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Vaccine Terminology

Descendants of human fetal cells in the making of vaccines

by TheVaccineMom February 7, 2015

Are there fetal cells in vaccines? No. Do some vaccines contain viruses grown in cells from the human fetal origin? Yes. But, I feel this needs some explanation.

And before I get started, this isn’t meant to be a debate or opinion article. These are just the facts as I’ve researched them. And before I get into the issue at hand, you’re going to be getting a microbiology lesson…

The cell theory states: All cells arise from pre-existing cells.

Remember the term mitosis from biology class? That’s how parent cells make their daughter cells. The parent cell replicates all of their chromosomes into two sets and then splits into two cells, leaving one set of chromosomes in each cell. That’s it, in a nutshell. This happens over and over and over: parents forming daughters, and daughters becoming parents and forming more daughters.

Under the right conditions, cells love to reproduce. Scientists can take all kinds of cells and grow them in the laboratory under controlled conditions. Cells that are grown in an artificial environment, such as a culture dish, in a nutrient-rich solution to support the growth of the cells, and under controlled/ideal conditions of temperature, humidity, and gaseous atmosphere are called a cell culture.

Cells in a culture can be grown directly from living tissues. This is called primary cell culture. And oftentimes a primary cell culture will contain many types of cells in one dish.

These primary cultures can be manipulated in the lab until only one type of cell remains. Cell culture with only one type of cell is called a cell strain.

The cell strain is then used to establish a cell line. A cell line is a cell culture formed from a single cell, and thus, each cell in the culture will be daughters of that cell. That means each cell in the culture will have the exact same genetic makeup. This uniformity allows for experimental control.

Got it? Okay. Now, just focus on the cell line, daughters of just ONE CELL. Daughters becoming parents and making more daughters…

And a side note: Cells do not reproduce to infinity. There are a set number of times a cell can reproduce before it can no longer make daughter cells (called the Hayflick limit). So, scientists have to introduce a genetic mutation into cell lines that allow them to reproduce indefinitely, this is called an immortalized cell line.

Now we jump to virology. A virus lacks the ability to reproduce on its own. It needs to use a cell in order to make many, many copies of itself in order to cause disease. Therefore, to make a vaccine to create immunity to a virus, you must first have many copies of a virus, and to have many copies of a virus, you need cells to infect the virus with.

So, researchers infect cells with a virus to get more viruses to use in a vaccine. Okay. But, you can’t use the virus as is in the vaccine because it will lead to infection with the disease, so there has to be something done to the virus so that it cannot cause disease. A virus is unable to cause disease if it cannot make enough copies of itself to infect enough cells in the body. So, the best way to weaken, or attenuate a virus, is to make it so that it is unable to replicate in the body.

How do you do this?

A cell line is infected with a virus. Once the virus establishes itself and begins to reproduce in the cells, the conditions under which the cells are grown are slowly changed. This causes a mutation in the virus so that the virus grows best under the altered conditions. These are conditions that are different from those of the normal human body. We call this new virus an attenuated (weakened) virus.

The attenuated virus is the virus that can now be injected into the body as a live attenuated vaccine. The weakened virus provokes an immune response by the body but cannot replicate efficiently, so it is unable to cause disease. This type of vaccine elicits the most potent and long-lasting of all vaccine-related immune responses on the market today, requiring the fewest boosters.

On to the matter at hand: The cells used to make the cell lines.

There are two human cell strains used to create vaccines that are in use today. The cells used to grow the viruses for these vaccines are descendants of aborted fetal cells. And I want to stress the fact that NOT ALL vaccines use pathogens grown in human cell lines.

The first cell line, WI-38 (Winstar Institute 38), was developed by Leonard Hayflick in 1962. These cells are descendants of lung cells (human diploid lung fibroblasts) from a four-month-old female fetus aborted because the family felt they had too many children.⁶

Notice the phrase, “descendants of”. All of the cells in this cell line are daughters of one cell found in the lung tissue of a fetus, generations removed from the original cell.

The cell line, WI-38, was found to grow many viruses very well, including the rubella virus. The history and making of the rubella virus vaccine paints a great picture of how an attenuated viral vaccine is made using a human cell line:

The rubella virus was isolated by an unrelated physician, Stanley Plotkin, also working at Winstar Institute. Plotkin grew the rubella virus in the WI-38 cells at a much lower temperature [86°F (30°C)] than normal human temperature [98.6°F (37°C)]. This created a rubella virus that grew best at lower than normal temperature, and that grew very poorly at normal body temperature. After 25 growth cycles of cells in culture, the virus was considered unable to reproduce efficiently and cause disease in a human. It could still, however, evoke quite the immune response and leave the body with powerful memory antibodies to the rubella virus.

This rubella vaccine is still used in the United States today.

The following are the vaccines created using WI-38 cells:

Live vaccines against rubella²:

the monovalent vaccines against rubella Meruvax® (Merck), Rudivax® (Sanofi Pasteur, Fr.), and Ervevax® (RA 27/3) (GlaxoSmithKline, Belgium)
the combined vaccine MR against rubella and measles, M-R-VAX® (Merck, US) and Rudi-Rouvax® (AVP, France)
the combined vaccine against rubella and mumps, marketed under the name of Biavax® (Merck, U.S.)
the combined vaccine MMR (measles, mumps, rubella) against measles, mumps, and rubella, marketed under the name of M-M-R® II (Merck, US), R.O.R.®, Trimovax® (Sanofi Pasteur, Fr.), and Priorix® (GlaxoSmithKline UK).

Other vaccines²:

A vaccine against chickenpox, Varivax®, produced by Merck (using WI-38 and MRC-5 cell lines)

The second human cell line used to grow viruses in for vaccines is called MRC-5 (Medical Research Council 5), developed by J.P Jacobs in 1966.⁵This cell line is also a descendant of a human lung fibroblast. The cells came from a 14-week male fetus aborted for “psychiatric reasons” from a 27-year-old woman in the UK.

The vaccines produced with viruses grown in MRC-5 cells include:

two vaccines against hepatitis A, one produced by Merck (VAQTA), the other one produced by GlaxoSmithKline (HAVRIX)
one vaccine against chickenpox, Varivax®, produced by Merck (using WI-38 and MRC-5)
one inactivated poliovirus vaccine Poliovax® (Aventis-Pasteur, Fr.)
one vaccine against rabies, Imovax®,
one vaccine against smallpox, AC AM 1000 (still on trial)

The WI-38 and MRC-5 cell lines are the only two human cell lines used in the making of vaccines.

Some things to note:

These cell lines began using fetal cells aborted over 50 years ago, and since then, the cell lines have grown independently.
Neither abortion used for the creation of these cell lines was performed for the purpose of vaccine development. They were done so by maternal choice.
Not all vaccines are made using viruses grown in cells with a human fetal origin.
Fetal cells are not contained in vaccines.

Resources:

“Human Cell Strains in Vaccine Development”. The history of vaccines. The College of Physicians of Philadelphia. 31 July 2014.
Sgreccia, E. Moral Reflections On Vaccines Prepared from Cells Derived From Aborted Human Foetuses. 9 June 2005. A letter found under Immunization Action Coalition’s “Vaccine Concerns”. www.immunize.org/concerns.
Plotkin. “History of Vaccination.” Pnas. 5 Febuary 2014. Vol. 111, no. 34, pp. 12283-12287.
Sven, G., S. Plotkin, K. McCarthy. “Gamma Globulin Prophylaxis; Inactivated Rubella Virus; Production and Biological Control of Live Attenuated Rubella Virus Vaccines”. American Journal of Diseases of Children. August 1969. vol. 118, no. 2, pp. 372-381.
Jacobs, J.P., C.M. Jones, J.P. Bailie. “Characteristics of a Human Diploid Cell Designated MRC-5”. Nature. 11 July 1970. vol. 277, pp.168-170.
Wadman, M. “Medical Research: Cell Division.” 27 June 2013. Vol. 498. Pp 422-426.
Plotkin, S., D. Cornfield, and T. Ingalls. “Studies of Immunization With Living Rubella Virus.” Amer J Dis Child. October 1965. Vol. 110. Pp. 381-389.
“First Step Towards Vaccine for Hepatitis A.” The New Scientist. 31 May 1979. Vol. 82. No. 1157. p. 730.
Nunnally, B.K., V.E. Turula, and R.D. Sitrin. Vaccine Analysis: Strategies, Principles, and Control. 27 November 2014. pp. 54-57.

February 7, 2015

Vaccine Terminology

The Use of Formaldehyde in Vaccines–This chemical may surprise you.

by TheVaccineMom December 19, 2014

written by TheVaccineMom

Formaldehyde, a chemical sometimes found in vaccines, has many immunization-hesitant people concerned. Putting formaldehyde in your body may sound scary, but stay tuned because this chemical may surprise you.

Why is formaldehyde found in some vaccines?

Sometimes a killed (inactivated) form of the virus or bacterial toxin is used in the making of a vaccine. When a virus or bacterial toxin is inactivated, it is unable to make you sick when it’s introduced to the body. Scientists use formaldehyde to inactivate germs.

Surprise! Formaldehyde is found naturally in your body!

Your body produces formaldehyde during normal metabolic processes, and formaldehyde found inside you is either made by your body or obtained externally.

Formaldehyde is found in the environment. It’s a common chemical used in the production of resins and adhesives, some fabrics, foams, paper products, insulation, and it’s used to preserve dead tissues.

According to the NIH, the air we breathe is our primary source of exposure to formaldehyde. It comes from off-gassing from products like carpet, upholstery, and combustibles. It’s found in car exhaust, tobacco smoke, power plant smoke, forest fires, and wood stoves.

If you aren’t inhaling formaldehyde from the environment, you’re ingesting it. It’s in the soil, in our foods, in our drinking and bottled water, and surface and groundwater. It’s in apples, pears, carrots, milk. Sometimes it’s in our cosmetics.

Eating certain fruits, vegetables, or drinking fermented drinks that contain methanol breaks down in your body into many byproducts, including formaldehyde.

Your body NEEDS formaldehyde. If you don’t get it from the environment, your body will make it. The body makes formaldehyde when demethylating DNA (a process used to control gene expression). It makes it just to break it down. When it is broken down, it’s products are used to synthesize DNA, mediate hormone signaling, and aid in energy transfer.

Your body doesn’t distinguish one molecule of formaldehyde from another. No matter where it comes from–your carpet, an apple, a vaccine–it’s all the same. It also doesn’t discriminate when breaking it down. Your body can get rid of excess amounts that would be toxic, and it’s all broken down into byproducts and then excreted in the same way. Formaldehyde is eliminated as formate in the urine or breathed out as CO2.

Excessive amounts may be very harmful. This is most common in people who use formaldehyde in large quantities for long periods of time. Cancer in these people are found in tissues of the respiratory pathways due to excessive inhalation of formaldehyde. However, there is very little data to back even this up.

There is no evidence that the trace amounts of formaldehyde in vaccines lead to cancers. Any side effects due to short term low-level exposure are reversible. (2)

You do not need to worry about formaldehyde building up in your body or accumulating in your children after multiple vaccinations. The trace amounts injected are eliminated rapidly within hours.

If you’re still concerned, the most formaldehyde your child will ever get from vaccinations will occur at the 6-month check-up. The vaccines with formaldehyde include the HepB, DTaP, IPV, and sometimes the influenza vaccine. If your child gets these four vaccines all at once, the amount of formaldehyde will be around 307.5μg. This amount is 160 times less than the total amount their body naturally produces every single day. (Compare that to the 428.4-1,516.4μg of formaldehyde in a single apple.)(4)

So, there you have it. A chemical that once sounded pretty frightening doesn’t have to be so scary anymore.

Without formaldehyde, you’d actually be dead. (And not well preserved, might I add.)

Resources:

1. “Common Ingredients in U.S. Vaccines.” U.S. Food and Drug Administration. U.S. Department of Human Health and Services. www.fda.gov

2. Vaccine Education Center. Children’s Hospital of Philadelphia. http://vec.chop.edu

3. Centers for Disease Control and Prevention. www.cdc.gov

4. Harpocrates Speaks. www.harpocratesspeaks.com

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December 19, 2014

Children's Vaccines Vaccine Terminology

Do you need to worry about thimerosal in vaccines?

by TheVaccineMom April 11, 2014

written by TheVaccineMom

Way back before the 1930’s lots of kids were dying from vaccine-related bacterial infections. That’s because kids were given their vaccines from multi-dose vials–vials intended to be used more than one time, but with different needles.

It turns out that’s not a very clean way of giving vaccines.

This allowed for bacteria and fungi to grow inside the vials. Then, the microorganisms would get injected into the bodies of the kids that came after the first injection. However, that changed with the addition of preservatives in vaccines.

Preservatives are used in vaccines to prevent or kill any growth of bacteria, fungi, or other microorganisms that might have contaminated the vaccine vial.

Due to tragic events in history, such as the infection of children with deadly bacteria after injection with multi-dose vaccines, the United States Code of Federal Regulations (the CFR) required preservatives to be added to multi-dose vials of vaccines.

Preservatives have been required in multi-dose vaccines since the 1930s.

Since then, thimerosal has been the most widely used preservative in multi-dose vaccines. It has a long record of safety and has been proven effective at preventing bacterial and fungal contamination of vaccines. However, over the past several years, thimerosal has become a target for controversy due to its mercury concentration and concern for safety.

The Vaccine Mom Discusses Thimerosal in Vaccines

Let’s talk thimerosal:

Yes, thimerosal contains mercury. It is about 50% mercury by weight.¹ A vaccine composed of 0.01% thimerosal as a preservative contains approximately 25 micrograms of mercury per 0.5 mL dose.¹

Mercury is an element that is found as inorganic mercury salt in the water, soil, plants, and animals. It occurs naturally in the Earth’s crust, air, soil, and water. Since the beginning of time, occurrences such as volcanic eruptions, rock weathering, and coal-burning have all contributed to the release of mercury into the environment. The mercury in the environment then gets changed by certain types of bacteria into a compound called methyl mercury. Methyl mercury accumulates in the aquatic food chain an organic form and can land in larger quantities on your plate in seafood. These organic forms of mercury are more easily absorbed and harder to eliminate from the body when ingested.¹

At high levels, methyl mercury can be toxic to people. Methyl mercury is a neurotoxin and not the form of mercury found in thimerosal. The consumption of this form of mercury, such as through eating contaminated fish or exposure to methyl mercury fungicide, for example, has been associated with physical side effects. Many studies have been conducted on methyl mercury, of which the mercury health guidelines have been established.

But not all forms of mercury are the same.

Thimerosal is a derivative of ethyl mercury. This tiny change in wordage relates to a hugely different toxicological profile. Studies comparing methyl and ethyl mercury suggest that these two types of mercury are processed differently in the body.²Ethyl mercury has been shown to break down by the body and get excreted much more rapidly than methyl mercury, and therefore is much less likely to accumulate in the body and cause harm.²

Thimerosal Toxicity:

Allergic reactions to thimerosal have been described in the clinical setting.¹ Most of the reactions seen have been delayed hypersensitivity reactions such as redness and swelling at the injection site.^4,5The reactions tend to be mild and last only up to a few days. However, when an allergic reaction is seen in the clinical setting, it’s nearly impossible to tell whether the reaction was due to the thimerosal or to another component of the vaccine.¹

One study published in 1931 involved the injection of a 1% thimerosal solution into subjects, with no reported side effects except for 2 cases of skin sloughing.⁶ As stated before, the thimerosal component in vaccines currently is 0.01%, ten-fold lower than the concentration used in this study.

Another study conducted in 1985 compared the toxicity of ethyl and methyl mercury in adult rats. After feeding the rats the mercury concentrations daily, the study found that the ethyl mercury, the mercury found in thimerosal, to be less neurotoxic than the methyl mercury.⁷Still, guidelines for mercury safety are based on methyl mercury.

Finally, a study conducted in 2002 may be of the most importance. Due to the concern that infants may lack the ability to eliminate the mercury in vaccines, a study conducted at the University of Rochester and National Naval Medical Center in Bethesda, MD looked at the levels of mercury in the blood and other samples from infants who had received routine vaccinations containing thimerosal. They found that in every infant included in the stud,y the levels of mercury in the blood samples didn’t exceed the methyl mercury safety guidelines.8 Also, they found that mercury was cleared from the infants’ blood faster than predicted for methyl mercury and that most of the mercury was excreted in the stool fairly quickly.⁸

The study suggests that thimerosal is removed much more rapidly from the body than methyl mercury. Currently, follow-up studies are being conducted, paid for by the National Institute of Allergy and Infectious Diseases (NIAID).

Thimerosal and neurodevelopmental disorders, such as autism:

Many studies have shown that there is no association between thimerosal exposure and autism.

For a list of studies on thimerosal and autism, check out the Children’s Hospital of Philadelphia (CHOP) website.

In 2001, the Institute of Medicine (IOM) convened a committee to discuss and review vaccine safety-related issues. One review focused on the potential relationship between thimerosal in vaccines and neurodevelopmental disorders. They concluded that the evidence that thimerosal caused autism, attention deficit hyperactivity disorder (ADHD), and speech or language delay was not great enough to link the two.⁹

In 2004 the IOM issued its final report on thimerosal and autism. The committee concluded that there is no causal relationship between thimerosal-containing vaccines and autism.¹Also, they stated that the benefits of vaccination are tried and true and that “the hypothesis of susceptible populations is presently speculative, and that widespread rejection of vaccines would lead to increases in incidences of serious infectious diseases like measles, whooping cough and Hib bacterial meningitis”.¹

However, the IOM committee decided that the removal of thimerosal from vaccines was “a prudent measure in support of the public health goal to reduce mercury exposure of infants and children as much as possible”.¹

So, is thimerosal safe?

The three U.S. health agencies, The Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH), have looked at all of the current research on thimerosal and have found it to be safe to use in vaccines.³

Also, the organizations, The National Academy of Sciences’ Institute of Medicine, the Advisory Committee on Immunization Practices (ACIP), and the American Academy of Pediatrics (AAP) have found thimerosal to be safe after reviewing the research.³

What vaccines still contain thimerosal?

The great news is that all of the childhood vaccines are thimerosal-free! So you don’t need to worry about it any longer!

Some of the influenza vaccines are produced in multi-dose vials, and therefore contain thimerosal. You can always ask for a thimerosal-free flu vaccine.

Several other vaccines do contain thimerosal. For a complete list of the vaccines containing thimerosal: HERE.

*Note: Vaccines that are considered trace-thimerosal-containing formulations have 1 microgram or less of mercury per dose. Full thimerosal vaccines have around 25 micrograms per dose, with the exception of inactivated influenza vaccine.

Resources:

U.S. Food and Drug Administration (FDA). Department of Health and Human Services. www.fda.gov
Vaccine Education Center at The Children’s Hospital of Philadelphia (CHOP). www.chop.edu
The Centers for Disease Control and Prevention (CDC). www.cdc.gov
Cox NH, Forsyth A. Thimerosal allergy and vaccination reactions. Contact Dermatitis 1988;18:229-233.
Grabenstein JD. Immunologic necessities: diluents, adjuvants, and excipients. Hosp Pharm 1996; 31:1387-1401.
Powell HM, Jamieson WA. Merthiolate as a Germicide. Am J Hyg 1931;13:296-310.
Magos L, Brown AW, Sparrow S, Bailey E, Snowden RT, Skipp WR. The comparative toxicology of ethyl- and methylmercury. Arch Toxicol 1985,57:260-267.
Pichichero ME et al. Mercury levels in premature and low birth weight newborn infants after receipt of thimerosal-containing vaccines. J Pediatr. 2009 Oct;155(4):495-9. Epub 2009 Jun 26.
IOM (Institute of Medicine). Thimerosal-containing vaccines and neurodevelopmental disorders. Washington DC: National Academy Press; 2001.

April 11, 2014

Vaccine Terminology

How are vaccines made and released to the public?

by TheVaccineMom February 17, 2014

written by TheVaccineMom

A vaccine’s main goal is to teach your immune system to recognize and remember a bacteria or virus.

The word “vaccination” means to stimulate the immune system to make antibodies against the bacteria or virus targeted by the vaccine.

“Immunization” is different; it’s used in relation to injecting a person with pre-formed antibodies to a particular disease to make the person immune to it.

These terms are often used interchangeably, and that’s just fine, however it’s important to understand that these are two very different ways of creating immunity to a disease.

February 17, 2014

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