Behind the Unproven H1N1 Flu Vaccine, from TIME.com
By Alice Park / ATLANTA Wednesday, Aug. 26, 2009
Public health officials have been warning for some time that nothing about the flu is predictable. But here's something that is: When it comes to a new strain of the flu like H1N1, which has already stoked global fears of a massive pandemic, there's almost certain to be some overreaction. That's what happened this week when the public was hit with a double-play of scary news: A new estimate showed that that up to 90,000 Americans could die of H1N1 in the upcoming season; and a simultaneous report that the government was taking some unprecedented steps to get a vaccine ready in time. But the fatality numbers are more complicated — and less alarming — than they seem; and the vaccine report is less a reason for alarm than a sign of smart epidemiological planning.
What sparked the reports about insufficient testing of the new vaccine was a statement by Dr. Thomas Frieden, director of the Centers for Disease Control, confirming that the government has given flu vaccine manufacturers a green light to begin bottling up still-experimental shots and readying them for shipment, even before the final results from the ongoing tests on the vaccine's safety and effectiveness are completed.(Read: "Study: H1N1 Vaccine Works On Animals.")
It's an unusual step, but one that was also recommended by the President's Council of Advisers on Science and Technology (PCAST) in a report released the same day. By initiating the so-called "fill and finish" step of vaccine production, manufacturers can be prepared to ship vials as quickly as possible in mid-October, once testing confirms that the shots are safe and effective at producing immunity against H1N1. "The recommendation was to proceed with filling and finishing even before dosage information is available," said Frieden. "That step has been taken."
That doesn't mean, however, that anyone will get an unproven vaccine. The vials will stay right where they are until the testing is completed--and for now, those trials are going well. Secretary of Health and Human Services Kathleen Sebelius, also speaking at the workshop, noted that "So far there are no red flags. I think we are on target for mid-October to have the vaccine coming off the production lines."
The reason for the wait is biological. The first volunteers to test the new vaccine were inoculated in August, and because most people will not have any existing immunity to H1N1, it will require two shots, spaced three weeks apart, to educate the immune system to recognize H1N1, and another six to eight weeks after that to generate true immunity to the virus. That's when scientists will know if the vaccine provided enough protection to allow the bottled inoculations to be shipped. After decades of making flu vaccines, the scientists are sure they know what they're doing. Indeed, had the pandemic begun earlier, in December or even January—when the World Health Organization made its determination of which flu strains to include in the routine seasonal flu vaccine—instead of April, then H1N1 might have simply been included as part of the 2009 shots. (Read "Inside The Fight Against A Flu Pandemic.")
Still, the decision to approve the fill and finish steps underscores how unusual H1N1 is, and highlights the fact that the upcoming flu season may yet hold surprises. In its report, PCAST also released projections of how severe the pandemic could get: up to 120 million people coughing, sneezing, feverish and otherwise sick with the symptoms of flu, 90,000 people potentially dead from the illness, and half to 100% of beds in intensive care units of hospitals in hard-hit regions filled with flu patients.
But even those alarming numbers require some perspective. The figures, says PCAST member Dr. Harold Varmus, president of Memorial Sloan Kettering Cancer Center in New York and former director of the National Institutes of Health, were generated using data from previous flu pandemics--from 1918, 1957 and 1968--along with the latest data from last spring's outbreaks of H1N1 around the world. Those stats, say officials at the Centers for Disease Control, were then run through models used in the government's 2005 pandemic preparedness efforts that began in the wake of bird flu cases of H5N1 that arose in Asia. (See "Mapping Swine Flu.")
That's a lot of moving statistical parts, and when it comes to an ongoing pandemic such as the current one with H1N1, it's especially difficult to get reliable data on how many people are infected, how effectively the virus is moving from person to person, and how much disease it can cause. Death rates from H1N1 are particularly challenging, since making reliable projections requires comparing the total number of people infected with H1N1, as confirmed by a lab test, to those who have died from the disease. At the moment, officials don't know how many people have actually been infected with the virus; they can only count people who are sick enough to see a doctor or come to a hospital. For every person who shows up in a hospital, however, there are likely hundreds or thousands more infected with H1N1 who never see a health care professional, because they don't get very ill. That means there's a lot of educated guesswork at play. (See "H1N1: How The Virus Works.")
By no measure, however, were the new numbers reassuring—and that was the point. While the report's authors, which include some of the country's sharpest minds from science, medicine and engineering, stress that the forecast is not predictive of what could actually occur in coming months, it was intended to remind everyone how devastating a flu pandemic can be.
"There are some people taking the figures too literally," says Varmus. "But it's a wake-up call. The public wants to be aware that while these numbers are not predictive, they are certainly well within the realm of possibility."
Such predictions are also a way for public health officials to get a handle on how infectious a new influenza like H1N1 might be, how it spreads, and how quickly. That helps them know how much vaccine might be needed, how to distribute it, and when to expect a surge in demand for flu treatments, including antiviral drugs such as Tamiflu and Relenza. It can also help predict when hospitals might become overwhelmed by flu cases, and prepare them to patch up already strained health care resources.
"We can't yet predict what proportion of the population will be infected," says Varmus. "But it is very likely that something upward of 50% will be affected. All of us have a responsibility to blunt the epidemic by decreasing the spread of virus. If people understand that they can mitigate the epidemic by washing their hands and staying home when they are sick, it means the peak of disease will occur later, when there is more vaccine available." That could also help to keep the impact of H1N1—on the health care system, on families and on the economy in the form of fewer sick days—to a minimum.
What's the Danger of Swine Flu Vaccinations?
by Dr. Anders Bruun Laursen
Global Research, August 20, 2009
There seems to be quite a lot of uncertainty about the technical nature of Swine Flu (H1N1) vaccines.
As a medical doctor, I wish to clarify a number of improtant issues: First, we should talk about vaccines instead of vaccine, since the vaccines vary as for their compositions and even their ways of being dispensed: some by injection, another by the nose.
I think the fears as for the vaccines can be referred to:
1. the adjuvants – in particular squalene which was in all probability responsible for the Gulf War syndrome,
2. the virus antigen´s condition (dead, attenuated, live)
3. a deeply rooted mistrust in our politicians and the vaccine producers´ motives and morals: e.g. Baxter´s live bird flu virus last Winter (12), the Bayer AIDS haemophiliac product scandal (15).
First it is necessary to understand, that pandemic vaccines are made according to two procedures:
1. The Developement of a totally new vaccine from scratch. This takes more time, administration and testing than mock up vaccines (see below).
2. A Mock-up vaccine is a vaccine with all the adjuvants of the pandemic vaccine – but without the killed or attenuated pandemic virus. (1) This virus is – until the pandemic virus is known – a different, attenuated known potentially pandemic virus, in the case of the Pandemrix vaccine for the EU it is an attenuated H5N1 bird flu virus. This is the mock-up vaccine. When the nature of the pandemic swine flu virus (H1N1) is known, it replaces the H5N1 virus in an attenuated form, the adjuvants being left unchanged.
Until now mock-up vaccine test-vaccinations have been going on on voluntary ”human guinea pigs.” Since most of the contents of the vaccine has already been approved, the approval of the pandemic vaccine is easier to implement.
After the exchange of virus in the vaccine, the company will have to apply for a ”variation”. However, this is just a matter of form, since such a variation approval is given by the EU within 5 days – which means that there is no objective testing of the vaccine requiring official approval. The safety is entirely left to the vaccine producer, who has been granted immunity to actions of damages due to expected side effects (2).
So, as you see, there is no confusion with regard to swine flu and bird flu viruses. But there is another important consideration: the role of squalene.
The average quantity of squalene injected into the US soldiers abroad and at home in the anthrax vaccine during and after the Gulf War was 34.2 micrograms per billion micrograms of water. According to one study, this was the cause othe Gulf War syndrom in 25% of 697.000 US personnel at home and abroad. (3). You can find this table of FDA analyses from the Gulf War lots on The Military Vaccine Resource Directory website (4)
a.. AVA 020 - 11 ppb squalene (parts per billion)
> b.. AVA 030 - 10 ppb squalene
> c.. AVA 038 - 27 ppb squalene
> d.. AVA 043 - 40 ppb squalene
> e.. AVA 047 - 83 ppb squalene
These values were confirmed by Prof. R. F. Garry (5) before the House of Representatives. Prof Garry was the man to discover the connection between the Gulf War syndrome and squalene.
According to his findings, the Gulf War syndrome was caused by squalene, which was banned by a Federal Court Judge in 2004 from the Pentagon´s use. (6)
As seen on p. 6 of this EMEA document (7), the Pandremix vaccine contains 10,68 mg of squalene per 0,5 ml. This corresponds to 2.136.0000 microgrammes pr. billion microgrammes of water, i.e. one million times more squalene per dose than in (4). There is any reason to believe that this will make people sick to a much higher extent than in 1990/91. This appears murderous to me.
I have contacted the Danish National Health Service: They are to decree mass vaccinations in Denmark - and yet they knew nothing about the composition of the Pandremix vaccine.
Then I addressed the Danish Medicinal Agency. They admitted that the Pandremix vaccine from GlaxoSmithKline does contain squalene and thimerosal. They have not rejected my remark that the squalene concentration is dangerous. In contrast, the AstraZeneca MedImmune nasal vaccination (8) avoids squalene side effects.
So far the use of squalene has been banned by the FDA in the US according to Der Spiegel (9). However, this may not last long (10).
"Clearly bypassing the FDA requirements for safety testing of these new adjuvants and the vaccines which contain them puts the entire population at risk for serious, possibly life threatening side effects, particularly any of the 12,000 paid trial participants (6,000 children) who are unfortunate enough to be randomized into the adjuvant containing groups.”
Still, on July 23, 2009, the FDA announced, “Currently, no U.S. licensed vaccine contains the adjuvants MF-59 or ASO3 (squalene). It is expected that a novel influenza A (H1N1) vaccine manufactured using the same process as U.S. licensed seasonal inactivated influenza vaccine but administered with MF-59 or ASO3 will be authorized for emergency use only.”
Furthermore, “Two of the manufacturers (Novartis and GSK) have proprietary oil-in-water adjuvants (MF-59 and ASO3, respectively) which have been evaluated in a number of clinical studies including studies with influenza vaccines. These manufacturers will include an evaluation of the utility of the adjuvant for dose sparing and higher effect in their clinical studies.“
"The same document indicates that vaccines containing the un-approved adjuvants will be given to 100 children 6 months to 3 years old, 100 children 3 years old to 8 years, 100 individuals 18 to 64 years old and 100 individuals 65 and older in each of the multiple clinical trials. In addition, 700 individuals in each trial will be given non-adjuvanted vaccine".
Now for the immunological side effects of squalene to occur takes months to years – and cannot be evaluated after up to 6 weeks of observation. Der Spiegel (9) calls the mass vaccinations on Europeans a gigantic cost free experiment to provide the FDA with mass vaccination experience to clear the track for sale in the US.
EMEA admits that side effects can only be found through extensive vaccination campaigns! (1).
Here is what EMEA (4) has to say about risks of GSK Pandemrix:
EMEAs Pandemrix is commonly or very commonly associated with a range of local and systemic adverse reactions but these are not often of severe intensity and the safety profile would not preclude the use of the vaccine in healthy adults aged 18-60 years or > 60 years.
However, there are some adverse reactions known to be very rarely associated with influenza vaccines and it is currently not possible to predict if higher rates might be observed with Pandemrix compared with, for example, seasonal influenza vaccines.
Dr Keiji Fukuda, the WHO's flu chief, today warned about the potential dangers of the untested vaccine (11): "There are certain areas where you simply do not try to make any economies. One of the things which cannot be compromised is the safety of vaccines."
Which is exactly what is going on!
What I do not know is, if they are going to leave the attenuated (or live - Baxter (12)) bird flu vaccine - or to totally replace it by the H1N1 virus.
Other severe, but rare side effects are autism in children due to thimerosal (13) and the Guillan-Barré syndrome seen with 400-500 Americans after the 1976 unnecessary mass vaccinations against swine flu (14) – videos. As for additional severe side effects of squalene – see Stephen Lendman (15).
My advice: If you are forced to be vaccinated against the harmless swine flu (H1N1) – demand a vaccination with the AstraZeneca nasal vaccine MedImmune (8)– thereby avoiding squalene side effects.
(2) Global Research 20 July
(3 Wikipedia http://en.wikipedia.org/wiki/Gulf_War_syndrome
(4) The Military Vaccine Resource Directory
(5) Statement for Hearing Record, The House Subcommittee on National Security, Veterans Affairs, and International Relations
(6) Wikipedia http://en.wikipedia.org/wiki/Gulf_War_syndrome
(7) EMEA http://www.emea.europa.eu/humandocs/PDFs/EPAR/pandemrix/H-83...
(8) Reuters http://www.reuters.com/article/rbssHealthcareNews/idUSL11997...
(9) Der Spiegel http://www.spiegel.de/international/germany/0,1518,640853-2,...
(10) Your Spine http://www.yourspine.com/Chiropractic/Swine+Flu+Squalene+Adj...
(11) The London Evening Standard
(12) The Toronto Sun http://www.torontosun.com/news/canada/2009/02/27/8560781.htm...
(13) Global Research 23 July, 2009 http://www.globalresearch.ca/index.php?context=va&aid=14510
(14) Video 1 http://www.youtube.com/watch?v=IFcnneAqnTM
Video 2 http://www.youtube.com/watch?v=-9Bvf9AaC-4
(15) Youtube http://www.youtube.com/watch?v=wg-52mHIjhs
(13) Global Research 23 July 2009 http://www.globalresearch.ca/index.php?context=va&aid=14510
(14) 1. video http://www.youtube.com/watch?v=IFcnneAqnTM 2. video http://www.youtube.com/watch?v=-9Bvf9AaC-4
(15) Stephen Lendman, Global Research, 10 June, 2009 http://www.globalresearch.ca/index.php?context=va&aid=13925
Surveys can be seen here http://euro-med.dk/?p=9152 and here http://euro-med.dk/?p=9895
Link between swine flu jab and deadly syndrome will be probed, from Telegraph.co.uk
Neurologists have been ordered to monitor whether new swine flu vaccinations could trigger a deadly nerve disease.
By Laura Donnelly, Health Correspondent
Published: 8:15AM BST 16 Aug 2009
The Health Protection Agency (HPA) has asked doctors to check for increases in a brain disorder called Guillain-Barré syndrome (GBS) once the national vaccination programme begins. Its letter refers to the use of a swine flu vaccine in the United States in 1976, when 25 people died from GBS, while just one died from swine flu.
The syndrome, which can be fatal, attacks the lining of the nerves, causing paralysis and inability to breathe. Concerns have already been raised that the new vaccine has not been sufficiently tested and that the effects, especially on children, are unknown.
The jabs being developed by pharmaceutical companies and will be given to about 13 million people during the first wave of the programme, expected to start in October.
Priority will be given to everyone aged six months to 65 with an underlying health problem, pregnant women and health professionals.
In a letter sent by the HPA on July 29, neurologists have been asked to monitor closely any cases of GBS as the vaccine is rolled out.
It alerts them to the use of a swine flu vaccine in the US in 1976, which was followed by more than 500 cases of GBS, including 25 deaths. The US programme was stopped after 10 weeks because of concerns over its safety, and the Government paid out millions of dollars in compensation to those affected.
The swine flu virus in the new vaccine is a different strain from the 1976 virus, but the possibility of an increased incidence of GBS remains a concern.
According to the Mail on Sunday, two letters were posted together to neurologists advising them of the concerns. The first, dated July 29, was written by Professor Elizabeth Miller, head of the HPA's Immunisation Department.
It says: "The vaccines used to combat an expected swine influenza pandemic in 1976 were shown to be associated with GBS and were withdrawn from use. GBS has been identified as a condition needing enhanced surveillance when the swine flu vaccines are rolled out. Reporting every case of GBS irrespective of vaccination or disease history is essential for conducting robust epidemiological analyses capable of identifying whether there is an increased risk of GBS in defined time periods after vaccination, or after influenza itself, compared with the background risk."
A second letter from the Association of British Neurologists is written by Dr Rustam Al-Shahi Salman, chairman of its surveillance unit (BNSU), and Professor Patrick Chinnery, chairman of its clinical research committee.
It says: "Traditionally, the BNSU has monitored rare diseases for long periods of time. However, the swine influenza (H1N1) pandemic has overtaken us and we need every member's involvement with a new BNSU survey of Guillain-Barré syndrome that will start on August 1 and run for approximately nine months. Following the 1976 programme of vaccination against swine influenza in the US, a retrospective study found a possible eight-fold increase in the incidence of GBS. Active prospective ascertainment of every case of GBS in the UK is required. Please tell BNSU about every case."
Last night, the HPA insisted that it did not expect to find links between the new vaccine and GBS, and said it wanted to monitor any connection between the flu virus itself and the syndrome.
Professor Miller at the HPA said: "This monitoring system activates pandemic plans that have been in place for a number of years. We'll be able to get information on whether a patient has had a prior influenza illness and will look at whether influenza itself is linked to GBS. We are not expecting a link to the vaccine but a link to disease, which would make having the vaccine even more important."
The UK's medicines watchdog, the Medicines and Healthcare Products Regulatory Agency, is already monitoring reported side effects from Tamiflu and Relenza and it is set to extend that surveillance to the vaccine.
A Department of Health spokesman said: "The European Medicines Agency has strict processes in place for licensing pandemic vaccines.
"In preparing for a pandemic, appropriate trials to assess safety and the immune responses have been carried out on vaccines very similar to the swine flu vaccine. The vaccines have been shown to have a good safety profile. It is extremely irresponsible to suggest that the UK would use a vaccine without careful consideration of safety issues. The UK has one of the most successful immunisation programmes in the world."