NerdGasm: Hit me with your best shot. 9


Full Frontal Disclosure:
My travel, accommodations and food (except for the bagel and an extremely necessary cup of tea) were covered by GlaxoSmithKline. They did not require me to write about the trip at all, nor did they pay me, review this post or dictate what I have to say. Which is a really impressive release of control for these folks.

A casual demonstration of some of the gowning procedure

A demonstration of parts of the elaborate gowning procedure for working in a sterile environment. Coverage is, of course, more comprehensive when they do this for real.

Let me open with – I love vaccines because vaccines save lives. As an asthmatic, I get a flu shot each year because the flu SUCKS. One year I got sick and stayed with my mother. I was having so much trouble breathing that she gave me a baseball to sleep with so that when I woke up suffocating, I could throw it to break a window to wake her up. Flu shot? Yes please. Also, I read The Demon in the Freezer in grad school and found it to be TotallyOmigodTerrifying. Whenever there’s talk of smallpox on the news, I lurk extra close to my husband’s smallpox vaccination scar as if I could receive immunity by proximity.

And so I was super excited to be invited to visit the GlaxoSmithKline (GSK) vaccine facility in Pennsylvania, and redonkulously thrilled to get a tour of the packaging plant that required the donning of paper lab coats, haircovers and goggles and a whole procedure where you put your dirty shoe into a clean cloth wrapper and then set it down on the “clean” side of a taped line on the floor. Squee! My inner nerd was plotzing. My outer nerd bemoaning how I look in goggles, and trying really hard not to scratch my itchy nose in their clean, clean room. I mean, it was incredibly spotlessly fresh and clean by my standards, but apparently pretty squalid by theirs. More on their housekeeping rituals in a bit.

Upon arrival, we all gathered in a conference room where our hosts explained what happens at the plant (which has been there since, get this, 1882 when it was the Lancaster County Vaccine Farm, which, if you believe the Internets, was once the world’s largest producer of smallpox vaccine). Here, the folks at GSK take the vaccine ingredients, mix ‘em up, and package them. Of course, it’s a much longer story than that, and I’m making it sound about one million times more slapdash than it is, but I’m a writer and no lives are hanging on whether I’m funny or not. This is totally not at all the case with the jobs of any of our hosts. It is IMPERATIVE that they’re funny. No, it’s imperative that they’re careful and accurate.

A couple of highlights from the presentation:

  • There are more than 500 quality control steps in the packaging of the vaccines alone.
  • It takes 10 months to produce a simple vaccine. That’s produce, not develop.
  • More complex vaccines take up to 25 months to produce.
  • Some amazing percent (that I didn’t write down) of adults aren’t fully vaccinated because we think of kids when we think of the vaccination schedule. Do you know when you had your last tetanus shot?

To paraphrase site director David Callaert, this job isn’t for everyone. People who don’t want to spend their day following strict protocols and carefully outlined procedures to the letter will probably be happier somewhere else. When you’re producing compounds to inject into healthy people, there is no margin for error or sloppiness. When you are developing a treatment for, say, heart disease, you’re dealing with a sick person. And a treatment that is effective most of the time is a great thing. But when you’re treating the well? You have to nail it every time. So why do we need to treat the well? If you’ve never had the flu, why should you get a flu shot? Well, I’ve never had HIV and if they had a vaccine for it, I’d be there. I haven’t had cancer yet, but would surely vaccinate against it if I could. Why? Because I watched my Rockstar Grandma suffer through kidney, bladder and lung cancer.

Neat Freaks

This place has an aseptic manufacturing area, which sounds So Freaking Cool. Wisely, we were not allowed within a couple of acres of it, but they did do a little demonstration of some of the gowning procedures that people who work there have to go through to get to their workstations. It begins with donning scrubs, moves on to a sterile outer layer, mouth-hole cover (with optional beard supplemental cover), eye-hole covering, comical hood and gloves. And space boots. All of which you have to put on without touching the outside, or you’ve contaminated them.

They discussed what I’m going to call (for dramatic effect) The Five Pillars of Sterility:

  1. Facility design: The layout, HVAC and how people move through it.
  2. Cleaning schedule, plans, materials and methods.
  3. Gowning: Summary – God help you if you have to pee.
  4. Aseptic simulation: Constant testing at all phases of the process.
  5. Monitoring of normal processes: They mentioned that even the air pressure is carefully controlled. It’s higher when you’re in cleaner areas so that if a door opens or something contaminants aren’t sucked in.

How It’s Made

But the best part, of course, was the tour of the facility. Which I can’t show you. But, if you’ve ever seen “How It’s Made,” on the Science Channel you get the gist.Hurt that Richard spends by prohibiting in and for payday loans online and. Atiuans understand it as. Payday Loans Online Subsequently some members of subject to the same interest on loans. I?ve said is let?s based peer to business payday loans online let?s initiate long. Here’s my overview of the process:

Filled and sealed vials are brought into the packaging facility, where a guy in a blue paper dress loads them into a circly-whirly thing, where they spin around a little before moving single-file out and down the line to labeling, where the Most Complicated Label Extruder Ever applies labels and checks each to make sure it is perfect. Then, they go down a ramp (with an area that contains a backlog of vials in case something gets hung up in the label machine so that the line downstream can keep humming) and into another array that checks, lines up, boxes and shoves those informative inserts into the box, which is bound together into bundles of multiple boxes, and packed into bigger shipping boxes. There are more inspection steps than I can name, so I won’t risk spreading misinformation by trying to name any of them. There are lots.

I’ve done my reading and even written a site or two for clients about vaccines and I like ‘em. The benefits seem to me to far outweigh the risks, which are low when compared to such deathsports as driving an automobile or eating in restaurants. Far be it from me to tell anyone else what choices to make for their own families, and if I get on a rant about herd immunity and what I think about taking medical advice from Hollywood, we’ll be here all day.

The World According to Spouse

Spouse – who grew up in Soviet Russia, where everyone was considered to be property of the state and therefore routinely vaccinated without discussion – has strong opinions on vaccines. He has consented to letting me share them here. They are as follows:

1) People who decline vaccinations should also have to decline to avail themselves of other modern conveniences such as the Internet, clean drinking water and electricity. Why should they get to pick and choose, when this one actually impacts the health and well-being of others?

2) When people get their driver’s license, they should have to select one of two lines to get out of the DMV: Vaccination or sterilization.

Spouse is popular at cocktail parties. He also hails from a family with serious scientific cred, who’s very impressive qualifications I’d love to brag about here, but they’re private people. Suffice it to say, they know their shit.

In Good Company

It was a great trip – my first of its kind – and I was impressed by the other bloggers. They were personable, funny, and asked great questions. It was a pleasure to meet you all.


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9 thoughts on “NerdGasm: Hit me with your best shot.

  • Bill

    I’m all tingly imagining the packaging facility. Robot box-stuffers are way cool. Was there cheesy music playing and pronouns being left dangling all over the place like on “How it’s Made”?

    I’m also fascinated that the nose remains sticking out from all that protective gear. That seems like a bad idea.

    You and Spouse have some good ideas on vaccination requirements. Non-vaccinators should also have to pay into a liability pool to cover the health care costs of all the people they end up infecting. Actually, that’s probably in Obamacare somewhere, along with all those other odious individual mandates.

  • Thea Post author

    Oh, the nose is totally covered in the real deal – this was just a casual, partial demonstration in a conference room. Thanks for the input – I just adjusted the caption to be more clear.

    No cheesy music, except in my head. :)

  • Bill

    By the way, there was an article in The Atlantic last year about how sketchy the evidence is for the effectiveness of flu vaccines (www.theatlantic.com/magazine/archive/2009/11/does-the-vaccine-matter/7723/). Unlike other recent vaccine controversies, this one has actual scientists with actual data on both sides, not just porn stars and crackpots.

    One problem if the vaccine isn’t doing much good–completely aside from the vast amounts of money being wasted on it–is that it may encourage people to be overconfident in the magic bullet solution and neglect to take cheaper, simpler, and possibly more effective preventive steps, like washing their hands and avoiding contact with sick people.

  • Thea Post author

    Many thanks for sharing the article Bill! It raises some really interesting points. Like, “they hypothesized that on average, people who get vaccinated are simply healthier than those who don’t, and thus less liable to die over the short term.” They call it “the healthy user effect,” and it’s sure to gum up the math.

    I hadn’t considered how many variables there are to gauging the effectiveness of the flu vaccine in particular, and the difficulties of conducting placebo-controlled studies with at-risk populations.

    Thanks!

  • carmen

    DUDE. I was THERE and I didn’t write up anything approaching this in magnitude. You are phenomenal.

    And I line up for my vaccines all the time. Going for the flu shot as soon as I kick this redonkulous cold.

    You are a rock star.

  • Thea Post author

    *you* are a rock star. It was so great to meet you! Truth be told, I haven’t had my flu shot yet this year either. My daughter has, though.

  • Matthew

    I’ve toured both the solids and steriles production facilities where I work, and both are really interesting. It was hysterical, as we were mostly non-scientists / non-production people. The production folks showed us their new fully-automated production line (which cost millions and, to the untrained eye, looked just like their semi-automated production lines). But we were most impressed with the machine that seals the glass ampules, with it’s 12 parallel blowtorches nodding back and forth. Fire! Oh!

    Have also been through the whole gowning/ungowning procedure (and wondered how many times in a day you can wash & sterilize your hands before they crack and chap into oblivion) but found it odd that when we moved from a ‘less’ clean area (solids production) to a ‘more’ clean area (steriles/injectibles) we had to put booties over our booties. By the end of my tour, I was wearing three sets of booties and had washed my hands a dozen times.

    And just for the record, my last tetanus vaccine was on Sept 14, 2005. Along with diptheria and polio. And Hep A & B. And Typhoid. And H1N1. And seasonal flu.

    I’m big on vaccines. It doesn’t hurt that we make them and I get them free…

  • Lisa

    FWIW, that Atlantic article came in for some pretty heavy criticism from the likes of the Reveres at Effect Measure – not reflexive vaccine champions by any means, but scientists who would like science writing to reflect, you know, science. It seems the authors of the Atlantic article overemphasized the extent to which there is a real dispute over the efficacy of flu vaccines.