By Kate Kelland
Reuters

GlaxoSmithKline's Pandemrix swine flu vaccine has been linked to cases of the rare sleep disorder narcolepsy in children in a scientific study in England that confirms similar findings elsewhere in Europe.

The vaccine, more than 30 million doses of which were given during the H1N1 flu pandemic in 2009-2010, contains a booster, or adjuvant, and may have triggered an adverse immune reaction in some children at higher genetic risk of narcolepsy, scientists said in new research published on Wednesday.

Researchers at Britain's Health Protection Agency (HPA) who published the study in the British Medical Journal said the at least 14-fold increased risk they found had "implications for the future licensing and use of adjuvanted pandemic vaccines".

Narcolepsy is a life-long disorder and thought to be an autoimmune disease in which patient's immune system attacks the body's own cells. Its symptoms include frequent bouts of daytime sleepiness and in its severe forms it also causes night terrors, hallucinations and cataplexies - when strong emotions trigger a sudden loss of muscle strength.

Studies in Finland, Sweden and Ireland have also found a Pandemrix link to narcolepsy, and GSK says more than 800 cases linked to the shot have been reported in Europe.

A spokesman for the British drugmaker told Reuters on Wednesday: "We really want to get to the bottom of this and understand more about the potential role of Pandemrix in the development of narcolepsy."

He added, however, that GSK believes "the available data are insufficient to assess the likelihood of a causal association between Pandemrix and narcolepsy."

As Reuters reported earlier this month, scientists investigating the link further are homing in on the vaccine's adjuvant, a booster called AS03, and analysing whether its super-charging effect may have played a role.

According to the UK results, vaccination with Pandemrix at any time was associated with a 14-fold increased risk of narcolepsy, whereas vaccination within six months before onset of the disease was associated with a 16-fold increased risk.

"The increased risk of narcolepsy indicates a causal association," said the research team led by Liz Miller, a consultant epidemiologist with the HPA. They added, however, that because of variable delay in diagnosis, the risk may be overestimated because vaccinated children may have been referred to specialist sleep clinics more rapidly.

Scientists said the risk translated into around one in 50,000, lower than studies have found in other countries such as Finland and Sweden where Pandemrix was used more widely and the risk was around one in 16,000 to 17,000 children vaccinated.

In total, more than 30 million doses of the GSK shot were given in 47 mainly European countries during the H1N1 flu pandemic. It was not used in the United States.

The UK study looked at 75 children aged between four and 18 who were diagnosed with narcolepsy from January 2008 and who attended sleep centres across England. Eleven of the children had been vaccinated with Pandemrix before their symptoms began. 

Finn stressed that Pandemrix is the only vaccine linked to this problem: "There is nothing to suggest that it occurs after other flu vaccines or vaccines against other diseases." 

Narcolepsy is thought to be due to loss of function in cells called hypocretin cells in one of the brain's sleep centres.

John Shneerson, a consultant physician from the Respiratory Support and Sleep Centre at Papworth Hospital in Cambridge who co-led the UK study, said Pandemrix may have triggered an immune reaction against those cells, causing narcolepsy in some children who were genetically vulnerable.

Experts say around 25 percent of Europeans have a genetic profile making them more susceptible. Narcolepsy has no known cure, but specialist doctors say symptoms can be treated with drug combinations aimed at re-regulating the sleep-wake cycle. 

Just about everyone is supposed to get a flu shot every year, and two groups are particular no-brainers -- pregnant women and health care workers. But new numbers released on Thursday show that fewer than half of pregnant women got vaccinated last year and just two-thirds of health care workers did.

Although they’ve been pushing flu vaccination hard for more than a decade, public health officials admit they are still finding it a hard sell. But it’s not necessarily resistance. It just may not yet be easy enough to get the vaccine. And recent mild flu seasons haven’t helped.

About 128 million people, or about 42 percent of the U.S. population, got immunized against influenza last year. Because flu viruses constantly mutate and evolve, people must get vaccinated with a fresh formula every year to be fully protected. This year’s vaccine protects against the three most common circulating strains.

The best vaccination rates are among babies aged up to 2, with nearly 75 percent vaccinated. That’s because babies make regular visits to pediatricians, and vaccinations are a routine part of those visits. And more than 63 percent of 2- to 4-year-olds were vaccinated last year. But just 29 percent of 18- to 49-year-olds had a flu shot.

Pregnant women are especially vulnerable to flu. Not only do they get sicker, because pregnancy suppresses the immune system, but the infection can lead to losing their babies. The vaccine also protects a woman’s newborn, who cannot get the vaccine until age six months.

“Influenza is five times more likely to cause severe illness in pregnant women than women who are not pregnant,” said Dr. Laura Riley of Massachusetts General Hospital in Boston and the American College of Obstetrics and Gynecology.

But a CDC survey released Thursday showed that just 47 percent of pregnant women had a flu vaccine last year. If their doctors both recommended and provided the vaccine, nearly 74 percent of pregnant women got the shot. Just 11 percent of women whose doctor said nothing got immunized.

Even though doctors have been stressing for years that flu vaccines cannot give people the flu, a full quarter of the pregnant women who refused the vaccine said they believed it would infect them. Another 13 percent thought their babies were at risk.

“Pregnant women worry about everything,” Riley said. “We spend a lot of time in this country talking about you can’t eat this, you can’t eat that. It takes us a little while to get the message out about how efficacious (the vaccine) is. We are preventing a very severe disease potentially and we are protecting your baby.” Vaccination does not raise the risk of miscarriages or birth defects.

Don Emmert / AFP - Getty Images file

A mild flu season last year and memories of the H1N1 pandemic that didn't turn out to be as serious as expected have made flu shots a hard sell to the general public.

Flu may be off many people’s radar because the last two years haven’t been especially bad, and because the 2009 H1N1 swine flu pandemic didn’t turn out to be as bad an initially feared.

Yet, 1,300 children died from H1N1 that year and about 100 U.S. children die every year from flu, half of them previously perfectly healthy, CDC says. The CDC estimates that anywhere between 3,000 to 49,000 people a year die from flu in the United States. A lot depends on the strains circulating.

“Flu is unpredictable. Just because we got off easy last season does not mean we will get off easy this season,” Riley said.

The other group that should have 100 percent vaccination is health care workers. The CDC data show that more than 86 percent of physicians are vaccinated, followed by more than three-quarters of nurses. But the numbers plummet to just half of workers in long-term care facilities, where patients are especially vulnerable to flu.

“I believe that the immunization of the health care provider community is both an ethical and professional responsibility,” said Dr. William Schaffner of Vanderbilt University in Nashville and the National Foundation for Infectious Diseases. “It’s a patient safety issue so that we do not transmit our influenza infection. When an outbreak strikes, we need to be vertical, not horizontal.”

As with the pregnant women, health workers were more likely to get vaccinated if it was easy for them. More than 78 percent of health care workers got immunized if free vaccine was made available for several days at work. And 21 percent of the health workers said getting flu vaccine was now a condition of employment. More employers should consider making it a requirement, said Litjen Tan of the American Medical Association.

This year, 135 million doses of flu vaccine will be available to the U.S. market. People can get vaccinated at pharmacies, at big-box stores, grocery stores, doctor’s offices and often at their places of employment. Most private insurance companies and Medicare pay for the whole cost of the vaccine.

And while the vaccines are not specifically formulated to protect against some new flu strains that a few people have caught from pigs, they may offer some help, health officials said.

So far, the three new variants identified this year --  H3n2v (the little v stands for “variant”), H1N1v and H1N2v -- don’t spread easily from person to person. Almost everyone infected has been close to pigs. One person has died from the new H3N2v virus, but everyone else has recovered.  The CDC’s Dr. Daniel Jernigan says people alive in the 1990s have some immunity to the H3N2 version, and the new H1N1v is close to the strain that the current vaccine targets, although the protection is not perfect.

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(Updated Aug 11: CDC has raised the number of people confirmed infected to 153)

As many as 153 people have been infected this summer with a new pig flu virus, the U.S. Centers for Disease Control and Prevention said this week, although the disease does not appear to be any more serious than normal seasonal flu. Nine out of 10 of them are children, CDC says.

Most cases appear to be among people who were showing pigs, or people visiting fairs and other places where these pigs are, CDC says. This suggests they are catching the flu directly from infected pigs. So far everyone has gotten better on their own, Dr. Joseph Bresee, from the CDC's influenza division, told reporters on a telephone briefing Thursday.

“At this point there is no evidence of sustained, efficient human to human spread,” Bresee said. “This is not a pandemic situation.”

But Bresee cautioned that even seasonal flu can kill people and this is likely the case with the new form of flu, which is designated H3N2v.

The new strain of H3N2 was first seen last year, and three people were confirmed to have caught the bug from other people. So far it has not been any more serious than regular, seasonal flu, causing fever, a sore throat and achy muscles. Last year no one ended up in the hospital with the new flu. This year, two people have but they are fine now, Bresee said.

While the current flu vaccine does not protect against this new virus coming straight from pigs to people, patients can be treated with the two drugs that work against seasonal flu – Tamiflu and Relenza.

Most of the cases have been in Indiana, where 120 have been reported, the CDC said. There have also been 31 cases in Ohio, one case in Hawaii and one case in Illinois.

Flu viruses have eight genes, and this one is seven-eighths pig virus -- a virus designated H3N2 that’s been circulating among swine for years. But one single gene comes from the H1N1 swine flu virus that caused a new pandemic of influenza  among people in 2009 and which is now part of the human seasonal flu mix.

The names can be confusing because there's also an H3N2 virus that causes seasonal flu in people, and it's one of the three strains of flu virus that is included in the vaccine that's just arriving in doctor's offices and clinics now. "Get your flu vaccine," Bresee advised. "Everybody should get a flu vaccine this year in the U.S. because regular, seasonal flu will be here soon."

CDC stressed that only people who have contact with pigs are at any real risk of catching this flu. "This time of year is the time when you have state and county fairs…there’s thousands of them," Bresee said. CDC has some simple advice to prevent infection:

• Wash your hands after you've been near any live pigs
• Don't bring any food or drink into areas where live pigs are
• Stay away from swine if you are at high risk from flu, for instance if you are elderly or have a weakened immune system.

Swine flu vaccine may lead to broader flu protection

Swine flu outbreak 15 times deadlier than thought, study finds

By Rachael Rettner
MyHealthNewsDaily

The vaccine against swine flu seems to offer broader protection against other flu viruses, compared with the seasonal flu vaccine, researchers say.

This vaccine, officially called the 2009 H1N1 vaccine, was administered in 2009 to protect against a new virus strain that caused a pandemic that year.

In the new study, people who received this vaccine developed antibodies against not only H1N1, but also several other flu strains, the researchers said. Such protection against multiple strains is rarely seen in people who receive the seasonal flu vaccine or are infected with seasonal flu, the researchers said.

The findings bring researchers closer to developing a universal flu vaccine — one that provides broad protection against flu viruses and lasts for years, said study researcher Rafi Ahmed, director of the Emory University's Vaccine Center. Currently, a new seasonal flu vaccine must be developed and administered every year because its protection is limited to certain strains, and wanes over time.

The study will be published this week in the journal Proceedings of the National Academy of Sciences.

Broad protection
Previously, Ahmed and colleagues found that people who became sick with the 2009 H1N1 flu virus produced antibodies against multiple flu viruses, but it was not known whether the vaccine could do this as well.

The new study involved 24 healthy adults who were immunized with the 2009 H1N1 vaccine. Seven days after they received the flu shot, the researchers analyzed their blood.

A universal vaccine for flu?
Flu viruses consist of a "head" region that changes over time and varies between strains, and a "stalk" region that remains fairly constant. Usually, antibodies against the flu bind to the head of the virus, and for this reason, the protection that seasonal flu vaccines offer is typically quite specific.

However, in the new study, participants produced some antibodies that could bind to the stalk of the flu virus — it's these antibodies that could be the basis for a universal flu vaccine, Ahmed said.

Antibodies are produced by cells called B cells. The researchers speculate that, because H1N1 was such a "new" strain of flu, it forced the body to activate a rare type of B cell, one that could produce antibodies that bind to the virus' stalk.

"The next step now is to design a vaccine to target these B cells," Ahmed said.

"The study is encouraging, that we're seeing antibodies generated against the conserved portions of the virus," said Dr. Bruce Lee, an associate professor at the University of Pittsburgh Graduate School of Public Health. "But it's just an initial step," Lee said, noting that much more work is needed before the results could be translated to a universal flu vaccine.

And while the production of antibodies against a virus suggests that people will be protected against it, it remains unclear whether they could avoid catching the disease, Lee said.

Participants had increases in antibodies against several flu strains, including H1N1, H5N1 and H3N2. Antibodies are immune system proteins that bind to harmful pathogens, such as viruses.

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By Rachael Rettner
MyHealthNewsDaily

Here's a reason to get your flu shot that you probably haven't considered: infection with swine flu may trigger baldness.

A new report from Japan suggests a link between alopecia areata, a condition in which patches of hair fall out, and swine flu. The researchers report that seven patients experienced hair loss one to four months after developing the illness.

The exact cause of alopecia areata is unknown, but it is thought to occur when the immune system attacks a person's hair follicles, causing the hair on their head to fall out. Rarely, patients may lose all the hair on their head, or on other parts of their body. While the condition may have a hereditary component, a "trigger" from the environment, such as a traumatic event or illness, may also be needed to set off the disease.

Previous studies have linked viral illnesses, including infections with the Epstein-Barr virus, and onset of alopecia areata. The new findings suggest flu infection may be another trigger of this form of baldness, said study researcher Dr. Taisuke Ito, an assistant professor of dermatology at Hamamatsu University School of Medicine in Japan.

Between 2009 and 2010, the researchers examined seven patients with hair loss following swine flu infection s that caused high fever. Four of the cases were recurrences of the condition, and three were first-time occurrences. On average, hair loss occurred 1.5 months after swine flu infection in those who experienced recurrences, and 2.7 months after swine flu infection in those who experienced first-time hair loss.

All of the patients were under 30 years old, and four were under 10. Three of the cases involved females.

In one case, a 4-year-old girl first experienced alopecia areata in 2006, but recovered completely. Then in 2010, she contracted swine flu and had hair loss two months later.

"I consider it very plausible," that a flu infection could trigger hair loss, said Nanette Silverberg, director of pediatric and adolescent dermatology at St. Luke's-Roosevelt Hospital Center in New York City, who was not involved in the study. "I definitely have seen individuals develop autoimmune conditions," after infection with common viruses, Silverberg said. (An autoimmune condition is one in which the immune system attacks the body's own tissues, rather than foreign germs.)

The fact that more than half of the cases were recurrences of alopecia areata further suggests that certain people are genetically predisposed to develop the condition, Ito said.

Individuals who have had alopecia areata in the past should consider getting their flu vaccination, Silverberg said.

The study was published online Dec. 5 in the Journal of Dermatology.

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Centers for Disease Control and Prevention

A transmission electron micrograph shows some of the structural details of the H3N2 flu virus that infected patients in Indiana and Pennsylvania earlier this year. The virus was formed through the reassortment of two other flu viruses.

Three children in Iowa have come down with a new type of flu virus previously linked to pigs, but this time the bug appears to have been spread by people.

The children, who live in rural Webster and Hamilton counties, did not become seriously ill, said Dr. Patricia Quinlisk, medical director for the Iowa Department of Public Health. But the detection of the virus known as swine-origin A/H3N2 in patients who hadn't had contact with animals raises concerns about potentially greater spread of a new type of flu.

"We have pretty good evidence of person-to-person spread," Quinlisk said. "None of the children or anyone around them had exposure to swine, turkeys or other sources."

Officials with the Centers for Disease Control and Prevention had previously detected seven cases of people with the new H3N2 virus that appears to have acquired a gene that may make it more transmissible from H1N1, the flu that sparked the so-called swine flu pandemic in 2009. Flu viruses often swap genetic parts. Officials say the new virus was probably formed when a pig became infected with the H3N2 virus and the H1N1 virus at the same time.  

The new bug has components of human, avian, H1N1 and swine flu viruses, all mixed together in what scientists call a recombinant virus.

The first new H3N2 case was identified in a child in Indiana in July, and has been followed by cases in Pennsylvania, Maine and, now, Iowa.

In the previous cases, however, the patients either had direct exposure with pigs, or exposure to a person who'd been around pigs. In the new cases, it appears that one of the children transmitted the flu to the other two, and none of them had any animal exposure, Quinlisk said. She declined to identify the children or their ages, saying only they were younger than 18. No further cases have been identified in the past week, she said.

The Iowa cases are nothing to panic about, health officials emphasized. The H3N2 flu causes symptoms similar to the regular seasonal flu, including fever, cough, fatigue, body aches and loss of appetite. 

"People need to be most concerned about the regular, everyday seasonal flu," Quinlisk said.

But Iowa health officials are now testing samples of people with flu-like illness to detect further spread of the new bug. And CDC officials have asked states across the country to be vigilant in looking for it, said Dr. Joe Bresee, the agency's influenza and epidemiology branch chief.

The current seasonal flu vaccine being offered by doctors and clinics was not developed to protect against the H3N2 virus. It contains some antigens similar to a flu virus that circulated in the 1990s, so some people who had the flu then or were vaccinated could have some immunity, but it's not clear how much, Quinlisk said. The Iowa children apparently had not been vaccinated, she added.

With the new cases, CDC officials have confirmed 31 cases in the U.S. of the new swine-origin virus since 2005, including 10 with the H3N2 virus that carries the M gene from the 2009 H1N1 virus.

The best prevention for the new flu, as with any flu, is to wash hands frequently, cover coughs and sneezes and limit spread of germs by staying home when you're sick, health officials said.

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