Smallpox Vaccine Injury Law Project

SEC. 7001. SENSE OF CONGRESS ON SMALLPOX VACCINATION.

The sense of Congress is as follows:

(1) The President has determined that to protect Americans against the threat of a smallpox attack, there is a need for a program for smallpox vaccination announced December 13, 2002. The plan is to vaccinate military personnel, civilians, and smallpox response teams. Smallpox response teams will include health care workers and first responders.

(2) Military vaccination has already begun. Civilian vaccination is scheduled to begin January 24, 2003.

(3) As part of the program for smallpox vaccination, the President should--

(A) guarantee medical care, compensation for injuries, and other protections for individuals who are vaccinated; and

(B) provide adequate resources for States and hospitals to administer the program fairly, safely, and without adverse consequences to other critical public health needs.

(4) The facts about smallpox vaccine are as follows:

(A) Smallpox was eradicated in 1980. The United States stopped routine vaccinations in 1972.

(B) The President has determined that the threat of an attack using smallpox warrants a National Smallpox Vaccination Program.

(C) Smallpox vaccine contains a live virus called vaccinia, which is similar to the smallpox virus and can spread to another part of the body or to other people from the vaccine site.

(D) Past experience indicates that for every 1,000,000 vaccinated, between 15 and 52 people will suffer life-threatening consequences, and 1 or 2 will die.

(E) Pregnant women, babies, and people with eczema or weakened immune systems should not receive the vaccine, making proper medical screening of candidates for the vaccine critical.

(F) In a recent trial of 200 healthy, young adults who received the vaccine, one-third of participants missed at least 1 day of work or school, 75 had high fevers, and several took antibiotics.

(G) Administration of the smallpox vaccine is different from administration of other vaccines and many health professionals have never administered the vaccine.

(5) To administer the President's smallpox vaccination program, there is an urgent need--

(A) for emergency appropriations to States for purposes including administering the vaccine, education about the vaccine, medical screening of candidates for the vaccine, medical surveillance of vaccine recipients, medical treatment of those injured directly or indirectly by the vaccine, efforts to mitigate the impact of lost productivity due to individuals' adverse reactions to the vaccine, and planning, coordination, and evaluation of smallpox vaccine activities;

(B) to ensure that those who are injured from the vaccine (whether directly or indirectly) have access to and compensation for the health care they need;

(C) to set up effective safeguards for administering the vaccine, including education for those administering the vaccine, education for prospective recipients of the vaccine, proper medical screening and confidentiality protections for medical information, education for vaccine recipients on how to prevent accidental transmission, post-vaccination medical surveillance and treatment, the supply of safe needles for vaccine administration, the provision of adequate vaccinia immune globulin (VIG) to treat adverse reactions, and mandatory centralized reporting of adverse consequences;

(D) to protect civilian workers from disclosure of medical information, from discrimination in the workplace if they refuse to be vaccinated, and from lost wages and benefits, adverse employment consequences, or other losses if they miss work as a result of the vaccine; and

(E) to ensure that adequate protocols for protecting vulnerable patients from exposure to accidental transmission from a health care worker who has been vaccinated are followed.

(6) The Homeland Security Act of 2002 shielded from liability those who manufacture or administer smallpox vaccine under that Act. Individuals who are harmed by the vaccine or their survivors must sue the Federal Government for compensation for their injuries under the Federal Tort Claims Act. Under that Act, individuals who are injured are required to prove negligence in order to be compensated. Since smallpox vaccination may cause injuries even without negligence, many of those harmed by the vaccine may be unable to collect any compensation under this stringent standard and thus will never receive compensation for their injuries. To provide a fairer and more complete system for those who are vaccinated, including workers who voluntarily put themselves at risk to protect America, Congress should establish, in addition to the tort claims system, a system to compensate those injured by the vaccine, including those who are injured by contact with someone who has received the vaccine. The compensation system should be adequately funded. It should include both a no-fault component for those individuals who experience foreseeable adverse reactions already known to be associated with the vaccine, and a mechanism for proving causation for those individuals who suffer unforeseen consequences from the vaccine.

(7) The Homeland Security Act of 2002 failed to protect from liability a vaccinated person who transmits vaccinia accidentally. This section should be amended to protect these people from liability. The section also failed to protect hospitals that did not administer the vaccine, but employ vaccinated health workers. The section should be amended to clarify which hospitals are covered.

(8) Implementation of the President's smallpox vaccination program depends upon significant State and local government participation. The President should provide resources to those entities to accomplish his smallpox vaccination goals. To assist State and local governments with this burden, Congress should establish emergency grants for carrying out smallpox vaccinations pursuant to the President's plan.