Merck’s Julie Gerberding, Former CDC Director, on the Future of Vaccines

6/24/11Follow @xconomy

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manufacturing we do, the more we cover our fixed costs, and the less expensive on a per-dose basis our vaccines will become. So the more global our outlook, and the more we reach people in the developing world that are the hardest to reach, the more value we bring.

X: What are the biggest challenges in this job? I heard you talk on the panel about so many different priorities people have. There is getting vaccines we already have to people who need them, developing novel ones, optimizing existing ones, stockpiling for pandemics. What are your top priorities, and lower priorities?

JG: Our top vaccine priority is to get vaccines to the people who need them most. We are really working hard on access and coverage and completion. We have some products where we can give the first dose, but we need to make sure people get all the doses they need so they are completely covered. We have some challenges in opening markets in new environments, and really reaching the people there. And we have challenges in financing, in things like GAVI (Global Alliance for Vaccines and Immunizations) mechanisms, getting them to work in a reliable, long-term way. One of the things I think all the manufacturers face, whether they are in an emerging market environment or a multinational company, is that we need stability of forecasting. We can’t live in a situation where we might be able to provide 60 million doses to GAVI this year, but next year, they might not have money. We need stable, long-term commitments so we can do our own production forecasting, and achieve those cost savings that will allow us to be able to offer vaccines at the access price. That seems like an easy thing to do. GAVI is talking about five years of funding, but one of the things people don’t understand about vaccine manufacturing is that they have a much longer runway than pills. Our planning horizon is 10 years, not five years. We’ve got to know what we are doing 10 years from now, because if we have to scale up our production capability or change something, it takes that long to commission a vaccine production facility, or de-commission one and change it to do something else.

X: Do you see a real advantage here, though, with vaccines in terms of not having the patent cliff issue like you see with drugs? Because these products aren’t as easy to cheaply copy like conventional small-molecule pills.

JG: Sure. The business model is very different. It’s not about trying to maximize your unit profitability fast before your patent wears out. With a vaccine, it’s about how can we continue to position the product, or evolve the product in its life cycle so that it continues to deliver value to people. That can be forever. Our measles vaccine has been around a long time, and it’s still delivering enormous public health value. We don’t have the patent cliff in our way. A bigger challenge is that we, all of us in the world of vaccines, can imagine innovations, bio-process improvements, other things that might improve our ability to lower costs, or speed up production, or localize production in new markets, but the regulatory environment hasn’t caught up with our innovation capability. For me, the biggest single issue is improving regulatory science so that we have the opportunities to implement and execute on bio-process innovations that we think will accelerate market access for poor people.

X: What exactly is the problem at the regulatory level?

JG: In vaccines, the process is the product. Any change you make in how you process your route to the vaccine actually changes the product. Often, you are faced with needing to do clinical studies, or make macro investments in a way that would simply discourage you from moving in that direction. That’s a little different from making a tablet. As long as at the end of the day you have the stated composition of matter, and quality, there’s more flexibility. There are more stringent controls of biologics, for safety purposes. The intent is right, but we need to figure out mechanisms where we can have a continuous quality improvement process that works for the regulators and also allows us to accelerate innovations that allow greater market access.

X: When you talk about regulatory agencies, and government agencies that are the purchaser of vaccines, you get into politics. That brings the whole vaccine-denier world into the equation. How big of an obstacle is that, and how do you deal with it?

JG: On a global basis, it’s a small issue today. Most people in the world are so grateful … Next Page »

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  • Maurine Meleck

    Gerberding talks about the first model(which is not used anymore) that gave information to parents about vaccines. I beg to differ. We never got information on the negative side effects of vaccines. They need to start doing this now-and let the parents read the vaccine inserts before deciding. The autism community is not anti-vaccine(remember we vaccinated and that’s how our children got sick), but we are safe vaccine. Big difference here. No problem here if they do away with mandated vaccines and let people pick and choose what drugs should enter their childrens’ bodies and their own. Personal choice and parental consent will do it. If someone wants to give their child 10 vaccines on the same day–fine–their choice.
    maurine Meleck SC

    • Erwin Alber

      Vaccines are by their very nature as chemical and biological agents unsafe Maurine, which is why all the clamour for safe vaccines or green vaccines is a lot of nonsense. Vaccines need to be abolished, not made safer. Because it’s not a good idea to hold one’s breath waiting for this to happen, parents meanwhile just need to say NO to vaccines because this toxic garbage is injected into babies and children not to prevent, but to PROMOTE ill-health. Think about it: sick people are profitable – healthy people are not! The reactions, disorders, disabilities and deaths vaccines cause are consequently not as we are led to believe unfortunate, accidental “side”-effects, but their only and in my opinion INTENDED effect.

      • Prudence Dagg

        I doubt anyone who knows their child is vaccine injured has a hard time believing that. However, those who oppose vaccines are bullied and browbeaten, so probably some feel pushed to keep it to discussion of making vaccines “safer,” when no one has ever needed a vaccine. I would say they are the hoax of the century except that they have been here longer than that.

  • Aimee Doyle

    My son was vaccine-injured. I saw him develop seizures with his DPT, lose language and social skills with his first MMR, develop autistic behaviors with his second MMR, and develop self-injurious behaviors with subsequent vaccines. Until you’ve lived with a child who hits his leg so many times there are permanent bruises and yells at the top of his lungs for hours every night, I’m not interested in hearing about how vaccines are “safe.” I could accept the coincidence argument once, perhaps, but my son has regressed and shown adverse effects with each vaccine. He was diagnosed with autism at age 4. He is now 21, so I’ve been in the trenches a long time and I’ve read just about every study on the issue of vaccines and autism.

    Clearly vaccines are not always safe. The Supreme Court, in the Bruesewitz decision, noted that vaccines are “unavoidably unsafe”; that’s the reason we have a vaccine court — because there is a genetically vulnerable subpopulation of children who do not respond well to a vaccine, and may respond even worse to vaccines given together.

    I am skeptical about the “future of vaccines” unless the industry acknowledges that there may be problems for some children with some vaccines and abandons the “one size fits all” vaccination policy.

    • Prudence Dagg

      Oh, Aimee, so sorry you have gone through this and perhaps still do. I know from family experience just what that is like.

      Have you tried detoxing or the Kerri Rivera protocol (Healing the Symptoms Known As Autism)? I am *not* selling anything…this has helped my sister. Please feel free to connect with me on facebook.

      Praying for the healing of all these precious individuals, and their families as well.

  • Jamie Jamison

    Oh boy, the Anti-vaccine nuts are at it again. The evidence linking vaccines and autism is garbage. Andrew Wakefield, the physician who published this information is a lying fraud who did so to make money for himself and a vaccine company that he was involved with. The thimerosal link was also discredited and most of the people pushing therapies to treat autistic children who were supposedly damaged by vaccines are lying frauds and snake-oil salesmen just like Wakefield was. Let me repeat, there is no scientific evidence, none whatsoever, that vaccines are in any way, shape or form linked to autism, anyone who says there is is either a) a lying fraud like Andrew Wakefield b) a lying fraud like the peddlers of various ineffective and/or dangerous “cures” for autism or c) ignorant.

    • http://www.facebook.com/candyce.estave Candyce Estave

      Not anti-vaccine, freedom of choice is more our bag… Yes, vaccine injured children are everywhere. You are a nut if you inject that vaccine, so go ahead get your damn flu shot. Who’s the nut now???

    • Erwin Alber

      You have swallowed mainstream and medical garbage propaganda hook, line and sinker Jamie. You need to get a grip of reality: vaccines have never prevented anything apart from health, sanity and common sense.

      To get a much needed reality adjustment, I suggest you watch the excellent lecture ‘Dr Wakefield defends his research’ on YouTube.

      If it’s any consolation to you, I believed in this vaccination nonsense as well for many years, until I found out that it was all a massive and dangerous fraud.

      • Larry

        Erwin,

        Jamie was VACCINATED!

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  • Jessica

    Anyone who believes that vaccines are safe and go out of their way to defend them along with the companies who develop them for people are dumber than a bag of hammers and are being bought themselves.
    There is so much evidence that supports the fact that vaccines have dangerous side effects and that they even cause death. Parents who have dealt with sick children as a result of being vaccinated know how deadly these vaccines truly are and will continue to be.
    If you’re stupid enough to vaccinate your child(ren) and be brainwashed by all of the propaganda then I truly feel for your complete and utter ignorance and your children and that they have such moronic parents.
    I could continue – but, my comments have summed this topic up nicely.

    • Erwin Alber

      You have summed up this topic very nicely indeed Jessica! Based on my research I have arrived at the inevitable conclusion that vaccination is an organised criminal enterprise dressed up as disease prevention by means of junk science. In my books, vaccination is bioterrorism against civilians – particularly our young – and vaccines biochemical warfare agents and weapons of mass destruction.

      The fact that Julie Gerberding previously held a high position at the CDC is an example of the “revolving-door-policy” between vaccine policy-makers and the vaccine-industry and an illustration of the serious conflict of interest these people are involved in.

      In New Zealand, a few years ago a well-known TV journalist who was involved in the making of a documentary about the adverse effects caused by Merck’s genetically engineered hepatitis B vaccine was offered the job of New Zealand Public Relations Manager for Merck. Needless to say in return for the favour, the documentary was canned.

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  • Adam Hogan

    I am so worried ffor all off your children… Where are the polio cases in the western world? Tuberculosis? Smallpox? Prior to vaccines, disease killed 25% of children before the age of 10. Are they still dying at that rate? Are the rates of autism anywhere near that, even if it WERE caused by vaccines? You people are not only going to have children that die horrible, drawn out, disease related deaths at a much higher rate because you DON’T vaccinate, you are responsible for the resurgence of a number of highly deadly diseases that we had, as a society, almost managed to eradicate THROUGH THE USE OF VACCINES. Honestly, you people have fifty different conspiracy theories that blame everyone from big pharma to the government, and not one off them is really feasible. Obama can’t even hide a memo that says he knew that you wouldn’t be able to keep your doctor or your policy under the ACA when he said you would be able to, yet you think the government, big pharma, doctors, researchers, universities and more can all for DECADES lie to the public at large without one truly plausible whistleblower (the guy you met in a chat room doesn’t count. I mean a person who stands in the light of day, in front of the cameras, with his proof. An Edward Snowden of the vaccine industry.) You can say that they suppress it, but how many people over the years would have to be involved? How many MILLIONS of doctors, researchers, bureaucrats, politicians, janitors, and more would have to be involved in the production and distribution not just of the “bad” vaccines, but the “false” research from UNIVERSITIES, done by COLLEGE STUDENTS AND PROFFESSORS. not big pharma CEO’s, that has shown time and time again that vaccines have saved millions of lives in the last century…. I seriously worry that you guys must have some kind of paranoid psychosis to believe something like that.
    P.S. THIOMERSAL (IDK where it’s name got changed in popular vernacular to thimerosal, but that’s not what it’s called) is a preservative that is no longer used in vaccines in the U.S. because of fear-mongers like you guys. BUT, despite what Dr.Dipshit says, it contains non-toxic ETHYL mercury, as compared to highly toxic METHYL mercury. (It’s really about how the mercury is bonded, because mercury is the toxic part, but ethyl mercury can not be broken down by the body, and passes right through our systems. And yes, some small amount of free raical mercury will always exist in these situations… the average human ingests four times the amount of unbonded mercury PER DAY than they would receive from an injection of a medicine that uses thiomersal.
    P.S.S. I recommend the Skeptoid podcast to all of you. He does a great job of covering vaccine fears, and also covers a lot of other pop-culture phenomenon, from snake–oil salesmen (like chiropractors who don’t tell you that chiropractic is based on your flow of CHI (as in ancient Chinese energy fflows through the body, as per acupuncture. Yes, chiropractic is based on the same thing, and your chiropractor took classes in it. He does NOT offer physical therapy based science. If he does, he had better be a physical therapist, or he’s practicing medicine without a license.)) UFO’s, and conspiracy theories. Listen with an open mind to the ones about topics you DON’T believe, and then ask yourself WHY you don’t believe it. Then ask if the same can be said about your belief in vaccine conspiracy theories…)
    tl;dr summary – you guys are completely wrong. If you were right that vaccines don’t prevent disease, why don’t you know 20 kids with polio and have 20 friends who have lost children to smallpox?

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  • Grim Fandango

    Part of what brings Merck, Pfizer, GlaxoSmithKline, and other
    major vaccine companies into the conversation is the realization that
    vaccines are no longer just a low-margin, high-liability corporate backwater.

    That’s right, Vaccines are now a high-margin, ZERO-liability
    corporate free-money machine. These psychopaths can’t be sued, for any
    reason whatsoever, including knowingly and intentionally distributing a
    vaccine that cripples and kills. Read it and weep:
    http://www.amednews.com/article/20110307/government/303079950/7/

    And here is the propaganda spun at warp speed, Julie Gerberding, the former director of the U.S. Centers for Disease Control and Prevention, is now the president of Merck’s vaccine unit. She’s the latest in a long line of revolving-door movements of top executives from FDA and CDC decision making positions, to top executive positions in the drug companies they used to “regulate”, and often back again to the FDA and CDC. According to the article above, It’s a good thing, now the little psychopath can do even more good for humanity. Barf bag please, and hurry.

    Just wait for the final single payer nightmare iteration of ObamaKare, and the mandated vaccines that you will be forced to submit to in order to receive any heath care whatsoever.

  • Larry

    There are 2 other MMR vaccine whistleblowers

    By Jon Rappoport

    September 24, 2014

    http://www.nomorefakenews.com

    —-For some reason, when I sent this story out an hour ago, it turned up blank in email boxes. So here it is again.

    We all know about CDC whistleblower William Thompson now.

    On August 27, he released a statement through his lawyer, Rick Morgan, in which he admitted research fraud.

    Thompson confessed he and his co-authors cooked the data in a key
    2004 study, thereby exonerating the MMR vaccine from any connection to
    autism.

    But what about Stephen Kraling and Joan Wlochowski?

    Who?

    They’re two former Merck virologists who filed a qui tam suit against Merck, the manufacturer of the very same MMR vaccine.

    The suit claims Merck defrauded the US government by selling the vaccine, under a federal contract, when Merck knew the mumps component of the vaccine was far less effective than advertised.

    Of course, Merck disputed this claim, but on September 5th, Judge Jones, of the Federal District Court for the Eastern District of Pennsylvania, gave the green light for the suit to move forward.

    Kraling and Wlochowski assert several levels of Merck fraud:

    To achieve a slam-dunk success, Merck tested the effectiveness of the MMR vaccine against the version of the virus in the vaccine, rather than against the natural mumps virus a person would catch in the real world.

    Merck irrelevantly and deceptively added animal antibodies to the test results, thus giving the false appearance of strong human immune response to the vaccine.

    On top of that, Merck faked the quantitative results of the tests to which the animal antibodies had been added.

    Here is where these two Merck whistleblowers and Thompson, the CDC whistleblower, intersect:

    In 2004, Thompson wrote a letter to CDC Director, Julie Gerberding, warning her that he was about to present troubling and sensitive data about the MMR vaccine at an upcoming conference on vaccines and autism.

    Thompson’s meaning was clear. He had found a connection between the MMR vaccine and autism.

    Gerberding never answered his letter, and Thompson’s presentation at that conference was canceled.

    Gerberding left the CDC in 2009.

    She is now…

    the president of Merck Vaccines, the manufacturer of the MMR vaccine.

    Major media consider this a non-story, on the level of a can of overflowing garbage on a quiet street corner.

    Well, they have to consider it a non-story. If they reported it and pressed it, they would fracture the pillars of the entire vaccine establishment.