What do you need to know?
Make Informed Choices for Yourself and Your Baby
There are many factors that go into making medical decisions, like personal family history, risk vs. benefit analysis and making a logical decision that is right for you and your children. Most parents are not fully informed when it comes to vaccines. This often occurs simply because the information is so complex and vast. Many providers do not even know the full details themselves. The best place to start is to find a doctor who is comfortable and knowledgeable with vaccine discussions and who supports parents to make decisions for their child's body and medical care. Reading the package insert, the ingredient lists and discussing those with your care provider can be informative. These documents can be easily accessed online through the CDC and FDA websites. The next course of action is to look into the source for the products. Find out what companies are making them and how vaccinations may differ from other products they produce. Look at their track record and company ethics. Next, question the studies that brought each product to market. Find out how the study was done and by whom. Are there different standards for vaccines than other products? Do these make you feel more comfortable with their safety profile? How is post-marketing safety evaluated for these products? What are the historical events surrounding vaccine production? How do you feel about these events? Then, finally, speak to other mothers, fathers and children who have various views on vaccination. We can learn so much from hearing the experiences of others. We might also find more resources and information on the topic. The knowledge that exists is vast and difficult to contain on a page, so this is intended just to get you started. I'm always open to talking on this topic if you want to reach out to me personally. I support whatever decision you make as you are always the best decision maker for your child. Please let me know if you think I can help as you learn and process all of this information! And finally, trust your gut. Our maternal instincts are powerful and if something is telling us to make a certain decision, we should look deeper to understand the product or topic more thoroughly so that we can feel settled and certain in our decisions. Parenting is a challenging and sacred task. You will do a great job!
The package insert contains information about the product that can help you make an informed decision. Hepatitis B is often recommended on the first day of birth or at the first appointment with the pediatrician. It is a disease that is transferred through blood contact and high risk groups include prostitutes and those who are exposed to drug needles. It's use in the general population is a public health measure.
There are multiple Hepatitis B vaccines to choose from. We will look at the Recombivax HB*. This particular product is recommended from "birth through 19 years of age." These are some considerations from the package insert:
Severe allergic or hypersensitivity reactions (e.g., anaphylaxis) after a previous dose of any hepatitis B-containing vaccine, or to any component of RECOMBIVAX HB, including yeast. (4, 11)
WARNINGS AND PRECAUTIONS
The vial stopper, the syringe plunger stopper, and tip cap contain dry natural latex rubber which may cause allergic reactions in latexsensitive individuals. (5.1)
Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including RECOMBIVAX HB, to infants born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination. (5.2)
In healthy infants and children (up to 10 years of age), the most frequently reported systemic adverse reactions (>1% injections), in decreasing order of frequency, were irritability, fever, diarrhea, fatigue/weakness, diminished appetite, and rhinitis. (6.1)
In healthy adults, injection site reactions and systemic adverse reactions were reported following 17% and 15% of the injections, respectively. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877- 888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility RECOMBIVAX HB has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility
The United States has the highest day one death rate for babies in the industrialized world. This is worth looking at closely and is highly concerning, especially when we know that most other industrialized countries do not give Hepatitis B on the first day of birth. Also, the following adverse events are important to be aware of, in addition to the fact that post-marketing data is passive despite attempts to automate the system, meaning the data is less reliable:
Incidence Equal To or Greater Than 1% of Injections GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site reactions consisting principally of soreness, and including pain, tenderness, pruritus, erythema, ecchymosis, swelling, warmth, nodule formation. The most frequent systemic complaints include fatigue/weakness; headache; fever (≥100°F); malaise. GASTROINTESTINAL DISORDERS Nausea; diarrhea RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Pharyngitis; upper respiratory infection Incidence Less Than 1% of Injections GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Sweating; achiness; sensation of warmth; lightheadedness; chills; flushing GASTROINTESTINAL DISORDERS Vomiting; abdominal pains/cramps; dyspepsia; diminished appetite RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Rhinitis; influenza; cough 5 NERVOUS SYSTEM DISORDERS Vertigo/dizziness; paresthesia SKIN AND SUBCUTANEOUS TISSUE DISORDERS Pruritus; rash (non-specified); angioedema; urticaria MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Arthralgia including monoarticular; myalgia; back pain; neck pain; shoulder pain; neck stiffness BLOOD AND LYMPHATIC DISORDERS Lymphadenopathy PSYCHIATRIC DISORDERS Insomnia/disturbed sleep EAR AND LABYRINTH DISORDERS Earache RENAL AND URINARY DISORDERS Dysuria CARDIAC DISORDERS Hypotension 6.2 Post-Marketing Experience The following additional adverse reactions have been reported with use of the marketed vaccine. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to a vaccine exposure. Immune System Disorders Hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria have been reported within the first few hours after vaccination. An apparent hypersensitivity syndrome (serum-sickness-like) of delayed onset has been reported days to weeks after vaccination, including: arthralgia/arthritis (usually transient), fever, and dermatologic reactions such as urticaria, erythema multiforme, ecchymoses and erythema nodosum [see Warnings and Precautions (5.1)]. Autoimmune diseases including systemic lupus erythematosus (SLE), lupus-like syndrome, vasculitis, and polyarteritis nodosa have also been reported. Gastrointestinal Disorders Elevation of liver enzymes; constipation Nervous System Disorders Guillain-Barré syndrome; multiple sclerosis; exacerbation of multiple sclerosis; myelitis including transverse myelitis; seizure; febrile seizure; peripheral neuropathy including Bell's Palsy; radiculopathy; herpes zoster; migraine; muscle weakness; hypesthesia; encephalitis Skin and Subcutaneous Disorders Stevens-Johnson syndrome; alopecia; petechiae; eczema Musculoskeletal and Connective Tissue Disorders Arthritis Pain in extremity Blood and Lymphatic System Disorders Increased erythrocyte sedimentation rate; thrombocytopenia Psychiatric Disorders Irritability; agitation; somnolence Eye Disorders Optic neuritis; tinnitus; conjunctivitis; visual disturbances; uveitis Cardiac Disorders Syncope; tachycardia The following adverse reaction has been reported with another Hepatitis B Vaccine (Recombinant) but not with RECOMBIVAX HB: keratitis.
Here are the ingredients for the Recombivax Hep B from the CDC's excipient summary:
Hep B (Recombivax) 12/2018 formaldehyde, potassium aluminum sulfate, amorphous aluminum hydroxyphosphate sulfate, yeast protein*
Amorphous Aluminum Hydroxyphosphate Sulfate is a controversial new ingredient in vaccines. Here is an article from the BMJ** that details the concerns with it's use, mainly in relation to HPV where it was introduced:
"Aluminium is considered an effective adjuvant in vaccines, but its safety may not have been sufficiently in focus.1 Aluminium is a known neurotoxin and inflammagen,2 and interferes with several biomolecules and biochemical pathways, for example, disturbs calcium metabolism, increases oxidative stress, binds to phosphate groups of nucleoside diphosphates and triphosphates such as ATP, and competes with iron and magnesium.3 4 Several research groups have raised concerns about the health effects of using aluminium in vaccines.1 5–10 However, both the US Food and Drug Administration Center for Biologics Evaluation and Research and the US Agency for Toxic Substances and Disease Registry concluded that traditional aluminium adjuvants are safe.11 12
Aluminium adjuvants have been associated with a number of adverse effects, including injection site pain and tenderness, persistent lumps, granulomas, contact dermatitis and postimmunisation headache,13 but also more severe adverse events such as macrophagic myofasciitis14 and the autoimmune/inflammatory syndrome induced by adjuvants.15 Animal models have demonstrated the toxicity of aluminium adjuvants16 and their translocation away from the injection site.17 18
Criticisms have been raised of the prelicensure randomised clinical trials, that forms the body of evidence for the approval of Gardasil, a Merck Sharp & Dohme Corp manufactured human papilloma virus (HPV) vaccine made of recombinant HPV types 6, 11, 16 and 18 L1 virus-like particles.19–23 One criticism is the use of amorphous aluminium hydroxyphosphate sulfate (AAHS) as a comparator in the prelicensure trials.20 23 However, the European Medicines Agency (EMA) and the WHO conclude high vaccine safety and efficacy.24 25 AAHS produced by Merck has a short history prior to the use in the Gardasil vaccine. A recent study by Doshi et al found that participants in Gardasil trials were not adequately informed that the placebo was AAHS.23 As AAHS is both physically and functionally distinct from all previously used aluminium adjuvants,26 it is crucial to know the body of evidence regarding safety that constitutes the basis of approval of randomised clinical trials using AAHS by medicines agencies. Here we describe some discrepancies in the documents that constitute the foundation for authorisation of two Gardasil randomised clinical trials in Denmark.
It is important to stress that we are not against safe vaccines in general. However, inadequacies in the regulation of vaccine adjuvants may fuel concerns—rightly or wrongly—in the highly polarised environment that surrounds vaccine sciences. It is therefore imperative to ensure transparent documentation and adequate informed consent in randomised clinical trials."
The CDC briefly discusses vaccines on their website*** and looks at references to dietary consumption of aluminum**** broadly in an attempt to alleviate concerns over it's use. Many parents find this an insufficient analysis from the CDC.
VAERS (Vaccine Adverse Event Reporting System) is the current method for collecting post-marketing data of adverse events. Many parents are concerned with its passive status and the low level of data collection. A study done by HHS through Harvard Pilgrim Group showed a less than 1% reporting rate.*
"Likewise, fewer than 1% of vaccine adverse events are reported. Low reporting rates preclude or slow the identification of “problem” drugs and vaccines that endanger public health. New surveillance methods for drug and vaccine adverse effects are needed. Barriers to reporting include a lack of clinician awareness, uncertainty about when and what to report, as well as the burdens of reporting: reporting is not part of clinicians’ usual workflow, takes time, and is duplicative. Proactive, spontaneous, automated adverse event reporting imbedded within EHRs and other information systems has the potential to speed the identification of problems with new drugs and more careful quantification of the risks of older drugs.
Unfortunately, there was never an opportunity to perform system performance assessments because the necessary CDC contacts were no longer available and the CDC consultants responsible for receiving data were no longer responsive to our multiple requests to proceed with testing and evaluation."
The CDC did not follow through and take action to improve the reporting system. The "CDC contacts were no longer available and CDC consultants responsible for receiving data were no longer responsive to our multiple requests to proceed with testing and evaluation." This lack of reporting concerns many parents.
The 1986 Act removed liability from vaccine manufactures with certain conditions.*
The National Vaccine Injury Compensation program was created with the 1986 Act.**
In a 2011 court case, the Supreme Court ruled that vaccines are unavoidably unsafe.***
When the general population takes a pharmacological product, they have legal recourse in the event of an injury from said product, except where vaccines are concerned. The manufacturers can not be directly sued. They are protected from any due process. The injured party is instead sent to a secret court, without a jury and with a reduced time frame for taking action. Many people do not even know this court exists and those who do often find it an unfruitful, frustrating and difficult process.
It is interesting to note that the schedule exploded after 1986 and we now give many more vaccines than we did before this Act was passed. Many parents are concerned that there is a lack of transparency and accountability.
It may be beneficial to listen to one of the vaccine court lawyers discuss the proceedings.****
There is also a documentary that details the 1986 Act and the issues surrounding it.*****