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Reported Side Effects Deal Blow to Meningitis Vaccine

Sep 23, 2005 | Arizona Republic

News earlier this year that federal health officials were recommending use of a new vaccine against four deadly strains of bacterial meningitis for adolescents brought tears to Jim Garcia's eyes.
    
"I was sitting in my favorite restaurant in Rocklin having breakfast," said the Loomis man, whose son, John, died in 2000 from meningococcal meningitis. "I broke down. It was this calm, this peace came over me."

Although it was too late for his son, he thought, routine vaccination would mean that millions of other youngsters and their families never would have to confront the devastation of meningococcal disease.

The promise of mass protection, however, suffered a setback recently with news of a potential, but unproven, association between the vaccine, Menactra, and a serious neurological disorder called Guillain-Barr syndrome, or GBS. The information initially caused some local pediatricians to suspend use of the vaccine.

The concerns were prompted by an alert issued Sept. 30 by the federal Centers for Disease Control and Prevention. It noted five youngsters had come down with GBS soon after getting the Menactra vaccine. A sixth case was reported after the alert was sent out.

The initial five cases were in patients 17 or 18 years old, and all developed weakness or abnormal sensations in their arms or legs two to four weeks after the shot. Each of the cases remains under investigation. All of the teens are recovering.

Federal health officials stress that, while the timing of the events is cause for concern, the number of cases so far reported among teens immunized with Menactra is no greater than what would be expected to occur without vaccination. They note, also, that no cases of Guillain Barr cropped up during clinical trials of the vaccine.

"It is something we need to look at very carefully, and that's what's being done," said Dr. Joseph Bocchini, chief of pediatric infectious diseases at Louisiana State University Health Sciences Center and a member of the infectious disease committee of the American Academy of Pediatrics.

"In the interim, we have recommended those individuals at risk for meningococcus infection should continue being given the vaccine because that is a very severe, life-threatening disease."

Menactra, approved by the FDA in January, protects against four types of Neisseria meningitidis, the bacterium that causes a significant percentage of meningococcal infections.

The infection can result in meningitis the inflammation of the lining of the brain and spinal cord and menigococcemia, a related blood infection. Both can be deadly. Meningococcal disease is fatal in 10 percent of cases. Of those who survive, up to one in five will have permanent problems such as hearing loss, neurological damage and limb amputation.

Although meningococcal disease is rare, the Sacramento region had a frightening spate of cases in 2000 and 2001 when five otherwise healthy teenagers, including John Garcia, died after contracting the infection. The deaths spurred state legislation to boost awareness of the disease, and in 2001, several colleges began recommending the vaccine an earlier version called Menomune to all incoming freshmen.

But the coup for parents such as Jim Garcia came with FDA approval of an improved vaccine and the CDC's subsequent recommendation for its use in 11-and 12-year-olds, those entering high school and college freshmen planning to live in a dorm, among other groups.

"We were elated for what part we played in it all of us who came together and put pressure on the CDC," Garcia said.

He said he was shocked to learn of the potential link between Menactra and GBS, ironically the disease that took his father's life. "But until further tests are done, and they can prove (a link), we may have vaccine out there that can prevent a lot of people from contracting meningococcal meningitis."

GBS is a fairly mysterious disease in that its cause is not well understood and there is no real cure, although treatments developed in recent years are effective in reducing the symptoms.

Dr. Robert Miller, a neurologist at California Pacific Medical Center in San Francisco and a member of the International GBS Foundation's advisory board, said GBS is an immune system abnormality.

"The immune system gets stirred up by something  an infection, an immunization, a surgical procedure or a traumatic injury," he said. The swine flu vaccine, used during an outbreak in 1976, was shown to trigger GBS.

He said scientists believe the body's immune system overreacts to the foreign invader. In the case of GBS, the immune response inflames the nerves and degrades the surrounding myelin sheath, inhibiting the nerve's ability to transmit impulses.

"And when you can't transmit an impulse, the muscle won't react. It can cause paralysis and it can be permanent," he said.

The majority of people recover, he said, but it can take weeks or months.

In response to the cases of GBS reported to the FDA in youngsters who had received Menactra, the CDC revised its recommendations, but only slightly. The agency now advises that anyone who has had GBS in the past should talk to their doctor before getting the vaccine.

Rose Kwett lost her daughter, MaryJo, a Loretto High School student, to meningococcemia in 2000.

She has been working since to educate students about the disease, and said the greater threat is the vaccine manufacturer's inability to keep up with demand.

Sanofi Pasteur has distributed about 2.5 million doses of Menactra, according to the FDA. About 24 million children are eligible for the immunization.

Even Kwett's son, now 17, was unable to get the vaccine at his last doctor's visit because the stocks were gone, she said.

"(The manufacturer) needs to get to it," she said. "My son is due."