Five Develop Nerve Disorder After Receiving Meningitis Vaccine (NY Times)
Wednesday October 5th, 2005
Five teenagers developed a serious neurological disorder within two to four weeks after receiving the vaccine Menactra, which prevents a severe and deadly form of meningitis, the Food and Drug Administration reported yesterday.
All have recovered or are recovering from the illness, Guillain-Barré syndrome, which causes weakness in the arms and legs and can spread to the chest and impair breathing. The drug agency said in a news release, "It is not yet known whether these cases were caused by the vaccine or are coincidental."
In the meantime, parents should continue to vaccinate their children, said Dr. Karen Midthun, deputy director of the drug agency's Center for Biologics Evaluation.
The vaccine is needed because meningococcal disease is a horrific illness that comes on suddenly and can be rapidly fatal, with a death rate of about 10 percent. Among survivors, up to 19 percent wind up with permanent disabilities.
The meningococcal disease affects about one person in 100,000 annually, and college freshmen living in dormitories are among those at greatest risk of contracting it.
Guillain-Barré syndrome has a death rate as high as 5 percent, Dr. Midthun said, adding that a majority "do recover, and recover fully."
Dr. William Schaffner, chairman of the department of preventive medicine at Vanderbilt University, agreed that vaccination should continue and said that he would insist on vaccination if he had children in the age group generally vaccinated.
Menactra, made by Sanofi Pasteur, was licensed in the United States in January and recommended for high school and college freshmen, 11- and 12-year-olds and all travelers to certain countries. So far, more than 2.5 million people have received Menactra shots, and there have been no other reports of Guillain-Barré.
Statistically, the five cases could be coincidental. No cases were detected in studies in 7,000 patients before the vaccine was licensed.
Experts from the company, the drug agency and the Centers for Disease Control and Prevention are studying the cases to try to determine whether the vaccine was to blame. One possibility they will consider is whether the syndrome was related to an infection caused by Campylobacter bacteria, a common cause of food poisoning, particularly from chicken. In the United States, the bacterium is linked to up to 40 percent of Guillain-Barré cases.
The five cases occurred in New York, Ohio, New Jersey and Pennsylvania. The limited region is puzzling, given the vaccine's wide use. That pattern suggests that it is at least possible that something other than the vaccine could be responsible, Dr. Schaffner said.
To find out if there are more cases, the Food and Drug Administration is asking doctors and the public to report any possible cases of the nerve syndrome after vaccination, via the Internet at www.vaers.hhs.gov or by calling (800) 822-7967.
Meanwhile, Dr. Andrew von Eschenbach, the interim head of the Food and Drug Administration, announced late Friday afternoon that he would no longer hold two full-time jobs, the interim one at the drug agency and his original job as head of the National Cancer Institute.
Dr. von Eschenbach told the F.D.A. staff of his decision in a memorandum, explaining that Michael O. Leavitt, secretary of health and human services, had asked Dr. von Eschenbach's deputy, Dr. John Niederhuber to handle "day-to-day management" at the cancer institute. Staff members there received a similar memorandum.
Dr. von Eschenbach was appointed to the F.D.A. post on Sept. 23 by President Bush when the recently confirmed F.D.A. commissioner, Dr. Lester Crawford, abruptly resigned. Dr. von Eschenbach initially said he would remain at the cancer institute and perform the drug agency job.
That left him open to criticism that he was taking on too much and that the two jobs could lead to conflicts of interest. The cancer institute applies to the F.D.A. to test cancer drugs and conduct clinical trials.
In his memorandum, Dr. von Eschenbach wrote that he would recuse himself from drug agency business that involves the cancer institute unless the Department of Health and Human Services asked him to participate in particular cases.