HHS sets rules for smallpox vaccine injury compensation

Dec 15, 2003 (CIDRAP News) The Department of Health and Human Services (HHS) has announced details of how the compensation program for civilians who are injured by the smallpox vaccine will work.

The $42 million program is intended to provide financial and medical benefits to people who suffer complications from a smallpox shot given under an HHS-approved smallpox emergency response plan. The program also is designed to help unvaccinated people who are harmed as a result of contact with vaccinees. Almost 39,000 healthcare, public health, and emergency workers have received shots since the civilian smallpox vaccination program began last January.

HHS Secretary Tommy Thompson announced on Dec 12 an interim rule that describes program eligibility standards, the process for requesting and receiving benefits, and other policies and procedures. The rule will be published Dec 16 in the Federal Register, Thompson said. Public comments on the rule are invited, and HHS may amend the rule on the basis of comments, officials said.

HHS has published an online table that lists and defines the complications covered by the vaccination program. The list includes, among other conditions, significant local skin reactions, inadvertent inoculation, generalized vaccinia, eczema vaccinatum, progressive vaccinia, postvaccinial encephalopathy, and vaccinial myocarditis or pericarditis.

The table lists how soon after vaccination (or secondary exposure) the first symptoms or signs of a complication must appear to warrant a presumption that the problem is vaccine-related, HHS said. People who experience a condition described in the table within the specified time need not prove it was caused by the vaccine to qualify for benefits, the announcement states.

HHS also said there may be smallpox vaccine complications that are not listed in the table. "A person who can present sufficient evidence to prove likely causation may still be eligible for program benefits," the statement says.

An online report by the Centers for Disease Control and Prevention (CDC) shows a total of 49 adverse events in the civilian smallpox shot program through November. The reported cases include myocarditis or pericardits, 22; inadvertent inoculation (nonocular), 20; generalized vaccinia, 3; ocular vaccinia, 3; and postvaccinial encephalitis, 1.

Anyone seeking eligibility or application information can contact the Smallpox Vaccine Injury Compensation Program by calling 1-888-496-0338 or sending an e-mail to smallpox@hrsa.gov.