The Calgary Sun: Flu shot suspect in death
Tuesday, January 6, 2004
Flu shot suspect in death
By BILL KAUFMANN, CALGARY SUN
The grieving family of a 22-month-old Calgary girl who died mysteriously are wondering if the tot suffered a fatal reaction to a flu vaccination. Relatives say on Dec. 30, Emma Bealing came down with a high fever, then suffered multiple seizures and died Sunday night at the Alberta Children's
Hospital after her parents consented to unhook their daughter from life support. "She died in her dad's (Douglas's) arms," said Emma's aunt, Joanne Bealing, yesterday.
Said Anthony Bealing, Emma's uncle: "No parent should have to decide how their child dies."
The seizures "came out of the blue" said the uncle, adding Emma was placed on life support last Tuesday. Her brain, he said, subsequently experienced severe swelling consistent with the condition Acute Disseminated Encephalomyelitis (ADEM). Along with bacterial or viral infections, ADEM can be caused by a severe response to inoculation -- a reaction that can lie dormant for two to three weeks.
Seizures are one symptom of an adverse reaction to inoculation, according to the Canadian Medical Association. A family member said the girl had received a flu vaccination about a month ago.
"(Vaccination as a cause) is only one theory we're looking at," said Anthony. "We wish the doctors did know for sure but they don't." He said Calgary Health Region officials told them an autopsy will be done to determine what led to the tragedy. The CHR wouldn't comment on the case.
Douglas Bealing and his wife Maureen had overcome medical challenges to have both Emma and her older brother, Harrison, 6, said the girl's aunt, Joanne. "It's just extremely tragic -- this couldn't come to a more loving or undeserving little family," she said. "Emma had a good personality even at 22 months and a good sense of humour." She said the death that's shocked and devastated the family now has struck fear in her own household. "I have a six-year-old and I'm going to be paranoid with every little fever she has," said Joanne.
Late last month, Jayden Tucker, 2, of Airdrie died after what might have been complications arising from the flu. Meanwhile, a three-year-old Nova Scotia girl died on the weekend from what health officials believe was the flu, the province's chief medical officer said yesterday. "It is rare for an otherwise healthy child to get severely ill with influenza," Dr. Jeff Scott said. So far this season, there have been three confirmed cases of the flu causing or contributing to the death of a child in Canada -- two in Ontario and one in British Columbia.
To date, three other cases are under investigation.
Devlin said a 22-month-old girl from Wake County died from the flu on Dec. 17 after being hospitalized on Dec. 15. She was the fifth child in the state to die from the flu this flu season.
Because she was under 23 months, the girl was at high risk for flu complications. She had received a flu shot October 17, but had not received a second shot. Children receiving flu shots for the first time should receive two vaccinations, 30 days apart, in order for the vaccination to be fully effective. There are no studies that show how effective the vaccination is in a previously unvaccinated child after just one dose. Two of the five children died in the recovery period, one from an infection that can occur on the back end of a flu sickness. Devlin said the elderly, despite the recent deaths of children, remain the most likely group of people to die from the flu. This flu season, more than five times the number of children have been immunized than were immunized in past flu seasons.
Last year, 29,000 high-risk North Carolina children got their flu shots through the state's immunization program. This year, more than 153,000 have been immunized. Data is not available on the numbers immunized through private providers. None of the new vaccine doses being delivered will be reserved for flu booster shots for children under 9. Engel said those children should still have partial protection from their first shot.
Thursday, December 18, 2003
By Matt Leingang
The Cincinnati Enquirer
The parents of an 11-month-old girl who had the flu and died this week say it is not important to them whether health officials determine the exact cause of her death. No autopsy on Olivia Harrison, who died at Cincinnati Children's Hospital Medical Center, is being requested, her parents said Wednesday. She suffered enough. "We're satisfied that doctors did everything they could to save her," said Olivia's mother, Joyce Harrison, 36, of Forest Park. Olivia's death is not officially being blamed on flu. The Ohio Department of Health is waiting for more information.
But Olivia's parents, speaking at a news conference at the hospital, said the toddler tested positive for Type-A influenza when they brought her to the emergency room Saturday evening. Over the next 24 hours, the virus quickly caused her body's respiratory system to shut down, they said. "I want everyone to know that Olivia was chosen for this," said her father Terence Harrison, 32. "God called her home."
Joyce Harrison, a dialysis nurse who works in Blue Ash, said that her daughter - who would have celebrated her 1-year birthday Dec. 26 - became ill Saturday morning with a cough and fever. The symptoms did not appear severe enough initially to warrant extra concern. By evening, though, the child became lethargic and the family rushed to the hospital. Olivia had received half a dose of the flu vaccine this fall, the dosage recommended by her doctor, her parents said. Joyce and Terence Harrison said they are relying on their religious faith to get them through this time. Said her mother: "I grieve. I bawl. I cry. It's hard for all of us, but I have strength in God."
Pediatr Int. 2004 Apr;46(2):122-5. Related Articles,Links
Failure of inactivated influenza A vaccine to protect healthy children aged
Maeda T, Shintani Y, Nakano K, Terashima K, Yamada Y.
Department of Pediatrics, Public Shisou General Hospital, Shisou, Japan.
Abstract Background: The efficacy of inactivated influenza vaccine in healthy infants and children younger than 24 months has not been confirmed. The aim of the present study was to determine the prophylactic effect of inactivated influenza vaccine against influenza A in healthy children aged 6-24 months. Methods: Healthy infants and young children (6-24 months old) were immunized by subcutaneous injection of inactivated influenza vaccine before influenza seasons. Age matched children were randomly assigned as the control. These children were followed up from January to April in each year (2000, 2001 and 2002). The attack rates of influenza A infection was compared and statistically assessed. Results: The attack rate of influenza A virus infection in the vaccine group
and the control group were 14.8% (n = 27) vs 12.5% (n = 32) in 2000 (P = 0.526); 2.8% (n = 72) vs 7.2% (n = 69) in 2001 (P = 0.203); and 3.4% (n = 52) vs 8.9% (n = 56) in 2002 (P = 0.205). The attack rates of influenza A between the two groups were not significantly different. Conclusion: Inactivated influenza vaccine did not reduce the attack rate of influenza A infection in 6-24 month old children.
PMID: 15056235 [PubMed - in process]
100M Doses of Flu Shots to Be Available
Wed Jun 23, 4:45 PM ET
By DANIEL YEE, Associated Press Writer
ATLANTA - Determined to avoid a repeat of last year's flu-shot shortage, the government said Wednesday that vaccine makers will have 100 million doses ready for this winter. That figure does not include the estimated 4.5 million doses of flu shots the Centers for Disease Control and Prevention (news - web sites) is planning to keep in reserve for children in its first-ever stockpiling of the vaccine.
For the 2003-04 season, there were 86.9 million doses available, compared with 95 million in 2002.
Last year, the nation's two producers of flu shots shipped their entire supplies of the vaccine by December, thanks to an early start to the flu season and fears that a dominant flu strain would cause more severe illness than in recent years. Clinics around the country ran out of the injected vaccine — which takes months to prepare — and officials urged healthy people to opt for a nasal-spray version to save the traditional flu shot for children and the elderly.
Memories of last season's flu shot shortages will compel people to get vaccinated this year, and new flu shot recommendations — including having children 6 months to 23 months old get the shot — also will prevent an oversupply, said Gregory Wallace, of the CDC's immunization services division.
All the vaccine must be used by the end of the season — which typically ends around April — because the shots cannot be used for other seasons as the flu strains vary each year. In another change, the CDC has directed states to collect data on any children hospitalized with the flu and to report child flu deaths. Because such data has not been consistently collected, health officials do not know how many children typically die from the flu each year.
In the last flu season, the CDC found 152 children who died from the flu. Their average age was 3, and about 70 percent of them had not received flu shots. 30% did and died anyway?
Failure of Inactivated Influenza A Vaccine To Protect Healthy Children Aged 6–24 Months
[Not yet available online.]
Pediatrics International (2004) 46 , 122–125
Taro Maeda, Yukihiro Shintani, Kanako Nakano, Kazuhiro Terashima And Yoshiyasu Yamada
Department of Pediatrics, Public Shisou General Hospital, Shisou and
Department of Pediatrics, Rokko Island Hospital, Kobe, Japan
Background: The efficacy of inactivated influenza vaccine in healthy infants and children younger than 24 months has not been confirmed. The aim of the present study was to determine the prophylactic effect of inactivated influenza vaccine against influenza A in healthy children aged 6–24 months.
Methods: Healthy infants and young children (6–24 months old) were immunized by subcutaneous injection of inactivated influenza vaccine before influenza seasons. Age matched children were randomly assigned as the control. These children were followed up from January to April in each year (2000, 2001 and 2002). The attack rates of influenza A infection was compared and statistically assessed.
Results: The attack rate of influenza A virus infection in the vaccine group and the control group were 14.8% ( n = 27) vs 12.5% ( n = 32) in 2000 ( P = 0.526); 2.8% ( n = 72) vs 7.2% ( n = 69) in 2001 ( P = 0.203); and 3.4% ( n = 52) vs 8.9% ( n = 56) in 2002 ( P = 0.205). The attack rates of influenza A between the two groups were not significantly different.
Conclusion: Inactivated influenza vaccine did not reduce the attack rate of influenza A infection in 6–24 month old children. Different countries have selected a range of different programs for influenza vaccine recommendations. In the United States, inactivated influenza vaccine is recommended for any person aged greater than 6 months old who is at increased risk for complications.
Children, not the elderly, 'should get flu vaccines'
By Steve Connor, Science Editor
22 November 2004
Children, rather than the elderly, should be vaccinated against influenza to protect the rest of the population against an epidemic, a study showing that the virus spreads fastest in schools has concluded.
Present vaccination policy is to offer free flu jabs only to the over-65s, but scientists have found that it would be better to target school-aged children, because they are the ones who trigger an epidemic.
A pilot scheme to vaccinate thousands of children in Texas found that when just a quarter of them were given the vaccine it led to a drop of up to 18 per cent in flu cases among unvaccinated adults.
Computer models suggest that vaccinating half the child population would reduce the chances of an epidemic among adults by two-thirds. Vaccinating 90 per cent of children reduces the probability of an epidemic to just 4 per cent.
Scientists involved in the study believe that vaccinating even a minority of school-aged children against flu would lead to a significant decline in outbreaks among the very old and the very young, who are at the greatest risk of serious complications, such as pneumonia.
Paul Glezen, professor of virology and epidemiology at Baylor College of Medicine in Houston, Texas, said there was little doubt that flu epidemics were spread mainly by schoolchildren and that targeting them with a vaccine was the best way to avoid a wider death toll. "There's a lot of evidence that children have the highest infection rates and that the virus then spreads from these children to their older and younger contacts," he said. "The elderly and the very young are at the end of the transmission chain so inoculating them won't have any effect on the rate of spread of an epidemic."
Even if only a proportion of children is vaccinated against flu, this could lead to wider "herd immunity" within the population at large, said Pedro Piedra, a member of the Baylor research team. "There have been studies demonstrating that children contribute to the spread of flu in families and communities. By reducing influenza in children, hopefully we can reduce the spread of influenza in the community," Dr Piedra said.
"With the current policy [of vaccinating the elderly], you only try to control mortality. If you want to control flu, our hypothesis is to focus on children."
The Baylor researchers vaccinated 20,000 eligible children in the Texas towns of Temple and Belton in 1998-99. The vaccine was delivered as a nasal spray rather injection.
Cases of flu in adults over the age of 35 in the two towns fell by between 8 and 18 per cent compared with similar communities where there was no significant childhood vaccination. Professor Glezen said this meant that there were thousands of people who did not catch flu who otherwise would have succumbed to the infection, and some would have developed more serious respiratory illnesses.
John Watson, head of respiratory diseases at the British Government's Health Protection Agency, said that any changes to Britain's vaccination policy would have to be decided by the Department of Health. "This is an interesting study that the Health Protection Agency will be keen to look at in more detail. It is well recognised that children play an important role in the transmission of the influenza virus in closed environments such as households, schools and nurseries," he said.
Japan imposed widespread flu vaccination of schoolchildren but the policy was abandoned in 1987 before epidemio- logists realised it had saved at least 10,000 elderly Japanese from respiratory diseases.
Professor Glezen said that in the US the number of people needing hospital treatment as a result of flu had increased in recent years despite an increase in the proportion of people over 65 who had been vaccinated.
"I don't think we can say we have an effective vaccination policy ... but it doesn't mean that the vaccine is ineffective. We need to target schoolchildren instead," he said.
Mother claims son had adverse reaction to flu shot
Web Posted: 01/19/2005 05:00 PM CST
A San Antonio woman believes a simple flu shot nearly killed her 5-year-old son Maurice.
Maurice was a healthy kindergarten student when his mother took him for a flu shot in October. Maurice has asthma and the doctor recommended the vaccine. That night, according to his mother Michelle Mouille, "He began running a high fever and two days later, lapsed into seizures." "He was drooling, totally down his mouth and stiff as a board and couldn't move or talk," said Mouille. " I just feel devastated." That's the last time Mouille heard her son speak. He spent 40 days in intensive care at the hospital and several weeks in rehabilitation.
Neurologists and a team of doctors say his brain swelling and injuries were not caused by any obvious virus, and may have been a rare reaction to the flu shot. The city's top health official says right now, there 's no hard proof. "At best, it's coincidental, but because of the temporal sequence, we have to say that at least there is that hypothetical possibility, or theoretical possibility that it might be related," said Dr. Fernando Guerra, Metro Health District Director.
Maurice is covered by Medicaid, which is paying for outpatient therapy. He's walking and eating again, but there's no way to gauge how much brain function he'll regain. If he was the victim of an adverse flu shot reaction, his case would be one in a million. Maurice's mother feels compelled to share her story. "Before they would get their child the flu shot to really think about it because it might not help them like it's supposed to and it could really damage them for life," said Mouille. Guerra says parents should not be scared away from the vaccine, which he considers safe. "I would certainly recommend to parents that they opt to protect their children," said Guerra.
The Centers for Disease Control and Prevention is investigating Maurice's case, but it will be months or even years before they determine if the flu shot or a mysterious virus caused his brain damage.
No Evidence Flu Vaccine Works For Toddlers
By Amanda Gardner
HealthDay Reporter By Amanda Gardner
THURSDAY, Feb. 24 (HealthDay News) -- There is no good science to back new American and Canadian policies of vaccinating children under the age of 2 against the flu, a new report claims.
However, the researchers stress, this doesn't mean the vaccine is ineffective in toddlers; it just means it needs to be studied further. "In children below the age of 2, we could find no evidence that the vaccine works, but that does not mean that the vaccine doesn't work," said Dr. Tom Jefferson, lead author of the study, which appears in this week's issue of The Lancet. "The data is insufficient to draw any conclusion," said Jefferson, who works at Cochrane Vaccines Field, in Rome, Italy. "We need more research."
The researchers also did not find any convincing evidence that vaccines have an effect on death rates, hospital admissions, serious complications and transmission of the flu. Again, this doesn't mean that the vaccines are ineffective, just that there's no research to prove they work. But before making vaccination of very young children a public health policy, Jefferson and his colleagues believe large-scale studies need to be conducted.
As the study authors pointed out, both the United States and Canada have already started vaccinating children under the age of 2 against the flu. Infants aged 6 months to 23 months were included in recommendations starting in the 2004-05 flu season. Historically, vaccination efforts have targeted people 65 and older. U.S. federal statistics released earlier this month revealed that 57.3 percent of children aged 6 months to 23 months were vaccinated from September through December 2004. At the time, Dr. Julie Gerberding, director of the U.S. Centers for Disease Control and Prevention, called those results "wonderful" -- especially since a 2002 survey showed that only 7.7 percent of children in this age group were immunized.
The current review looked at the available data on the efficacy and effectiveness of the flu vaccine on children 16 years old and younger. Efficacy meant any reduction laboratory-confirmed cases of the flu (children who actually got infected), while effectiveness referred to a reduction in symptomatic cases, which is measured by reductions in mortality, hospitalizations, school absenteeism, transmissions, and other indicators. This analysis was part of a longer review, which should be released this summer.
The authors identified 25 comparative studies that evaluated the efficacy and/or effectiveness of flu vaccines in children aged 16 and younger. They looked specifically at flu, flu-like illness, hospital admissions, school absences, complications and secondary transmissions. Overall, vaccines with live viruses had a 79 percent efficacy and 38 percent effectiveness in children older than 2, compared with no immunization or a placebo. Inactivated vaccines had an efficacy of only 65 percent and, in children under 2, were similar in their effects to placebo. They had an effectiveness of about 28 percent in children over 2.
Vaccines seemed to be effective in reducing long school absences, but otherwise had little effect on hospital stays and other measures when compared with a placebo or no intervention. This information was based on a small number of studies, however. Information for hospitalizations was similarly weak. "One small Italian study looked at length of hospitalizations and found no difference, but the number of children was very small, so you'd be wrong in concluding that it doesn't work," Jefferson said. "We just don't know." The problem with ascertaining effectiveness, said Dr. Keith Powell, a member of the American Academy of Pediatrics' infectious diseases committee, is that kids may be hospitalized or miss school because of any number of respiratory infections. "The average kid has eight respiratory infections a year," he said. "Only one of those is going to be the flu."
"Unless we're doing something to diagnose and distinguish between the two, you wouldn't know if you just looked at hospital rates by age for respiratory illness," he added. While Jefferson called for more research, Powell said he believes it is still a good idea to vaccinate kids aged 6 to 23 months.
(I hate when they experiment on children)
Doctors say flu shot may be linked to boy's mysterious illness
By The Associated Press
(3/10/05 - SAN ANTONIO, TX) - A South Texas boy's mysterious and debilitating illness has drawn attention from doctors across the country, some of whom suspect that a flu shot may be to blame. Five-year-old Maurice Lamkin was healthy and happy until Oct. 27, when he received the vaccination at a clinic. That night he developed a fever, and a few days later he ended up in an intensive care unit, his brain swelling as puzzled doctors reviewed his case.
He fought for his life for 40 days and, after a stay at a rehabilitation facility, returned home on New Year's Day. But he can't speak and has returned to diapers, and all of his meals must be pureed to the texture of baby food. While some doctors suspect the flu shot is to blame, others say it's probably just a coincidence. Dr. Kenneth Mack, a pediatric neurologist who consulted on Maurice's case, said an adverse reaction to the flu shot can cause encephalitis, an inflammation of the brain.
"The body's immune system can get overactive and attack the brain," he said. Maurice's pediatrician recommended he get a flu shot because he has asthma and lives in a home with his infant sister. He had been vaccinated once before without ill effects. His mother, Michelle Mouille, said she regrets having him vaccinated. "He was just a healthy little boy. He was running around -- he was so proud because he'd just learned to write his first and last name," Mouille said. "He was living his life, singing, dancing, wrestling with his brother -- it's so hard to understand."
Maurice's case has been reported to the Centers for Disease Control and Prevention's National Vaccine Monitoring System. Dr. John Iskander, an epidemiologist and pediatrician with the agency, said the cause of Maurice's illness may remain a mystery. "It's very difficult to make a determining decision whether the flu vaccine was to blame," he said.
Iskander said the CDC will monitor other reports of reactions to see if a pattern emerges. But he reminded parents that the benefits of getting a flu shot outweigh the small risk of a vaccine causing serious harm. Each year in the United States, about 36,000 people die of the flu and 200,000 are hospitalized.
(Copyright 2005 by The Associated Press. All Rights Reserved.)
Ultrasound device might remove needle from flu shot
BY ERIC HAND
St. Louis Post-Dispatch
ST. LOUIS - (KRT) - There might be a way to get a flu shot without a shot. St. Louis University researchers are getting flu vaccine under the skin of volunteers without needles. The SonoPrep, an ultrasound device made by Sontra Medical Inc., opens skin pores so that vaccine can seep through. Nothing ever touches nervy muscles. "There's a machine and there's a sensation. But if there's no needle, that takes away the biggest fear," said Dr. Robert Belshe, director of the Center for Vaccine Development at St. Louis University. At least 10 percent of the adult population has a severe fear of needles, according to a 1995 study in the Journal of Family Practice. Belshe hopes the new method will encourage the phobic to get in for their needleless flu shots.
The method is not only pain-free but also uses less vaccine, according to research Belshe published in November in the New England Journal of Medicine. Belshe found that less than half of the normal muscular dose worked just as well when injected into the skin only. Belshe said researchers have for decades known about the skin's superior ability to create antibodies in response to a vaccine. It makes sense, he said, since the skin needs plenty of immune defenses to deal with cuts and scrapes.
"But there wasn't any reason to look at it until we had a vaccine shortage," he said. The trial used the tiny skin-pricking needles of tuberculosis syringes and found that 40 percent of the normal dose was just as effective for 18- to 60-year-olds, and nearly as effective for older people.
Franklin, Mass.-based Sontra contacted Belshe after reading the paper, hoping to try it without any needles at all. In August, the company won FDA approval for SonoPrep, which was originally used to deliver a skin-numbing drug. Sontra also has tested it as a way to deliver insulin, and is currently conducting a hepatitis vaccine trial in Worcester, Mass. The St. Louis flu vaccine trial, which began in April, will test 60 volunteers between the ages of 18 and 49.
Nurse Jan Tennant said that, so far, only a few people have complained of a tingling sensation created by the hand-held device. Inside the SonoPrep is a vibrating horn. The vibrations make thousands of microscopic bubbles in a thin layer of soap water on the skin, said Shikha Barman, a Sontra researcher.
The outermost layer of skin is made up of hardened dead cells held together by fats, like bricks and mortar. The bubbles open pores and create pathways by dissolving the fatty "mortar." The bubbles also disrupt the natural electrical conductivity of skin, Barman said. The SonoPrep shuts off once it detects the conductivity for a certain pore size. Other things, like water, can change the permeability of skin. But the SonoPrep does it in seconds and to the same level, regardless of your skin's oiliness, Barman said.
"If you could simply take a shower and slap on a vaccine patch, that product would be out there," she said.
Nurses next place a doughnut-shaped patch on the skin, within which goes a drop of vaccine. The vaccine seeps through the epidermis to dendritic cells, immunilogic sentinels that eat the vaccine and "show" it to the immune system in nearby capillaries, which produce antibodies. Nothing reaches nerve cells in the deeper dermis. In a month, Belshe will see how many antibodies the volunteers produced in response to the vaccine. He said it would likely be two years before the method could be approved for routine use.
Barman said SonoPreps cost about $2,000.
Children Who Get Flu Vaccine Have Three Times Risk Of Hospitalization For Flu, Study Suggests
ScienceDaily (May 20, 2009) — The inactivated flu vaccine does not appear to be effective in preventing influenza-related hospitalizations in children, especially the ones with asthma. In fact, children who get the flu vaccine are more at risk for hospitalization than their peers who do not get the vaccine, according to new research that will be presented on May 19, at the 105th International Conference of the American Thoracic Society in San Diego.
Flu vaccine (trivalent inactivated flu vaccine—TIV) has unknown effects on asthmatics.
"The concerns that vaccination maybe associated with asthma exacerbations have been disproved with multiple studies in the past, but the vaccine's effectiveness has not been well-established," said Avni Joshi, M.D., of the Mayo Clinic in Rochester, MN. "This study was aimed at evaluating the effectiveness of the TIV in children overall, as well as the children with asthma, to prevent influenza-related hospitalization."
The CDC's Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) recommend annual influenza vaccination for all children aged six months to 18 years. The National Asthma Education and Prevention Program (3rd revision) also recommends annual flu vaccination of asthmatic children older than six months.
In order to determine whether the vaccine was effective in reducing the number of hospitalizations that all children, and especially the ones with asthma, faced over eight consecutive flu seasons, the researchers conducted a cohort study of 263 children who were evaluated at the Mayo Clinic in Minnesota from six months to 18 years of age, each of whom had had laboratory-confirmed influenza between 1996 to 2006. The investigators determined who had and had not received the flu vaccine, their asthma status and who did and did not require hospitalization. Records were reviewed for each subject with influenza-related illness for flu vaccination preceding the illness and hospitalization during that illness.
They found that children who had received the flu vaccine had three times the risk of hospitalization, as compared to children who had not received the vaccine. In asthmatic children, there was a significantly higher risk of hospitalization in subjects who received the TIV, as compared to those who did not (p= 0.006). But no other measured factors—such as insurance plans or severity of asthma—appeared to affect risk of hospitalization.
"While these findings do raise questions about the efficacy of the vaccine, they do not in fact implicate it as a cause of hospitalizations," said Dr. Joshi. "More studies are needed to assess not only the immunogenicity, but also the efficacy of different influenza vaccines in asthmatic subjects."
Adapted from materials provided by American Thoracic Society, via EurekAlert!, a service of AAAS.