By John Lauerman

Nov. 13 (Bloomberg) -- Vaccines against influenza that the U.S. government is pushing to cut annual deaths and prepare for a possible pandemic may be linked to slightly higher rates of a paralyzing nerve disorder, a study found.

Patients with the disorder, called Guillain-Barre syndrome, were more likely to have been diagnosed in the seven weeks after vaccination than in a comparison period four to six months later, Canadian researchers said in today's issue of the Archives of Internal Medicine.

The results of the study are consistent with earlier research on flu vaccine, and won't change federal recommendations, said Jeanne Santoli, a vaccination expert with the U.S. Centers for Disease Control and Prevention, in a teleconference today. Federal officials are encouraging the production and use of flu shots to cut an estimated 36,000 deaths and more than 200,000 hospitalizations each year from influenza.

``The risk is real. You don't want to have this blindside you,'' said Canadian researcher David Juurlink, who led the study, in a telephone interview, ``But the benefits of vaccination are really substantial.''

Sanofi-Aventis SA, GlaxoSmithKline Plc, Novartis AG and MedImmune Inc. make flu vaccine for the U.S. market, based on strains that public-health officials identify each year as the most common currently circulating. The CDC has expanded its guidelines for flu vaccine in recent years, and the agency now recommends immunization for almost two-thirds of Americans.

While the risk of Guillain-Barre is so small that rates of the disease didn't increase when a vaccination program began in Ontario, patients should be informed, Juurlink said.

Ontario Program

Increasing flu vaccine use will also help the U.S. prepare for mass immunizations in the event of a worldwide outbreak of lethal flu, which government health officials have said is inevitable.

Ontario began a universal flu vaccination program in 2000 after a severe outbreak the previous year overloaded hospitals with patients. The program also presented flu experts with a way to examine suspected complications of the vaccine, such as Guillain-Barre.

Concerns about the mysterious, paralyzing disorder, which is usually temporary, arose in 1976 during an outbreak of the so- called swine flu that U.S. health officials warned might cause a pandemic. While the pandemic never materialized, the link raised long-standing fears about the safety of flu vaccine.

A 1998 study in the New England Journal of Medicine found that flu vaccination raised the risk of Guillain-Barre 70 percent. However, a 2003 review of other studies by the U.S. Institute of Medicine, the agency that creates volunteer expert panels to advise the government on health issues, found no association between Guillian-Barre and seasonal flu vaccination.

Timing

Juurlink, a researcher at Canada's Institute of Clinical Evaluative Sciences in Toronto, and his team found 269 patients diagnosed from April 1992 through March 2004 who developed the nerve disease within a six-month period after vaccination. Patients were 45 percent more likely to develop the disease in the first two months after vaccination than in the fifth and sixth months, the researchers said.

Ontario also had begun a large immunization program against pneumococcal disease, a bacterial infection, that may have been responsible for some complications, said David Fedson, a former vaccine developer and University of Virginia professor of medicine, in an e-mailed response to questions.

``The association is there,'' with flu vaccine, Fedson said, ``but the increase in risk is very small.''

Benefits, Risks

Young children and people who are at least 65 years old are at highest risk of complications from flu vaccination. More studies in these age groups, along with teens and young adults, are needed to show the benefits of vaccination against potential risks, he said.

``Only in this way can people balance the benefit and risks of vaccination,'' he said.

Juurlink said he would continue to recommend vaccination for his patients and family.

``It's a no-brainer,'' he said. ``Literally tens of thousands of Americans don't get hospitalized or die each year because they've had flu vaccine, and to me it's worth the trade- off.''

To contact the reporter on this story: John Lauerman in Boston at jlauerman@bloomberg.net ;

I had been waiting since I knew the shot would be given free today at work.  Let's hope I build enough antibodies before the flu gets here from the NC mountains (I am in the piedmont of NC).

I just may be getting paranoid, could be.  But my health care facility always has public flu clinics with the vaccine not used for employees, contract personnel, etc. so that it does not go to waste.  There is a charge for the vaccine that is comparable to the MD offices, etc.   Each year, the local health departments give flu shots at a cost.  Never have I ever in 10+ years seen any of our local HD give a flu shot for free to anyone.  Even during the year of shortages and desperate high risk persons begging for them.

Painkillers May Threaten Power Of Vaccines

With flu-shot season in full swing and widespread anticipation of the HPV vaccine to prevent cervical cancer, a new University of Rochester study suggests that using common painkillers around the time of vaccination might not be a good idea.

Researchers showed that certain nonsteroidal anti-inflammatory drugs (NSAIDs), also known as cyclooxygenase inhibitors, react with the immune system in such a way that might reduce the effectiveness of vaccines.

The research has widespread implications: study authors report that an estimated 50 to 70 percent of Americans use NSAIDs for relief from pain and inflammation, even though NSAIDs blunt the body's natural response to infection and may prolong it.

"For years we have known that elderly people are poor responders to the influenza vaccine and vaccines in general," said principal investigator Richard P. Phipps, Ph.D., a professor of Environmental Medicine, and of Microbiology and Immunology, Oncology and Pediatrics. "And we also know that elderly people tend to be heavy users of inhibitors of cyclooxygenase such as Advil, aspirin, or Celebrex. This study could help explain the immune response problem."

The study is available online in the Dec. 1, 2006, Journal of Immunology, and was funded in part by the National Institutes of Health.

When a person is vaccinated, the goal is to produce as many antibodies as possible to effectively neutralize the infection. To do this, white blood cells called B-lymphocytes, or B cells, spring into action to produce those antibodies. B cells also serve as the immune system's memory for future protection against the illness.

But Phipps and colleagues discovered that human B cells also highly express the cyclooxygenase-2 (cox-2) enzyme, which is not intrinsically bad unless it is overproduced, causing pain and fever. So, when a person takes a drug to block the cox-2 enzyme -- and thereby reduce pain and fever -- the drug also reduces the ability of B cells to make antibodies.

"The next step is to figure out the worst time to take drugs that inhibit cox-2 in the context of getting vaccinated. Is it the day before, the day of, or the day after" The timing is likely to be very important," Phipps said. "But meanwhile, we believe that when you reach for the medicine cabinet to reduce pain at the injection site, that is probably the wrong thing to do."

The findings are based on laboratory studies of blood samples from people who participated in early clinical trials for the HPV vaccine, and on studies of mice.

For the animal portion of the study, researchers vaccinated normal mice and mice engineered to be cox-2 deficient with a component form of the HPV vaccine. They analyzed the amount of antibodies the animals produced, focusing on the critical virus-neutralizing antibodies. The cox-2 deficient mice made 50 to 70 percent less of these key antibodies.

The same experiment was done on preserved blood samples from people who had been vaccinated against HPV-16, the strain linked to cervical cancer. Scientists reactivated the B cells in the blood samples and watched them churn out antibodies, as expected. But when researchers treated the B cells with a cox-2 inhibiting drug, the cells significantly diminished their production of antibodies -- showing that cox-2 is essential for an optimal immune response against HPV 16.

This study is not questioning the effectiveness of the newly marketed HPV vaccine, the Rochester scientists said. They pointed out that in many clinical trials involving thousands of women, the vaccine offered complete protection against the development of cervical cancer. And presumably some of these women were taking NSAIDs at the time.

"There's no doubt the HPV vaccine showed 100 percent efficacy. Still, our data does suggest that it might be wise to limit the use of NSAIDs when you receive any vaccine," said co-author Robert Rose, Ph.D., associate professor of Medicine and Microbiology and Immunology at the University of Rochester, and one of the virologists whose work led to the development of the new cancer vaccine.

Scientists do not completely understand the mechanism by which cox-2 influences the immune response in humans. They do believe the response may depend upon the dose and frequency of NSAID use.

The negative effects of blocking cox-2 could be more pronounced in people with compromised immune systems, such as AIDS or cancer patients, the study noted. Moreover, if a vaccine is in short supply and needs to be given in lower-than-optimal doses, taking an NSAID could hamper the immune response even more.

In addition to Phipps and Rose, graduate student Elizabeth Ryan was a co-author on the study, with assistance from students Matt Bernard and Christine Malboef.

Don’t let flu ruin holidays for you

If you haven’t had a flu shot, get one as soon as possible, experts advise

By LINDA H. LAMB

llamb@thestate.com

The crimson tide of influenza has reached South Carolina — though at this point, it’s more of a trickle as flu patients begin to show up in hospitals and doctors’ offices.

Starting with an unusually early outbreak in Alabama, the Southeast became the first region of the country significantly affected by flu this year, according to the Centers for Disease Control and Prevention.

The CDC’s surveillance map shows local or regional outbreaks of flu in South Carolina, Florida, Georgia, Mississippi and Louisiana. The disease already is considered to be widespread in Alabama, where the first case showed up in late August — a full five weeks before the state received its first batch of flu vaccine.

The good news here is that with scattered cases, there’s still plenty of time to get a flu shot, said Clair Boatwright of the S.C. Department of Health and Environmental Control.

“And there’s more vaccine than ever before,” with 1,256,650 doses distributed to public and private health care providers in the state, she said.

South Carolina has recorded only one laboratory-confirmed case of flu, the respiratory ailment that poses special risks for the very young, the very old and people with chronic medical problems. A spot check of local hospitals and schools found a few reported cases of flu, but no major outbreaks of flulike illness and no significant absenteeism.

However, doctors are reporting an increase in patients with flulike symptoms, and influenza “rapid tests” have turned up positive in several regions of the state including the Midlands.

“We’ve been seeing cases for the last couple of weeks,” said Cindy Brown, infection control coordinator at Palmetto Heath Richland. “It’s just a matter of time before more start popping up.”

While flu patterns vary from year to year, it’s common for more illness to occur as the holiday season gets under way, Brown said. People travel for family gatherings or vacations, increasing their chances of being exposed to areas where outbreaks are occurring.

“We’ve been trying to send (the flu) your way,” joked Dr. J. P. Lofgren, Alabama’s state epidemiologist.

For disease-trackers like him, it’s been weird to see Alabama as the early epicenter of flu this season. Usually, the CDC map shows initial flu outbreaks in the West.

“Every year, I’ve watched it sweep from west to east,” Lofgren said. But this year, three strains of flu turned up in southern Alabama, the first occurring in a group of middle-schoolers. As in South Carolina, it is more common for flu cases to start there in the fall and peak around February.

There’s no telling why the pattern was different this year. “Flu is unpredictable,” Lofgren said.

So far, the strains of flu occurring in Alabama have been relatively mild, he said.

Whatever is coming our way, South Carolina officials are urging people to boost their chances of avoiding flu altogether by seeking out flu vaccine that should be plentiful at doctors’ offices and county health departments.

Brown of Palmetto Health echoes their advice.

“The most important thing is to get a flu shot,” she said. “After that, it’s also important to clean your hands well, avoid touching your eyes and face, and if you are sick, stay home.”

If you still plan to get a flu shot, you also might want to consider a study just published in the Journal of Immunology.

Researchers at the University of Rochester in New York found that Cox inhibitors — contained in nonsteroidal anti-inflammatory (NSAID) drugs such as aspirin and ibuprofen — impede the body’s ability to develop infection-fighting cells following vaccination.

Does that mean you shouldn’t pop an Advil if you have a headache on the day of your flu shot? The researchers said more study is needed on that. Their study was done in mice and in blood samples taken from patients who had received the new human papilloma virus vaccine.

However, the lead researcher, Richard P. Phipps, has said he and his family avoid taking NSAIDs around the time they get their flu shots.

Reach Lamb at (803) 771-8454.

AVOIDING FLU

• It’s early in the flu season and there’s still time to get a flu shot, which takes full effect in about two weeks. With the conclusion of most vaccination clinics in stores and offices, you’ll need to call your doctor or county health department for an appointment.

• Eating right, exercising regularly and managing your stress can help you maintain a healthy immune system.

• Stay away from people who are sick — and if you get sick, stay home from work and church. In general, you’re contagious about five more days after symptoms start.

• Cover coughs and sneezes with tissues. Wash your hands thoroughly and often. Avoid touching your eyes, nose and mouth, which can help transfer viruses into your body.

• Flu symptoms include high fever, headache, fatigue, dry cough, sore throat, runny or stuffy nose. Children and some adults also may have nausea and vomiting.

• If you do get the flu, promptly taking prescription antiviral medication can lessen its effects. Avoid smoking. Get enough rest and drink plenty of fluids — but not alcohol.

SOURCES: S.C. Department of Health and Environmental Control; Palmetto Health

Rockland's first flu cases diagnosed

By JANE LERNER
THE JOURNAL NEWS

Mississippi Mama: My neighbors took me to the emergency room about an hour away. ER immediately gave me a tetnus shot as I had not had one since 2001 when I was bitten by a brown recluse and had not received one since 1998 when, well you get the picture of my life, LOL. Needless to say I'm the outdoors type, LOL.