The Vaccine Adverse Events Reporting System

 

In 1990, the Vaccine Adverse Event Report System (VAERS) was created by the Center for Disease Control (CDC) and the Food and Drug Administration (FDA). Medical professionals are required to report and adverse events to the system and concerned parents can also report via fax, mail, or online. The system’s purpose is to be a “post-marketing safety surveillance program, collecting information about adverse events (possible side effects) that occur after the administration of vaccines licensed for use in the United States,” (according to the VAERS itself).

Anti-vaccine proponents use data from the VAERS database to claim that there is scientific evidence for the risks they claim. 10-15% of adverse events reported are for "serious adverse events involving life-threatening conditions, hospitalization, permanent disability, or death, which may or may not have been caused by a vaccine." However, according to skepticalraptor.com, “The data is considered to be ‘passive’ because the individual reports can be made online, by fax or by mail–real causal events may be underreported and hyped, imaginary issues with no causality, can be over-reported. However, without medical investigations of causality between the vaccination and the claimed adverse events that are reported to the VAERS database, the data have no real value.” Therefore, the data cannot prove causality.

Not only is the data passive, the reporting system is particularly flawed. Dr. Laidler reported,

“The chief problem with the VAERS data is that reports can be entered by anyone and are not routinely verified. To demonstrate this, a few years ago I entered a report that an influenza vaccine had turned me into The Hulk. The report was accepted and entered into the database.”

Dr. Laider literally told the VAERS that the vaccine turned him into the Hulk and they had to report it. Since this adverse event is rather unusual, the VAERS called Laidler to ask for details. After explaining it, Laidler gave permission for the report to be removed from the database. If he had refused permission, the VAERS would have been obligated to keep the bogus report.

Anti-vaxxers have claimed Dr. Laidler’s experiment a hoax and maintain that the VAERS collects accurate data. In response, a few people have gone ahead and tried similar things. Such as this man in the UK,

“VAERS has a helpful popup which tells you exactly what it needs to know – which are the most important pieces of data it needs. However, the fact that I live in the UK was not deemed of importance. Neither was the fact that I told VAERS that my daughter had been turned into Wonder Woman. The only piece of contact data I submitted was my email address and I wasn’t even asked for that. I submitted it voluntarily...

The Javascript routine caught the fact that I tried to submit an adverse event *before* the fictional date of my daughter’s birth but it failed to catch that I stated the vaccine was administered at 18months and that the date for vaccination I provided was only 6 months after the ‘birth’ date.”

So if this man in the UK can find that many flaws in our system and record himself doing it, what’s to keep the data truthful? The answer: nothing. People using data from the VAERS must take the majority of the information with a grain of salt or find a completely different source. Well, then what’s the point of having the VAERS at all?

The VAERS is a tool that was created for two reasons. First, it appeases the anti-vaccination crowd, and second, the system can be used for observing data to form a hypothesis about the effects of vaccines. In addition, the VAERS has the power to report its findings to the CDC. The CDC can then use that information to more effectively shape policies. The recent issues with the rotavirus vaccine have proven where the real importance of the VAERS lies.

The rotavirus vaccine is an oral vaccine given to children under 5. Two main types of this vaccine are given Rotarix and RotaTeq. The difference between these two is mainly the packaging.

As you can see, Rotarix looks much more like a syringe that a nurse would inject. In 33 of 39 cases reported to the VAERS, the nurses did mistake the oral vaccine for a shot. Luckily, the children were not hurt by this mistake, but the vaccine does nothing when injected this way. The VAERS reported the delivery errors to the CDC which now reminds health professionals about proper delivery of the vaccines. Therein lies the purpose people should focus on, not the easily skewed data.

Sources:
http://www.skepticalraptor.com/skepticalraptorblog.php/reports-vaccine-related-effects/
http://antiantivax.flurf.net/#VAERS
http://leftbrainrightbrain.co.uk/2006/03/14/on-using-vaers/
http://vaccines.procon.org/
http://vaers.hhs.gov/index

Vaccines and Government in the 1980s

In 1986, Congress passed the National Childhood Vaccine Injury Act. This act was in response to the large number of lawsuits being filed claiming vaccines were causing harm. The act shielded vaccine manufacturers and medical professionals from liability. This meant that claimants would bypass the civil court system and immediately go to federal court. In addition, the plaintiff only needed to prove that the vaccine caused injury.

On October 1^st, 1988, the National Vaccine Injury Compensation Program (VICP) was formed. The VICP was "established to ensure an adequate supply of vaccines, stabilize vaccine costs, and establish and maintain an accessible and efficient forum for individuals found to be injured by certain vaccines,” according to the US Department of Health and Human Services.

US Codes (found in Cornell University’s legal database) state,

(3)

 (A) In the case of any person who has sustained a vaccine-related injury after attaining the age of 18 and whose earning capacity is or has been impaired by reason of such person’s vaccine-related injury for which compensation is to be awarded, compensation for actual and anticipated loss of earnings determined in accordance with generally recognized actuarial principles and projections. 

 (B) In the case of any person who has sustained a vaccine-related injury before attaining the age of 18 and whose earning capacity is or has been impaired by reason of such person’s vaccine-related injury for which compensation is to be awarded and whose vaccine-related injury is of sufficient severity to permit reasonable anticipation that such person is likely to suffer impaired earning capacity at age 18 and beyond, compensation after attaining the age of 18 for loss of earnings determined on the basis of the average gross weekly earnings of workers in the private, non-farm sector, less appropriate taxes and the average cost of a health insurance policy, as determined by the Secretary.

“Between 1989 and July 1, 2014, 3,645 compensation awards have been made (amounting to over $2.7 billion in awards and $113.2 million to cover legal costs) and 9,786 claims have been dismissed (amounting to $62.8 million paid to 4,925 dismissed claimants to cover legal costs),” (also from the Dept. of Health and Human Services).

Sources:
www.hrsa.gov/vaccinecompensation/index.html
http://vaccines.procon.org/
http://www.law.cornell.edu/uscode/text/42/300aa-15

Passive Immunity

                Since before birth, newborns will be developing an immune system. Starting three months before birth (aka the third trimester), mothers begin to send antibodies to their unborn child. This is called passive immunity because the child’s immune system is not actively creating its own antibodies and is just accepting them from the mother through the placenta.

For a few days after birth, the breast milk (known as colostrum) the mother gives the child also contains a great number of antibodies to add to the immune system. This milk has a thick, yellowish appearance due to the high amount of antibodies present.

                The mother’s immune system plays a very important part in what antibodies the child receives. For example, if the mother has had chickenpox, the baby will receive antibodies to protect against chickenpox. If the mother hasn’t had chickenpox, then the child is left unprotected since there are no antibodies to exchange. Also, the child receives antibodies against bacteria and other microorganisms that the mother typically encounters in her environment.

                This immune system is not particularly strong at birth and actually wears away as the child grows older. Some antibodies disappear in a very short amount of time, which is when doctors recommend getting the first shots. The National Health Society (or NHS, which is based in London) states,

“The first immunisation, given when your baby is two months old, includes whooping cough and Hib (haemophilus influenza type b) because immunity to these conditions decreases the fastest. Passive immunity to measles, mumps and rubella usually lasts for about a year, which is why the MMR vaccine is given just after your baby's first birthday.”

                Without the passive immunity, newborns would be much more fragile. Unfortunately, these antibodies do not last forever, which brings us back to the importance of vaccinations. Without a doubt, my sister’s daughters will be receiving vaccines to boost their immunity. So this is the end of baby week! Thank you for reading!

Sources:

http://www.nhs.uk/chq/Pages/939.aspx?CategoryID=54
http://www.gentlebirth.org/vre/newimmun.html

Vaccines and Your Baby Video Series | The Children's Hospital of Philadelphia

Vaccines and Your Baby Video Series | The Children's Hospital of Philadelphia

The First Hours

                The picture that most people have of newborn babies is the new mother and father holding the child and fawning over it. Then the baby gets passed around the family who all adore it together. However, right after a baby is born, there are a certain number of things that obstetricians are supposed to do with babies.

Most importantly is the Apgar test which ascertains that the baby is healthy within the first minute. Doctors measure heart rate, breathing, activity and muscle tone, reflexes, and skin color. They repeat this after five minutes to double check that the baby is still healthy or has scored higher in the scale. After five minutes, if the child still is below a seven, they are kept for close medical attention.

There also are two shots: an injection of Vitamin K and the Hepatitis B vaccine. The Vitamin K just ensures that the baby’s blood can clot since newborns generally have low levels of this vitamin. Hepatitis B (the focus of my last blog post) should be given before leaving the hospital. There are other smaller procedures such as eye drops and hearing tests that ob. perform while the baby is in the hospital.

As a patient, there are certain rights that parents have. Parents are allowed to refuse vaccinations for their child. Before an expectant mother goes into labor, lawyers suggest the parents get a waiver of immunization if they intend to avoid vaccines. However, many doctors refuse to treat patients that plan to circumvent immunizations. These patients can put the doctor at risk of lawsuits for malpractice. Pediatrician sometimes will refuse to treat an unvaccinated child.

Although it is possible to refuse treatment for your child in certain states, this decision might not be the wisest course of action. The vaccine given at birth will protect the child throughout their lifetime from Hepatitis B. According to the Hepatitis B Foundation,

“The hepatitis B vaccine is the first anti-cancer vaccine because it can prevent liver cancer. Worldwide, chronic hepatitis B causes 80% of all liver cancer, which is the 9^th leading cause of death. Therefore, a vaccine that protects against a hepatitis B infection can also help prevent liver cancer.”

That sounds like a pretty good reason to get your newborn vaccinated against Hepatitis B if you ask me.

Sources:
http://www.womenshealth.gov/pregnancy/childbirth-beyond/labor-birth.html
http://blogs.lawyers.com/2013/05/newborn-vaccination-without-permission/

Babies on Board

                Babies tend to be a touchy subject for any debate. Generally, protective new mothers can go two ways with vaccinations. Either mothers want to protect their babies and get them vaccinated or they view vaccinations as dangerous and refuse them. Still, there are others who are uninformed about what doctors recommend or what state laws may require. My sister is due sometime next week, so questions about newborns and vaccinations have been running through my head. So what do vaccinations have to do with newborns?

                First, what shots are required at birth? Right after birth, vaccination against Hepatitis B is recommended. Besides that, shots tend to take a break until one or two months when the second dose is suggested. So what about Hepatitis B is so bad that the first thing doctors do is vaccinate against it?

                According to The Children’s Hospital of Philadelphia,

“Hepatitis B virus attacks the liver. Hepatitis B virus infections are known as the ‘silent epidemic’ because many infected people don't experience symptoms until decades later when they develop hepatitis (inflammation of the liver), cirrhosis (severe liver disease), or cancer of the liver (hepatocellular carcinoma). Every year in the United States about 3,000 people die from hepatitis soon after they are infected, and another 10,000 go on to develop long-term hepatitis, putting them at high-risk for cirrhosis and liver cancer.”

                Like I did, you may be wondering how newborns are supposed to be getting Hepatitis. That’s a blood transmitted disease from doing intravenous drugs or having unprotected sex, right? There’s a rationale for that too (also from the Children’s Hospital of Philadelphia).

“However, it is also possible to catch hepatitis B virus through more casual contact, such as sharing washcloths, toothbrushes or razors. In each of these cases, unseen amounts of blood can contain enough viral particles to cause infection. In addition, because many people who are infected don't know that they are infected, it is very hard to avoid the chance of getting infected with hepatitis B virus.”

                It’s hard to keep everything that ever touches your child immaculately clean. So a pre-emptive strike might counteract the risks your child will face throughout their life.

Sources:

http://www.chop.edu/service/vaccine-education-center/a-look-at-each-vaccine/hepatitis-b-vaccine.html

 

 

Just Jenner

“I shall endeavour still further to prosecute this inquiry, an inquiry I trust not merely speculative, but of sufficient moment to inspire the pleasing hope of its becoming essentially beneficial to mankind.”

-Edward Jenner

 Edward Jenner was born on May 17^th, 1749, in Berkley, Gloucestershire. He was the eighth of nine children born to Sarah Jenner and Reverend Stephen Jenner. By the age of five, Jenner’s parents had both passed away leaving him to be cared for by his older sister, Mary.

                “Edward Jenner was himself variolated whilst at school. He was "prepared" by being starved, purged and bled; then locked up in a stable with other artificially infected boys until the disease had run its course. He suffered particularly badly. It was an experience he would never forget.” Beginning at 14, Jenner began to study medicine as an apprentice surgeon first under Mr. Daniel Ludlow, a surgeon of Chipping Sodbury and then under surgeon and experimentalist, John Hunter. With Hunter, Jenner began to refine his investigation and dissection skills.

                Due to his negative experience with variolation, he became particularly interested in the gossip of the country-folk. They claimed that people who had been infected with cowpox would not become sick with smallpox. Cowpox was similar to smallpox but with much milder effects: a few pocks on the hand and some mild fever.

                When Sarah Nelmes, a dairymaid, called on Jenner to look at some pocks she had, Jenner determined she had contracted cowpox. Seizing the opportunity, Jenner decided to test the rumors. James Phillips, the eight year-old son of his gardener, was his first experimental group. Jenner made small cuts in James’ arm and rubbed some of the cowpox material into the wound.

                James became mildly ill with cowpox a few days later proving the vaccination had some effect. Then came the real test: Jenner needed to see if James was now safe from smallpox. On the 1^st of July, Jenner variolated James and waited. Remarkably, James did not become infected with smallpox. Jenner repeatedly tested to be sure of his results, but James’ immune system warded of the virus again and again.

                After more experimentation, Jenner became more convinced his results were not isolated cases. He chose to publish his findings to the medical community in a book entitled: 'An Inquiry into the Causes and Effects of the Variolae Vaccinae; a Disease Discovered in some of the Western Counties of England, Particularly Gloucestershire, and Known by the Name of The Cow Pox'. This was the first recorded introduction of vaccination. And thus, Jenner became the Father of Immunology.

Sources:

http://www.jennermuseum.com/vaccination.html

Let's Start at the Very Beginning

Inoculations have existed for a very long time. Though there is no proper documentation for most of these cases, many cultures put inoculations into practice. It is believed that the Chinese used matter from and infection and scratched the matter into the skin of a healthy person at least since the 10^th century. India practiced even before then since possibly 10,000 BCE.

The philosophy behind inoculations followed the smallpox disease that spread from northeastern Africa across India, into China and the Western world. Northeastern Africa appears to be the cradle of the disease. From that point, Egypt dealt with the disease (as can be seen in mummies including Ramses V). Egyptian merchants are believed to have transferred it to India. As India was a popular trading center, it is easy to see it’s progression along the trade routes.

Smallpox begins with a rash that then progresses into pus-filled blisters that forever mar the skin. Smallpox killed 1 in 3 of its victims. Those that survived the disease had cases of blindness and disfigurement. However, many people, including the Greek philosopher, Thucydides, soon began to notice a peculiar trend: the survivors of the disease, deformed though they were, DID NOT BECOME SICK WITH SMALLPOX AGAIN. This observation led people to begin inoculations in the form of variolation. Variolation is different than modern day vaccination. It uses a live and virulent strain of the virus (as compared to modern vaccinations which use either dead virus or a less virulent cousin). Variolation kills 1 in 100 people (slightly better odds than 1 in 3).

Variolation was soon introduced to Europe primarily through Lady Mary Montagu. She and her husband, the British ambassador, traveled to the Ottoman Empire where she became interested in the strange habits of the native folk. Every September, families would gather their children to visit a set of old women. These women would have “nutshells” of smallpox matter which they inserted into small scratches on the arms or legs. In a letter, Montagu states, “The children or young patients play together all the rest of the day, and are in perfect health to the eighth. Then the fever begins to seize them, and they keep their beds two days, very seldom three. They have very rarely above twenty or thirty in their faces, which never mark, and in eight days time they are as well as before their illness.” Montagu went on to have her own children inoculated and became a major proponent of the Inoculation introduction in Western society.

Sources:
http://www.infoplease.com/cig/dangerous-diseases-epidemics/smallpox-12000-years-terror.html
https://explorable.com/who-invented-vaccination
http://www.jenniferleecarrell.com/Speckled%20Monstersmallpox8a.htm
http://www.fordham.edu/halsall/mod/montagu-smallpox.asp
http://www.historyofvaccines.org/content/timelines/all

An Overview

A child’s least favorite word: shots. The thought of needles makes many youths cringe. Still most kids go through with all the required vaccinations without a second thought. However, some remain unvaccinated against preventable diseases such as measles and mumps. Why are these youth being left unprotected?

The many rumors surrounding inoculations are hard to dispel. Many internet stories circulate about whether or not vaccines are safe. If all of these concepts were true, the true nature of vaccines is the world’s best kept secret. Medical fraud and government conspiracies mislead the population down a dangerous path. According to these rumors vaccines cause autism, ADHD, diabetes, tics, seizures, paralysis, and even death.

I have a three-year old niece who is up-to-date on all of her shots and a niece to be born within a month. If those rumors were true, then my nieces should remain on the safe side: unvaccinated. But scientific research has refuted these claims again and again. So why do these arguments continue?

Interestingly, the opinions of the anti-vaccination debate have their own scientific findings. Some of this data comes from the discredited scientist Andrew Wakefield. Wakefield is no longer allowed to practice and has since moved to the US. He wrote Callous Disregard: Autism and Vaccines: The Truth behind a Tragedy that reignited the vaccine debate, now with celebrity support from Jenny McCarthy (anybody remember McCarthyism?).

If enough parents swallow these concepts and refuse to get their children vaccinated, not only will it put those kids at risk, it could put the general public in danger. Herd immunity involves the risks of exposure to an infected person. The more people vaccinated against the disease, the less risk of the disease spreading. The more infectious the disease, the higher the percentage of people vaccinated against the disease needs to be.

 

                According to the Center for Disease Control (CDC), many states are beginning to fall below the required percentages for herd immunity. The population is steadily becoming more at risk for epidemics once thought to be extinguished. Oddly enough, I think if we were to experience an epidemic, the anti-vaccination crowd would tell us it was because of shots.