CDC Officials Announce System To Monitor Safety of Smallpox Vaccine

CDC officials yesterday announced that a "network of experts" will be established to provide around-the-clock consultation for physicians treating patients with smallpox vaccine complications, the New York Times reports. The program will be the "most comprehensive system ever" created to monitor the safety of a vaccine, according to health officials, the Times reports. One day after the Advisory Committee on Immunization Practices recommended vaccinating 510,000 health care workers against smallpox, CDC officials announced plans for a system to track the frequency of complications experienced by people receiving the inoculation. Under the system, each hospital employee who receives the vaccine will receive a personal identification number and a telephone hotline number to report any possible side effects, such as fever, rash or changes in mental status caused by encephalitis. Officials expect an estimated 35% of vaccine recipients, or 175,000 people, will call the hotline, which will provide advice or referrals to physicians. The system also will be used to determine which vaccine recipients will receive the two medications, vaccinia immune globulin or cidofovir, required to treat some side effects. Vaccinia immune globulin is in short supply and cidofovir is approved only to treat a different virus, the Times reports. CDC officials said the system also is being enacted to maintain the agency's credibility and public confidence. The agency was "widely criticized" for failing to communicate effectively with physicians and the public during last year's anthrax attacks. "We are responding to criticism that we have not had comprehensive, standard clinical evaluations" of vaccines' side effects, Dr. Walter Orenstein, an official at the CDC, said (Altman, New York Times, 10/18).

Meanwhile, there is "little or no support" among members of the advisory panel to make the smallpox vaccine available to all Americans, the Washington Post reports. HHS officials two weeks ago announced support for making the vaccine available nationwide. "I think it's a mistake. I think we don't help the public if we say, 'You can be immunized. It's up to you,'" Paul Offit, chief of infectious diseases at Children's Hospital of Philadelphia and one of the panel's members, said. According to the Post, many panel members expressed concerns about the risks associated with the vaccine and the potential of legal and logistical problems (Brown, Washington Post, 10/18). Foremost in those problems is the estimate that at least 20% of the population would be ineligible to receive the vaccine because of compromised immune systems or other medical conditions (McKenna, Atlanta Journal-Constitution, 10/18). Dr. John Modlin, chair of ACIP, said that the following groups would be precluded from receiving the vaccine because of their medical condition: women who are pregnant or expect to be pregnant; people with skin conditions, such as eczema; and people with HIV/AIDS or other conditions that may compromise their immune system (Ricks, Long Island Newsday, 10/18). The panel also recommend against vaccinating people who have or live with anyone who has a skin condition, such as psoriasis, shingles or "severe" acne. The Journal-Constitution reports that skin disorders alone will rule out 20% of potential vaccine recipients. Other concerns for panel members include liability issues for both vaccine manufacturers and the government; "uncertainty" concerning compensation for those people who do experience side effects; and the ability of the government to enact a "patient-tracking and record-keeping system" before the first vaccinations begin (Atlanta Journal-Constitution, 10/18).