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  • Swine flu vaccines, adjuvants, equity, safety

    Swine flu vaccines, adjuvants, equity, safety




    When it comes to US swine flu vaccine policy, I'm not calling the shots, but if I were I'd do it differently than the current plan, which calls for a vaccine containing only viral antigen and no immunity boosting adjuvant. I opt for a vaccine with an adjuvant, probably the one that has been used for years in Europe, MF59. If I were to make a decision like that, I could well be making a mistake, because no one really can know at this point what is going to happen or not happen. We can only go on the best data we have coupled with some principles of what's right. On that basis and using my own fallible judgment I'd move as fast as I could to develop, distribute and deliver a swine flu vaccine that contained an immununity-boosting adjuvant.


    Europe's adjuvanted flu vaccines don't appear to be any less safe than non-adjuvanted ones and are far more effective and efficient in the use of the scarce active ingredient, the viral antigen. It is availability of viral antigen that is limiting vaccine production. Unadjuvanted vaccines require much more viral antigen than those with adjuvants. We have written about adjuvants many time here (e.g., here), and recently Vincent Racaniello over at Virology Blog had a great post on the likely requirement for an adjuvant in any swine flu vaccine that could be given with only one dose. Obviously anything that will make more protection available to more people is a good thing, but like everything in public health, there is a balance to be struck and no sure way in knowing how to strike it.


    One balance is between the potential added risk of a vaccine with an adjuvant versus one without it. The risks are on both sides. Any vaccine carries a risk but a call to slow down approval until the safety of the vaccine and/or adjuvant is assured misunderstands the problem and carries the risk of killing people who might have gotten the vaccine earlier or in a more effective form. Let's briefly discuss the safety issue (we've done it before, so this isn't new). The problem with any vaccine, adjuvanted or not, is that it will be given to hundreds of millions of people. Any clinical trial would involve at most a few thousand. If some very rare adverse event occurred in one in every 100,000 people from the vaccine, then there would be 500 such events if 50 million people were vaccinated (roughly the number vaccinated in 1976 against swine flu). No clinical trial could pick up an event that rare. It would be invisible.


    The difference is that in 1976 the virus never infected anyone outside of the soldiers at Fort Dix (see our post here). But the current virus has gone pandemic. If it infects (conservatively) 30% of the population of the US and the vaccine is 70% effective, we would prevent 10.5 million people from being infected (that's the 1/6 we reach with vaccine -- 50 million out of 300 million -- 15 million [30%] of whom will be infected, of which 70%, or 10.5 million will be protected). If this is like seasonal flu, where the estimated CFR is 0.1%, we have 500 rare adverse events (some, but not all of which might be fatal) versus an estimated 10,500 flu fatalities and many more severely ill in the ICU. If the CFR is anywhere higher than 0.1%, the imbalance gets much worse. If we vaccinate many more than 50 million things tip in favor of the vaccine even more. But of course we don't know the attack rate, the vaccine efficacy, the CFR or the rate of rare adverse events (1 in 100,000 is actually pretty high). But almost any way I figure it, vaccination comes out ahead and there is no way to estimate the rate of a rare adverse event prior to using the vaccine. That's true for every drug or over the counter consumer product. It's why we need good post market surveillance. But saying we're going to wait to find out isn't an option. It's not feasible and it means no vaccine if we require it.


    Another balancing problem. The regulatory approval process for an adjuvanted vaccine will take somewhat longer. The delay will mean that people who might have gotten vaccinated with an unadjuvanted earlier approved vaccine will be saved. This may or may not be true (Canadian authorities deny it). But the more important question has to do with global supply. If the rich countries like the US won't use adjuvanted vaccine, they will use up twice as much or more of the scarce viral antigen, meaning that much less for the rest of the world, including the world's poorest countries. Helen Branswell has a typically thorough article on the debate:
    Individuals and organizations concerned about global equity are urging countries with vaccine contracts to stretch supplies by using boosting compounds called adjuvants so developing countries can also get some serum. [snip]
    The WHO had asked countries with first access to pandemic shots to employ vaccine sparing approaches, such as the use of adjuvants, so that there will be more to go around. Without frugal use in wealthy countries, the vast majority of nations will have limited access, at best, to vaccine against the novel H1N1 virus.
    [snip]
    U.S. authorities have made it clear they will only use adjuvanted vaccine if their supplies won't meet American needs. They will not use the boosting compounds to stretch supplies for the developing world.
    That position has also drawn fire, including by the head of the Gates Foundation's global health program.
    In a commentary published in the New England Journal of Medicine, Dr. Tachi Yamada said it would be inexcusable for people in poorer countries to die because richer countries use up most of the limited vaccine supplies. And he specifically pointed to the reluctance to use adjuvanted vaccines, currently licensed in parts of Europe but not in North America.
    "Under a global health crisis where millions could die we have to really think hard whether we play by the rules we establish for normal times, or we think much more aggressively and take greater risks," he said in an interview last month. (Helen Branswell, Canadian Press)
    There are a lot of other balance issues here, including one raised by WHO's vaccine chief Dr. Marie-Paule Kieny. If the swine flu virus drifts genetically, those getting an adjuvanted vaccine may be at an advantage.


    The bottom lines for me as a public health professional and as an advisor to friends and family is this. For reasons of global equity and plausible public health advantage, the US should move expeditiously to an adjuvanted vaccine, probably with something like the MF59 adjuvant that has been used for a dozen years in Europe without apparent mishap. I will myself get both seasonal flu vaccine, and when my turn in the queue comes, the swine flu vaccine (containing an adjuvant, I hope, which would be especially helpful to people my age). I will urge every member of my family from my youngest grandchildren to my aged mother-in-law to do the same, and to add pneumococcal vaccine to the mix if they haven't already done so. I will urge this on anyone and everyone who asks or is within hearing to do the same. But . . .


    I am not in favor of forcing people to be vaccinated. If too many people decline this could result in a public health tragedy, the loss of life or productivity that could have been saved. If enough people are vaccinated to produce sufficient herd immunity to dampen an epidemic, those who aren't vaccinated will have been free-riders, but that's the way it is sometimes. Some will decline out of fear, some will decline out of selfishness, some will decline out of ignorance, too many will be denied by lack of access. And some will, like me, make a decision based on their own informed and considered judgment and come up with a different answer.
    Good luck to all of us.

  • #2
    Re: Swine flu vaccines, adjuvants, equity, safety

    i am sure i will take it, but from what i am hearing at work, if the manufacturers are getting a free pass from lawsuits that will make anyone think twice about taking it. They think, what do they know that we don't?
    They do a disservice to people with that -people will not trust and then many won't take it. Bites them in the foot.

    Comment


    • #3
      Re: Swine flu vaccines, adjuvants, equity, safety

      As a discussive article, I feel it is not inappropriate to include a 'discussive' type response to this essay here - F1 please feel free to move if you feel this would be better placed elsewhere.

      The issues with adjuvants are many and complex (having studied this question in quite a lot of depth.) One point to be aware of, is that safety testing involves comparison of use of influenza vaccine with adjuvant directly compared with use of unadjuvanted vaccines. There is not direct testing of the effects of adjuvant, adjuvant plus vaccine and vaccine only vs. placebo in three seperate arms that would allow a throough and proper comparison to be made.

      Additionally, there is a propensity in medical trials to exclude certain population groups in which there are concerns there may be ADR's. An example is the recent Novartis adjuvanted vaccine, in which individuals with an adverse event were excluded from receiving a second jab. If the ADR was deemed to be so mild as to be inconsequential, why exlude this group from the second arm. Will medics involved in practical execution of any mass vaccination campaign using a 2 jab protocol know to watch for this and prevent these individuals from getting a second jab? I doubt it, and if this is the case, what will the consequences be? If individuals with asthma and other underlying health conditions are specifically excluded, how do we know if the effects of the vaccine will be postivie or harmful, when these are the priority groups that need protection?

      Also,the vast majority of the data generated in studies that use adjuvanted vaccines involves people over 65 which is quite understandible, as in seasonal years this is the priority age group for protection. Immune senescence in the elderly is well recognised, and response to vaccines can be poor. In this age group, whose immune response is quite often less than optimal, adjuvanted vaccines have proven to be sufficiently safe for widespread use, IMHO, without equivocation.

      However, the level and degree of testing in younger adults has been less thorough, and less trouble free. Adjuvants also work differently with different viruses, and so data from adjuvant use with one virus cannot be simply applied to its use with an influenza virus. Much testing cited has relates to adjuvant use with other viruses.

      Simply put, science does not know the effects of adjuvants in children and young adults whose immune systems are fully functional and operating at peak levels, or in the case of children, still developing.

      There may also be subsets of population who are more at risk of auto-immune disease, and for whom use of adjuvant would be less advisable. Examples would be children with diseases routed in immune system dysfunctions e.g. asthma, psoriasis and so forthe. The simple fact is - we dont know. The testing has not been done. There is not a widespread history of use in these age groups and persons with such medical conditions- and until such testing is done, there can be no clear answer on this.

      So - in my humble opinion, there would be little risk of going full speed ahead with use of adjuvanted vaccines in older individuals, and quite possibly this could be extended to adults between the ages of say 40 - 65 in whom there is no history, familial or otherwise, of diseases related to immune system disorders... at least UNTIL sufficient safety testing has been done to ensure that there are not important groups whom should be excluded from receipt of an adjuvant, including children and young adults and those with underlying medical conditions. These individuals could receive non-adjuvant vaccine whilst the answers are being determined.

      Most of all, the precautionary prinicple must apply to children and young adults, especially when ADR consequences can be lifelong and severe.

      In the vaccine debate over adjuvants it seems to be an 'all or nothing' response. Why? I, for one, cannot understand why a proportionate use selected by age group cannot go ahead now, with reservations for children and young adults until we have definite answers from proper clincial trial work.

      The virus is likely to change before this pandemic is over. We may need to repeat the vaccinations we are planning now to counter a mutated or changed virus, that could well be more severe. We need these answers to make proper plans for the future - and if necessary select popualtion groups for whom adjuvanted vaccines may be inadvisable, leaving adjuvant vaccines available for the vast majority and freeing up resources for more peoples of the world - safely.

      Comment


      • #4
        Re: Swine flu vaccines, adjuvants, equity, safety

        I Have to Land Here,

        I read Reveres post this morning, honestly I believe any honest person could not bluntly say that we can Trust the producers of vaccines, they have cheated over and over on clinical datas, they have made (presumably made mistakes that could have killed billions Baxter) and we all know that all these are just the tip of the Iceberg.

        What will happened is that vulnerable people will be the guinea pigs, in rich and poor countries.

        Some in desesperation might opt for the vaccine and I understand that and probably in the majority of cases it should be fine.

        But for all of those who knows how to avert or treat an infection and taking into considerations their environment (arsenic, nitrites, etc..) the climate, the social mood and their access to alternatives options should back off and wait until spring if possible.

        But it is an individual choice, but people should be aware of what big pharma have done at the expenses of poor people and the absence of ethics guiding those entreprises.

        Finally not being allowed to sue big pharma looks like govs have been blackmail either we have a waiver or you're gonna wait.

        To be coherent vaccination should be consider as an essential service and should be control and produced by the government not by the second most paying multinational in the world after the arms dealers of course.

        Snowy Owl

        Gov get into nuclear reactors to check if everything is ok why dont they do the same thing with big pharma?

        Comment


        • #5
          Re: Swine flu vaccines, adjuvants, equity, safety

          My comments are just that - my opinions and thoughts on the subject.

          As someone with underlying health conditions who falls into one of the groups being given priority (under 64 with health problems), I haven't made a firm decision yet, but I doubt that I will have the H1N1 vaccination.

          I'm in that priority group because I was harmed by a seasonal vax in 2006. I doubt that there was anything wrong with the vaccine as supplied by the manufacturers, but it was probably not handled properly somewhere on it's path. 2006 was the only time we chose to take advantage of free drive-thru flu shots provided by our local health department and it's the only time in many years of being vaccinated, that either of us has had an adverse reaction. We both became ill within hours of receiving the jab and I developed pneumonia. The damage continued because of an incompetent physician who first provided an antibiotic that was not supposed to be used, but he hadn't read the alert. Then when my condition was worsened by the antibiotic, he refused to prescribe a different one or run any definitive tests to identify the type of pneumonia.

          Compost happens and we know going into this thing that everyone involved in the creation, production and distribution of the vaccine is provided immunity in the event problems develop.

          I'm a bit gun shy after my bad experience with a seasonal vax and a bad doctor.
          I still get seasonal flu jabs, but only use the visiting nurse service or get the shot in my doctors office (different doc, of course).

          On top of my concern over the true safety of the vaccine, whether or not it contains adjuvants, I'm not entirely sure how much protection it would provide.
          My husband and I have both been sick multiple times this summer and know many others who seem to be experiencing the same thing.
          While none of us has been tested or confirmed to have H1N1, given the symptoms, it's the most likely scenario.
          If we continue to contract it, over and over again, after having had it - how much more protection would an iffy vaccine provide?
          "There's a chance peace will come in your life - please buy one" - Melanie Safka
          "The greatest way to live with honor in this world is to be what we pretend to be" - Socrates

          Comment


          • #6
            Re: Swine flu vaccines, adjuvants, equity, safety

            Thank you everyone. Please voice your opinions. This is not a news thread. I expect a vigorous debate about the novel H1N1 09 vaccine.

            For the record - FluTrackers is 100% against forced vaccination.

            We think that being vaccinated is a personal decision.

            We advocate school closures, N95 masks for health care workers, and 90 days of essential supplies per living unit.

            Comment


            • #7
              Re: Swine flu vaccines, adjuvants, equity, safety

              Glaxo has a cervical cancer vax, Cervarix, that is anticipated to be approved by the FDA in a week or two. It contains AS04 so this will help alieviate safety concerns over the adjuvant and pave the way for its approval in other drugs according to Financial Times.

              Cervarix is approved in nearly 100 countries and has been tested here on over 18,000 women.
              --------------------------------------------

              US regulators have downplayed safety concerns over GlaxoSmithKline’s vaccine against cervical cancer in a decision that will have repercussions for many other vaccines, including those to protect against the pandemic flu virus.

              Documents made public ahead of an advisory committee of the Food & Drug Administration on Wednesday downplay previous concerns over Cervarix, paving the way for the likely approval of the first vaccine in the US in 80 years to contain a patented “adjuvant” to enhance efficacy.

              http://www.ft.com/cms/s/0/dd7c9258-9...44feabdc0.html
              The salvage of human life ought to be placed above barter and exchange ~ Louis Harris, 1918

              Comment


              • #8
                Re: Swine flu vaccines, adjuvants, equity, safety

                WHO Position

                WHO supports fair access to influenza A (H1N1) vaccine. An interview with Marie-Paule Kieny

                <table class="bgbx"><tbody><tr><td class="bx7">
                <table width="144" align="left" border="0" cellpadding="0" cellspacing="0"> <tbody><tr> <td class="ileft">
                WHO/L Solberg
                Dr Marie-Paule Kieny
                </td> </tr> </tbody></table> Dr Marie-Paule Kieny is director of the Initiative for Vaccine Research at the World Health Organization (WHO). She received a degree in Economics in 1977, followed by a PhD in microbiology in 1980, both from the University of Montpellier in France. Her research career began with the development of a recombinant rabies vaccine. Since then, she has worked on the design of AIDS vaccine candidates and done research on cancer immuno-gene therapy, targeting mainly breast and cervical cancers. She has also served on several expert committees on vaccine discovery, AIDS and cancer research.


                </td> </tr></tbody></table> The vast majority of cases of pandemic influenza A (H1N1) have been mild so far with few deaths. It remains to be seen whether the virus will mutate into a more virulent strain. Marie-Paule Kieny explains how WHO is supporting countries’ efforts to protect their populations with vaccines that should become available as of this month.



                Q: When will the first doses of vaccine for the pandemic influenza A (H1N1) be ready?

                A: Some manufacturers announced in July that vaccine is available, but that doesn’t mean it’s ready for use, as it needs regulatory approval. Regulatory authorities are considering the best way to register these vaccines as quickly as possible. The consensus is that the first doses will be available to governments for use in September.


                Q: Who will get vaccinated first? Who decides this?

                A: Vaccine will not be available on the private market and governments will decide who gets vaccinated first. WHO recommends that health workers be the first, to protect the health system and allow them to care for influenza and other patients. The strategy a country takes will depend on its policy objectives and the availability of vaccine.



                For example, if a country decides to concentrate on protecting essential infrastructure, it may target different people, such as truck drivers, if they are critical for food delivery. Others may try to reduce transmission of the virus. For example, the United States of America decided to immunize children before or at school entry who are in closer physical contact than adults and can amplify infection rates. Countries may also try to reduce morbidity and mortality and target specific groups, such as pregnant women. Some high-income countries have ordered enough vaccine for the whole population. Nevertheless, no countries will have vaccine for everyone from the first day it is available for use, so that each country will need to prioritize. Some middle-income countries have also placed contracts with pharmaceutical companies and have been purchasing vaccine for between 1% and 10–20% of the population.



                WHO is working hard with manufacturers, governments and donors to ensure that developing countries can access vaccine as soon as possible to immunize their health workers, and when more vaccine becomes available, other groups will be immunized.


                Q: How are influenza vaccines produced?

                A: The main method is by injecting seed virus into embryonic chicken eggs and harvesting the fluid after several days and purifying it. There are two technologies. More than 90% of influenza vaccines available are known as “inactivated vaccines”, which means you kill the virus to produce the vaccine. Less common are “live attenuated vaccines”, which are derived from a weakened form of the virus that is not killed.


                Q: How many different vaccine candidates will be available for A (H1N1)?

                A: About 30. Most will be inactivated virus vaccines made in eggs, some will be killed virus vaccines made in cell cultures and a few will be live attenuated virus vaccines. Then you have a lot of variation in the way vaccine is purified and in whether or not it is mixed with an additive, called an adjuvant, which is a booster of immunogenicity (which is the capacity of a vaccine to evoke an immune response) and which is used with killed virus vaccine. All vaccines create antibodies to fight the virus; some will produce a local response, such as attenuated vaccine administered in the nose to give more immunity at the port of entry of the virus. The industry will use tiered pricing, so high-income countries might pay between US$ 10–20 per dose, middle-income countries may pay about half that and low-income half that price again.



                These are ballpark figures but this is the order of magnitude.


                Q: Isn’t it too early to produce vaccines because the pandemic virus could mutate?

                A: Although the virus can mutate, we hope that there will be enough cross-protection through recognition of the new virus. But if the virus changes too much, we will need new vaccines.


                Q: WHO has recommended the use of adjuvant in pandemic vaccines, but some countries don’t plan to follow this guidance.

                A: Many countries, including the USA, have not licensed vaccines with adjuvants of any kind yet. Other vaccines with the same type of adjuvant as planned for pandemic influenza A (H1N1) vaccines have, however, been licensed in European countries. Countries that intend to use vaccine with adjuvant will find that there is a large body of safety data for adults and some for children. In any case, all countries will need to carry out good post-marketing surveillance to make sure that they pick up any early sign of a safety problem with a particular vaccine.


                Q: These must be the fastest vaccines ever produced. Given their fast-tracking, what is the guarantee of safety and efficacy?

                A: The testing of influenza vaccines is different from that of other vaccines, because the rabies and measles vaccines for example do not change. Since influenza viruses evolve constantly, it is impossible to carry out a complete clinical analysis of seasonal influenza vaccines yearly because the composition changes each year to adapt to the virus and so you are always a year behind. A complete clinical evaluation is not needed also because manufacturers produce seasonal influenza vaccines using the same procedure and equipment, but for a different virus each year. In the USA, vaccines for seasonal influenza are licensed without clinical trials on the basis of a “strain change”.



                The US regulatory authorities consider the change from seasonal to pandemic H1N1 influenza vaccine production (using the same procedure) as a change in the strain and therefore will not request clinical trials before registration. Having said that, all manufacturers will perform clinical trials to find out whether one or two doses are necessary, to test it in special populations and to administer it jointly with other vaccines. In Europe, a strain change is accompanied by a small clinical trial requested by the European Medicines Agency.



                In the last couple of years, manufacturers in the European Union registered “mock-up” or prototype H5N1 bird flu vaccines as nobody knows which H5N1 strain might become a pandemic strain. Manufacturers made clinical batches of an H5N1 vaccine with virus stocks from China, Indonesia and Viet Nam. They carried out clinical trials and submitted the results to the regulatory authorities who said the vaccines were fine. They are not allowed to sell H5N1 vaccines, since there is no H5N1 pandemic, but they can use the same procedure to make H1N1 pandemic vaccine. That way they can get a licence in a few days. This is another way vaccines can be licensed without clinical trials, while still ensuring safety on the basis of what is known about influenza vaccines.



                Based on the extensive knowledge available on seasonal vaccines and the results obtained through evaluation of H5N1 avian influenza vaccines, there is no doubt that it will be possible to make effective H1N1 pandemic vaccines.


                Q: What’s been done to ensure that developing countries get enough vaccine?

                A: It depends on what we mean by “enough”. Some countries want to vaccinate every member of the population, but there is no way we can do this for the whole world. WHO has a cross-organizational operation that is in place to secure vaccines for developing countries. This is spearheaded by the Director-General’s Office and the legal and vaccine departments. We are engaged in three types of activities.



                The first is to negotiate donations with manufacturers. Two have been announced: 100 million doses by sanofi-aventis and 50 million doses from GlaxoSmithKline. Second, we are working with other manufacturers to reserve a portion of their vaccine production for WHO at a reduced price. Third, we are working with governments to raise funds to purchase vaccines. We are also working with 11 vaccine manufacturers based in developing countries, providing them with seed financing and technical expertise to help them produce influenza vaccine domestically. We have also helped them access technology and given them sub-licences to use technology for producing live attenuated vaccine. These 11 companies will be manufacturing some of the 30 different expected vaccines.


                Q: What happens if developing countries have only partial coverage?

                A: Coverage will be partial and not only in developing countries. But we should not be “hypnotized” by vaccines. There are other measures, such as social distancing, school closure, avoidance of large gatherings, antibiotics and personal hygiene. This is not like rabies, which is 100% fatal: we are talking about a disease from which most people recover very well.



                We will try to help countries to gain access to as much vaccine as possible, at least to preserve their health systems functioning, but there is just not enough vaccine for every country in the world to vaccinate every member of the population twice. ■


                http://www.who.int/bulletin/volumes/.../en/index.html

                Comment


                • #9
                  Re: Swine flu vaccines, adjuvants, equity, safety

                  Glaxo's anti-HPV vaccine, Cervarix, uses AS04 as its adjuvant. I don't believe this contains squalene. For its upcoming pandemic H1N1 vaccine, Glaxo will be using its novel squalene-based adjuvant, AS03. Unlike Novartis' squalene-based MF59, AS03 is relatively new and has not been used as extensively. Call me stupid, but I think here in the UK i would rather go for Baxter's unadjuvanted H1N1 vaccine. (Although I am intrigued about protection from antigenic-drift offered by adjuvants.)

                  There is still a lot of claim and counter-claim on the web regarding squalene and gulf war syndrome. I would be interested in anyone's views.

                  hermit

                  Comment


                  • #10
                    Re: Swine flu vaccines, adjuvants, equity, safety

                    Without proper, well constructed trials, there will be no answers. Gulf war syndrome is likely to be multifactorial but I am not persuaded that squalene had no role to play. If you dont look you don't find, in this case I think.

                    Until there is robust safety data I too would elect to go for the Baxter vaccine - but as stated for certain population groups (age 65+), I expect the risks are low and that vaccines with such adjuvants have thier place and thier benefits. On the basis of the risk - benefit equation, I would not advocate that mychildren had it though unitl there is evidence to show that it is safe, with THIS virus. if we were facing an H5N1 pandemic my answer might well be different, as the risk - benefit equation would be wholly different.

                    Comment


                    • #11
                      Re: Swine flu vaccines, adjuvants, equity, safety

                      I concur with your conclusions Vibrant62. Its one thing to take a (all be it small) risk with one's own health, but I would not be prepared to have my 3 year-old's long term health put at risk by a novel adjuvant. I am not one of the many anti-vaccine reactionaries that inhabit flublogia, my child has had the full UK infant vaccination program (a not inconsiderable number of jabs) and seems to be totally fine and in rude health. However, this is a fastracked vaccine developed for a catastrophic scenario being applied to a relatively mild virus. Its a dream opportunity for the pharmaceutical companies to mass trial their novel agents with little risk of litigation. It makes me uneasy. If this was H5N1 it would be a different risk/benefit analysis. But injecting relatively untested agents into the immune system of a child; not happening.

                      The same applies to the Gardasil vs Cervarix decision when that eventually arises.

                      On a different point I am concerned at the disparity between the vaccine priority groups advocated in the UK compared to elsewhere. Healthy children are not a priority here, unlike the US. My child has started preschool, and I know that in the absence of vaccination she will get flu, its just a matter of time. It is a worry .

                      Comment


                      • #12
                        Re: Swine flu vaccines, adjuvants, equity, safety

                        July 21, 2009

                        Regulators face tough flu-jab choices
                        Rich countries' pandemic strategies may cause vaccine shortages elsewhere.

                        by Declan D Butler
                        Nature News

                        ...The United States' global responsibility to consider dose-sparing strategies is briefly alluded to in the minutes of a mid-June US National Bio*defense Science Board meeting, released on 17 July: "Federal decision-making will affect not only the 300 million Americans who depend on the government to support the public health system but also people all around the world."

                        The United States has certainly kept open the option of using adjuvants. It has already allocated almost US$2 billion for antigen and adjuvant to provide every American with up to two doses of vaccine. That sum includes orders of $483 million for Novartis's MF59 adjuvant, and $215 million for GlaxoSmithKline's AS03 adjuvant. ......

                        http://www.bioedonline.org/news/news.cfm?art=5474

                        Comment


                        • #13
                          Re: Swine flu vaccines, adjuvants, equity, safety

                          Dificult evaluation.

                          I think many have in family, or knows persons who are flu susceptible and at the same time have many chronic illness at once.

                          Some heart patients are on risk of severe illness and death from sesonal flu also, and thus they must vaccinate themself.
                          Similar need have the lung/.../ or dialised patients.

                          It was reported by news text about people having lung, renal or heart conditions, constricted on vents or even died because of this pandemic.

                          The above facts can't be ignored, and because of vaccine lack, and vaccine under-production of the corporations which don't enlarge the production lines in time, now the adjuvant options entered.

                          The same moment when unisonic - the WHO, and all of the countries, by rejecting previous suggestions of posponing the schools/Univers. openings, or made strict closures at the first several infected scholars (leaved the decisions to indiv. countries).

                          By doing so, they push faster us all into the vaccination/adjuvant or non/ decision, for the risk groups especialy, but other more sane also.


                          One thing seems to me that screaming at the world level -
                          the inability of the world scientific community, and the vertic suggestion health body (WHO), to made a clear scientific singular statement about:
                          WHY it was possible to regulatory allow the usage of one adjuvant (MF59) in one part of the world (EU/...), and at the same time scientificaly discarded it in other world countries (USA/...), all based on scientific results?

                          The result can be only one everywhere, if it is scientific proven.

                          Science is so proud of it's repetitivity when make sci. claims, and decisions to follow.

                          So, if it is scientificaly proved good for EU/... regulation processes to allow the use of MF59 - the only stated long used before, than it must be the same scientificaly good for all (US/...world) regulators, or it must be no good for both.

                          If the WHO, or an scientific vertics world body of scientists, now evaluate that MF59 is safe to be used (even in some groups only), than it must be good and safe used in all humankind countries worldwide.
                          If it is proved that it is not good, than it must be banned everywhere.

                          But there will be no half measures scientists decisions - they must decide - not leave it on us, and tolerate changes of laws which could allow harmfull things on the field.

                          Several other questions:

                          #12:
                          "Regulators face tough flu-jab choices
                          Rich countries' pandemic strategies may cause vaccine shortages elsewhere."

                          #11:
                          "However, this is a fastracked vaccine developed for a catastrophic scenario being applied to a relatively mild virus. Its a dream opportunity for the pharmaceutical companies to mass trial their novel agents with little risk of litigation. It makes me uneasy. If this was H5N1 it would be a different risk/benefit analysis. But injecting relatively untested agents into the immune system of a child; not happening."

                          #10:
                          "Until there is robust safety data I too would elect to go for the Baxter vaccine - but as stated for certain population groups (age 65+), I expect the risks are low and that vaccines with such adjuvants have thier place and thier benefits. On the basis of the risk - benefit equation, I would not advocate"

                          #9:
                          "Unlike Novartis' squalene-based MF59, AS03 is relatively new and has not been used as extensively. Call me stupid, but I think here in the UK i would rather go for Baxter's unadjuvanted H1N1 vaccine. (Although I am intrigued about protection from antigenic-drift offered by adjuvants.)

                          There is still a lot of claim and counter-claim on the web regarding squalene and gulf war syndrome. I would be interested in anyone's views."
                          An recent FT posted study (excerpted) claim that by standard guideliness proper procedures used and conducted to asses such claim, such squalene link with gw syndrome is not established.

                          It's the researchers/WHO part, to dismiss or not, such claims which now could represent a reason to not be inoculated if demonstrated, or the oposite.

                          #8:
                          "...
                          WHO recommends that health workers be the first, to protect the health system and allow them to care for influenza and other patients. The strategy a country takes will depend on its policy objectives and the availability of vaccine.
                          ...
                          Q: WHO has recommended the use of adjuvant in pandemic vaccines, but some countries don’t plan to follow this guidance.

                          A: Many countries, including the USA, have not licensed vaccines with adjuvants of any kind yet. Other vaccines with the same type of adjuvant as planned for pandemic influenza A (H1N1) vaccines have, however, been licensed in European countries. Countries that intend to use vaccine with adjuvant will find that there is a large body of safety data for adults and some for children. In any case, all countries will need to carry out good post-marketing surveillance to make sure that they pick up any early sign of a safety problem with a particular vaccine.
                          ...A complete clinical evaluation is not needed also because manufacturers produce seasonal influenza vaccines using the same procedure and equipment, but for a different virus each year. In the USA, vaccines for seasonal influenza are licensed without clinical trials on the basis of a “strain change”.
                          ...
                          In Europe, a strain change is accompanied by a small clinical trial requested by the European Medicines Agency.
                          ... they can use the same procedure to make H1N1 pandemic vaccine. That way they can get a licence in a few days. This is another way vaccines can be licensed without clinical trials, while still ensuring safety on the basis of what is known about influenza vaccines.
                          ...
                          There are other measures, such as social distancing, school closure, avoidance of large gatherings, antibiotics and personal hygiene.
                          ...
                          there is just not enough vaccine for every country in the world to vaccinate every member of the population twice."
                          Than - WHO must not suggest schools openings, free gatherings and free traveling in hotzones, but the oposite: closures, and restrictions.

                          Because of free roaming advisories now the question circled about not enaugh vaccines, and not in time, or adjuvants needed, instead to have additional several months to augment the vaccines quantities.


                          #6:
                          Please voice your opinions.


                          #5:
                          "I'm a bit gun shy after my bad experience with a seasonal vax and a bad doctor.
                          I still get seasonal flu jabs, but only use the visiting nurse service or get the shot in my doctors office (different doc, of course).

                          On top of my concern over the true safety of the vaccine, whether or not it contains adjuvants, I'm not entirely sure how much protection it would provide.
                          My husband and I have both been sick multiple times this summer and know many others who seem to be experiencing the same thing.
                          While none of us has been tested or confirmed to have H1N1, given the symptoms, it's the most likely scenario.

                          If we continue to contract it, over and over again, after having had it - how much more protection would an iffy vaccine provide?"
                          The vaccine administration must not be leaved to not trained staff.

                          Bulk doses delivered vaccines could make more problems of adverse effects if remained open more time than several minutes, so make one-dose-ready vaccines. Don't spare on others neck - introduce an individualy payed 1additional ticket if it is necessary to pay more.

                          If it will be repetitive, we will have big problems, but at least we will try to shield us.

                          #4:
                          "But for all of those who knows how to avert or treat an infection and taking into considerations their environment (arsenic, nitrites, etc..) the climate, the social mood and their access to alternatives options should back off and wait until spring if possible.
                          ...
                          Gov get into nuclear reactors to check if everything is ok why dont they do the same thing with big pharma? "
                          Unfortunately, it seems that to avert enaugh the pandemic, because of so much toxicals and other diferences, it could be also a risk to not be (safely) vaccinated, for many patients with various joined illness present.

                          About the checkings, it is realy a failure if the gov. safety check hand can't check any item which will affect the taxpayer population in any way, especialy if claimed as an shielding safe vaccine.
                          The insertion of production corp. shielding must not negate the gov evaluation, or produced more harming products without other safe shielding options on the field for the endangered population.

                          #3:
                          "why a proportionate use selected by age group cannot go ahead now, with reservations for children and young adults until we have definite answers from proper clincial trial work.

                          The virus is likely to change before this pandemic is over. We may need to repeat the vaccinations we are planning now to counter a mutated or changed virus, that could well be more severe. We need these answers to make proper plans for the future - and if necessary select population groups for whom adjuvanted vaccines may be inadvisable, leaving adjuvant vaccines available for the vast majority and freeing up resources for more peoples of the world - safely."
                          Good possibility, but the researchers must fast exit the diatribes and made an joint statement about, especialy the WHO which "suggestions" must became exact guideliness.

                          #1:
                          "There are a lot of other balance issues here, including one raised by WHO's vaccine chief Dr. Marie-Paule Kieny. If the swine flu virus drifts genetically, those getting an adjuvanted vaccine may be at an advantage."
                          WHO, knowing the above drifted virus adjuvant protection, must assure a fast global world scientific singular only answer about adjuvant MF59 at least, or even others adjuvant safety for people usage.

                          #1, Link1:
                          link2:
                          http://www.virology.ws/2009/09/01/ad...-h1n1-vaccine/

                          "I know that many readers are concerned about the possible side effects of adjuvants. MF59 has been used for 12 years in seasonal influenza vaccines in Europe and is considered a safe adjuvant. However, the Centers for Disease Control and Prevention believes that the 2009 H1N1 vaccine will likely not be used with adjuvant.

                          Dormitzer, PR, Rappuoli, R, Casini, F, Wack, A et al (2009). Adjuvant is necessary for a robust immune response to a single dose of H1N1 pandemic flu vaccine in mice PLoS Currents: Influenza"
                          It must be conducted one scientifical global world result, and fast evaluated the problem of the several years used MF59 - safe, or not,
                          or at least (as above suggested by a poster) safe for which groups of people.

                          Comment


                          • #14
                            Re: Swine flu vaccines, adjuvants, equity, safety

                            Canada to buy unadjuvanted vaccine for pregnant women, health officer says
                            By Helen Branswell Medical Reporter (CP) –


                            TORONTO — Canada will purchase supplies of unadjuvanted swine flu vaccine to offer to pregnant women who might otherwise choose not to be vaccinated, the country's chief public health officer has revealed.

                            Dr. David Butler-Jones told The Canadian Press that Canada will buy 1.2 million doses of unadjuvanted pandemic vaccine which will be reserved for pregnant women, who are at significantly greater risk of becoming severely ill and dying if they contract the virus.
                            "I'm anticipating for pregnant women we will have an option," he said in an interview.

                            The vaccine will be supplied by GlaxoSmithKline, Canada's pandemic vaccine manufacturer, and is expected to be available at the same time as the country's other supplies of vaccine.

                            Adjuvants are compounds that boost the immune system's response to vaccine, allowing smaller doses to be used per person. Canada is buying adjuvanted pandemic vaccine partly in response to a call from the World Health Organization for affluent countries to use "antigen (vaccine) sparing" techniques so that limited global supplies can be stretched as far as possible.

                            While some European countries have used adjuvanted flu vaccines for a number of years, none of the currently licensed flu vaccines in Canada contains an adjuvant.

                            And there are no data on the use of adjuvanted flu vaccine in pregnant women - a fact that may add to the already high degree of reluctance many pregnant women feel about taking any medication or therapy.

                            "What is absolutely clear is that there is much more of a safety data base in pregnant woman with non-adjuvanted vaccine," said Dr. Marie-Paule Kieny, head of the WHO's vaccine research initiative, the division overseeing pandemic vaccine issues.
                            "Does it mean that it (adjuvanted vaccine) will be unsafe? No. It means that there is no hard evidence that it will be (safe)."


                            The lack of evidence led a panel of experts that advises the WHO on vaccine issues to recommend unadjuvanted vaccine be offered to pregnant women if that option is available.

                            Comment


                            • #15
                              Re: Swine flu vaccines, adjuvants, equity, safety

                              When my now-10 year old was 7 weeks old, the pediatrician called me and told me that she was seeing many cases of rotavirus in her patients and recommended that I give my son the rotavirus vaccine. Although he and my other children had always been given every vaccine that was recommended, I had a "funny feeling" about this one (mother's instinct). I placed a call to the CDC to see if there had been any harmful reactions to the vaccine in newborns and spoke to a doctor who was very reassuring and told me I had nothing to fear. My child had the vaccine, and as a result was hospitalized with bloody, awful diarrhea that was attributed to the vaccine. He recovered, thank God, but several months later the vaccine was pulled because of the many adverse reactions, including death, in young children. This vaccine obviously was not tested well enough, or IMHO, children wouldn't have died.

                              Now, again, I'm being told a vaccine is "safe" although it clearly is being rushed through testing, and the drug compainies are told they will not be held liable if anything goes wrong. (So where is the motivation to test well? If they test *too* well, they might discover something bad, so better not to do that, right?)

                              As much as this flu scares me, I would in no way feel comfortable allowing my children to be guinea pigs with this vaccine. I wish we had PROOF of the safety of the vaccine, but that won't happen, or the drug companies would not have been given immunity.

                              Just my 2 cents!

                              Comment

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