Newsweek: Going Viral (observations from former vacccine lab worker)

[Guest guest]

Very interesting insight from a former vaccine lab worker - most

intersting - is that she won't get a flu shot!! (makes me wonder what

she left out)

Going Viral

When you work in a vaccine factory, getting dressed is half the job.

Inside one of the two American labs that produce millions of flu

shots every year.

Jeneen Interlandi

NEWSWEEK

URL: http://www.newsweek.com/id/169723

It's that time of year again, when people start asking themselves,

and each other, whether to get a flu shot. I actually get asked this

question a lot, presumably because I have a background in science,

and I used to work in a plant that manufactured the flu vaccine.

People also ask me if I think vaccines are safe, given my up-close

experience with making them. The short answer is somewhat

contradictory: yes they are safe, and no you probably don't need one

(though many doctors will send me hate mail for the latter part of

that statement). While I have fond memories of helping to make the

flu vaccine (which was my first job out of college), I've also

developed a sort-of working rationale against their utility.

It was not my fondest wish to work in a factory after college; most

of my friends were heading off to graduate school or taking office

jobs. I had hoped that my molecular biology degree would translate

into a spot in some pristine lab at Merck or & , both

of which have corporate headquarters in my hometown. Instead, I ended

up in a vaccine manufacturing plant (I'm withholding the name due to

a confidentiality agreement I signed before going to work there).

Because I had some lab experience, they stuck me in the formulation

facility. That's where all of a vaccine's given ingredients are

pooled into one giant stainless-steel vat before being sent down the

production line and packaged into the individual shots that most

people get injected with at one point or another.

Despite the hint of manual labor in my official job title—

manufacturing technician—it sounded exciting when I first signed on.

It was early in the millennium, and a rash of quality-control

problems had forced plants in Europe and the U.S. to suspend their

influenza programs, leading to a colossal shortage of flu vaccines.

When it came time to make that season's batch (after the Centers for

Disease Control had selected the appropriate virus strains) ours was

one of only two companies in the nation with the FDA approval needed

to get the job done. Even though we mixed and stirred and blended

hundreds of thousands of gallons of virus in a single season, we knew

it would not be quite enough to inoculate the masses. As we went into

overdrive (and overtime), expanding our campus and ramping up

production to some 150 million doses (and that was just for

influenza), public-health experts across the country were calling for

more factories and more vaccines. Talk about a sense of urgency.

It was a fun place to work, though I probably wouldn't have said that

at the time. We started at 6 a.m. sharp, which for me meant getting

up at 4:30 to make the hourlong commute. The upside was that because

we spent the whole day covered from head to toe in sterile gowns,

there was no need to bother with hair, makeup or fancy clothes. After

a quick breakfast in the cafeteria, we spent most of the morning just

preparing to enter the dense cubicle bunkers where the actual

formulating took place. That meant sterilizing everything, including

ourselves.

Moving from the cafeteria through the locker rooms and hallways to

the inner sanctum of the formulating rooms involved a series of

clothing changes we called " gowning up. " First we changed from street

clothes to scrubs. This included putting on special work shoes that

never left the building. Passing from the locker rooms into the lab

area meant covering those shoes with paper booties and donning a

hairnet, safety goggles and at least one layer of latex gloves.

Except for our own skin, which we couldn't do anything about except

cover, nothing that had seen the outside world, not even jewelry, was

allowed beyond that point.

Scrubs were OK for wiping down equipment—which we did obsessively,

throughout the day, with 95 percent bleach—or standing in the

hallways. But going into the formulating rooms required a whole extra

layer of clothing, a layer that had been autoclaved (cooked in a

steel vessel under pressures and temperatures high enough to kill any

and all microbes) and packaged just so.

Getting into that clothing actually took practice: no portion of the

outside of the jumpsuit could touch you, the walls or the floor. The

formulating rooms were completely sterile. If you gowned up the wrong

way and if even a single bacterium had managed to sneak past all

those other security checkpoints, you might introduce contamination.

So you had to open the package and remove the jumpsuit and hood

without touching the outfit's outside. Then, you would carefully

unroll the legs of the suit while stepping into them so that they did

not touch the floor, even for a second.

The suits themselves were stark white and the hoods looked like pure

science fiction. Between them, the goggles, the facemask and, by that

point, two pairs of latex gloves, absolutely no portion of your body

was exposed to the air. Heaven help you if you had forgotten to go to

the bathroom or felt an itch anywhere at all. (Every once in a while,

some exhausted manager or overworked technician would forget to

change into his or her street clothes and would stagger into the

cafeteria for lunch in a lab suit and safety goggles. You probably

had to be there to appreciate how funny this was).

Unlike the high-containment labs that provide such good fodder for

science fiction writers, none of the measures we took were meant to

protect us from the virus. By the time it reached our lab, all of

that stuff had long since been attenuated (modified in a way that

made it incapable of causing disease without diminishing its ability

to trigger an immune response). No, the idea behind all the gowning

and gloving and alcohol spraying—the goal of pretty much every

technique we employed, actually—was to protect the viruses and

bacteria from us. Humans, even the most fastidious among us, are a

notoriously filthy lot. And damned if we were going to let a stray

hair or an aberrant sneeze lay waste to so much medicine. All in all,

I think we did a pretty good job of it. Most of the same people that

I worked with are still there now; they're smart and experienced and

they take their work very seriously.

The labs themselves had windows that looked out onto the halls and

sometimes, like when the protocol called for 45 minutes of automated

stirring, the people inside the lab would play charades with the

people standing in the hallway. Occasionally, the FDA inspectors

would come to watch us, and we would act very serious and use extra

bleach on everything.

Standing in the hallway was actually a job. The people who did this—I

called them runners—were responsible for watching through the window

in case anything went wrong, or an extra piece of equipment was

needed. Almost nothing ever went wrong (at least not in the year I

spent there), but it wasn't inconceivable. A hose could blow, or a 14-

gallon bottle of reagent could have some particles floating in it.

Anything like that had to be fixed immediately (hence the running)

because the manufacturing protocols called for each step to be

completed in a very finite period of time, and if too much time was

lost, 500 gallons of vaccine, worth millions of dollars, would be

wasted.

The low men on the totem pole were always runners. In the beginning,

I was a runner. To earn a spot in the lab, you had to win the respect

of the senior techs. That meant showing up on time, working hard and

proving that you were not a complete idiot. A good sense of humor

went a long way, but nothing topped a strong work ethic.

Formulating the flu vaccine was a matter of mixing the three

different Centers for Disease Control-selected strains of the virus

and adding the mercury-based preservative (the source of much anxiety

for so many parents of late), along with several other ingredients

(the details of which are proprietary). Sounds simple, I know. But

the devil is in the details, and the details were all about pacing,

documenting and being sure to read the labels. Except for the flu

strains, which were somewhere between the color of honey and syrup,

all the other ingredients looked exactly the same—clear liquid in a

giant, clear glass bottle with a giant black rubber stopper at the

mouth. Each liquid flowed from its own container into the main vat,

usually a 500-gallon tank—shiny, silver and doused in bleach—from

which all sorts of rubber hoses and metal clamps protruded.

Everything was very heavy, and after gowning, the worst part of the

job was hoisting the containers from the cart to the countertop and

back again.

The formulating rooms were small, and, for the most part, we worked

in teams of three that almost never changed. Each group developed its

own routines and rhythms. The heavy masks and the roar of sterile air

blasting down through the ceiling made conversations nearly

impossible, and the teams that had been together longest could get

through a three-hour procedure without so much as a whisper.

Many of the techs had been there a few decades, long enough to see

the old factory through a string of corporate mergers and buyouts,

which instilled in them a stoic humor and stubborn pride. Come what

may, the vaccines would be made. Through two world wars, the Great

Depression and countless changings of the guard, theirs was the proud

site that had churned out the bulk of America's vaccines, including

most of the shots that helped eradicate smallpox in the late '70s.

It was a real family place, too, the kind where co-workers were also

spouses, siblings and childhood friends. Some of that closeness was

inspired by the urgency of our work, though no one there would admit

that to you. But a lot of it was a consequence of simple geography:

the factory sat on the edge of a sparsely populated mountain town

with only a handful of places to socialize and practically no other

places to work. So we ate together and drank together and learned to

love and hate the same things about our shared experience.

Despite my faith in the good people of the vaccine plant and despite

my deep faith in science, I have never actually been injected with

the flu vaccine myself. In fact, every time someone asks me whether

they should get a flu shot, I almost always tell them no, even if

they are elderly. Especially if they are elderly. It's actually a

misconception that older people stand to gain the most from the

influenza vaccine. Yes, like the very young, people over the age of

65 tend to have weaker immune systems. And yes, that means that they

face a greater risk of contracting whatever devious bugs happen to be

flying around. But studies have shown that, unlike infants and

toddlers, the immune systems of elderly people are less adept at

converting the influenza vaccine—meaning the shot does not trigger in

them an immune response strong enough to protect against subsequent

infection. In fact, a 2005 analysis by the National Institutes of

Health suggested that giving the flu shots to elderly people has not

saved any lives over the past three decades. (The CDC still includes

people over the age of 65—along with infants and toddlers, pregnant

women and health-care workers—among those who should most definitely

get a flu shot. That policy will not change until more studies are

done).

Kids, on the other hand, have no trouble with conversion, and their

penchant for playgrounds and general disdain for washing hands make

them the ideal beneficiaries of the vaccine formulators' efforts. If

my 10-year-old niece were to ask my opinion, I'd tell her to get a

shot straight away. I am not alone here. Many experts have begun to

suggest that school-age children would make a much better target for

protecting the population at large. Again, more studies are needed

before the CDC will change its policy.

In the meantime, I am a firm believer in the theory of herd immunity.

As long as a certain portion of the population has been inoculated

against a given infectious disease, the rest of the population will

be largely protected. The portion that needs to be vaccinated for

this to work (called the herd-immunity threshold) depends on several

factors, including what pathogen we're talking about. For influenza,

it's around 70 percent. That means as long as somewhere near 70

percent of the people around me have gotten their shots, I don't

really need to get mine, because most people I interact with will not

be capable of catching the virus or passing it on to me. Their

vaccinations basically act as a firewall that protects me and anyone

else too busy with holiday shopping to make it to the doctor. I admit

it's a bit of a gamble; the percentage of New Yorkers who get

vaccinated may be well below 70 percent, and there's no accounting

for tourists. But it's just not the biggest gamble I take. After all,

I still smoke.