PULSE POLIO BUNGLE

UNTESTED VACCINE SURFACES IN POLIO OUTBREAK

A potent new vaccine introduced in Uttar Pradesh by the WHO has had no safety tests; the rash of new polio cases in the state may’ve been caused by the vaccine itself, reports Mihir Srivastava

Surrounded by mango groves, village Rahimabad is situated 10 kilometers off the Lucknow-Sitapur highway in the Khairabad block of Sitapur district. Rahimabad is in news for a dubious reason. A two-year-old girl of this village, Saniya, suffers from Type I polio despite being administered more than seven doses of the new polio monovalent vaccine (MOPVI), which is made specially for the Type I poliovirus. The vaccine was introduced in mid-2005 and tom-tommed as the final step in the eradication of polio from India. Before its introduction, a trivalent vaccine was in use that simultaneously targeted the three poliovirus strands found in India, Type I, II and III, by introducing into the body live viruses of all the three strands to develop immunity.

Saniya’s is not the only case. There are 15 cases of Type I polio spread across Uttar Pradesh (There are also 41 cases of Type II polio which takes the total count to 56). While there has been no reported Type I case in the endemic Moradabad, the new cases have been reported from eastern and central Uttar Pradesh; so instead of just a region, cases of wild polio are being reported from all over Uttar Pradesh now.

Saniya’s mother, Noorjahen, is furious. “She is having polio drops ever since she was four days old. She has had over a dozen doses of the polio drops.

(And this is a mystery why she has polio? )


We came to know about her polio when she got a high fever. She could barely manage to stand, could not walk at all, after the fever. We took her to the local hospital where they did a stool test. We were later told that she has polio,” she recounts. “There must be some thing wrong with the polio drops if even after so many doses my child has contracted polio. The government should test medicines before they are used. Pata nahin bachchoo ko kya pila rahin hain!” (Don’t know what they are making my child drink), she adds.

Mistrust is not only rife among the patients’ families, it has also gripped the doctors and field operatives overseeing the vaccination project. Add to this the latest controversy about the MOPVI vaccine, introduced in India by the World Health Organisation (who), and the organisation’s National Polio Surveillance Project (npsp), and you get a sense of the callousness plaguing the polio campaign.

Pulse of the polio programme
Thursday October 18 2007 09:12 IST Farah Baria
http://newindpress.com/NewsItems.asp?ID=IE220071017225054&Title=Second+Article&rLink=0

Not long ago, a gentleman turned up at our door with a large box. “Madam,” he said gravely, “according to our records your children have not availed of the government’s Pulse Polio Programme yesterday. Please ensure that this is done now.”

Two days later, my daughter complained of a pain in the leg. “Could be vaccine-associated paralytic polio,” warned my doctor. Eventually that turned out to be a false alarm. But it left me with a vague sense of dread.

The disquiet returned when a fouryear- old Mumbai girl died of the virus recently. Alarmingly, the child’s records show she had received several doses of the vaccine this year. More alarmingly, the Pulse Polio Programme prescribes one dose every month, way in excess of the internationally prescribed standard of seven doses over a lifetime.

Government officials believe this unprecedented blitzkrieg will check the resurgence of our Ninja bug — 676 fresh cases in 2006, another 223 this year — and plug “coverage lapses” in the implementation of its aggressive Rs 2,000 crore Polio Eradication Initiative (PEI). The strategy: propaganda and door-todoor implementation.

At one level, this meticulous planning is impressive in a country where public health initiatives die early of official neglect. Meticulous it may be but it is not exactly democratic. Even if I am a layperson, as a parent I have some questions to ask. Is this battery of “supplementary” vaccinations safe for our children? Does the government have the authority to prescribe it in the absence of any long-term studies? And what about our right to be informed about the possible side-effects?

Incidentally, question three remains a moot point. Reason: medical literature maintains that the Oral Polio Vaccine (OPV) occasionally backfires because it contains a live virus which can mutate and become neuro-virulent, causing Vaccine Associated Paralytic Polio, also known as Acute Flaccid Paralysis (AFP). Despite the “negligible” risk, in 1997, there were 3,047 cases of AFP; in 2005, 26,000. Also, to be effective, the OPV must be continuously stored in temperatures below minus two degrees centigrade. In a land of power cuts, this is virtually impossible.

Interestingly, many western countries have reverted to an older, more stable, Injectable Polio Vaccine (IPV) which uses a dead virus that does not require cold storage, and carries no known risk. Recently, an article in Lancet warned that the OPV is giving rise to a new strain called Vaccine Derived Polio Virus, and recommended the use of IPV.

This is controversial, especially since the OPV seems tailor-made for India. It is about six times cheaper than IPV, easier to administer, and has a “herd immunisation” effect, protecting both child and community. But the government needs to weigh the merits and demerits of both through democratic debate, not high-handed policy. Surely as parents we have the right to make an informed choice on matters that concern our children’s health. And we would like to know why we are using the OPV for our children after the West spurned it?

And how we square these questions with the WHO declaring last year that India is “actively exporting polio” to other countries. It even threatened to issue a travel advisory requiring Indians travelling overseas to provide proof of vaccination. Subsequently, the Union health minister called polio a “national shame” and vowed to atone. Again, while it is understandable to maintain that such advisories are avoidable, the government must act when warnings are based on demonstrable facts.

Disease prevention must remain essentially, indeed wholly, a medical exercise, informed by the best medical evidence and choices. Which is to say, the Polio Eradication Initiative cannot and must not become an exercise in diplomacy.

Let’s aim for some perspective. Polio is a dreadful bug which must be eradicated. But we should ask ourselves if we are going about it the right way — and for the right reasons. We may even perhaps need to pause, revaluate, and rethink

Common Children's Vaccine Recalled
By MIKE STOBBE and LINDA A. JOHNSON – 2 hours ago

ATLANTA (AP) — More than a million doses of a common vaccine given to babies as young as 2 months were being recalled Wednesday because of contamination risks, but the top U.S. health official said it was not a health threat.

The recall is for 1.2 million doses of the vaccine for Hib, which protects against meningitis, pneumonia and other serious infections, and a combination vaccine for Hib and hepatitis B. The vaccine is recommended for all children under 5 and is usually given in a three-shot series, starting at 2 months old.

Drug maker Merck & Co., which announced the recall after testing this week showed a sterility problem in a Pennsylvania factory, said concerned parents should contact their child's doctor.

"The potential for contamination of any individual vaccine is low," said Merck spokeswoman Kelley Dougherty.

Dr. Julie Gerberding, head of the Centers for Disease Control and Prevention, echoed that in a news conference.

"This is not a health threat in the short run, but it is an inconvenience," she said.

Merck produces about half of the nation's annual supply of 14 million doses of Hib vaccine.

Barbara Kuter, executive director of pediatric medical affairs for Merck, told The Associated Press that because of the contamination, the company's production line has been shut down for at least nine months.

"Manufacture of vaccines is pretty complicated, and we have to basically make some changes in the process," then get approval from the Food and Drug Administration before resuming production and shipments, Kuter said. Merck hopes to restart production in the fourth quarter of 2008, she said.

"It's likely that there's going to be a shortage of this product," Kuter said, adding that the impact on the public is unclear because the other company making the vaccine in the U.S., Sanofi Pasteur, may be able to produce more.

Health officials said they already are talking about prioritizing shots for American Indian and Alaska Native children, who are considered at higher risk for Hib-caused illnesses, said Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases.

Health officials said they did not know how many of the 1.2 million doses were administered to children.

The recalled doses are considered potent, so children who got vaccine from the recalled lots will not have to be revaccinated, Schuchat said.

Parents will probably be concerned, CDC officials acknowledged. Should the vaccine later prove contaminated, health officials believe most children will experience, at worst, a skin irritation around the vaccination site. Problems could be worse for children with compromised immune systems.

Such problems would have appeared within one week of the vaccination, Schuchat said, adding that there have been no reports suggesting vaccine contamination so far.

The contamination involved unspecified equipment used in making the vaccine, which involves taking concentrated Hib virus, diluting it and combining it with other agents. Kuter said that during a routine evaluation of Merck's West Point, Pa., vaccine plant, a sterility test determined that the equipment was contaminated with a bacteria called Bacillus cereus, or B. cereus.

It is a spore-making microorganism commonly associated with food poisoning and has caused diarrhea and vomiting in people who eat contaminated foods.

"It's one of the most common organisms" around, Kuter said.

The recall is likely to heighten a debate over childhood vaccines and their safety and whether too many are required. Some parents are distrustful and suspect some vaccines of being linked to autism, although scientific studies have not shown such a connection.

This week, New Jersey took a controversial step toward becoming the first state to require flu shots for preschoolers after a health advisory board backed new vaccine requirements over opposition from parents.

Merck, based in Whitehouse Station, N.J., is one of the few drug makers that produces a significant number of vaccines.

While the company took a black eye with its September 2004 withdrawal of the painkiller Vioxx due to increased risk of heart attacks and strokes, the company has been performing well recently. On Tuesday, it gave an upbeat assessment in its annual briefing for analysts.

Five weeks ago, Merck reached a deal to settle up to 50,000 Vioxx lawsuits for $4.85 billion, an amount expected to save the company millions in trial costs.

Its stock price has more than recovered from its post-Vioxx slump, a two-year-old restructuring plan is going well and profits are up. For example, Merck posted a 62 percent increase in its third-quarter profit as revenues jumped by double digits.

The company also has had an impressive seven new products approved for U.S. sale in the last two years, including three vaccines: RotaTeq, to prevent an intestinal virus that is the top cause of early childhood diarrhea; Zostavax to prevent shingles, and Gardasil, to block the virus that causes cervical cancer.

Merck shares fell 68 cents Wednesday to close at $59.72 before the recall announcement. The shares fell 12 cents in after-hours trading.

AP Medical Writer Mike Stobbe reported from Atlanta and AP Business Writer Linda A. Johnson reported from Trenton, N.J.
 

Chinese Parents Take "Bad Vaccines" Case To Court
By Tan Ee Lyn, Reuters Health
http://tinyurl.com/2fa7co

HONG KONG (Reuters) - Three children who suffered severe brain damage after being vaccinated against Japanese encephalitis had their case heard in a Chinese court on Thursday, casting the spotlight once again on the safety of China's drugs and food.  Ordinary citizens suing powerful state companies are rare in China and this case is especially sensitive as it calls into question the standards and safety of Chinese medicines.  "Our chances of winning are zero because our opponents are mighty, but we won't back down," said Yu Tongan, father of one of the three.  "As victims we have to stand up not only for ourselves but to tell the
world such things are happening to us and many, many other children."  Passed by mosquitoes, Japanese encephalitis can result in paralysis, seizures, coma and death. It is endemic in most parts of Asia, and countries such as China, India, South Korea, Japan, Taiwan and Thailand control the disease with vaccines.  At the start of the two-day hearing, Tang Jingling, a lawyer representing the children and their families, told the court in Jiangmen city, in southern Guangdong province, how Liang Jiayi, a lively two-year-old, ran a high fever after she was given a vaccine shot in a government clinic in August 2003.  She fell into a coma four days later and when she came to, she was paralysed and has remained in a vegetative state.  The other two children, Tan Jieyi and Yu Ronghui, were vaccinated in Jiangmen in March 2005. Now 12 and 14 respectively, they can walk but are mentally retarded and have been refused places in school.

JUST BAD LUCK?
Defendants named in the lawsuit were vaccine manufacturer Chengdu Institute of Biological Products, and the Centers for Disease Control and Prevention in Xinhui district and Jiangmen. "Treatments for all three children are ongoing and they hope to get compensation ... of around 1 million yuan ($132,200) each ... for
their medical fees and disabilities," Tang told Reuters later. Parents of the affected children had petitioned authorities in Beijing, southern Guangzhou city and even Hong Kong, but were arrested when they mounted a protest in Beijing's Tiananmen Square last year.  But now a court has agreed to hear their case, weeks after a senior Chinese official was executed for taking bribes and approving unsafe drugs. The parents say they have asked for an explanation of what happened to their children, only to be told by officials that it was bad luck. China's Health Ministry told Reuters last year that there were no problems with the vaccines. Rare complications happen with any kind of vaccine, especially when recipients have poor immunity or genetic defects.  But Tang said is this case there was a fairly large cluster of seven children in Jiangmen who were all injected in March 2005 - raising questions over its quality. Liang, now 6, and her parents were not in court but in Beijing, where she was recuperating from recent brain surgery. "She was getting very frequent seizures and was constantly foaming in he mouth. We had to raise money to bring her here for surgery," her father, Liang Yongli, told Reuters by telephone.  "We want the state authorities that are responsible for this to cure her."
 

OSAKA: Out-of-date ingredient used in vaccine
06/29/2007

THE ASAHI SHIMBUN


A foundation affiliated with Osaka University used out-of-date ingredients in a measles-rubella vaccine that was shipped for 530,000 people from March, sources said.

The vaccine, produced in 2004 by the Research Foundation for Microbial Diseases of Osaka University, contained Australian cattle blood serum whose quality guarantee date had expired in 2002.

The batch of vaccine passed government tests and was shipped.

Although the Ministry of Health, Labor and Welfare said the out-of-date ingredients will not affect the safety of the vaccine, critics say the manufacturing process of medical products should be made more transparent to ensure product safety.(IHT/Asahi: June 29,2007)

 

Families Raise Concern Over Mercury In Vaccines
Debate Continues Over Past Use Of Thimerosal
POSTED: 1:37 p.m. EST November 4, 2002
 11:08 p.m. EST November 4, 2002 DURHAM COUNTY, N.C.

A growing contingent of parents believes a mercury-based preservative in those vaccines may have done more harm than good. In 1999, at the request of the Food and Drug Administration, drug companies agreed to begin removing a controversial preservative called thimerosal from vaccines. Some families believe the removal comes too late. Jackson Bono is a happy, curious 13-year-old challenged by a myriad of medical and developmental problems. Jackson has trouble speaking and focusing and works with a tutor.

"The toll it takes on a family is remarkable," said Scott Bono, Jackson's father. Like most parents, Scott and Laura Bono had their son vaccinated when he was a baby. They now blame his problems on thimerosal and its main ingredient, mercury.
"Little did we ever suspect that the very immunizations that were to protect him from childhood diseases were poisoning him with mercury," Scott Bono said. Thimerosal kills harmful bacteria and has been in vaccines for decades. In the early 1990s, the number of recommended childhood vaccines increased. Over the last decade the national autism rate has risen drastically. In North Carolina, the rate has more than quadrupled, according to the state Department of Public Instruction.

Some people see a connection. If you add up the amount of mercury in baby vaccines with thimerosal, the levels exceed those considered safe for adults by the FDA. The Bonos said Jackson was a normal, healthy baby until he received a bundle of vaccines when he was 16 months old. They said, soon after, he stopped talking and making eye contact. Jackson developed autistic tendencies, like spinning uncontrollably. He also suffered severe allergies, seizures and stomach trouble.

"It was a cruel tragedy that happened with our son," Laura Bono said. Dr. Samuel Katz, chairman emeritus of pediatrics at Duke, is considered one of the foremost authorities on vaccines in the country. He raises doubts that thimerosal ever hurt children. "Whenever we have a problem, we like to know whose fault is it. Unfortunately, vaccines have become an easy target," he said. Katz said, "The evidence to support these claims is lacking." However, in 1999, he recommended drug companies take thimerosal out of vaccines. A 2001 report from the National Institute of Medicine also concluded the evidence does not support the claims. Researchers conceded, "the hypothesis is biologically plausible."

"Given that its mercury and we know that mercury has no beneficial effects, my statement to the FDA was that there's really no reason to use something like thimerosal," said Michael Aschner, a Wake Forest University neurobiologist. Aschner has studied mercury for 20 years. Research from the University of Calgary backs up his work and found mercury can destroy brain cells. Aschner points out that the ethylmercury in thimerosal is different from the damaging methylmercury found in some fish. He feels the issue clearly deserves much more study.

"If you do it in a dish, ethylmercury does cause significant effects, toxic effects. There's no question about it," Ascher said. "But, again, what you have to be careful of is how you translate what you see in a dish into a human being." The biggest obstacle parents of special needs children face in making the thimerosal argument is the fact that millions of children, a vast majority, got the same vaccine and never got sick.

"Why is it that all people who smoke don't get cancer? The body reacts differently to different antagonists," Salisbury attorney Bill Graham said. Graham represents 40 families who believe thimerosal hurt their children. He believes evidence is mounting that federal regulators knew that thimerosal could be harmful long before drug companies felt pressure to remove it from vaccines. A study sanctioned by the Centers for Disease Control and Prevention shows infants immunized with thimerosal vaccines were 2.5 times more likely to develop neurological disorders, but it was never released. Instead, the study continued and the results changed. Graham questions why vaccines were never recalled.

"Do you think that thimerosal vaccines that are potentially harmful could still be out there? They could be. They could be on the shelf right now," Graham said. "I really think the thimerosal issue has become a feeding frenzy. It's like the sharks with blood in the water," Katz said. The Bonos said they do not want blood. They want families like theirs to be heard for Jackson's sake, and others like him. "He's lost his childhood and he may not ever be what he should have been," Laura Bono said. Parents like the Bonos can file claims with the National Vaccine Injury Compensation Program. Because of the debate over thimerosal, the federal government has put all the claims on hold until further studies are completed. There was no recall of thimerosal vaccines, so it is possible some could still be on shelves. Anyone with concerns should talk to their child's pediatrician and ask for thimerosal-free vaccines. Both sides of the debate stress the importance of immunizing children.
Reporter: Cullen Browder
Photographer: Gil Hollingsworth
OnLine Producer: Michelle Singer
 

http://timesofindia.indiatimes.com/cms.dll/html/comp/articleshow?artid=28006270
Hep-B vaccine drive a farce, claims PEEM

TIMES NEWS NETWORK  [ WEDNESDAY, NOVEMBER 13, 2002 02:00:00 AM ]

HYDERABAD: All children suffering from the side-effects of the hepatitis-B vaccination campaign in the state must be compensated by Bill Gates, founder of the Bill and Melinda Gates Foundation. The hepatitis-B campaign in the state is a farce and unnecessary. This was the contention of People for Economical and Effective Medicare (PEEM) chairman Dr P V R Bhaskar Rao at a press conference here on Tuesday.

It was well-known that there are adverse effects of the vaccine. The US Congress, having accepted this, has included the vaccine in the National Vaccine Injury Compensation Programme in August 1998, Dr Rao said. Further, he said in the United States, authorities no longer advocate that all newborns be vaccinated against hepatitis-B unless they are born to infected mothers.

Despite this, the state government has no compensation policy for victims suffering from adverse effects of the vaccine, no registry of the children the vaccine has been administered on, no studies about the effectiveness of the vaccine in the state and no information education and communication (IEC) activities carried out, Dr Rao said.

PEEM representatives also appealed to all parents of children who have received the vaccine to claim for a damage of Rs 25 lakh if the child has any side-effects from the Gates foundation. According to the National Vaccination Information Centre (NVIC) report, the protective effect of the vaccine was still unknown, PEEM vice chairman Dr K Venugopal said. Further, the Federal Drug Authority (FDA) has reported that between 1994 and 1998, a total of 23,000 cases of adverse effects due to the vaccine. The PEEM said Bill Gates, his foundation and the state government were using children of the state as guinea pigs.

WASHINGTON (AP) -- A vaccine that cleared toxic deposits from the brains of laboratory mice also doubled the risk of stroke in the animals, according to a study that may offer a new warning sign about a promising therapy for Alzheimer's disease.

The study, appearing Friday in the journal Science, is the first to detect in animals serious side effects of a proposed vaccine that other research has suggested will halt the progression of Alzheimer's disease. A similar vaccine was tested briefly in humans. Researchers have been intensively studying the idea that the brain-destroying disease could be controlled by removing deposits of a toxic substance called amyloid beta that accumulates in the brains of Alzheimer's disease patients.

While researchers are uncertain if amyloid beta is the cause of Alzheimer's or the result of another mind-destroying process, some earlier animal studies found that a vaccine that prompts the body to remove amyloid beta was able to halt the disease and even restore some brain function. The promising results led an Irish pharmaceutical firm, Elan Corp., to test an amyloid beta vaccine on 360 human patients, but the clinical trial was suspended early this year after 15 patients developed inflammation of tissues in the brain. Elan has since said it would no longer test the original vaccine, but will continue to monitor patients who received it.

Unexpected side effects
Now the new study in Science suggests that a vaccine against amyloid beta may have other problems -- a significant increase of bleeding in the brain. Swiss, German and American researchers used a lab mouse strain that had been genetically manipulated to develop the major symptoms of Alzheimer's disease, including the formation of amyloid beta. The mice were injected with a vaccine that caused their bodies to make antibodies against amyloid beta. After five months, the researchers said there was a 23 percent reduction of the amyloid beta in the test mice compared with animals that did not receive the vaccine.

However, the test mice also had twice the number of cerebral hemorrhages, or bleeding in the brain, compared with mice that did not get the vaccine. Additionally, the researchers found six major blood clots among the immunized mice, versus only one among the control mice. The findings, said co-author Dr. Paul M. Mathews of New York University School of Medicine, suggest that scientists still lack a clear appreciation of the possible side effects of Alzheimer's vaccine therapy. "Up to this point, all of the animal studies have been very promising," said Mathews. "This is the first study to show any serious side effects in mice." Back to the drawing board Mathews said the mouse strain used in his study is a closer mimic to the way Alzheimer's appears in the human brain than animals used in earlier studies. He said the mice had deposits of amyloid beta on blood vessels, a very common characteristic of human patients.

Finding this new side effect, he said, suggests that the human trials of Alzheimer's vaccine "were premature." "We need to move back into animals and sort this out," said Mathews. "We need to develop antibodies (vaccines) that don't cause this problem. Otherwise, I don't think this (type of therapy) will work in humans." Bill Thies, vice president for medical and scientific affairs of the Alzheimer's Association, said the new study "is an interesting paper and something that we should look at carefully."

But he said Alzheimer's vaccine therapy remains promising and research should be pursued vigorously. "We are continuing to unravel some of the nuances of it," said Thies. "Whether it ends up being a useful therapy or not is still an open question, but it has enough promise that a lot of people are still working on it."
http://www.cnn.com/2002/HEALTH/conditions
/11/15/alzheimer.study.ap/index.ht=
 

West Nile Vaccine- Adverse Reaction
Horse Owner Speaks Out

Before I speak, let me preface this article to make it clearly understood, this information is not a blame or vendetta towards anything or anyone. It also needs to be unmistakably understood that I am not for or against vaccinating horses. My sole intent and/or purpose is to educate and inform the horse owner regarding concerns of their horse(s) health in an effort to assist and/or prevent the tragic misfortune that happened to our gelding, Dartanian. He was one of the principal characters in the book, "The Spiritual Life of  Horses." His love, integrity, courage, loyalty and quite often humor, will  live on in our hearts through his inspiration and valor.

 In mid August we were suggested to vaccinate against West Nile Virus, I  simply was not well-educated on the vaccine nor the virus or knew the right  questions to ask at the time. With the first shot, three of our horses  reacted. Our pregnant mare, our gelding and Dr. Donald Warren's stallion, a  boarder, all had the same re-action, their front legs swelled. Within 2  days, our gelding Dartanian foundered, shortly there after he died!  These are adverse reactions to a vaccine. The reactions our horses  experienced are not soley limited to what we saw. Other adverse reactions  stated by Fort Dodge's safety study are: systemic reactions, colic,  diarrhea, fever, swellings.

 The West Nile Vaccine is new. According to Dr. Charles L. McDaniel from  USDA, "this is what is called a conditional vaccine. New vaccines such as  this, are granted a one year "conditional" trial period. If safety and  efficacy are established, a renewal license for a second year may be  granted." The West Nile Vaccine license has been renewed for another year.  He also stated "when a new vaccine is released it is sold and provided only through veterinarians for one reason, because the manufacturer needs to  monitor the field response." (**more information from Dr. Charles McDaniel  regarding conditional licensing)

 If any reaction occurs then it is the responsibility of the practicing  veterinarian to record it and report it to the manufacturer immediately in  case there is a problem with that serial batch of vaccine.  In the case of the West Nile Vaccine, the manufacturer is Fort Dodge. I  spoke with Dr. Tuttle at Fort Dodge regarding our situation and also  explained what I was dealing with afterward. Dr. Tuttle, listened intently  to what I described, documented my report and said to me, "Lynette, please  accept my greatest apologies for what you have gone through, I am a  practicing veterinarian, this information is not falling on deaf ears, I  will investigate this immediately."

 He also stated, "we urge and encourage people to contact us immediately and  report adverse reactions to our vaccines. We subsequently report it to the  USDA and investigate the serial numbers of the batches that were being used  to see if the batch has been contaminated. If people don't report problems  then we don't know."  Dr. Tuttle also stated to me, " if there is the slightest indication that  the vaccine caused a problem then it needs to be reported to us without  delay so that we can investigate and research that batch."  If your horse(s) have had a reaction to this vaccine, Dr. Charlie McDaniel,  USDA and Dr. Tuttle from Fort Dodge are asking you to contact them and  report it. The following is their contact information:

 Dr. Charlie McDaniel, USDA,
 Email: charles.1.mcdaniel@aphis.usda.gov
 Tel# 1-515-232-5785 ext. 146

 Also www.usp.org/vprp.htm this is a website where you document what  happened. Once the information is received it is therefore reported to the  manufacturer. The manufacturer then investigates and researches the problem.  If a bad batch of vaccine has made it's way to the public it is then  recalled. This is my understanding of recourse from both Dr. McDaniel and  Dr. Tuttle.

 Dr. Tuttle, Fort Dodge,
 Email: info@equinewestnile.com Attn: West Nile Product Manager
 Tel# 1-800-533-8536

Alzheimer's treatment makes mice brains bleed Immunization used in halted human trial may weaken blood vessels. 15 November 2002

JOHN WHITFIELD

Alzheimer's attacks blood vessels, as well as brain tissue.
© SPL

Immunizing mice against a condition akin to Alzheimer's disease makes their brains prone to bleeding, researchers have found1. This hints at why cerebral inflammation halted an experimental human vaccine trial early this year. The link between mouse and human symptoms is still unknown. But both probably stem from the effects of immunization on damaged blood vessels, says the study's leader, Mathias Jucker of the University of Basel, Switzerland. "These findings are pretty bad for the vaccine," comments neuroscientist Christian Haass of Ludwig Maximilians University, Munich, Germany. "The bleeding is terrible - it could be deadly."

The results suggest that immunization may be more suited to protecting healthy brains than curing diseased ones. Another possibility would be to screen patients for vulnerable blood vessels before vaccination. But other Alzheimer's experts believe that the different symptoms and side-effects in mice and humans make it impossible to connect this research with the trials. "It would be a giant leap to apply this to an Alzheimer's patient," says Roger Nitsch of the University of Zurich, Switzerland.

This is the first time that bleeding has been seen in any animal or human test of Alzheimer's therapies. "We've never seen anything like this - and we've looked hard for it," comments Dale Schenk, head of research at Elan Pharmaceuticals of South San Francisco, the company behind the trial vaccine. The mice that Elan use to study Alzheimer's do not have damaged blood vessels, Jucker counters - so one would not expect immunization to affect them in this way.

Despite the setback, Alzheimer's researchers are still optimistic about the prospects for immunization. Most agree that more results are needed from humans for us to truly understand immunization's effects. Follow-up studies and post mortems of the 375 people immunized in the aborted trial should still give us invaluable information. Beta test The brains of Alzheimer's sufferers contain deposits of a protein called amyloid beta. These are thought to relate to the brain damage and dementia that are symptomatic of the disease. Three years ago, researchers at Elan proposed that injecting amyloid beta into the blood triggers an immune response that fights the disease. No one is yet sure how this works.

Tests were spectacular in mice engineered to develop a form of Alzheimer's. Amyloid deposits shrank, and the animals' memories improved. The vaccine was made from a synthetic version of amyloid. But trials in Alzheimer's sufferers were halted in January, when some patients developed symptoms similar to meningitis and encephalitis. The new finding suggests how this may have come about.

It would be a giant leap to apply this to an Alzheimer's patient Roger Nitsch University of Zurich

Jucker and his colleagues injected elderly mice with antibodies against amyloid, rather than amyloid itself. Five months later, the mice had smaller deposits of the protein in their brains. But they also had many small haemorrhages in cerebral blood vessels. The mice - and most human Alzheimer's patients - have amyloid deposits in the brain's blood vessels, as well as its tissue. Clearing out the protein might weaken these vessels. Vaccinating people before they get Alzheimer's, or in the very early stages of the disease, might help, as amyloid would not have had time to build up, says Richard Harvey, research director of Britain's Alzheimer's Society.

But if immunized human patients bled, it is surprising that none of them had a stroke, Harvey adds. "I doubt that the bleeding is the whole story". Bleeding may be a second side-effect to put alongside inflammation, agrees neuroscientist Dave Morgan of the University of South Florida. <http://www.nature.com/nsu/slices/spacer_trans.gif
References

* Pfeifer, M. et al. Cerebral hemorrhage after passive anti-AB immunotherapy.
Science, 298, 1379, (2002). |Homepage|

© Nature News Service / Macmillan Magazines Ltd 2002
 

http://www.cm-life.com/vnews/display.v/ART/2002/10/30/3dbf7da3740a9
Meningitis vaccines recalled

By Amanda Cutler
Central Michigan Life
October 30, 2002

Aventis Pasteur issued a recall of four of its single-dose lots of Menomune vaccine, which protects against four strains of bacterial meningitis. Aventis Pasteur is an international researcher, developer, manufacturer and supplier of vaccines. Affected lots were issued after Jan. 2, 2001. University Health Services, which issues the vaccine, did not receive any of the affected lots, said Sarah Campbell, director of University Health Services.

“As a precaution, the company withdrew not only those four lots, but all of the single-dose vials and we did have some single-dose vials,” she said. The company recommends that anyone who received the vaccine from the recalled and withdrawn lots, and is planning to travel to a high-risk country should contact their health care provider to discuss re-vaccination. “They tested some of the vaccine to see if it was effective at the 6-month and 12-month point,” Campbell said. “In four single-dose lots, they discovered that at the 12-month point, it did not protect against one of the four strains of bacterial meningitis.”

Symptoms associated with serogroup A, the strain of bacteria not protected against, include severe headache, stiff neck, nausea and vomiting, fever, a rash and mental confusion. The disease progresses rapidly, Campbell said. Someone affected by the disease could experience symptoms in the morning and be near death in the evening. “There has only been one case of serogroup A meningitis in the United States in the last 10 years,” she said. “So, the people that would need to be concerned are people that were traveling to other parts of the world where they do have epidemics of the serogroup A meningitis.”

Other people who might be affected are those who work in a laboratory or industrial setting, dealing with the serogroup A bacteria, she said. “It’s fairly rare, but we encourage students to consider the vaccination, because of the fact that it is potentially fatal,” Campbell said. Even when it’s not fatal, there are sometimes very serious complications that include amputations, organ failure and brain damage, she said. “I think its important to note that the vaccine still does provide protection against serogroups C, Y and W-135,” Campbell said. “Those are the strains that have been occurring most commonly in outbreaks on college campuses.” University Health Services is still giving the vaccine with the multiple-dose vials, which provides full protection, she said. Students can contact University Health Services at 774-6599 or visit the Primary Care Suite in Foust Hall 104, if they have concerns.
 

http://www.wfsb.com/Global/story.asp?S=1025686

COLCHESTER -- State health experts are investigating an outbreak of chicken pox in Colchester. 65 students at the Jack Jackter Elementary School got chicken pox last year. It was one of the largest outbreaks in the state. The Centers for Disease Control is also involved in the investigation.That's because some of the students who got sick were vaccinated against chicken pox. The chicken pox vaccine has a 20-percent failure rate.

http://mdn.mainichi.co.jp/news/20021129p2a00m0dm006000c.html
Group outbreak of deadly measles confirmed

KITAIBARAKI, Ibaraki -- A group of junior high school pupils who fell ill earlier this year have been confirmed as Japan's first group outbreak of a potentially deadly measles virus, health officials said Friday. The 109 pupils from Kitaibaraki who fell ill from February to April were afflicted with a H-1 measles virus of a type that has struck widely in China and South Korea. Over 70 percent of the afflicted pupils had been immunized against measles, yet still fell ill. "We need to look into what caused their immunity to weaken," a spokesman from the Ibaraki Prefectural Government's preventative medicine section said. Kitaibaraki Municipal Government officials said the prefectural government will examine why so many of the 109 pupils fell ill even though they had received shots to prevent them from picking up measles. Usually when measles breaks out in Japan, it is carried by D3 or D5 viruses. The differences between these and the H1 virus are not great, but enough for the H1 virus to counter some defense barriers formed by immunization. (Mainichi Shimbun, Nov. 29, 2002)
 

http://www.chinapost.com.tw/taiwan/detail.asp?ID=32734&GRP=B

Newborn baby killed,six others injured by mistaken
injection
2002/11/30
The China Post staff

One newborn baby was killed, and six others injured yesterday when a nurse at a Taipei County hospital mistakenly injected them with anesthetics that caused them to fall into comas, health officials said. The nurse at Tucheng's Peicheng Hospital was supposed to give the babies hepatitis B vaccinations, but mistakenly injected them with a muscle-relaxing drug, Atracurium, for patients due to undergo surgery, the Department of Health (DOH) officials said. The babies, who had stopped breathing as a result of the injection, were rushed separately to bigger hospitals in the city and county of Taipei for emergency treatment at about 9 a.m., but one of them was pronounced dead in the afternoon. The other six babies were reported to be in a stable condition, but doctors said they had yet to determine whether they had sustained brain damage due to a lack of oxygen.

"Something's wrong, hurry up," a Peicheng nurse, surnamed Liang, reported a panicking voice from within the baby room while she was not far from room teaching mothers how to take care of their new- born babies at about 800 a.m. Liang said before she realized what had happened, emergency crews were rushing the babies away to other hospitals. DOH Secretary-General Lai Chin-hsiang said prosecutors are now investigating the criminal and civil liabilities in the case. A report of the findings of the investigation will be submitted the medical oversight committee, and the hospital may be punished with a license revocation, Lai said. The 21-year-old nurse who committed the lethal mistake, Huang Ching-hui, was granted NT$250,000 bail after an interrogation by the Taipei District Prosecutors Office.

Peicheng director, Hsu Mu-chuan, admitted to an administrative error on the part of the hospital, partly blaming the new packaging of the hepatitis B vaccination for the mistake. Hsu said the vaccines, used to be stored in one-shot (1 cc) bottles, has recently repacked into 10-cc bottles, which he said were similar to those of the muscle-relaxing drug. "We deeply regret the mistake," said Hsu, adding the hospital would give a preliminary compensation of NT$100,000 to each of the victims' families. An anesthetist, surnamed Lee, admitted that she placed nine bottles of Atracurium in the baby ward's refrigerator that also stored the vaccines. She explained that she thought the Atracurim would come in handy when pregnant mothers needed operations. Maintaining that a warning sign was placed on the bottles, she regretted the mistake.

"Nurses should triple check the drugs before making injections," the Central News Agency quoted Lee as saying. But the county's health bureau chief, Lee Lung-teng, came up with a conspiracy theory, saying human error was "unlikely." He said Atracurium did not need refrigeration, and the drug was contained in 2.5 cc bottles. He said the sizes and labels of the two kinds of containers differed a lot, and it would have been impossible for the nurse to misidentify one for the other, and give seven injections without knowing. He said he did not rule out the possibility of the hospital "being set up." DOH head Twu Shiing-jer said the health authorities would provide the families of the victims with help should there be any litigation against the hospital.
 

http://www.nytimes.com/2002/02/16/international/16BRAZ.html

Merck Says Tens of Thousands May Need Another Hepatitis Shot

 Merck & Company said on Friday that an unknown number of people in as many as 27 nations, including 60 000 youngsters in Brazil, might need new shots to prevent infection with the hepatitis A virus because vaccines they received might have been defective.

A unit of the French pharmaceutical group, Aventis, which sells the vaccine in Europe in a joint venture with Merck, disclosed in December that it was recalling batches of pre-filled syringes because they might not be potent enough to protect against the virus, which is spread by poor sanitation and can cause liver damage. At the time, however, neither Merck nor the Aventis Pasteur unit indicated how many people who had taken possibly faulty batches made between December 1999 and December 2001 would need new vaccines.

Although the batches may have been ineffective in protecting against the virus, Merck said the vaccines were not harmful. Gwen Fisher, a spokeswoman at Merck's headquarters in Whitehouse Station, N.J., said on Friday that the possibly ineffective shots of its hepatitis A vaccine given in the past 2 years include both the VAQTA K vaccine for children and the VAQTA vaccine for adults.

"Merck is offering to pay in most countries for either retesting people to see if they are effectively vaccinated or for revaccinations," said Ms. Fisher, who added that she did not know Merck's potential financial liability. Merck commented on the potential number of people affected by the faulty vaccine in response to inquiries by Reuters following reports by local newspapers in Brazil about the use of the possibly ineffective vaccine in Brazil.

Merck sells the VAQTA K vaccine against hepatitis A for young people in the United States, Latin America, Asia, and parts of Europe. The vaccine is put into syringes in Britain by Evans Vaccines, part of PowderJect Pharmaceuticals. In Brazil, a spokesman for Merck's unit there, Merck Sharp & Dohme, said about 60 000 children and adolescents in the country could need another dose of the preventive drug. Merck said the young Brazilians were among those who took about 117 000 possibly faulty vaccines in the past 2 years, mostly in private clinics in the industrialized states of Sao Paulo, Rio de Janeiro, and Minas Gerais. Each dose of the vaccine was given twice to the Brazilian youths and, although not harmful, it may not be potent enough to prevent the disease, the company said. "The reaction varies from person to person and we cannot guarantee that the doses in the problem lots will be effective," said Marcos Levy, director of corporate affairs for Merck in Brazil. Mr. Levy said oxygenated water had seeped past the seal in pre-filled syringes of the medicine packaged in Britain and also sent to the United States, France, Ireland and Germany. "We recalled that lot and other lots that, although still valid, used the same type of seal on the syringes," Mr. Levy said. He added that the Brazilian clinics that gave the vaccine are contacting patients so that they can return for testing and perhaps a new shot. Unlike hepatitis B or C, hepatitis A is rarely deadly and only severe in about 2 percent of cases.
 

Manitoulin residents get shots of wrong flu vaccine
http://www.thesudburystar.com/webapp/sitepages/content.asp?contentid=14491&c
atname=Local+News
By Star Staff

Wednesday, November 20, 2002 - 11:00

Local News - As Homer Simpson might say, "Doh!"

The Sudbury and District Health Unit announced Tuesday it has learned that some of last year's influenza vaccine was inadvertently included in this year's shipment from the Ontario Government Pharmacy. As a result, people on Manitoulin Island who have already received their flu shot may have to have a second shot to be fully immunized. Using a prior year's vaccine is safe, but may result in inadequate protection for the strain of flu expected to circulate in the current year, the health unit said in a news release. "The Sudbury and District Health Unit has reviewed its records and identified that two clinics on Manitoulin Island used last year's vaccine," the news release said.

"These individuals have already been contacted directly by the health unit and advised to obtain a second flu shot." The health unit also said it has contacted all health-care providers who received flu vaccines this year. Health-care providers were asked to check their vaccine stock and to review immunization records. The health unit requested that anyone identified as having received last year's vaccine be notified directly by the health-care provider.

"If people were immunized with last year's vaccine, they may be only partially protected from the influenza viruses expected to circulate this year," said Kelly Reilly, manager of clinic services with the Sudbury and District Health Unit. "That is why we recommend re-immunization for anyone who is informed that they received last year's vaccine," Reilly said. "Getting a second flu shot is safe and will ensure that people are appropriately protected against influenza this season." The health unit said it will closely monitor the response to its letter to health-care providers and offer assistance as needed. Hope you enjoyed reading The Sudbury Star online. Click here to order convenient home delivery.
 

Baby, eight weeks, given MMR vaccine Dec 13 2002
http://icwales.icnetwork.co.uk/0100news/0200wales
/page.cfm?objectid=12451367&method=full&siteid=50082

By Owen Fairclough, PA News

A doctor's surgery was today carrying out an inquiry into how an eight-week-old baby received the controversial MMR jab by mistake. Shannon Whitter was given the mumps, measles and rubella vaccination by a nurse at the Bellevue Medical Centre in Birmingham instead of diphtheria, whooping cough and tetanus. The tot has so far suffered no adverse effects from the wrong jab, which is normally GIVEN to youngsters at 12 months. Critics of MMR claim it can lead to autism and irritable bowel syndrome in young children.

Shannon's father, George Whitter, 43, said: "Fortunately, Shannon seems to be fine. "But we're keen to see the outcome of this inquiry because another child may not have been so lucky." Shannon's mother, Christine Fullen, took Shannon to the surgery for her inoculations on Tuesday. After a nurse carried out the vaccinations, they returned to their home in Acorn Grove, Ladywood, - and Miss Fullen found a message on her answering machine from the surgery reporting the blunder. Shannon was taken to the Diana, Princess of Wales Children's Hospital in Birmingham, where doctors told her parents that she was protected against any adverse effects because her mother's antibodies was still in her system.

Miss Fullen said: "We are really angry about this because it should not have happened in this day and age."  Dr Andrew Carson, of the medical centre, said the nurse involved would not be administering any further vaccines. "We are looking further with the practice team into what exactly led to this error and procedures will be reviewed to prevent this from happening again," Dr Carson said. "We deeply regret this incident and the concern this has caused to the family." Dr Carson added that manufacturers of the MMR vaccine advise that it is safe to administer it earlier than 12 months, in the event of an outbreak of measles, for example.

Warning over 'useless' mumps vaccine

Dec 3 2002
http://icberkshire.icnetwork.co.uk/0100news/0400bracknell
/page.cfm?objectid=12422754&method=full&siteid=50102

By Colin George

DOCTORS are warning Bracknell parents to be on the look out for a grey-market mumps vaccine which could be useless against the contagious disease. The single jab imported from the Czech Republic is not used by the NHS, but may have been injected into children at private clinics in the area. And youngsters who received the faulty cure may now have to take the controversial combined measles, mumps and rubella vaccine, which some claim to be linked to autism. Medical experts also believe nearly 6,000 doses of the drug Pavivac - which is not licensed by the Government's Medicines Control Agency - are sitting in surgeries waiting to be used. If the vaccine is not kept at a precise temperature it can break down, leaving children unprotected from a range of symptoms including swollen glands, sore throats and fever.

In extreme cases the infection can go on to cause deafness, viral meningitis and sterility in adults. Medicine safety committee chairman Professor Alasdair Breckenridge said: "There are a number of major questions about the manufacture, testing and storage of the unlicensed vaccine Pavivac which are not answered by the information currently available.  "Because of this lack of information we are advising its importation and use should be halted as a precautionary measure, and we have also urgently asked for further information and clarification." racknell GP George Kassianos said children who received the suspect vaccine should be given the controversial MMR jab to ensure they are protected. He said: "It is perfectly safe to repeat the dose. Children or adults who have had a single vaccine previously are either immune and unlikely to suffer side effects, or are not immune and need the vaccine."
 

Published 12/3/2002 http://www.lsj.com/news/local/021203_vaccine_1a-6a.html
Meningitis vaccine might not halt disease
MSU contacting students who got vaccinated
By Sharon Terlep
Lansing State Journal
EAST LANSING - MSU is sending letters to 2,300 students who received meningitis vaccines, after the manufacturer said the inoculations might not work.The nation's only producer of the adult version of the vaccine says it may not ward off a strain found in certain parts of Africa or in laboratories that study the disease.

Vaccine recall
Some meningitis vaccines made between January 2001 and October 2002 have been recalled. People should consider being revaccinated if they received a vaccine in that time and: Work in a laboratory or industry that exposes them to the meningococcal group A. Travel to parts of the world known at the "meningitis belt." This includes parts of Benin, Burundi, Burkina Faso, Cameroon, Chad, Ethiopia, Gambia, Ghana, Mali, Niger, Nigeria, Rwanda, Senegal, Sudan and Tanzania. People who may need a new vaccine should call the place where they received their first one. Revaccinations will be paid for by the manufacturer. On the Web www.menomune.com/page2.html

Michigan State University has Study Abroad programs in Ghana and Senegal - where people could be at risk. But most MSU students are not at risk for meningitis, which is an inflammation of the lining surrounding the spinal cord and brain. The school is sending the letters as a safeguard. "The reality is there aren't a large number of students who travel to Sub-Saharan Africa," said Kathi Braunlich, communications and planning coordinator at MSU's Olin Health Center. "But we want people to be well informed." The faulty vaccines date to January 2001. They're produced by Aventis Pasteur in Bridgewater, N.J. The firm will pay for revaccinations among people who are at risk, spokesman Len Lavenda said. He wouldn't say how much vaccine the company produces or how much might not work. He said, in some cases, tests by the company revealed the vaccine might not protect against Group A of the meningococcus bacteria - found in a strip of African countries known as the "meningitis belt." The illness affects nearly 3,000 Americans a year, though there's been only one death involving the group A strain in the last decade, according to Aventis. "This is not a safety issue and no one needs to be concerned about it," Lavenda said. The Ingham County Health Department is sending about 50 letters to people who may have received the faulty vaccine, Medical Director Dean Sienko said. Shiawassee Country put out a notice Monday offering free revaccinations to people in the affected groups.

At Central Michigan University in Mount Pleasant, 70 miles north of Lansing, a few students have come in for another vaccine, officials said. Meningitis is an issue on college campuses because students living in close quarters are more likely to become sick. It's spread through intimate or household exposure such as kissing, sharing eating utensils or by secretions from the nose and throat. The bacteria have infected six MSU students in the past five years. Three died.
Contact Sharon Terlep at 377-1066 or sterlep@lsj.com.
 

New military recruit died of meningitis shortly after being vaccinated for it.

http://story.news.yahoo.com/news?tmpl=story&u=/ibsys/20021224/lo_kgtv/1432569

Officials: Recruit Did Not Die Of Strep A
Tue Dec 24, 1:56 PM ET Add Local - KGTV TheSanDiegoChannel.com to My Yahoo!


A Marine recruit who died Dec. 15 had an overwhelming meningococcal bacteria infection that was different from the streptococcus A that infected 185 other recruits at the Marine Corps Recruit Depot, it was reported Tuesday. No other recruits at the MCRD have shown symptoms or have been diagnosed with a meningococcal infection, Capt. John Malone, medical services director at Naval Medical Center San Diego, told the San Diego Union-Tribune. It was purely chance that the two separate bacterial infections, meningococcal and step A, hit the recruit population at the same time, Malone said.

Other members of Pvt. Miguel Zavala's platoon received a special oral antibiotic the day he died that should safeguard them against the bacteria, Malone said.

Doctors did not give the antibiotic, called levofloxacin, to all 4,500 recruits and depot staff because no one else showed symptoms of the rapidly moving infection that killed Zavala, Malone said. Recruits in other platoons and the public are not at risk because the bacteria is only spread to others in the same living area, Malone said. "You have to be in the same household," Malone told the Union-Tribune. "You don't get it by just walking across the parade ground." All recruits entering MCRD are vaccinated against the meningococcal bacteria, but the vaccine is not always effective, Malone said. One recruit remains in critical condition from the step A-related pneumonia outbreak that struck the depot. More than 126 people were hospitalized with pneumonia, though not all were related to strep A.

 

On a side note, if I had access to the "phials" or "vials", I'd throw them overboard too.
http://www.guardian.co.uk/uk_news/story/0,3604,879153,00.html

Rebecca Allison
Tuesday January 21, 2003
The Guardian

The Ministry of Defence has launched an internal investigation into how dozens of phials of anthrax vaccine were found washed up on a south coast beach yesterday. The packages of ampoules, which were discovered at West Bay, Dorset, posed no risk to health or the environment, according to the MoD.

"There are ampoules of anthrax in containers on the beach but they are not posing a risk to public health. We are working together with local police to make sure the vaccines are disposed of safely," a spokesman said. Anthrax, a biological agent, is one of the main concerns of the UN biological weapons teams searching Iraq. It is believed that the investigation into the discovery of the ampoules will include looking at whether they came from a warship involved in the recent Navy taskforce deployment to the Gulf headed by HMS Ark Royal. Dorset police said the alarm was raised at 11am by the Bridport harbourmaster after a sighting of unidentified packages on the beaches at West Bay. "The phials were confirmed as anthrax vaccine and we were advised they were sterile and contained no anthrax. The services worked to collect the packages.

"As the work was under way other packages, also found to be a medical substance, were washed up and disposed of in chemical bins," a spokesman said. The MoD confirmed that the packages contained two types of phials. One type contained the anthrax vaccine and the other contained phials of a drug called dimercaprol which acts as an antidote to heavy metal poisoning. The packages consisted of individual sealed ampoules which were packaged in sealed plastic boxes and wrapped in polystyrene inside cardboard boxes, the spokesman confirmed.

He said the batch numbers of the anthrax vaccines had been checked and were found to have been manufactured at the Centre for Applied Microbiological Research at Porton Down. "We haven't been able to search the source of the vaccine, but we can confirm it was issued to the armed forces. There is an internal investigation under way to find out how the ampoules came to be in the water," he added.
 

Friday, February 7, 2003

1,900 got expired measles vaccine (in 1993)

Friday, February 7, 2003 at 09:30 JST
TOKYO — As many as 1,900 children may have been given shots of a measles-mumps-rubella (MMR) vaccine that had already passed its expiry date during the seven months up to the time such vaccinations were banned April 1993, Kyodo News learned Thursday. The Health and Welfare Ministry, the predecessor of the current Ministry of Health, Labor and Welfare, apparently did not disclose the use of the expired vaccine or report it to a sub-panel of the ministry's Council on Public Health that had been discussing rampant cases of the MMR vaccine's side effects.

A group supporting victims of the vaccine's side effects alleges that the government deliberately covered up the expired vaccine's use. An expired vaccine "will not lose its effectiveness immediately or raise the risk of side effects," a ministry official said, but added, "The use of expired vaccines is naturally a problem. We would like to look into the case to find out why that happened. "The vaccine was introduced in 1989 to protect children from the three diseases in a single shot. Production of the stock used for the MMR vaccine was banned in 1991 after it caused side effects in a large number of children. The expiry date for the vaccine was September 1992.

According to vaccine reports that prefectures submitted to the health ministry at the time and other materials, 1,829 people were given the vaccine in eight prefectures between October 1992 and April 1993. Kumamoto Prefecture saw the largest number of people who had the expired vaccine at 801, followed by Hokkaido at 318. Data gathered by members of the predecessor body of the National Institute of Infectious Diseases show that in Tokyo and Kanagawa, two prefectures with no existing records on MMR vaccine use, a total of 104 people were given the vaccine. In all, 1,933 received the vaccine over the period from October 1992 through April the following year.

The health ministry said, however, that the figure may include people who had the vaccine before September, the month it expired, noting that some reports may have come in late. The ministry recently found an in-house document showing it had received reports on five boys aged between 1 and 4 who developed aseptic meningitis after receiving the expired MMR vaccine, but it had kept the fact concealed. A court ruling is expected in March on a suit filed by people who remain disabled due to the vaccine's side effects and the families who lost their children because of the side effects.
 

Being open and honest defused a bad blunder
Pulse; Tonbridge; Jan 13, 2003;

Full Text:
Copyright CMP Information Ltd. Jan 13, 2003

MMR vaccine; DPT vaccine

Dr Andrew Carson examines the aftermath of a vaccine given in error

The child health clinic had been much like any other, apart from the fact that the regular nurse was away on an immunisation update course and her place had been taken by another practice nurse. The clinic finished just before evening surgery. Suddenly, the relative tranquillity of this interval was shattered by the appearance of the nurse in a state of some distress, come to inform me that she had inadvertently given an eight-week-old the MMR vaccine in place of the DPT and HiB. Discussion with the nurse and health visitor ensued, and the health visitor agreed to contact the family as soon as possible. I did not believe there was any increased risk to the child from the MMR vaccine being given early, but checked this with public health officials and the manufacturers. Both sources confirmed my initial assessment. Towards the end of evening surgery I heard from the parents, who expressed concern and anger. I apologised on behalf of the practice and reassured them that their child was not at any increased risk from the early administration of the vaccine. These points would need to be reiterated frequently over the coming days, at each contact with the parents.

Opportunity for discussion

I invited the parents to discuss things with me as soon as surgery had finished. The discussion was lengthy and covered their distress and concern over the fact their child had received a controversial vaccine without their consent. I felt my function at that time was to listen and be supportive without being defensive. The family have subsequently said that, although the incident should not have happened, they felt very supported through their anxieties by the actions of the practice team.

I concluded my interview with the parents by informing them about our complaints procedure and by giving them details of how I could be contacted personally at all times over the coming days. I contacted them later that night and early the following morning to check that the baby was well. The following morning the sequence of events was reported to our primary care manager who immediately started a Serious Untoward Incident investigation. This involved interviewing all the parties involved, including the parents, to try to establish the cause of the incident and see what additional safety measures could be put in place before the next clinic. The PCT was also informed early in the day.

By late morning on day two we were informed that a relative of the baby had approached the press, and we were asked for a statement by a daily newspaper. After obtaining consent from the baby's parents, a press release was prepared in conjunction with the PCT. The media agency employed by the PCT was invaluable at this stage, fielding much press attention. Misreporting and misrepresentation made the front page in the local paper that afternoon. For example, it was reported that the baby had been rushed to hospital, which hadn't been the case at all. This was followed by a request for an interview by the local television news. The media agency was again extremely helpful in preparing me for the questions.

Vaccinations as usual

We felt it was important to stress the support we were giving to the baby's family, the nurse involved, and the rest of the practice team. Furthermore, it was crucial to reinforce the importance of parents continuing to allow their children to be vaccinated in the usual way. The incident was, after all, a rare and isolated one that had not put the baby involved at any increased risk.

Subsequent activity revolved around accurate documentation and reporting of events surrounding the incident, as well as implementing new safety procedures and issuing a statement to our patients. The MPS had been involved from an early stage and appeared happy with the way we had handled the situation. We also sought advice on catching up with the DPT vaccine that had not been administered. Finally, the nurse involved had to go through a disciplinary hearing.

It was a frantic few days that involved a great deal of upset for everyone involved. But it was also a valuable learning experience and much good has come out of it. For example, we now plan to colour- code our vaccines for easy identification.

The nurse, along with the rest of the team, behaved with great honesty and integrity once the mistake had been discovered. This cannot be stressed too strongly. One hopes that aggressive press attention will never discourage individuals from admitting their mistakes. I am convinced that our being open and honest helped defuse a difficult situation.

Andrew Carson is a GP in Birmingham
 

Practice candid over MMR error
Pulse; Tonbridge; Jan 6, 2003;

Full Text:
Copyright CMP Information Ltd. Jan 6, 2003

MMR vaccine; DTP vaccine

Dr Andrew Carson found openness was the best policy when his practice nurse accidentally gave an eight-week-old the MMR vaccine. Dr Carson, a GP in Birmingham, commended the nurse for behaving 'extremely responsibly' by informing them immediately when she realised she had given MMR instead of DTP vaccine. Packaging confusion could be to blame. Dr Carson said: 'Once the vial is taken out of the pack the name of the vaccine is actually obscured by the lot number and expiry date. But that is not to excuse what happened.'

Copyright: CMP Information Ltd.

http://news.scotsman.com/latest.cfm?id=5731551
12:31am (UK)
Private Clinics Botched Children's Vaccines - Report

By Pat Hurst, PA News.

Hundreds of children may have been put at risk after two private clinics botched vaccinations for measles, mumps and rubella, it emerged today. Worried families have been told that single shot immunisations given to toddlers at two private clinics, one in Sheffield and one in Hertfordshire have not been done properly. It means children could pick up infections and may not after all be inoculated against the childhood diseases of measles, mumps and rubella. And the vaccines themselves may have become contaminated, leading to an increased risk of children suffering bacterial infections, experts warned. The parents paid the private clinics for their children to receive single injections of the vaccines. Some parents claim the three-in-one MMR injection delivered by the NHS can cause autism and Crohn's Disease. Instead of getting the NHS recommended MMR vaccines they paid around £70 for the single vaccines, according to the Mail on Sunday.

The clinics are run by Lifeline Care Ltd.

At the clinic held at the Hillsborough Sports Arena in Sheffield, 718 children were given the faulty vaccines, while 295 were given the single dose vaccines at the Elstree Aero-Medical Centre in Hertfordshire. The faulty vaccines were given at both clinics between June and December of last year. Most of the children are toddlers. The problem arose because the clinics changed the normal procedure for making up the vaccines, according to the local NHS trust in Hertfordshire. They began pre-preparing batches of vaccines so more children could be treated which investigators think led to the vaccines not working properly. It means potentially hundreds of children were not then protected from the diseases. The error only came to light after two doctors, who worked at the clinic in Hertfordshire, left and wrote a confidential letter to the local Hertsmere Primary Care Trust, which then investigated.

Dr Joel Bonnet, director of public health at the trust, said, "As a result of the changes in the way the vaccines were made up there is a possibility that the efficacy of the vaccine has been effected, so that children are not as protected as normally they would be. "There is a potential risk, which is why we are recommending parents get the children re-vaccinated with the MMR." Dr Bonnet said he was not aware of any of the children who were not properly vaccinated, subsequently falling ill with measles, mumps or rubella.

The clinics concerned defended their actions.

Dr David Pugh, medical director of Lifeline Care, told the Mail on Sunday they followed "common practice" when making up the vaccines. "During last year we had particularly busy clinics and decided to reconstitute the vaccine in advance," he said. "The vaccines were used within the six-hour time scale recommended. The view of the Department of Public Health was that the potency of the vaccine could not be guaranteed in those circumstances." The two clinics concerned will be investigated by the National Care Standards Commission which is the watchdog for all private medical clinics. The General Medical Council will also investigate what went wrong. The clinics are still in operation but have now reverted to making up the vaccines as recommended by the manufacturer. The Hertsmere Trust has written to all the families of the 1,013 children effected to tell them their children may not be properly protected.

It recommends that all children get the MMR vaccine. Any parents who think their child might be effected can ring NHS Direct on 0845 4647. Also more information on the MMR vaccine is available at the following websites:

www.immunisation.org.uk

www.mmrthefacts.nhs.uk

www.phls.org.uk
 

I guess monkeys, chicken embryos, aborted fetal tissue, and all that is Ok, but my gawd........not a dog. We all know its political, isn't it. BUT again, NO vaccine is safe, including this one. Its just their hypocrisy.....
Sheri

Mumps vaccine suspended in UK
http://www.praguepost.com/P03/2003/Art/0122/news6.php

Safety group concerned that materials in drug present infection risk

By Mindy Kay Bricker
Staff Writer, The Prague Post
(January 22, 2003)

What is good enough for the Czech Republic is not necessarily good enough for the United Kingdom. That was the message from a group of British medical officials who announced Jan. 16 that the United Kingdom would suspend the importation of Pavivac, a Czech-made mumps vaccine for children.

"There are a number of outstanding questions about the manufacture and testing of the unlicensed vaccine Pavivac that are not answered by the information currently available," said Alasdair Breckenridge, chairman of the Committee on Safety of Medicines (CSM), an independent scientific committee that advises the government on medicines. The committee said it was rejecting the vaccine because kidney cells from dogs are used to make it. The CSM said that using materials of animal origin in humans might present a risk from unknown infections.

"There are no other vaccines in the Department of Health's vaccination program which use this method of manufacture," reads a CSM press release. "As a result, there are a number of additional questions not all of which have been satisfactorily answered." Miroslav Reinhardt, export director for Pavivac-maker Sevapharma, said the vaccine was safe and that his company has been cooperative with UK officials. He said the kidney cells were taken from dogs bred at farms that follow laws regulating such practices.

"We cooperated with the Medicines Control Agency (MCA) intensely -- we provided them with our documentation," he said, "and we hope they will reconsider their decision." The vaccine was not licensed for distribution in the United Kingdom. If a medicine meets the special needs of individual patients, doctors in the United Kingdom are allowed to obtain unlicensed drugs. First, however, the drug must be approved by the MCA, the executive agency of the Department of Health that ensures that all drugs meet the appropriate standards of safety, quality and efficacy.

From June to November, more than 5,000 doses of Pavivac were sent to the United Kingdom. Physicians directly requested the vaccine from Sevapharma. Pavivac first came under fire in the United Kingdom in November, when the CSM suspended importation of the vaccine. At the time, some British doctors criticized the action, calling the suspension "appalling scaremongering." When the vaccine was suspended, Czech health officials said they tried to comply with the British government's demands for more information about Pavivac.

"Nothing [about the demands] was very specific or indicated that the product was substandard," said Milan Smid, a doctor for the Czech Regulatory Authority, the government agency that regulates drugs. The agency reviewed the product, Smid said, and did not find any reason to discontinue or halt production in this country. "We didn't have any indicator to take action against the product here," he said. Reinhardt said that no one who has taken the vaccine, which has been used for 14 years, has experienced any serious adverse reactions. "More than 1.4 million children have been vaccinated with no problem," he said of the single mumps jab used in the Czech Republic.

Smid agreed.

"Through the years of use, we had a normal spectrum of the side effects that is comparable to other vaccines," he said. "There is no reason to take actions against this vaccine." United Kingdom health officials said they were unsure how many of those doses imported into their country were administered to children. The CSM has asked clinics to provide a record of children who received the jab so that any adverse reactions can be quickly and thoroughly investigated. Breckenridge said that Sevapharma provided adequate information that proved Pavivac is effective in protecting children against mumps, as long as the child receives a second mumps vaccine between six to 10 months after the initial shot. Currently, Pavivac is sold only in the Czech Republic and is not licensed in any European Union country. The company also manufactures a single measles vaccine, Movivac. British health officials are investigating its safety, even though the measles vaccine has not been imported into the United Kingdom.

Mindy Kay Bricker's e-mail address is mbricker@praguepost.com
 

Family in new jabs scare
Feb 12 2003

By Ed Reed, The Huddersfield Daily Examiner
LITTLE Oliver Wilson may have to have more vaccinations after new health fears. The Waterloo toddler faces more injections after concerns that separate measles, mumps and rubella jabs given to babies at a private clinic in Sheffield may not have worked. Lifeline Care, which offered single injections at clinics held in Hillsborough Arena last year, failed to meet standards set down by a national watchdog. Now, Alison Wilson, aged 38, and husband John, 37, of Sunny Mead, do not know if 20-month- old Oliver is protected. Oliver went for a measles jab at the clinic last July and a rubella vaccination in October. His parents, who queued for three hours on their first visit to the clinic, wanted Oliver to have separate jabs after hearing how the triple MMR vaccination has been linked the development of autism and the bowel disorder Crohn's disease in toddlers. Single jabs are not available on the NHS. Mrs Wilson found out about the Lifeline Care clinics on the internet. Each injection cost £75. But this week they heard the vaccine given to their son may not have been properly prepared. Oliver, who is recovering from chickenpox, will now go for a blood test to determine whether the vaccines have worked. Sadly, the test is not foolproof and his concerned parents are unsure as to whether they should repeat the jabs. "You pay and put your trust in these people and then this happens," said a worried Mr Wilson. He and his wife were eager to get Oliver vaccinated, but not with a triple jab. "Our best course of action was to go with the single vaccinations," said Mr Wilson. "When I was a child we got single vaccinations. Parents should be able to say whether they want their children to have triple or single jabs." Lifeline Care goes against normal procedure and uses pre-prepared vaccines at its clinics. Health watchdog the National Care Standards Commission has investigated the Lifeline Care sessions and ordered the company to improve its practices and staff training.

Letters are being sent to the parents of 718 children who received vaccines at the Sheffield clinic between June and December, telling them of the problem. Mr Wilson questioned whether all children were affected, or just those who received a certain batch. He criticised Lifeline Care who, he said, had offered no information to worried parents. "They haven't come out with a statement to say whether it was particular batch. All we know is it's the vaccine distributed between June and December." He never remembered being asked for his address by Lifeline Care. Parents with any concerns about their child's vaccination should contact their GP or NHS Direct on 08457 4647.
 

Parents told to get babies a second MMR jab
By Ian Lloyd
http://www.thisishertfordshire.co.uk/news/barnet/display.var.696255.
index.parents_told_to_get_babies_a_second_mmr_jab.html
More than 40 children from Barnet are at greater risk of catching measles, mumps or rubella after it emerged their doctor is under investigation for giving them faulty vaccinations. Hertsmere Primary Care Trust (PCT) is urging parents whose children were given the MMR jab by GP Dr David Pugh at the Elstree Aeromedical Centre, Elstree Aerodrome, to get them treated again.

The PCT believes 295 children, including 44 from Barnet, 88 from Hertfordshire and 55 from Middlesex, are at risk after Dr Pugh gave them vaccinations prepared several hours before they were due to be administered against the manufacturer's guidelines. The children were treated between June and December last year. "Some children who have been vaccinated may not be adequately protected against one or more of the diseases," said the PCT's director of public health, Dr Joel Bonnet.

"Due to the way the vaccines were prepared, they may have become contaminated." Such contamination would increase the risk of bacterial infections or side effects to the vaccine, he said. While he could not deny he had prepared vaccinations earlier than he was supposed to, in a letter sent to parents Dr Pugh said he had done nothing wrong. "No parent has ever filed a complaint the only reactions notified are normal reactions to vaccinations and none serious," he wrote.

Investigations into standards at the clinic were started after two former members of staff wrote to Hertsmere PCT claiming vaccines were being prepared incorrectly. The clinic is now being investigated by the National Care Standards Commission (NCSC), which monitors standards at private health practices. The NCSC is also looking into Dr Pugh's claims to have administered 9,000 doses of the unlicensed drug Secretin to 1,500 autistic children.

Dr Pugh has been administering the drug since 1998, although there is no information available about its long-term effects.
 

http://news.sify.com/cgi-bin/sifynews/news/content/news
_fullstory_v2.jsp?article_oid=12631678&category_oid=-20611&page_no=1
      Kids given Insulin instead of Hepatitis B vaccine 
      Thiruvananthapuram, Feb 20 
 
    In a glaring case of medical negligence, about 400 children who were mistakenly administered insulin instead of hepatatis vaccine were rushed to the Medical College Hospital in Thiruvananthapuram from suburban Kalliyur on Wednesday evening.  Hospital sources said that the children were kept under observation, though the condition of none of them was stated to be critical.    "We continue to receive children from the locality as all the children who took the shot today are being asked to get admitted in the hospital," the sources said.     Official sources said the vaccination drive was carried out at the Kalliyur Primary Health Centre, near Peringammala In a glaring case of medical negligence, about 400 children who were mistakenly administered insulin instead of hepatatis vaccine were rushed to the Medical College Hospital in Thiruvananthapuram from suburban Kalliyur on Wednesday evening.

Hospital sources said that the children were kept under observation, though the condition of none of them was stated to be critical. "We continue to receive children from the locality as all the children who took the shot today are being asked to get admitted in the hospital," the sources said. Official sources said the vaccination drive was carried out at the Kalliyur Primary Health Centre, near Peringammala.
 

http://www.thisislocallondon.co.uk/news/
display.var.702494.Top+Stories.clinic_at_
centre_of_child_jab_scare_is_forced_to_close.html
Clinic at centre of child jab scare is forced to close By Ian Lloyd
The clinic at the centre of an investigation into whether it gave hundreds of children ineffective single inoculations against measles, mumps and rubella has been shut down. Lifeline Care Limited, which runs the Elstree Aeromedical Centre at Elstree Aerodrome, was ordered by the National Care Standards Commission (NCSC) to cease practising from 5pm on Friday last week. The clinic, which offered single jabs to combat measles, mumps and rubella, is not registered with the NCSC and was therefore operating illegally. Hertsmere Primary Care Trust (PCT) and the NCSC are currently investigating single-dose jabs given to children at the centre between June and December last year.

Some 295 children including 40 from Barnet may be affected. Meanwhile, there have been unconfirmed reports that a 19-month-old boy, who had the single jab vaccinations at the centre in September, has caught measles. The boy's mother had been told by doctors at Great Ormond Street Hospital that there was a 'strong possibility' he had contracted the disease. A spokeswoman for the NCSC, which monitors private clinics, said: "We have been told by several parents that their children seemed to have contracted measles. But you do sometimes get a mild form of the disease after the inoculation."

Sharon Gold, of Anthony Road, Borehamwood, was horrified when results of a blood test showed her son, who was treated at the clinic, was not immune to any of the diseases. "I am absolutely in shock," she said. The PCT is urging parents who believe their children may have contracted measles, mumps or rubella after being vaccinated at the clinic to write to Dr Joel Bonnet, Director of Public Health, Hertsmere Primary Care Trust, The Elms Clinic, High Street, Potters Bar, Herts EN6 5DA with full details.

 

http://www.bangkokpost.com/News/03Mar2003_news19.html
Hospitals given vaccines alert after infant's death

Aphaluck Bhatiasevi

State hospitals have been told to closely monitor any adverse effects from vaccine immunisations, following the death of a four-month-old infant this year. Though investigations did not confirm that the boy's death was due to vaccines, health authorities have not ruled out the possibility. Since 1997, there have been five confirmed deaths of children younger than five due to vaccines, according to the Diseases Control Department.

The investigating team, which published their findings in a recent Weekly Epidemiological Surveillance Report, said that although no other child who received the same vaccines suffered any serious side-effects, there was a possibility that the boy could have died from the vaccines. The boy was healthy when taken for a regular dose of DTP and OPV vaccines for diphtheria, tetanus, pertussis and polio at Tha Rua district hospital in Nakhon Si Thammarat on January 15 at 11.30 am. His mother found him dead at 8am the next day.

He had big red patches on the back, under his skin. Investigating authorities did not rule a vaccine-related death because his mother suffered from syphilis during his birth, for which both were treated for 10 days. From 69 children under five treated for side-effects from immunisation at Tha Rua district hospital between October last year and January 21 this year, 18 had pneumonia, 17 suffered from fever while 14 had diarrhoea. Public health authorities have been told to carefully monitor storage procedures and the use of vaccines to ensure safety for children below five years of age.
 

IVAX Pharmaceuticals Has Recalled ONXOL injection
(SafetyAlerts) - The Food and Drug Administration (FDA) released the following information.

PRODUCT
ONXOL injection (paclitaxel), 300 mg/50 mL (6mg/mL), 50 mL Multi Dose
Vial, Rx only. Recall # D-161-3.

CODE
M026861 Exp Date 02/04.

RECALLING FIRM/MANUFACTURER
IVAX Pharmaceuticals, Miami, FL, by letter on January 20, 2003. Firm initiated recall ongoing.

REASON
Lack of assurance of sterility: Environment in Class 100 Filling room exceeded the non-viable particulate limit specification.

VOLUME OF PRODUCT IN COMMERCE
1,039 vials.

DISTRIBUTION
Nationwide.

 

Eli Lilly Has Recalled GEMZAR for Injection
 (SafetyAlerts) - The Food and Drug Administration (FDA) released the following information.

PRODUCT
GEMZAR for Injection, (Gemcitabine HCl), 200 mg, For I.V. use only, 10 mL
Sterile Single Use Vial, Lilly, Rx Only, Vial No. 7501. Recall # D-157- 3.

CODE
Lot 6MH15.

RECALLING FIRM/MANUFACTURER
Eli Lilly & Company, Indianapolis, IN, by letter on or about December 20, 2002.
Firm initiated recall ongoing.

REASON
Container Defect: glass in vials.

VOLUME OF PRODUCT IN COMMERCE
31,200 vials.

DISTRIBUTION
Agentina, Brazil, Columbia, Mexico, Taiwan and Venezuela.


[http://www.safetyalerts.com/_includes/general.htm]


Of course, the fact that these people are now being exposed to a double dose of adjuvants, heavy metals and toxic contaminants doesn't rate a word of concern, right?

Immunizations underway after vaccination mishap More than 170 babies and children have so far been re-immunised after a vaccination mishap in Ingham in north-east Queensland. About 400 hundred people have been recalled for immunisations received during the past 10 months, because vaccines were wrongly stored at the Ingham Hospital.

Anna Morgan from the Tropical Public Health Unit says authorities have contacted the parents of all but two of the 220 children involved and says the re-vaccination program should last another fortnight. About 30 adults are yet to be contacted to have their tetanus vaccinations again.

 

http://www.thisishertfordshire.co.uk/news/barnet/display.
var.703249.index.parents_looking_at_legal_action.html
Parents looking at legal action
By Ian Lloyd
Parents of children treated at the controversial Elstree Aeromedical Centre which offers single jab alternatives to the combined MMR vaccine are contemplating legal action against its director Dr David Pugh. Denise Goldsmith said she had been speaking to solicitors following confirmation that her 19-month-old son Noah contracted measles despite being given a £65 single jab at the clinic in September. Noah is one of 295 children who may have been given a faulty jab at the clinic in Hogg Lane, Elstree, between June and December last year.

The National Care Standards Commission, which closed the clinic down on February 20 for not having a licence to practice, is currently investigating the claim. "I am in the process of speaking to different solicitors and I have had about 100 calls from mothers who have had their children vaccinated at the clinic who all want to take it further," said Mrs Goldsmith, of Mill Hill.

"What happened to Noah was absolutely horrific I wouldn't wish it on anybody. The doctors didn't know if it was measles or not because it is so rare as children are vaccinated. "When he went into hospital with big purple spots they were treating him for meningitis for 48 hours." She added: "We sent Noah to the clinic because we didn't want to do the MMR vaccine. "We didn't want to play Russian roulette with his health and risk having an autistic child or a child with bowel disorder."

Dr Pugh, director of Lifeline Care Ltd, which runs the clinic, said he was unable to comment to the Times Group on the matter as his insurance company stated it would invalidate his medical insurance. A statement to parents from the clinic reads: "We have been in private medical practice for over 17 years and offering single vaccines for over five years. "Dr Pugh has been a GP for over 32 years and there has not been a single complaint filed against him."

18:27 Tuesday 4th March 2003

 

http://mdn.mainichi.co.jp/news/20030312p2a00m0dm004000c.html
Outdated vaccine injected into 1,000s of kids

Over 2,000 children were immunized a decade ago with unreliable vaccines known for causing side effects and well past their use-by date, the Ministry of Health, Labor and Welfare said Wednesday. Physicians across Japan continued to inject children with vaccines for mumps, measles and rubella even after the ministry had decided they no longer should be used. But ministry officials said there was no danger in them doing so. "They're still effective (vaccines) even if they are about half a year past their use-by date," a ministry spokesman said. Typically, the ministry's plan of action is more like one of inaction.

"Our probe into the situation has left us with the impression that individual physicians didn't pay sufficient care with what they were doing. We will set up a panel of experts and look into the correct and fundamental approach to take regarding immunization," the ministry spokesman said.

Ministry officials said the MMR vaccinations were given to children aged from 1 to 6 during the four years from April 1989. As the vaccinations were producing too many side effects, their maker announced in September 1991 that it would cease producing them. The medicines were said to be effective for one year. Ministry officials looked into how much of the outdated vaccines were used after October 1992, the time the ministry's supplies of the drugs reached the prescribed end of their effectiveness.

Going through documents of the only 10 prefectures still with paperwork from the time, the ministry learned 2,070 children had been injected with the out-of-date vaccines. (Mainichi Shimbun, March 12, 2003

 

  Alzheimer's Vaccine Had Mixed Results

By RANDOLPH E. SCHMID
.c The Associated Press

WASHINGTON (AP) - The experimental vaccine withdrawn from testing after four Alzheimer's patients developed brain swelling seems to have reduced the accumulation of brain plaques associated with the disease but may have caused the dangerous inflammation, researchers report. The vaccine did not show success against another sign of the memory-destroying disease, tangled nerves and microfibers, according to the first autopsy results of one of the affected patients in the clinical trial. The 72-year-old woman died almost two years after first receiving the vaccine in July 2000.

The 360-patient trial was halted in January 2002 and the drug, AN-1792, made by Elan Corp. of Ireland, was withdrawn after the inflammation known as meningoencephalitis was found in four subjects. Doctors later discovered 11 more people with the symptoms. Doctors at the University of Southampton in England report that the autopsy results show that the swelling ``is likely to be a consequence of the immunotherapy.'' The vaccine had shown good results in mice, eliminating with few side effects the brain-damaging plaques called beta amyloid.

The accumulation of plaques associated with