Ø hepatitis B
Ø influenza (inactivated and live vaccines)
Ø MMR and MMRV
Ø pneumococcal conjugate
The VIS mentions some, but not all, risks related to vaccines. For example, the VIS for Hepatitis B vaccine mentions a potential allergy problem due to the presence of yeast in the vaccine, but does not mention that soy is also present, and it too is a common allergen.
Some vaccines contain eggs, which occasionally cause serious allergic reactions. Some vaccines contain gelatin (prohibited for kosher Jews); others are made in [aborted] fetal cells or their derivatives, and some people may choose to avoid a vaccine for that reason.
Listing vaccine ingredients may not be necessary all the time. But remember that FDA considers it important enough to require food manufacturers to list all ingredients on their packaging. This enables consumers to choose which ingredients to avoid, whether due to allergy, a religious dictate or for any other reason.
2. Hundreds of vaccines are in development, and they contain an array of new ingredients to stimulate increased immunity. These ingredients do not have to be tested for their "stand-alone" toxicity: their only required testing occurs during a clinical trial of the complete vaccine. Most human vaccine studies
last only one month. If no serious side effects are identified within that period, the candidate vaccine may be licensed.
However, this testing is insufficient to identify whether the vaccine or its components may cause or promote cancers. (Many vaccines have never been tested for carcinogenicity, for example, although many contain formaldehyde, a known carcinogen.)
Vaccine testing can miss birth defects that might be related to vaccination. This is because pregnant women are not included in vaccine trials. The HPV vaccine Gardasil was approved after a six-month, "fast-track" review by FDA. Merck, the manufacturer, was asked by FDA to collect information on possible birth defects after approval. The VIS for Gardasil vaccine says,
"Any woman who learns she was pregnant when she got this HPV vaccine is encouraged to contact the manufacturer’s HPV-in-pregnancy registry at 800-986-8999. This will help us learn more about how pregnant women respond to the vaccine."
3. In 2009-10, swine flu vaccines were made with and without novel adjuvants (new additives used to enhance the immune response), using abbreviated testing. Novel adjuvants had not been used in previously licensed US vaccines.
Here is an important example of how an ingredient list would be beneficial to vaccine recipients:
The 2009 Pandemrix swine flu vaccine caused narcolepsy (at a rate 12 times greater than expected) in hundreds of children and young adults, and some other swine flu vaccines caused seizures. Their use in children was stopped in some countries ( Finland , Ireland and Australia ).
Pandemrix used a novel adjuvant (named ASO3) to increase the vaccine's effectiveness . ASO3 had not been used in children before, nor had it ever been used in the US. It probably contributed to narcolepsy. A vaccine containing ASO3 is under consideration now by FDA for avian flu . I think it is very important that parents be informed when a vaccine that will be given to their child contains ASO3.
4. Consider the difference between ingesting food and injecting vaccines. Food has to pass through the gastrointestinal tract, which acts as a barrier against noxious substances entering the body, protecting us from harm.
Injections bypass all skin and mucosal barriers, overriding important protective mechanisms. Substances injected into us therefore need even more careful vetting than is given to foods. Vaccines should be at least as safe as foods, and their components should be equally transparent.
5. Providing a list of ingredients at the time of inoculation will not add a large burden to medical providers or manufacturers. The Vaccine Information Statement is already given out with most inoculations. An ingredient list is part of the vaccine package insert, which is included with each bottle of vaccine sold. This package insert or the list of vaccine ingredients it contains could easily be included along with the Vaccine Information Statement, when vaccinations are administered.
Thank you for the opportunity to comment on this piece of legislation.
Meryl Nass, M.D.