A "black box" warning has been issued by the Food and Drug Administration on a smallpox vaccine, manufactured by Wyeth Pharmaceuticals Inc, after it
became clear that healthy adults developed myopericarditis inflammation of the heart after vaccination with Dryvax.
The warnings apply to vaccines supplied to Government workers including first reponders.
Concerns were raised during 2002-2003, when the DoD conducted a smallpox vaccination program using Dryvax. 67 out of over 540,000 military personnel
developed the heart condition after vaccination.
The DoD has recently made anthrax and smallpox vaccinations mandatory for those personell serving in Asia and the middle-east.
Black box warning links smallpox vaccine to heart inflammation
By Diedtra Henderson, Associated Press, 11/12/2004 17:57
WASHINGTON (AP) Wyeth Pharmaceuticals Inc. will add black box warnings linking its smallpox vaccine to heart inflammation, the government announced
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 Sept. 11 domestic 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.
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.
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
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.
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I would have thought that after finding a serious problem with this vaccine, that the US Government would have scrapped it's use.
It would appear that the Government feels that these side effects are an acceptable risk to take, in the face of the danger of a smallpox attack.
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[edit on 13-11-2004 by zero lift]