Smallpox vaccine linked to heart inflammation

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DARocksMom

Mon, 15 Nov 2004 08:19:13 EST

Smallpox vaccine linked to heart inflammation

 

 

http://www.pittsburghlive.com/x/tribune-review/health/s_272498.html

 

Smallpox vaccine linked to heart inflammation

By The Associated Press

Saturday, November 13, 2004

 

WASHINGTON (AP) -- Wyeth Pharmaceuticals Inc. will add black-box

warnings linking its smallpox vaccine to heart inflammation, the

government announced Friday.

 

Healthy adults given Dryvax vaccine suffered acute myopericarditis

--

inflammation of the heart and its surrounding sac -- says the warning

approved by the Food and Drug Administration.

 

Wyeth spokesman Doug Petkus said the company no longer

manufactures or markets the smallpox vaccine. The vaccine had remained

in storage since the 1980s. After the Sept. 11, 2001, terrorist

attacks, the government asked Wyeth to test the smallpox vaccine to

ensure it was potent.

 

The black-box warnings apply to those vaccines repackaged by Wyeth

for immediate use by firefighters, medical personnel and other first

responders.

 

The company had provided nearly 15 million doses for government

use, enough to vaccinate up to 8 million people. Government health

agencies vaccinated 36,217 civilians. The military has inoculated

nearly 680,000 personnel since December 2002. Roughly 13 million

smallpox vaccine doses remain in the Centers for Disease Control and

Prevention's stockpile.

 

Because of life-threatening complications associated with existing

smallpox vaccines, the government has sought safer new-generation

smallpox vaccines to prepare for another terror attack.

In a recent clinical trial comparing Dryvax to an investigational

smallpox vaccine, eight confirmed or suspected cases of

myopericarditis were detected among 1,162 patients. That means people

had a 1 in 145 chance of developing the heart condition after

vaccination with Dryvax.

 

The conclusion followed concerns raised during a 2002-03

Department of Defense vaccination program. Of 540,824 military

personnel who received Dryvax, 67 developed myopericarditis -- or 1.2

per 10,000 vaccinations. The heart problems developed quickly, in

three to 25 days.

 

Among vaccinated civilians, 21 cases of myopericarditis were

reported as of May 9, 2003, according to the FDA.

 

Col. John Grabenstein, deputy director for military vaccine at the

Army Surgeon General's Office, said the Department of Defense has

warned about the heart problem since April 2003.

 

" This is not a new finding. This is paperwork catching up with an

old finding, " Grabenstein said. While the heart condition is alarming --

sending otherwise healthy people to the emergency room with chest

pains mistaken for heart attacks -- he said it remains uncommon.

 

People stricken with the heart ailment get better, according to

follow-up blood tests, heart exams and exercise stress tests. " Their

recovery is very good, " he said.

 

This summer, tens of thousands of troops stationed in the Pacific and

the Middle East received mandatory anthrax and smallpox vaccines to

protect against biological warfare.

 

In response to a federal judge's order in late October, the

Pentagon halted the mandatory anthrax vaccinations for the military --

six shots spaced over 18 months.

 

Mandatory smallpox vaccinations, not yet challenged in the courts,

continue for personnel headed to Afghanistan, Iraq and Korea. In

addition, a team of

smallpox-vaccinated staffers are assigned to nearly 100 military

hospitals and large clinics around the world, Grabenstein said.

 

Copyright 2004 Associated Press.