By Carla McClain
ARIZONA DAILY STAR

Reports of paralysis in teenagers — including an Arizona youth — who got the new meningitis vaccine are raising alarms about the shot’s safety.

Federal health investigators have not confirmed the new vaccine as the cause of the paralysis. And with case numbers still low, they have not limited its use.

However, a nationwide alert has been issued to all public-health departments, doctors and clinics, ordering that they warn anyone getting it of a possible link to a paralytic condition known as Guillain-Barré syndrome.

“I am not allowed to tell people they should not get this vaccine. But we have been telling them about this concern,” said Dr. Michelle McDonald, medical director for the Pima County Health Department.

“The vaccine came out last summer with a whole lot of hoopla — lots of publicity,” she said. “But right now, it’s really very difficult to say if what’s happening is just coincidence or a true risk.”

Paralytic episodes have been linked to vaccines in the past — most famously with the swine-flu vaccine of the 1970s, blamed for about 500 cases of Guillain-Barré and 25 deaths.

The new meningitis vaccine, known by the brand name Menactra, was released in the United States almost a year ago — shortly after the sudden death of Sabino High School soccer star Chris Maier from bacterial meningitis.

Described as more effective and longer-lasting than the old meningitis vaccine, Menactra was widely publicized in Tucson, where many were reeling from the shock of Maier’s death.

The shot is recommended for all adolescents around 11 or 12, and is especially targeted at teens entering college who plan to live in dormitories, which puts them at higher risk of infection.

Crowded living conditions and casual hygiene raise the risk of contracting the meningococcal bacteria, which is why outbreaks often cluster in college dorms, boarding schools, overnight camps and athletic locker rooms.

The new shot promises at least 80 percent protection against this most dangerous form of meningitis, which strikes 3,000 Americans every year, killing about 10 to 12 percent and leaving others with lasting brain damage, loss of limbs, strokes and seizures.

But alarms started to go off within months of Menactra’s debut last spring, when the first cases of Guillain-Barré appeared in several teens shortly after they were vaccinated.

Starting with weakness or tingling in the legs, the syndrome can progress to partial or total muscle paralysis — and can prove fatal if the breathing or heart rate is affected. Most people do recover, though some suffer permanent weakness.

By October, the first five Guillain-Barré cases showed up in teens within weeks of when they received the Menactra shot. Three more cases were reported this month, also in teens — including an unidentified 19-year-old Phoenix resident who was vaccinated in August. Three weeks later, he developed Guillain-Barré that left him severely weakened and unable to run or use his hands.

All these teens — from Arizona, Ohio, Pennsylvania, New York and New Jersey — have recovered. But one, an 18-year-old girl, almost died when her breathing muscles shut down, requiring her to be hospitalized on a ventilator for more than a week. After six weeks of rehabilitation, she has regained the ability to talk, feed herself and stand, according to a report by the U.S. Centers for Disease Control and Prevention.

What has set off alarms is that all the teens came down with Guillain-Barré within six weeks of vaccination — the window of time in which other vaccines have triggered the syndrome. Also, none had any recent history of viral gastrointestinal or respiratory illness — the agents most often linked to a Guillain-Barré episode.

However, with only eight Guillain-Barré cases so far reported out of 3.7 million Menactra doses distributed in the United States, the CDC has calculated that the risk remains no higher than normally expected in the overall population.

“CDC continues to recommend use” of Menactra — though not in people at low risk for meningitis, states the agency’s report on the most recent Guillain-Barré cases.

It says evidence so far is insufficient to conclude that Menactra causes Guillain-Barré. “However, the timing of the onset of … symptoms is still a concern, and further monitoring and studies are ongoing.”

The state Department of Health Services has distributed nearly 39,000 doses of Menactra to doctors and clinics, but only 14,000 have been used so far — with one Guillain-Barré case.

“At this point, one cannot completely refute there being a link to the vaccine,” said Dr. Ziad Shehab, a pediatric-infectious-disease specialist at the University of Arizona.

“But, on the advice of the CDC, we are using it, though it has to be monitored. We just have to be on the lookout for any bad reactions.”

Only “dozens” of Menactra shots have been given through the county Health Department, in part due to an early shortage of the vaccine, medical director McDonald said.

Now, only children with a rare immune deficiency, or those without a spleen, and college freshmen 18 or younger who live in dorms are getting the shot in public clinics here.

“I’m torn about it,” admitted McDonald, the mother of a teen headed for college this fall.
“It’s true there is a blip in the risk for meningitis for college freshmen, and it is a devastating disease — you’re alive, healthy, vibrant one day, and the next day you’re gone. But still, the numbers are relatively low. I’m still puzzling over this for my daughter.”

However, Leslie Maier, mother of Chris Maier — the soccer star who went from superb health to death within days of infection — remains convinced of the safety and the need for the vaccine, and mourns that her family did not know about it in time.

At her urging, Menactra was made available free to students at Sunnyside and Desert View high schools, in the Sunnyside Unified School District, where she teaches. At two clinics held this month, about 320 students were vaccinated, mostly athletes or college-bound seniors.

Their parents signed consent forms for the shot, which contained a warning of the Guillain-Barré cases.
“When I first heard about this, I did pull back for a few months,” said Leslie Maier, who has worked with her husband, John, to warn parents about meningitis, and about the benefits of vaccination, since their son died. But after lengthy discussions with experts at the National Meningitis Association, they decided to continue.

“Doctors there, fathers with young children, assured us it is safe and they would absolutely give their children Menactra,” she said. “What we know for sure is that bacterial meningitis is far more lethal.”

The risk Bacterial meningitis
l Strikes 3,000 Americans every year.
l Kills 10 percent.
l Causes brain damage or loss of limbs in 15 to 20 percent.
Guillain-Barré Syndrome
l Strikes 1 to 2 per 100,000 yearly.
l Kills a small, unknown number.
l Leaves 20 percent with prolonged disability.
l Has affected eight teens vaccinated with Menactra, out of 3.7 million doses distributed, though the actual number of shots given is unknown.
Sources: U.S. Centers for Disease Control and Prevention, National Institutes of Health

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