Needle Fight Ails Bush's Smallpox Plan
Tuesday, Jan. 28, 2003
WASHINGTON - The Bush administration is pushing forward with a plan
for millions of smallpox vaccinations without using the latest needle
technology to prevent injuries and the spread of disease, angering
some who are bucking the Bush plan.
Health workers complain the decision not to use the latest safety
needles, though they are available and encouraged under federal law,
is emblematic of an aggressive smallpox vaccination plan that is
moving forward too fast and disregards important health issues.
Officials at the Centers for Disease Control and Prevention counter
that the latest design of safety needles that could be used for the
vaccinations have flaws that do not make them any safer.
That does not satisfy critics.
"It is federal law that safe technology is required by employers, and
here we have a total disregard of a federal law by the federal
government," said Evelyn Bain, Occupational Safety and Health
Specialist at Massachusetts Nurses Association.
The association announced last week it was recommending its 20,000
members not volunteer until the government addresses several safety
Under the Bush program, the first vaccinations of 10.5 million medical
workers and emergency responders began Friday. The CDC began shipping
the first 21,600 doses to Connecticut, Nebraska, Vermont and Los
Angeles County last week.
The program does not use "safety needles" that come with features to
reduce the risk of needlestick injuries, which can expose health
workers to blood-borne pathogens such as HIV, Hepatitis B, Hepatitis C
or the vaccinia virus.
The Needlestick Safety and Prevention Act signed by Bill Clinton in
the fall of 2000 directs employers to use safety needles or employ
workplace controls to minimize the risk of injury.
In March 2002, the FDA approved a two-pronged "bifurcated" safety
needle for smallpox vaccinations that is manufactured by Univec, a
company in Long Island, N.Y. The vaccination kits for the government's
smallpox vaccination plan do not use safety needles, the CDC says.
Bifurcated needles look like tiny pitchforks, with two points at the
end that are dipped into the vaccine liquid. The liquid clings between
the two points as the needle is jabbed several times into the skin.
Safety bifurcated needles are mounted in a syringe base, to make them
easier to handle. The safety needles also have a plastic sheathe that
slides forward to cover the sharp points after use, when they are the
Health workers suffer between 600,000 and 1 million needlestick
injuries each year, according to American Nurses Association, and
1,000 are estimated to get serious infections from the injuries. ANA
says using safer devices could prevent 80 percent of the injuries.
"Our organization has said that they needs to use safety devices," for
the smallpox vaccination program, said Cheryl Peterson, a senior
policy fellow at American Nurses Association.
An analysis by Pharmacy Services, Inc., which licenses the bifurcated
safety needle, said that use of the bifurcated needle without safety
devices could result in 37,500 needlestick injuries if the entire U.S.
population eventually received smallpox vaccinations.
Dr. Ray Strikas, a medical epidemiologist at the CDC's National
Immunization Program, said the vaccine approved by the FDA was
approved as a package along with a needle that does not have a safety
device because no safety needle was available at the time the FDA
began considering the vaccine.
Strikas also said officials at the Department of Health and Human
Services have determined the safety needle has design flaws that might
not make it any safer. He said the bifurcated safety needle approved
by the FDA is "difficult to handle and prone to breakage."
"There is no reason to go jump through a bunch of regulatory hoops if
it is not going to make it any safer," Strikas said.
Health workers said the administration should find a way to send out
the smallpox vaccine with the safest needles available and required by
American Nurses Association wrote President Bush on Jan. 16 asking for
a delay in the vaccination program for health and safety issues,
including "the utilization of safer bifurcated needles." Several large
unions, including Service Employees International Union, also wrote
the president earlier this month asking that the vaccination program
As hospitals in a number of states last week announced they will not
vaccinate their staff, a 15-member independent panel of th Institute
of Medicine delivered concerns about the vaccination program and
recommended that CDC "proceed cautiously, allowing continuous
opportunity for adequate and thoughtful deliberation, analysis and
The panel noted a number of "important matters" could not be addressed
in their report, including "occupational safety issues, particularly
related to bifurcated needles."