Tag: preservatives

“Pro-Safe Vaccine” Doesn’t Mean What You Think It Means

As a pediatrician who has always fully vaccinated and protected his own kids, I didn’t totally understand what it meant when my first parents told me that they were pro-safe vaccine.

If they were interested in safe vaccines, I thought, why not get their kids vaccinated and protected? After all, vaccines are safe! Their baby was due to get several very safe vaccines at her upcoming two-month checkup.

At a screening for Vaxxed, Paul Thomas, MD, joked that kids with autism were brain damaged. And everyone laughed.
At a screening for Vaxxed, Paul Thomas, MD, joked that kids with autism were brain damaged! And everyone laughed.

I eventually got an answer.

“You don’t have to dig far to know that vaccines have caused tremendous harm. Have they had benefits? Absolutely. Which is why I remain somewhat on the neutral side in saying that I am not anti-vaccine,” said Dr. Paul Thomas. “I’m pro-safe vaccines. I’ve progressed along to the point where I now don’t believe there is such a thing.”

Folks who say that they are pro-safe vaccines typically:

And they want new, safer vaccines that can’t possibly cause any kind of side effects.

Of course, these new, safer vaccines must be toxin-free, without any preservatives, stabilizers, and especially, no chemicals of any kind. They should also be free of gluten, antifreeze, thimerosal, vaginal spermicides, and heavy metals. Essentially, they would just be antigens, without other ingredients, because these folks don’t understand how vaccines are really made.

“Pro-Safe Vaccine” Doesn’t Mean What You Think It Means

Are you starting to see the problem with folks who say that they are pro-safe vaccines now?

“I’m not for starting an epidemic of another disease. We just want there to be some type of conversation, once. Sit down with our side, with our doctors and scientists, to take a look at what we’re talking about. We’re not an anti-vaccine movement. We’re pro-safe-vaccine schedule. Until we have that conversation, people are going to think it’s an anti- and pro- side.”

Jenny McCarthy

Who were these doctors and scientists that she had on her side?

“In our community we say, “Yeah.” We firmly believe the cause of the epidemic of autism is due to a vaccine injury and/or other environmental exposures — pesticides also. But what on this earth we all kind of share the most is vaccines.”

Jenny McCarthy

Right. So she is not anti-vaccine, but she thinks that vaccines injure people and have caused and epidemic of autism?

And that’s where her pro-safe vaccine schedule comes in…

And we’re saying: “Delay them. Delay them till age 2. Skip some that you might not need.”

Jenny McCarthy

Like all of the other alternative vaccine schedules out there, Jenny McCarthy’s pro-safe vaccine schedule had no evidence that it was safe or effective.

And that gets to the root of the issue. We don’t know what causes autism, so it must be vaccines.

“To our community, Andrew Wakefield is Nelson Mandela and Jesus Christ rolled up into one.”

J. B. Handley

But what about the folks who have moved beyond listening to Jenny McCarthy and being concerned about autism?

They have the same goals and are still scaring parents with the same old messages that have been used by the anti-vaccine movement for hundreds of years.

And they just don’t believe the overwhelming evidence that vaccines are safe and necessary.

What Does It Mean to Be Pro-Safe Vaccine?

So what does it mean to say that you are pro-safe vaccine?

Essentially, it means that you are anti-vaccine, but don’t want to say that you are anti-vaccine.

More on the Pro-Safe Vaccine Movement

 

Thimerosal Hype or Hazard

You know the story about vaccines and thimerosal, right?

Unfortunately for the movie Trace Amounts, simple calling something a fact doesn't make it a fact.
Unfortunately for the movie Trace Amounts, simple calling something a fact doesn’t make it a fact. In addition to mischaracterizing how the process started, they seem to think that kids have been getting exposed to even more mercury in vaccines today…

Are you sure?

Thimerosal Timeline

Although it was never actually linked to any significant side effects, as a “precautionary measure,” the AAP recommended that thimerosal (mercury) be removed from childhood vaccines in 1999.

That’s not when the hype over thimerosal started though.

A few years before that, in 1997, an amendment to the Food and Drug Administration (FDA) Modernization Act called on the FDA to compile a list of foods and drugs with added mercury.

“At the time the FDA Modernization Act was passed, it was recommended that infants receive 3 different vaccines that contained thimerosal: diphtheria-tetanus-acellular pertussis (DTaP), hepatitis B, and Haemophilus influenzae type B (Hib). Infants who received all of these vaccines could have been exposed to a cumulative dose of mercury as high as 187.5 μg by 6 months of age. This value exceeded guidelines recommended by the Environmental Protection Agency (EPA) but did not exceed those recommended by the Agency for Toxic Substances Disease Registry (ATSDR) or the FDA.”

Offit et al on Addressing Parents’ Concerns: Do Vaccines Contain Harmful Preservatives, Adjuvants, Additives, or Residuals?

And it was found that in some circumstances, infants could get 187.5 μg of mercury from vaccines by 6 months of age, which exceeded some, but not all regulatory guidelines.

Which regulatory guidelines?

  • EPA – 89 µg
  • ATSDR – 266 µg
  • FDA – 354 µg

That led to the recommendation from the AAP, in July 1999, to remove thimerosal from vaccines, including the hepatitis B, DTaP, and Hib vaccines, the only routinely used, non-flu vaccines that had ever had thimerosal. Specifically, the AAP asked vaccine manufacturers “for a clear commitment and a plan to eliminate or reduce as expeditiously as possible the mercury content of their vaccines.”

“There is a significant safety margin incorporated into all the acceptable mercury exposure limits. Furthermore, there are no data or evidence of any harm caused by the level of exposure that some children may have encountered in following the existing immunization schedule. Infants and children who have received thimerosal-containing vaccines do not need to be tested for mercury exposure.”

Notice to Readers: Thimerosal in Vaccines: A Joint Statement of the American Academy of Pediatrics and the Public Health Service

It is important to note that thimerosal-free versions of the DTaP and Hib were already available at the time though.

So we had:

  • DTP vaccines – contained 25μg thimerosal, but had largely been replaced by DTaP vaccines at this point
  • Infanrix – a DTaP vaccine that never contained thimerosal since it was first approved in 1997 (most folks incorrectly state that Infanrix first contained trace amounts of thimerosal)
  • Tripedia – a DTaP vaccine that was first approved in 1992 and did contain 25μg thimerosal, a thimerosal-free formulation became available in March 2001 – it was discontinued in 2011
  • Acel-Imune – a DTaP vaccine that was approved in 1991 and did contain 25μg thimerosal, it was discontinued in 2001
  • Certiva – a DTaP vaccine that was approved in 1998 and did contain 25μg thimerosal, it was discontinued in 2000
  • TriHIBit – a DTaP/Hib combination vaccine that was approved in 1997 and did contain 25μg thimerosal, it was discontinued in 2011
  • Tetramune – a DTP/Hib combination vaccine that was approved in 19 and did contain 25μg thimerosal, it was later discontinued
  • OmniHib – a Hib vaccine that never contained thimerosal since it was approved in 1993
  • ActHIB – a Hib vaccine that never contained thimerosal since it was approved in 1993
  • ProHIBIT – the first Hib conjugate vaccine licensed in 1987, it contained 25μg thimerosal
  • PedvaxHIB – a Hib vaccine that never contained thimerosal since it was approved in 1989
  • HibTITER – a Hib vaccine that never contained thimerosal since it was approved in 1988, except in multidose vials (25μg thimerosal)
  • Comvax – a Hib/hepatitis B combination vaccine that never contained thimerosal
  • Recombivax HB – a hepatitis B vaccine  with 12.5μg  thimerosal that was approved in September 1983, but a thimerosal-free formulation became available in September 1999
  • Engerix B – a hepatitis B vaccine with 12.5μg  thimerosal that was approved in 1989, but a form with only a trace amount of thimerosal became available in March 2000, followed by a thimerosal-free formulation in January 2007

And of course, the other vaccines that younger kids got at the time never contained thimerosal, including hepatitis A, MMR, Varivax, polio, and Prevnar.

By January 2003, remaining stocks of vaccines with thimerosal expired.

Also in 2003, thimerosal-free flu vaccines became available, including thimerosal-free flu shots and FluMist, the nasal spray flu vaccine.

Thimerosal Hype or Hazard

So what was the big concern about thimerosal?

It wasn’t that infants were getting exposed to thimerosal in vaccines, but rather that they might get exposed to too much thimerosal.

Looking back at the available vaccines at the time, it is fairly obvious that most infants didn’t get that much thimerosal though, as there were already plenty of thimerosal-free versions of all routinely used vaccines. To get to the higher doses that some folks were concerned about, they would have to get the hepatitis B vaccine, plus thimerosal containing versions of both DTaP and Hib, and a flu shot.

Because young, otherwise healthy children are at increased risk for influenza-related hospitalization, influenza vaccination of healthy children aged 6-23 months is recommended.

Also, keep in mind that it wasn’t until 1991 that hepatitis B and Hib vaccines were added to the immunization schedule to be given to all infants.

And many kids didn’t get flu shots yet.

Remember, it was until the 2004-05 flu season that we started to see strong recommendations to give flu shots to anyone who wasn’t at high risk for complications from the flu. And by that time, thimerosal free flu shots were beginning to appear.

Still, the most important takeaway from all of this is that even though thimerosal was removed from vaccines, it was done as a precautionary measure and not because these kids were harmed. In fact, some kids were harmed in the process, especially as some infants didn’t get their newborn hepatitis B vaccine and at least one went on to get a fatal hepatitis B infection.

What to Know About Vaccines and Thimerosal

Even at the height of the thimerosal scare, most vaccines didn’t contain thimerosal.

More on Vaccines and Thimerosal

Which Vaccines Contain Antifreeze?

If you are already on the fence about vaccines, there are probably some you want to avoid…

For many parents, that likely means skipping all of the vaccines with toxins, like antifreeze.

Which Vaccines Contain Antifreeze?

Do vaccines really contain antifreeze, the stuff we put in our cars?

“Too many too soon. When I was on this show before, I said we need an alternate schedule. This is too much. We need to get rid of the toxins, the mercury — which I am so tired of everyone saying it’s been removed. It has not been removed from the shots. We’ll get into that later. Aluminum, ether, antifreeze — these are toxic ingredients in shots that need to be removed.”

Jenny McCarthy on Larry King Live

Jenny McCarthy warned folks about antifreeze in vaccines when she appeared on Larry King Live on April 2, 2008 to promote her book, Louder Than Words: A Mother’s Journey in Healing Autism.

“We are treating vaccine injury and the kids are getting better.”

Jenny McCarthy

First things first – autism is not a vaccine injury.

Jenny McCarthy is also wrong about her ideas of toxins in vaccines.

Besides the fact that vaccine ingredients aren’t toxic, the last remaining non-flu vaccines with the preservative thimerosal, a form of mercury, expired in 2003. And there have been plenty of thimerosal free flu vaccines available for kids and pregnant women since then.

Aluminum is used in many vaccines, but again, it is not toxic.

Ether? There is no ether in vaccines. Remember, ether, or diethyl ether was once used as a general anesthetic. At least it was until we developed anesthetics that didn’t blow up.

And antifreeze?

Why do so many anti-vaccine folks think that antifreeze, or ethylene glycol, is an ingredient in vaccines?

It isn’t. Not in any vaccine.

Jenny McCarthy and Jim Carrey went on a mission to Green Our Vaccines in 2008.
Jenny McCarthy and Jim Carrey went on a mission to Green Our Vaccines in 2008 and warn folks about toxins in vaccines, like antifreeze and ether.

Remember that toxic antifreeze, ethylene glycol, has a sweet taste, which helped contribute to it harming so many kids. You had a toxic substance that tasted good and which was sometimes stored inappropriately in the garage or kitchen cabinets.

Fortunately, ethylene glycol isn’t used as much as it used to be. Many people now use propylene glycol, which is considered to be a non-toxic antifreeze. Propylene glycol is not used in vaccines either.

Polyethylene glycol (PEG), which is also used in common laxatives, has been used to inactivate flu vaccines and was found in residual amounts in some of those flu vaccines.

And some vaccines do contain 2-phenoxyethanol. Another name for 2-phenoxyethanol is ethylene glycol monophenyl ether. A similar sounding name doesn’t make it the same substance though.

2-phenoxyethanol is used as a stabilizer or preservative in some vaccines.

But neither polyethylene glycol nor 2-phenoxyethanol are antifreeze and neither are toxic at doses present in vaccines.

What To Know About Vaccines with Antifreeze

Vaccines are safe and necessary and do not contain antifreeze or any other ingredients that are toxic.

More on Vaccines with Antifreeze

Vaccine Information Statements

Vaccine Information Statements (VISs) are produced by the CDC and help vaccine providers inform patients about the benefits and risks of the vaccines they are getting.

In fact, under the National Vaccine Childhood Injury Act, vaccine providers are required to give out a VIS before giving a vaccine, including those for:

  • Diphtheria, tetanus and pertussis containing vaccines (DTaP, DT, Td, and Tdap)
  • Haemophilus influenzae type b (Hib)
  • Hepatitis A
  • Hepatitis B
  • Human Papillomavirus (HPV)
  • Influenza (both Inactivated and Live, Intranasal vaccines)
  • MMR
  • MMRV
  • Meningococcal
  • Pneumococcal Conjugate (PCV13)
  • Polio
  • Rotavirus
  • Varicella

Unlike the package insert for a vaccine, “VISs are based on the ACIP’s recommendations, which occasionally differ from those made by the manufacturer. These differences may involve adverse events. Package inserts generally tend to include all adverse events that were temporally associated with a vaccine during clinical trials, whereas ACIP tends to recognize only those believed to be causally linked to the vaccine.” That makes the  VIS a better tool to use when doing your research on a vaccine.

For more information:

Antifreeze in Vaccines

Why would they put antifreeze in vaccines?

Well, they wouldn’t.

That antifreeze is an ingredient in vaccines is one of the easier anti-vaccine myths to debunk.

Antifreeze in Vaccines

That vaccines contain antifreeze is also one of those anti-vaccine myths that continue to scare parents away from vaccinating and protecting their kids.

Some vaccines do contain 2-phenoxyethanol, which can be used as a stabilizer or preservative.

2-phenoxyethanol is not antifreeze though, although it kind of sounds like it.

Antifreeze is also called ethylene glycol. This is the type of toxic antifreeze that causes poisoning. It is a colorless, oderless, sweet liquid that is toxic to humans, cats, and dogs in very small amounts.

Polyethylene glycol was once used to inactive some brands of flu vaccine, but PEG is not antifreeze.

What to Know About Antifreeze in Vaccines

Vaccines do not contain antifreeze or any other toxic ingredients.

More Information About Antifreeze in Vaccines:

Vaccine Ingredients

From antigens and adjuvants to preservatives, learn about common ingredients in vaccines and why they are safe.

What’s in Vaccines?

It is no secret what’s in our vaccines.

A list of ingredients is included on the vaccine’s package insert and can be found on a number of articles on the Internet.

In addition to other ingredients, a vaccine's package insert includes the viral or bacterial antigens that are in the vaccine.
In addition to other ingredients, a vaccine’s package insert includes the viral or bacterial antigens that are in the vaccine.

In addition to the active ingredients, the viral or bacterial antigens in the vaccine that you generate antibodies against, vaccines are made with a number of excipients, inactive substances or manufacturing by-products that are used to produce the vaccine:

  • preservatives – prevent bacterial and fungal contamination in multi-dose vials – thimerosal, 2-phenoxyethanol, phenol
  • adjuvants – help stimulate a stronger immune response so fewer antigens can be used – aluminum salts
  • stabilizers – maintain the potency of the vaccine and include sugars, amino acids, and proteins – lactose, MSG, gelatin
  • cell culture materials – what the vaccine antigens grow in – chicken egg proteins, yeast proteins, fetal bovine serum proteins
  • inactivating materials – kills viruses, inactivates toxins – formaldehyde
  • antibiotics – prevents bacterial contamination of the vaccine – neomycin, polymyxin B
  • suspending fluid – saline, etc.

Many of these excipients are removed from the final vaccine product and might only remain in residual amounts.

What’s Not in Vaccines?

Despite what myths you might have heard or read, many things are not in vaccines:

  • a vaginal spermacide
  • antifreeze
  • thimerosal – almost all vaccines, including over 130,000,000 flu vaccines this year, are thimerosal free!
  • aborted fetal tissue – there is no aborted fetal tissue or fetal parts in any vaccine, although some vaccines are made with fetal embryo fibroblast cells from cell lines that are derived (they can replicate infinitely) from two electively terminated pregnancies in the 1960s
  • Adjuvant 65 – an adjuvant that contained peanut oil that was tested with flu vaccines in the 1960s and continues to be blamed for causing peanut allergies, even though it has never been used in a vaccine

Vaccines are safe. Vaccine ingredients are safe.

What to Know About Vaccine Ingredients

Vaccines contain a number of ingredients that help them work stimulate a good immune response against particular viral and bacterial antigens to protect us against vaccine-preventable diseases.

More on Vaccine Ingredients

Thimerosal in Vaccines

Although it was never actually linked to any real side effects, thimerosal (mercury) was removed from almost all childhood vaccines in 1999.

Thimerosal, a preservative, only remained in flu vaccines for a few years, but thimerosal free flu vaccines have been available since 2003.

That’s also the year that the remaining non-flu vaccines with thimerosal expired – January 2003.

And this year, at least “120 million doses of thimerosal-free or preservative-free influenza vaccine will be produced.” That means that over 75% of flu shots are thimerosal free, leaving only some multi-dose vials of flu shots to still have thimerosal, but making it easy to avoid if you want to.

Myth of Continued Exposure to Mercury in Vaccines

Although thimerosal was removed from vaccines in 1999, some anti-vax folks still claim that many vaccines contain mercury.
Although thimerosal was removed from vaccines in 1999, some anti-vax folks still claim that many vaccines contain mercury. Photo courtesy of Refutations to Anti-Vaccine Memes

Although most anti-vaccine groups have moved on to other conspiracy theories to scare parents, some still falsely claim that vaccines continue to be made with thimerosal and that thimerosal is dangerous.

Robert F. Kennedy Jr., for example, continues to claim that even though thimerosal has been removed from pediatric vaccines, “thimerosal levels remain virtually unchanged.” This is mostly, he claims, because of flu shots with thimerosal. Also, when a pregnant woman gets a flu shot, Kennedy claims that the fetus gets a bolus of thimerosal “that’s about 800 times the amount of mercury the CDC recommends.”

First, it is important to remember that the original concerns about thimerosal were because children who received a complete set of thimerosal containing vaccines (only hepatitis B, DTaP, and Hib ever had thimerosal) could get up to 187.5 micrograms of ethyl mercury by the time they were six months old, which exceeded the EPA limits for methyl mercury ingestion (but was less than the FDA limits). They aren’t the same type of mercury though, and thimerosal free versions of DTaP and Hib were already available in the late 1990s, so many kids likely got less than 187.5 micrograms of ethyl mercury.

Since thimerosal was removed from almost all vaccines beginning in 1999, that left flu vaccines as the main pediatric vaccine that still used thimerosal as a preservative. So did expanded flu shot recommendations for kids mean that they still got a lot of thimerosal over the years?

It is extremely unlikely that many kids have gotten each and every one of their yearly flu vaccines with thimerosal. It is more likely that they got just a few with thimerosal and the rest without, as thimerosal free flu vaccines became more widely available. After all, a flu vaccine with reduced thimerosal was available as early as 2002.

In 2003, thimerosal free flu shots became available and Flumist, a thimerosal free flu nasal spray vaccine was also approved. The supply of thimerosal free flu vaccines increased each and every year. For the 2014-15 flu season, over 100 million doses of flu vaccine are available that are thimerosal free or preservative free (with only trace amounts of thimerosal).

Even if kids did get flu vaccines with thimerosal each year though, would it matter? A 2008 study in Pediatrics, “Mercury Levels in Newborns and Infants After Receipt of Thimerosal-Containing Vaccines,” found that the half-life of ethyl mercury was about two days, “suggesting that exposure to thimerosal-containing vaccines does not result in an accumulation of mercury in blood.” And the highest blood level they found was less than 5-8 nanograms/ml, which is far less than the 187.5 micrograms that anti-vax groups continue to talk about, even in infants who had already received a cumulative dose of 162.5 micrograms of thimerosal.

What about flu shots in pregnancy?

A 2010 study in Pediatrics, “Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism,” found that “prenatal and early-life exposure to ethylmercury from thimerosal-containing vaccines and immunoglobulin preparations was not related to increased risk of” autism spectrum disorders. Two other studies have also found that prenatal exposure to thimerosal from immunoglobulin preparations, like Rho(D) immune globulin, during pregnancy were not associated with an increased risk for autism.

And also consider that fewer than 15 to 30% of pregnant women got flu shots before 2009. After 2009 and the H1N1 pandemic, rates did increase, but only to about 38 to 52%.

Although current recommendations don’t state a preference for the type of flu shot for pregnant women, it is likely that at least some of them got thimerosal free flu shots. In California, for example, since the passage of their Mercury Free Act in 2006, pregnant women and children younger than age 3 years have to get vaccines that are ‘mercury free.’

What To Know About Thimerosal in Vaccines

Thimerosal is a preservative that was removed from vaccines beginning in 1999, which means that most teens today got little or no exposure to thimerosal from vaccines.

More Information About Thimerosal in Vaccines:

Updated April 8, 2017