Thread: Steps to Take When You Vaccinate

FDA:A Parent's Guide to Kids' Vaccines

Vaccines have contributed to a significant reduction in many childhood diseases, such as diphtheria, polio, measles, and whooping cough. It is now rare for American children to experience the devastating effects of these illnesses. Infant deaths due to childhood diseases have nearly disappeared in the United States and other countries with high vaccination coverage. But the germs that cause vaccine-preventable diseases and death still exist, and can be passed on to people who are not protected by vaccines.

Ensuring the safety and effectiveness of vaccines is one of the Food and Drug Administration's top priorities. Vaccines are developed in accordance with the highest safety standards; they must be safe to give to as many people as possible.

Like any medicine, vaccination has benefits and risks, and no vaccine is 100% effective in preventing disease. Most side effects of vaccines are usually minor and short-lived. A child may feel soreness at the injection site or experience a low-grade fever. Serious vaccine reactions are extremely rare, but they can happen. For example, signs of severe allergic reaction can include swelling, itching, weakness, dizziness, and difficulty breathing.

"But parents should also know that the risk of being harmed by a vaccine is much smaller than the risk of serious illness that comes with infectious diseases," says Norman Baylor, Ph.D., Director of the Office of Vaccine Research and Review in FDA's Center for Biologics Evaluation and Research (CBER). "Vaccination is an important step to get children off to a healthy start."

Vaccines may contain live, attenuated (but weakened) or killed (inactivated) forms of disease-causing bacteria or viruses, or components of these microorganisms. They trigger a response by the body's immune system when injected or given by mouth. Vaccines stimulate the body to make antibodies—proteins that specifically recognize and target the disease-causing bacteria and viruses, and help eliminate them from the body.

CBER is the part of FDA that regulates vaccines in the United States. CBER works with other agencies to study and monitor vaccine safety and effectiveness.


Steps to Take When You Vaccinate
Review the vaccine information sheets. These sheets explain to vaccine recipients, their parents, or their legal representatives both the benefits and risks of a vaccine. Health practitioners are required by law to provide them.

Talk to your doctor about the benefits and risks of vaccines. Learn the facts about the benefits and risks, along with the potential consequences of not vaccinating against certain diseases. Some parents are surprised to learn that children can die of measles, chicken pox, and other vaccine-preventable diseases.

Tell your doctor about bad reactions. Before your child receives a vaccine, tell your doctor if you, your child, or a sibling has ever had a bad reaction to a vaccine. If your child or a sibling has had an allergic reaction or other severe reaction to a dose of vaccine, talk with your health care provider about whether that vaccine should be taken again.

Ask about conditions under which your child should not be vaccinated. This might include being sick or having a history of certain allergic or other adverse reactions to previous vaccinations or their components. For example, eggs are used to grow influenza (flu) vaccines, so a child who is allergic to eggs should not get a flu vaccine.

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Steps to Take When You Vaccinate
Commonly Used Vaccines
Measles, Mumps, Rubella (MMR) Vaccine

Commonly Used Vaccines


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A Parent's Guide to Kids' Vaccines
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Measles "epidemic" risk as parents shun MMR jab

The number of measles cases has soared, leading to concern of an epidemic as a result of fears that the MMR vaccine could cause autism, health officials said on Friday.

There were 1,049 confirmed cases of measles in England and Wales up the end of October, already surpassing last year's total of 990 and the largest number since new monitoring methods were introduced in 1995, the Health Protection Agency said.

It said the fears about the MMR jab had led to a rise in parents choosing not to have their children vaccinated.

"This rise is due to relatively low MMR vaccine uptake over the past decade and there are now a large number of children who are not fully vaccinated with MMR," said Dr Mary Ramsay, an immunisation expert at the HPA.

"This means that measles is spreading easily among unvaccinated children. There is now a real risk of a large measles epidemic. These children are susceptible to not only measles but to mumps and rubella as well." In 1998, Dr Andrew Wakefield of Royal Free Hospital in London and colleagues sparked a fierce worldwide debate among scientists by suggesting the MMR jab could cause autism.

Before his comments more than 90 percent of children were given the MMR jab but when his now discredited views were made public that fell to 80 percent.

The largest study into the alleged link reported in February that there was no evidence the vaccination caused the development disorder.

Health bosses are now carrying out an MMR "catch up" programme to try and identify those who have missed out on the jab and offer them another chance to have it.

Evidence suggests there is a real risk of a large measles outbreak of between 30,000 to 100,000 cases in England, mainly centred in London, the HPA said.

"Measles is a very serious infection as it can lead to pneumonia and encephalitis, even in healthy children. It is highly infectious: it can be passed on without direct contact before the rash appears.

Dangerous Jabs - The MMR Scare

In recent weeks, there have been renewed fears of the dangers of childhood vaccines reported in the international press.

In the UK, it was triggered by Dr. Andrew Wakefield's latest study published in Adverse Drug Reaction and Toxicologica Reviews Vol 19 No 4 December 2000, in which he had documented 170 cases of children who developed autism shortly after the combined measles, mumps and rubella vaccine (MMR) jab.

'For MMR, autism and inflammatory bowel disease, a significant index of suspicion exists without adequate evidence of safety,' he concluded.

The public panic which ensued forced the UK government to launch an advertising campaign to reassure parents that the combined MMR vaccine is safe for children. Indeed, some parents with autistic children are suing the UK government for compensation.

Although the proportion of children immunised is currently 88 percent, down from 92 percent since 1998, vaccination in the UK has been falling, according to The Economist magazine (1st January) and continues to drop.

The alarm began three years ago when Dr. Wakefield and his colleagues at the Royal Free Hospital in London reported The Lancet in Feb 1998 that 12 children developed autism within two weeks or so of being given the MMR jab. They also had inflammatory bowel disease and behavioural problems.

The 12 children, who were referred to the hospital, had a history of diarrhoea and abdominal pain. In all the cases, the children had been developing normally when they suddenly lost their speech and other skills.

Eight of the 12 children developed autistic symptoms within 14 days of receiving their MMR jab. Five of the children had severe reactions, including fever, rash, delirium or seizures.

Most significantly, all 12 had intestinal abnormalities, with 11 showing patchy, chronic inflammation of the colon; seven exhibiting abnormal growths of small nodules of lymphoid tissue; and two suffering from thrush-like ulcers plus huge swellings in their small bowels.

Dr Wakefield, a gastroenterologist, stated that the evidence was strong enough to warrant further research into the links between MMR and bowel disease, and in turn, autism.

According to him, in children who are genetically susceptible to autism, the MMR vaccines may damage the intestinal function, which in turn could allow food by- products called peptides to pass through the intestinal walls, disrupting brain function and development.

In her book, The Vaccination Bible (1998), Lynne McTaggart cited the London- based firm of solicitors, Hodge, Jones and Allen - which had been contacted by some 1,500 families whose children have been allegedly affected by the vaccine - that half of their cases involve children who were developing normally but became autistic right after vaccination.

'Autism was the most common side effect reported to the solicitor's firm, occurring twice as much as any other serious side effect,' she said.

In fact, the firm's clients have videotapes of their child's development from birth, month after month, showing normal, healthy development up until the point of vaccination with MMR, usually at 12-15 months.

'By that time, the child is usually walking, may have a small vocabulary, and is pointing and interacting with the family. And then suddenly, in every one of these instances, the children have lost their speech and social interaction and made a sudden regression into behaviour patterns which are considered within the autistic spectrum,' she notes in her book.

In the US, the Institute of Medicine has concluded that the MMR vaccine may cause anaphylaxis, a life threatening allergic reaction and the causes of many other adverse outcomes could not be determined because of insufficient data.

These dangers also hold true for Hepatitis-B vaccines, according to the US Institute of Medicine. In fact, possible harm from a mercury-containing preservative in the Hepatitis-B vaccine has led to changes in the Hepatitis-B vaccine schedule.

These warnings were reported by Prof. Eric Hurwitz at the School of Public Health, Department of Epidemiology, University of California, Los Angeles in the International Herald Tribune in February this year.

According to him, 'a recent study suggests that the most widely used current vaccines for whooping cough may be linked with anaphylaxis, while the chicken pox vaccine has revealed anaphylaxis, encephalopathy (a disorder affecting the brain) and other reactions'.

He disclosed that 'vaccine safety has taken a back seat to development and rapid deployment' and 'even today, we lack procedures for the systematic collection of valid long-term safety data'.

In his view, 'Links of the MMR vaccine and other immunisations with autism have been neither proved nor disproved because of inadequate data'.

'Similarly little is known about the potential long-term consequences of multiple and combination vaccines administered to US children,' he added.

'Thus, because of how vaccines are tested and marketed, without large long-term safety studies before widespread public school use, lack of confidence in vaccine safety may not be a misconception, but a scientifically justifiable concern'.

'There are insufficient data to accurately estimate the risks; current investigatory systems are not designed to assess the risks of rare events or adverse outcomes with long latent periods; and post-marketing surveillance is arguably still research,' he added.

Given the harm that childhood vaccines can cause, he calls for voluntary informed consent in US immunisation policies until 'we can predict which children are at risk from current and future vaccines'.

Vaccine risks were officially acknowledged by the US Congress when it passed a law in 1986 which requires doctors to tell parents about the benefits and risks of childhood vaccines before vaccination and to report vaccine reactions to federal health officials. The problem however, is that 90 percent of doctors do not report suspected vaccine damage, according to the US FDA.

In these 'mad cow and GM foods' times, when public confidence in officialdom is at an all-time low, and fears concerning childhood vaccines escalate in the North, vaccine companies will be positioning vaccines shots for Third World babies.

Already the Global Fund for Children's Vaccines is pledging US$50 million worth of vaccines and funding to 13 countries in Africa, Asia and Latin America over the next five years.

The Global Fund was launched in late 1999 with a Bill and Melinda Gates Foundation donation of US$750 million. The Global Fund gives financial support to Third World countries to purchase new and under-used vaccines.

Northern governments, including the US, the UK and Norway, have pledged US$200 million to the Global Fund.

However, childhood diseases like mumps, measles and rubella are benign infections in healthy children. Children do not die of these problems when they are well-fed and healthy.

In the Third World, they are clearly diseases of poverty and deprivation. These are the real killers and the real solution lies in attacking them instead of tinkering with the symptoms selling vaccines.

'No evidence' MMR jab is unsafe

The government aims for 95% MMR uptake

The most in-depth analysis to date has cleared the controversial MMR vaccine of any link to autism or bowel disease.
The researchers say their findings provide clear reassurance for patients and health professionals that the combined jab for measles, mumps and rubella is safe.

A team led by Dr Anna Donald and Dr Vivek Muthu have examined research into MMR from 180 countries around the world.



MMR is the best way to protect children against measles, mumps and rubella

Department of Health
They found no evidence that MMR or single measles vaccines are associated with autism or inflammatory bowel disease.

But they did find strong evidence that both MMR and single measles vaccination virtually eliminate risk of measles and measles complications.

Fever

The researchers also found evidence that both types of vaccine are associated with a small risk of developing a minor fever within three weeks of vaccination.

However, measles itself causes acute fever in all infected children.


Dr Anna Donald said questions had been answered

The link between MMR and autism and inflammatory bowel disorders was raised by controversial research carried out in 1998 by Dr Andrew Wakefield, then of London's Royal Free Hospital.

Dr Wakefield highlighted a possible relation between MMR and developmental disorder in 12 children with bowel symptoms.

Subsequent public concern over the safety led to a record low vaccination rate between July and September 2001 of just 84.2%, though the rate has recently risen again.

The government says that 95% of children need to be immunised to eradicate the threat of a measles epidemic.

Flaws

The latest research, published in the journal Clinical Evidence, says that Dr Wakefield's research was flawed in a number of ways.

It was small, selective in its sample, and failed to make comparisons with healthy children.



How can scientists explain to parents the coexistence of these symptoms in their children?

David Potter
The researchers conclude that the study "does not establish MMR as a cause of inflammatory bowel disease, autism, or developmental regression, and that its hypothesis has been satisfactorily tested by scientifically reliable studies."

A Department of Health spokesman said "This review confirms earlier studies that the scientific evidence finds no link between MMR and autism or inflammatory bowel disease.

"We hope that parents are encouraged by these latest conclusions on the safety of this vaccine.

"Vaccine safety is a paramount concern and we will continue to monitor all the evidence.

"MMR is the best way to protect children against measles, mumps and rubella."

Scepticism

But Dr Peter Mansfield, a GP from Louth in Lincolnshire, who was reported to the General Medical Council for offering his patients single measles jabs, said the study did not offer conclusive proof that MMR was safe.

He said Dr Wakefield's research was not the only study that provided cause for concern. Another study had found traces of the measles virus in the bowel lining of children with a form of autism, but not in other children.

Dr Mansfield told BBC News Online: "It must be wrong to say there is no evidence linking MMR to autism and bowel disorders, although it may be possible to say that evidence is counterbalanced by evidence that points to the opposite."

Dr Mansfield said he was awaiting the results of a major review of the research currently being undertaken by the Oxford-based Cochrane Collaboration, due to be published at the end of the year.

The National Autistic Society said there were a significant number of parents whose children have autism and severe gastrointestinal symptoms.

But Jackie Fletcher, of campaign group Jabs, said: "This is a review of a review of reviews."

There had been a "missed opportunity" to examine fresh evidence of children with MMR, she said, adding that personal testimonies should be taken from parents.

David Potter, head of autism policy and information at the NAS, said: "How can scientists explain to parents the coexistence of these symptoms in their children?

"There is an urgent need to study these cases to establish what physiological and pathological mechanisms are occurring in these children if parents are to be reassured."

This thread reminds me of a case i saw in orthopedics dept last week.A 33 day old baby had come to get the sutures on its left arm removed.Why the sutures?Coz the baby had had to undergo a surgery at two weeks of birth to correct an abscess in the left humerus that developed coz the nurse who was supposed to give the intradermal vaccine BCG had accidentally injected the bone..Which is to say people should be aware of not just the harm a vaccine can cause but also of the risk the procedure entails.