By Erin K Costello
One of the most often used examples of proof provided by the AV community is the vaccine insert or package insert. They will often refer to this document as proof of vaccine injury or proof vaccines aren’t safe. As ironic as it sounds, AVers will often refer to this document written by big pharma as proof as to why big pharma shouldn’t be trusted. They often oversimplify this document without understanding this document in full. What is a package insert, and what does it all mean?
What is a Package Insert?
A package insert is the tiny folded up booklet that comes in a drug’s bottle or box. It is also part of what is referred to as the “labeling” of a drug. FDA regulators and pharmaceutical companies will often refer to inserts as “labeling.” In the US, the FDA has very strict rules and regulations about what should and shouldn’t be included in a drug’s labeling. This is referred to as Code of Federal Regulations (CFR). Part of the reason for the package insert is to protect the manufacturer from misuse of the medication.
How to write a package insert
Pharmaceutical companies have their Medical and Regulatory Departments write the package inserts. They will take scientific information collected during Phase I, II, and III clinical trials for a new drug to inform on all regulatory subjects in the FDA’s insert requirements. Once the original package insert has been written it then passes through many departments in the company for review and approval. Once a draft meets company approval it is then included with the New Drug Application (NDA) and then submitted to the FDA for approval to market in the USA. The FDA reviews the entire application, including all labeling and data before deciding on a drug’s approval. The FDA may or may not request changes made to the labeling if they find reason to do so. Sometimes the pharmaceutical company will try and add indications (proven reasons to use a medication) but the FDA will find insufficient data to support such reasons and will reject it until appropriate data is shown. Package inserts can be changed as new information is discovered. However, a pharmaceutical company can not simply change one as it sees fit. Every change must be submitted to the FDA for approval. Some changes can take years of clinical trials and review.
How to read a package insert.
As regulated by FDA codes, every insert must include the following:-Highlights; kind of a TL;DR summarization of important information.
-Table of contents; to better direct one through all the information.
-Boxed Warning; a large black box describing any serious warnings about a drug. I can’t find a single vaccine with a black box warning mind you.
-Date of U.S approval; self explanatory
-Description; a drug’s ingredients and other info
-Clinical pharmacology; how the medicine works in the body, it’s effects, absorption rates, how long it takes the body to eliminate, all at different concentrations. May also include information from clinical trials.
-Indications and usage; what the medicine is used for and approved for by the FDA
-Contraindications; information on who should not take this medication, situations when this medication should not be used. This is extremely important information.
-Warning and precautions; this will include possible side effects that could become serious, how to take the medication safely, or any other precautions.
-Nonclinical toxicology; this includes any cancer potential from the medications, or any possible mutations caused by the medication or changes to fertility.
-Use in specific populations; explains if and how the drug can be used in certain populations (pregnancy, labor and delivery, nursing mothers, pediatrics or geriatrics)
-Adverse reactions; this list includes ALL side effects observed in all studies of the drug, regardless of an established causative link between the side effect and the drug. Almost all reactions listed are coincidental and are rarely a concern. These listed reactions are not much more than just observations.
-Drug interactions; what if any interactions are caused when taken with another medication or drug.
-Drug abuse and dependence; whether or not continued use can cause a physical dependence.
-Overdosage; gives info on overdose results, what to do in case of an overdose, how to avoid an overdose.
-Dosage and administration; dosage amounts for different ages, sized, uses, medical conditions, and how to administer the drug.
-Dosage forms and strengths; different dosages and strengths of a drug.
-How supplied; detailed explanation about the the drug’s color, shape, markings, as well as storage information.
-Patient counseling and information; details on who to contact in an emergency, how to report any adverse reactions.
-Clinical studies; any information obtained through clinical trials conducted prior to FDA approval.
-References; all citations and other information related to the drug.
This is a lot of information included in a package insert. When it comes to vaccines though, not all of it is useful. The three most useful contents to medical personal and consumers alike are:
-Clinical pharmacology; this helps those educated in science understand how the drug works. If you understand this then you begin to see how a drug works, and how it isn’t related to certain adverse events. However, pharmacology is a very difficult science to understand.
-Contraindications; there are only a few contraindications in vaccines. There’s one for yeast sensitivity when using Gardasil.
-Warnings; adverse events with some evidence supporting a causal relationship with the drug or vaccine. This is different from the adverse reactions section because this section is where repeated scientific data is located supporting a possible causal link. Adverse reactions simply list observed events during a trial, regardless of any possible causal link, and usually without a causal link. Not a single package insert lists autism as a warning. The most misread and misunderstood part of a package insert is the “adverse reactions” section. Any reaction backed by evidence would be listed in the “warnings” section. The adverse reactions section is not based on evidence.
Don’t believe me. Believe the math.
Review the data and pay attention to what it’s telling you. Below is a comparison of the risks associated with disease to the risks associated with vaccination.
Pneumonia: 6 in 100
Encephalitis: 1 in 1,000
Death: 2 in 1,000
Congenital Rubella Syndrome: 1 in 4 (if woman becomes infected in early pregnancy)
Encephalitis or severe allergic reaction: 1 in 1,000,000
Death: 1 in 20
Death: 2 in 10
Pneumonia: 1 in 8
Encephalitis: 1 in 20
Death: 1 in 1,500
Continuous crying, then full recovery: 1 in 1,000
Convulsions or shock, then full recovery: 1 in 14,000
Acute encephalopathy: 0-10.5 in 1,000,000
Death: none proven.
According to the NVICP (National Vaccine Injury Compensation Program) figures, vaccines have a safety rating of almost 100%. From January 1, 2006 to December 31, 2016 there were about 3,153,876,236 inoculations administered. During this time period there were 5,426 claims made to the vaccine court. Of this total 3,676 claims were compensated, and 1,750 were not compensated. According to these figures, 0.00018% of those vaccinated at least or only once in the ten years provided ended up petitioning the court alleging vaccine injury. Of the total vaccines given during this time period, only 0.00012% were awarded compensation. Thus making vaccines 99.99982% safe from any reported reactions, and 99.99988% safe from any compensational reactions
When you compile this altogether, the package insert claims, the disease risk data, the vaccine risk data, and the NVICP figures, you’re left with a complete picture of just how safe and effective vaccines are, and just how fictional AV claims are as well. Hanging on to a “better safe than sorry” section of vaccine package inserts is not an evidence based argument, or evidence of anything other than their desperation to be right, rather than be accurate.
What's The Harm?