A pattern, among the swine flu fatalities in twin cities, has been detected. “Patients are dying within 24 to 48 hours after getting infected with A(H1N1). The virus is not giving any chance to the doctors to treat the patient. The virus has become virulent and that’s why we are losing patients who have good immunity,” said Gandhi Hospital Superintendent E.A. Ashok Kumar.

Between May and August, when A(H1N1) virus was imported from other countries, it did not cause severe illness to patients. “These days, the patient’s condition is deteriorating within 24 hours. There is a definite shift in the genetic make up of the virus. It might have genetically changed after coming into contact with local influenza virus,” Superintendent of Chest Hospital S.V. Prasad.

Taken from the Hindu Times

Wow!

I've been gone for almost a month.

Ironically i had the flu lol. Wasnt too bad, just a high temp for 5 days & felt nauseous - no more pain than usual.

The tiredness was the worst bit - slept for 3 days.

GP offered me tamiflu which i didnt take. Didnt take paracetamol either - just let nature take its course. Wise or unwise, who knows but i survived to tell the tale.

I did stop my methotrexate for a week though as i figured my immune system was having a hard enough time without the mtx making it worse.

Only other excuse for not posting is that i got busy getting kids back to school etc. Its like most things with me - if i dont do something for a while then i lose interest.

I've got approx 850 articles stacking up to read but there's no way i'm doing all that so i'll just scan em for anything interesting.

I work as a nurse & got word today that i have to go get fitted for a face mask next week - ugh. Plus here in N. Ireland they're planning to start vaccinations at the end of October - imagine my joy...........not.