Vaccine Preservatives

Dear Lisa,

I have a question about vaccines. I am not against vaccinations, but I am very concerned what's in them. I informed my baby's doctor that I don't want any Vaccinations that contain mercury. She said that none of her vaccines except for Flu vaccines have mercury. A few days ago my daughter had her routine visit and 2 shots. One of them was polio. After the doctor left the room I looked at the bottles and read that Polio vaccine had some preservatives and formaldehyde was one of them. I was shocked and very upset. I trusted that doctor will tell me about anything like that. I blame myself for not looking at the bottles before she administered the shot.... Please, tell me about formaldehyde in vaccines. How bad it is. Also, are there any companies that make vaccines without the preservatives? Maybe the next time I will request those. Thank you very much.

“Concerned Mom”

Dear “Concerned Mom”,

You are correct; the Polio vaccine does have formaldehyde as a trace ingredient. The Physician’s Desk Reference (PDR) reports that there is less than or equal to 100mcg residual formaldehyde in the Polio portion of the Pediarix Vaccine(one of the combination vaccines that contains Polio). This formaldehyde is left over from the process that creates the vaccine. There are many steps in the process of making any vaccine. The process involves growing the germ that causes a particular disease and inactivating it, or killing it so that the person who gets the vaccine will not develop the disease.

When making the Polio vaccine, each of the three strains of the Poliovirus are individually grown. After clarification, each viral suspension is purified by ultrafiltration, diafiltration and successive chromatographic steps. After this, it is inactivated with formaldehyde. This inactivation kills the Poliovirus. It is the residual formaldehyde from this process that accounts for the portion of formaldehyde found in the vaccine. If the vaccine was not inactivated, it would be live.

Before the year 2000, live Polio virus was routinely used for vaccination. This live Polio virus was shed in the stool of infants, which put immunocompromised caregivers at risk for contracting Polio. A small percentage of babies who received the live Polio Vaccine developed the disease. To reduce the risk of vaccine associated Paralytic Poliomyelitis, since 2000, an inactivated Polio Vaccine schedule was recommended for routine childhood Polio vaccination in the United States. (1) The Polio virus was changed to the inactivated form in order to protect individuals from getting Polio.

All vaccines have small amounts of preservatives/additional ingredients due to the complicated process that creates them. If the vaccinations didn’t have preservatives they would spoil and be ineffective. Pharmaceutical companies and physicians tend to not report these additives to their patients because they are in such small amounts and are considered safe. The general thought is that the benefit of receiving the vaccine against a disease that can cause death and paralysis outweighs the risk of a trace amount of preservative.

If a child was to contract Polio, the symptoms and long term effects could include meningitis, rapid onset of flaccid paralysis and residual paralytic disease. Paralysis of the respiratory muscles may occur which would render a person unable to breathe. Adults who developed paralytic Poliomyelitis in childhood may develop post-polio syndrome 30 to 40 years later. Post-polio syndrome is characterized by muscle pain, exacerbation of weakness and or new paralysis or weakness.

I truly understand your concern about vaccine additives. Unfortunately, the diseases that childhood vaccines prevent can be devastating and the benefits of the vaccines in most cases outweigh the risk of administration. As a parent it is important to be an advocate for your child and ensure that you provide your child with the best opportunity to achieve health and wellness. It is very smart of you to be concerned about the vaccinations that your child receives, including their actions, benefits and potential side effects.

It is important to discuss your concerns with your daughter’s Pediatrician. Different parents have different levels of information that they wish to receive and different levels of responsibility regarding decision making. For some parents all of the clinical terminology and decisions are overwhelming, for others they feel much more comfortable knowing all of the pros and cons and wish to be more involved in decision making. You certainly have the right to know all of the components of a vaccine that your child receives. You also have the right to know about the possible side effects of each vaccine, and an explanation of the disease state that it prevents.

To find out more information about vaccinations you can read the printed package insert that comes with each vaccine. This is different from the VIS sheets that are handed out to patients that contain general information. The package insert describes the process that was used in making the vaccine and provides a list of all of the ingredients in the vaccine. This information can also be found in the Physician’s Desk Reference. Some parents with allergic children ask their doctor for a copy of this package insert before administering a vaccine to their child, so that they can make sure their child is not allergic to any of the components. If you are interested in the process of making each vaccine and the ingredients you can ask your Pediatrician for a copy of the package insert to review before your child receives the vaccine.

In regards to your question about companies that make vaccines without preservatives. Vaccines that are administered from a single dose vial have less preservatives as compared to vaccines dispensed from a multidose vial. When a doctor’s office uses a multidose vial they use a larger bottle with multiple doses of the vaccine in the bottle. Each time a child needs the vaccine a new needle is used to remove the dose and the bottle is put back in the refrigerator, awaiting the next dose to be given. It may take hours to days before the bottle is empty. The vaccine would spoil if it did not have a preservative. A single dose vial on the other hand, has only one vaccine dose in the bottle or pre-filled syringe. The bottle or syringe is opened and used immediately and then discarded. This type of vaccine has the least amount of preservative because there is no concern that it will spoil between dosages. Some vaccines come in single dose vials, and some don’t. Therefore you do have an option to choose a vaccine with less preservative in some cases. You can ask your Pediatrician if he offers a single dose vial version of the vaccine that your child needs.

It is very wise of you to be concerned about vaccines and their ingredients because pharmaceutical companies are in the process of creating more childhood vaccinations. With the introduction of these new vaccines it is important to educate yourself regarding the diseases that they prevent and the benefit of the vaccines. With each new vaccine, parents have a decision to make. Your Pediatrician can help and guide you regarding which vaccines are necessary for your child. During this dialogue with your Pediatrician there are many questions to be answered. Common questions that parents should ask include:What disease does this vaccine protect my child from? What is the probability of my child getting this disease? What populations are more at risk for getting this disease? Will the vaccine prevent life threatening complications or will it just lessen or shorten the effects of the disease? What are the risks of not getting the vaccine? Is the vaccine intended for 3rd world countries with ineffective sanitation or needed in industrialized countries too? If my child doesn’t get the vaccine and gets the disease naturally will he have better long term immunity?

For more information about childhood vaccines you can log on to the following websites:
www.vaccine.org
www.vaccine.chop.edu
http://www.cdc.gov/

For more information about the additives and components of vaccines you can log on to: www.cdc.gov/nip/vaccine/components/additives.htm

(1) Physician’s Desk Reference. 2004. Montville, N.J. Thomson PDR at Montville. 1594-1599.

Lisa-ann Kelly R.N., P.N.P.,C.
Certified Pediatric Nurse Practitioner

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