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
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
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,
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.