Smallpox Vaccine Information

CDC PLAN TO RELEASE SMALLPOX VACCINE

National Vaccine Information Center

Barbara Loe Fisher, President

June 24, 2002

The National Vaccine Information Center (NVIC), the oldest and largest vaccine safety advocacy organization in the U.S., endorses the June 21 decision by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control (CDC) advising against releasing vaccinia (smallpox) virus vaccine for mass use by the general population. However, we maintain that the federal advisory committee's recommendation to use the live virus vaccine in up to 20,000 health care workers is premature in the absence of actual disease.

NVIC representatives attended and gave statements at public meetings the CDC held in Atlanta, New York, San Francisco, San Antonio and St. Louis. In all of the meetings to discuss smallpox vaccination options, there was no credible evidence presented to suggest that the smallpox virus was going to be intentionally released or could be successfully used by terrorists as a bioterrorism weapon. In fact, CDC experts continued to insist the theoretical probability of the eradicated virus being intentionally released was "very low." And yet, plans are now going forward to intentionally release the very reactive live vaccinia virus into our population by exposing at least 20,000 health care workers and their close contacts to the very real risks of injury and death from the most reactive vaccine humanshave ever used.

NVIC agrees that stockpiling smallpox and other vaccines to respond to potential bioterrorism is an important part of the nation's emergency preparedness plan. However, we are not in an emergency situation. There has been no bioterrorism attack using smallpox virus and the CDC should stand by the policy of restricting vaccinia virus vaccination to researchers exposed to vaccinia virus in lab work. Beyond that, vaccinia virus transmission into the general population could be minimized by confining the vaccination of potential emergency first responders to several hundred special personnel selected to investigate any suspected intentional release of the smallpox virus.

Outstanding questions remain about the wisdom of re-introducing the live vaccinia virus into the world, where it has not been circulating for more than three decades, in the absence of real disease or proof that weaponized smallpox virus has been acquired by terrorists and can be successfully deployed. It appears that the only reason bringing smallpox vaccine back into general use is being discussed is because of the anthrax-laced letters sent to politicians and the media immediately after September 11, 2001. And yet, the information the American public has been given about the anthrax "bioterrorism" attack is that it was an inside job and most likely involved a disgruntled scientist familiar with anthrax research at a U.S. government lab. Correcting lapses in internal security would be a much safer alternative to placing more American's lives at risk with a vaccine designed to prevent a disease that has been eradicated.

NVIC opposes the release of live vaccinia virus vaccine into the general population for the following reasons:

• smallpox was eradicated and the U.S. halted routine use of the vaccinia virus vaccine in 1971 after recognition of the vaccine's serious side effects;
  
  

• the live virus vaccine causes reactions in almost everyone who gets it (fever, spread of vaccine virus to other parts of the body) and causes life threatening reactions in 1 in 4,000 persons;
  
  

• the vaccine spreads vaccinia virus from one person to another and immune compromised individuals are at highest risk;
  
  

• up to 25 percent of the US population is estimated to be immune compromised and at risk for injury or death if exposed to vaccinia virus;
  
  

• at high risk of vaccinia virus infection complications are people who have a history of eczema or atopic dermatitis and it has been estimated that these individuals and their close contacts comprise as much as 50 percent of the US population;
  
  

• there is a window of opportunity to vaccinate individuals within four days of being exposed to the smallpox virus;
  
  

• smallpox infection used to kill up to 30 percent of those infected; however, today's medical care and treatment options in the U.S. would lower that death rate to 2-3 percent according to CDC experts (unless the virus has been genetically engineered to be more lethal);
  
  

• any use of smallpox virus in a bioterrorism attack is likely to be genetically engineered and diminish the effectiveness of the current vaccine;
  
  

• the smallpox vaccine was never tested in clinical trials before it was used on a mass basis and mandated;
  
  

• drug companies making old and new smallpox vaccines want