Smallpox & vulnerability: Study Tests Defrosted Smallpox Vaccine, Just in Case

[Guest guest]

This article illustrates an important principle: Most " safety " studies are based

upon treatment-responses in *healthy* volunteers. Results from such experiments

seldom apply to individuals with increased susceptibility to developing adverse

sequelae -- whether for acquired reasons (eg, a chronic or current illness)

and/or a genetic condition (eg, minor immune glitch). At least Grady's article

mentions subgroups with increased vulnerability. My view is that people should

begin evaluating their own and their family's personal markers of increased

susceptibility. And some such markers are only *clearly* evident via genetic

testing, although certain medication-reaction patterns or illness-patterns can

provide clues (1).

Study Tests Defrosted Smallpox Vaccine, Just in Case

By DENISE GRADY, NYTimes

http://www.nytimes.com/2002/10/10/health/10SMAL.html

NASHVILLE, Oct. 9 — Grey, a 24-year-old graduate student in chemistry at

Vanderbilt University, rolled up his sleeve today, and Dr.

scrubbed his upper arm with a gauze pad soaked in acetone. Then she unwrapped a

fine needle with two tiny prongs on one end and dipped it into a vial of

greenish liquid, swished it around and caught a drop between the prongs. Gently,

she rubbed the liquid onto a dime-size area on Mr. Grey's arm. Not so gently,

she jabbed the area 15 times, counting each jab out loud.

She had just vaccinated Mr. Grey against smallpox. It was the first day

of a government-sponsored test of smallpox vaccine, one in a series of studies

that began earlier this year, provoked by fears that terrorists or a hostile

country like Iraq has stocks of the smallpox virus and might use it as a weapon.

Given the potential threat, many health officials say the United States, which

ended routine smallpox vaccination in 1972, must be ready to start it again.

" I feel like I'm part of a frontier, stepping into a new era, " Mr. Grey

said. " Especially after 9/11. It's for the betterment of the United States, and

the world perhaps. "

Healthy young men and women, including other graduate students like Mr. Grey and

some health workers who expected to be called on to vaccinate others, waited

their turns at the clinic. Fourteen were scheduled for the first day of the

study. Many of the volunteers, like Mr. Grey, said part of their reason for

participating was simply to help researchers find out the best way to use the

nation's stockpile of vaccine, which has been frozen for decades. A few

volunteers said they were also lured by the $300 they would be paid to complete

the study. One said it would not hurt to be vaccinated " just in case. "

The United States stopped smallpox vaccinations in 1972 because the

disease had been wiped out in the Americas. Globally, it was eradicated in 1980,

and most other countries also stopped vaccinating. An important part of the

reason that countries willingly gave up vaccination once the disease was no

longer a real threat is that the smallpox vaccine, more than any other vaccine,

carries a significant risk of serious complications.

For every million people vaccinated, 1 or 2 die, 15 suffer

life-threatening complications and hundreds of others have serious skin rashes,

infections or other problems. [Higher rates of adverse events have been reported

in other news analyses.]

By the end of this month, Dr. and her team at Vanderbilt hope to have

vaccinated 150 volunteers from 18 to 32 years old, people who have never

received the smallpox vaccine before. The Vanderbilt study is part of a larger

one, sponsored by the National Institutes of Health, to include 150 volunteers

from each the University of Iowa and the University of Cincinnati.

The purpose of the study is to test the safety and effectiveness of a

smallpox vaccine, made by Aventis Pasteur, that has been frozen since the

1970's. From 70 million to 90 million doses of the vaccine are now available,

and the new study will also help determine how much those doses can be diluted

to stretch the supply. Volunteers in the study will receive the vaccine in one

of three forms: full strength, or diluted 1 to 5 or 1 to 10 in strength.

Over two months, researchers will gauge the effectiveness of the vaccine

by assessing sores and scabs at the vaccination site, a sign that the

vaccination has worked. They will also measure antibody levels in the

volunteers' blood at several intervals after the vaccinations. The researchers

at Vanderbilt hope to have results to report to the national institutes by

Christmas.

Similar studies earlier this year found that the Aventis Pasteur vaccine and

another one, Dryvax, made by Wyeth, had retained their potency despite being

stored for so many years. But if diluted too much they lose effectiveness, and

further studies are needed to find out the best way to use them.

The earlier studies also found that 20 percent to 30 percent of the

people who were vaccinated became sick enough with fever and aches and pains to

miss several days of work or school. All recovered. [And those subjects too were

probably *healthy* and did not have increased susceptibility to developing

adverse effects.]

Volunteers for the study go through an extensive screening process designed to

exclude anyone who has a high risk of being harmed by the vaccine. People at

risk include those with organ transplants, certain cancers, H.I.V. infection or

other conditions that might weaken their immunity. People with skin conditions

like eczema or atopic dermatitis — or even a history of them — are also

excluded. So are pregnant women.

People are also barred from the study if they live with someone who

might be endangered by the vaccine, including babies under a year old. The

reason is that the smallpox vaccine contains a live virus, vaccinia, a relative

of the smallpox virus, which could leak out of the vaccination site and infect

someone else. [How thorough will this type of screening be if an unnecessary war

prompts a host of retaliotory bioterror attacks?]

As part of the Vanderbilt study, researchers will swab the volunteers' bandages,

hands and vaccination site, to find out whether the virus is leaking out and

posing a threat to others. Researchers fear that today, complication rates may

be higher than they were in the past, because millions of people are now

infected with H.I.V., more people have organ transplants today, and rates of

eczema are higher than in the past. Dr. , who has made a career of

studying vaccines, said she was worried that the public was not fully aware of

the risks of the smallpox vaccine.

She added, " What's really sad is to think that you eradicated an

infectious agent from the world — and we have patients with so many other

diseases like malaria and H.I.V. and tuberculosis — and now we have to spend all

this time on something we had already conquered. "

Britain Stockpiles Vaccine

LONDON, Oct. 9 — Government officials said today that they were stockpiling

millions of doses of smallpox vaccine but that they did not plan mass

vaccinations unless there was a smallpox attack. " Our position would be to ring

vaccinate around the outbreak as a first line of defense " and to inoculate the

medical workers deployed to treat patients, a spokeswoman for the Department of

Health said.

Sir Liam son, the country's chief medical officer, said there was

no evidence of an increased risk of attack, but he told the BBC that " we should

have in place enough vaccine to vaccinate on a mass population basis if

necessary. "

Copyright The New York Times Company

See also:

Medical Conditions Create Vulnerability to Vaccine

By DENISE GRADY, September 24, 2002

http://www.nytimes.com/2002/09/24/national/24RISK.html

C.I.A. Warns That a U.S. Attack May Ignite Terror

By ALISON MITCHELL and CARL HULSE, NYTimes

http://www.nytimes.com/2002/10/09/international/middleeast/09IRAQ.html

References:

1: Westphal GA, Schnuch A, Schulz TG, Reich K, Aberer W, Brasch J, Koch P,

Wessbecher R, Szliska C, Bauer A, Hallier E.

Homozygous gene deletions of the glutathione S-transferases M1 and T1 are

associated with thimerosal sensitization.

Int Arch Occup Environ Health. 2000 Aug;73(6):384-8.

[Thimerosal is 49.6% ethylmercury by weight, remains in some vaccines,

and is known to cause reactions in some people who use thimerosal-containing

contact solutions.]