Bad science kills & injures

[Ravi]

it is hard to find stuff, if you aren't looking for it.

I'm looking for the needle in the haystack.

30,000+ children no vaccines, no autism.

Thank you for this fine example of bad science.

 

[Valerie]

Forced vaccinations. Making something mandatory whether one wants it or not sounds like force to me. If it is not forced and is not in fact mandatory then where are all of our alternatives? Who hid the alternatives list? If they didn't hide it where is it? Anybody have that website showing alternatives available to those who don't want this shit?

They call it a mandate with an opt-out for parents because it is more effective medicine than presenting it as an opt-in program.

HPV-vaccination mandates, which are aimed more at protecting the vaccinee than at achieving herd immunity, have been attacked as an unwarranted intrusion on individual and parental rights. The constitutionality of vaccination mandates is premised on the reasonableness of the risk–benefit balance, the degree of intrusion on personal autonomy, and, most crucial, the presence of a public health necessity. On the one hand, to the extent that required HPV vaccination is an example of state paternalism rather than community protection, mandatory programs lose some of their justification. On the other hand, the parental option to refuse vaccination without interfering in the child's right to attend school alters this balance. Here the mandates act less as state imperatives and more as subtle tools to encourage vaccination. Whereas an opt-in program requires an affirmative effort by a parent, and thus misses many children whose parents forget to opt in, an opt-out approach increases vaccination rates among children whose parents have no real objection to the program while perfectly preserving parental autonomy.

Opposition to HPV vaccination represents another chapter in the history of resistance to vaccination and, on some levels, reflects a growing trend toward parental refusal of a variety of vaccines based on the (erroneous) perception that many vaccines are more risky than the diseases they prevent. In most cases, pediatricians have largely restricted themselves to educating and counseling objecting families, since it is rare that the risks posed by going unvaccinated are so substantial that refusal is tantamount to medical neglect. In the case of HPV vaccine, parents' beliefs that their children will remain abstinent (and therefore uninfected) until marriage render it even more difficult to make the case for mandating a medical form of prevention. Even with an opt-out program, critics may argue that the availability of a simple and safe alternative — that is, abstinence — undermines the argument for a state initiative that encourages vaccination through mandates coupled with an option for parental refusal.

NEJM -- Politics, Parents, and Prophylaxis -- Mandating HPV Vaccination in the United States

 

[Valerie]

Rodishi, you make a lot of good points about government intrusion, but Si Modo is right....You're all over the place with some of this stuff. You had me going on post #46 about the GE crops and then you had to go and sling that crap about the vaccines in the middle there.

 

[Si modo]

Yes, Ro, your posts are interesting to read and like Valerie said, you do make some good points.

 

[RodISHI]

"Methylmercury is a neurotoxin."
"One final piece of data regarding thimerosal is worth noting. At the initial National Vaccine Advisory Committee-sponsored meeting on thimerosal in 1999, concerns were expressed that infants may lack the ability to eliminate mercury."

Once again taxpayers will foot the bill for something that should be paid for by the enterprises that should have responsibility. As much as I am glad they are going to do for those who have been injured by vaccines I am also concerned that once again corporate responsibilities are laid onto the backs of the people instead of the responsible parties.

National Vaccine Injury Compensation Program
Review of Adverse Effects of Vaccines

HRSA has contracted with the Institute of Medicine (IOM) to review the epidemiological, clinical, and biological evidence regarding adverse health events associated with specific vaccines covered by the Vaccine Injury Compensation Program.

The vaccines to be reviewed are

* varicella vaccines,
* influenza vaccines,
* hepatitis B vaccine,
* human papillomavirus virus vaccines,
* hepatitis A vaccines,
* meningococcal vaccines,
* measles-mumps rubella vaccines, and
* diphtheria, tetanus, pertussis vaccines

The committee will author a consensus report with conclusions on the evidence bearing on causality and the evidence regarding the biological mechanisms that underlie specific theories for how a specific vaccine is related to a specific adverse event.

Filing Deadlines

Charter

Purpose
The Secretary of Health and Human Services is mandated under Section 2119 of the Public Health Service (PHS) Act to appoint an advisory commission to give advice regarding the National Vaccine Injury Compensation Program (the Program), which provides compensation for certain vaccine-related injuries or deaths. The Advisory Commission on Childhood Vaccines (hereinafter referred to as the "Commission") shall advise and make recommendations to the Secretary on matters related to the Program responsibilities.

Authority
42 U.S.C. 300aa-19, Section 2119 of the PHS Act. The Commission is governed by the provisions of Public Law 92-463 (5 U.S.C. App. 2), which sets forth standards for the formation of advisory committees.

Functions
The Commission shall:

(1) advise the Secretary on the implementation of the Program;

(2) on its own initiative or as the result of the filing of a petition, recommend changes in the Vaccine Injury Table;

(3) advise the Secretary in implementing the Secretary's responsibilities under Section 2127 of the PHS Act regarding the need for childhood vaccination products that result in fewer or no significant adverse reactions;

(4) survey Federal, State, and local programs and activities relating to the gathering of information on injuries associated with the administration of childhood vaccines, including the adverse reaction reporting requirements of Section 2125(b), and advise the Secretary on means to obtain, compile, publish, and use credible data related to the frequency and severity of adverse reactions associated with childhood vaccines;

(5) recommend to the Director of the National Vaccine Program research related to vaccine injuries which should be conducted to carry out the Program; and

(6) consult regarding the development or revision of vaccine information materials as required by Section 2126 of the PHS Act.

Structure
The Commission shall be composed of the following:

(1) Nine members appointed by the Secretary as follows:

(A) Three members who are health professionals, who are not employees of the United States, and who have expertise in the health care of children, the epidemiology, etiology, and prevention of childhood diseases, and the adverse reactions associated with vaccines, of whom at least two shall be pediatricians.
(B) Three members from the general public, of whom at least two shall be legal representatives of children who have suffered a vaccine-related injury or death.(C) Three members who are attorneys, of whom at least one shall be an attorney whose specialty includes representation of persons who have suffered a vaccine-related injury or death and of whom one shall be an attorney whose specialty includes representation of vaccine manufacturers.

(2) The Director of the National Institutes of Health, the Assistant Secretary for Health, the Director of the Centers for Disease Control and Prevention, and the Commissioner of the Food and Drug Administration (or the designees of such officials), each of whom shall be a nonvoting ex officio member.

The Secretary shall select members of the Commission. The members of the Commission shall select a Chair and Vice Chair from among the members. Appointed members of the Commission shall be appointed for a term of office of 3 years. Members may serve after the expiration of their term until their successors have taken office.Subcommittees will be established from time to time. Upon establishment of each subcommittee, the Department's Committee Management Officer will be provided information on the subcommittee's name, membership, function, and estimated frequency of meetings.Management and support services shall be provided by the Division of Vaccine Injury Compensation, Healthcare Systems Bureau, Health Resources and Services Administration.

Meetings
The Commission shall meet not less than 4 times per year and at the call of the designated federal officer or designee who shall approve the agenda and shall be present at all meetings. A quorum for the purposes of a meeting is five. A decision at a meeting is to be made by a majority of the voting members present, rather than an absolute majority of voting members.Meetings shall be open to the public except as determined by the Secretary or other officials to whom the authority has been delegated in accordance with the Government in the Sunshine Act (5 U.S.C. 552b(c)). Notice of all meetings shall be given to the public.Meetings shall be conducted and records of the proceedings kept, as required by applicable laws and departmental regulations.

Compensation
Members of the Commission who are officers or employees of the Federal Government shall serve as members of the Commission without compensation in addition to that received in their regular public employment. Members of the Commission who are not officers or employees of the Federal Government shall be compensated at a rate not to exceed the daily equivalent of the rate in effect for an Executive Level 4 for each day (including travel time) they are engaged in the performance of their duties as members of the Commission. All members, while so serving away from their homes or regular places of business, may be allowed travel expenses, including per diem in lieu of subsistence, in the same manner as such expenses are authorized by 5 U.S.C 5703 for employees serving intermittently.

Annual Cost Estimates
Estimated annual cost for operating the Commission, including compensation and travel expenses for members, but excluding staff support, is approximately $95,509. The estimate of annual person-years of staff support required is 1.5 at an estimated annual cost of $303,271.

Reports
In the event a portion of a meeting is closed to the public, as determined by the Secretary of HHS, in accordance with the Government in the Sunshine Act (5 U.S.C. 552b(c)) and the Federal Advisory Committee Act, a report shall be prepared which shall contain as a minimum, a list of members and their business addresses, the Commission's functions, dates and places of meetings, and a summary of Commission activities and recommendations made during the fiscal year. A copy of the report shall be provided to the Departmental Committee Management Officer.

Termination Date
Unless renewed by appropriate action prior to its expiration, this charter will expire on July 21, 2010.

APPROVED:

Date


Wendy Ponton
Director, Office of Management

Compensation Program


* Home
* Omnibus Autism Proceeding
* Covered Vaccines
* Persons Eligible to File a Claim
* Filing a Claim with the VICP
* Filing Deadlines
* Vaccine Injury Table list of vaccines and associated injuries covered under the program
* Frequently Asked Questions
* Statistics Reports
* Strategic Plan
* Advisory Commission on Childhood Vaccines (ACCV)
* Contact Information
* Vaccine Injury Compensation Trust Fund
* Review of Adverse Effects of Vaccines
* Media Inquiries
* VICP Authorizing Legislation (PDF - 497 KB)


Vaccine Injury Table

The Vaccine Injury Table (Table) makes it easier for some people to get compensation. The Table lists and explains injuries/conditions that are presumed to be caused by vaccines. It also lists time periods in which the first symptom of these injuries/conditions must occur after receiving the vaccine. If the first symptom of these injuries/conditions occurs within the listed time periods, it is presumed that the vaccine was the cause of the injury or condition unless another cause is found. For example, if you received the tetanus vaccines and had a severe allergic reaction (anaphylaxis) within 4 hours after receiving the vaccine, then it is presumed that the tetanus vaccine caused the injury if no other cause is found.

If your injury/condition is not on the Table or if your injury/condition did not occur within the time period on the Table, you must prove that the vaccine caused the injury/condition. Such proof must be based on medical records or opinion, which may include expert witness testimony.

*
Printer-friendly Vaccine Injury Table (Adobe/PDF)

Vaccine Injury Table a

Vaccine


Adverse Event


Time Interval
I. Tetanus toxoid-containing vaccines (e.g., DTaP, Tdap, DTP-Hib, DT, Td, TT)
A. Anaphylaxis or anaphylactic shock 1 0-4 hours
B. Brachial neuritis 6 2-28 days
C. Any acute complication or sequela (including death) of above events 4 Not applicable

II. Pertussis antigen-containing vaccines (e.g., DTaP, Tdap, DTP, P, DTP-Hib)


A. Anaphylaxis or anaphylactic shock 1


0-4 hours
B. Encephalopathy (or encephalitis) 2 0-72 hours
C. Any acute complication or sequela (including death) of above events 4 Not applicable

III. Measles, mumps and rubella virus-containing vaccines in any combination (e.g., MMR, MR, M, R)


A. Anaphylaxis or anaphylactic shock 1


0-4 hours
B. Encephalopathy (or encephalitis) 2 5-15 days
C. Any acute complication or sequela (including death) of above events 4 Not applicable

IV. Rubella virus-containing vaccines (e.g., MMR, MR, R)


A. Chronic arthritis 5


7-42 days
B. Any acute complication or sequela (including death) of above event 4 Not applicable

V. Measles virus-containing vaccines (e.g., MMR, MR, M)


A. Thrombocytopenic purpura 7


7-30 days
B. Vaccine-Strain Measles Viral Infection in an immunodeficient recipient 8 0-6 months
C. Any acute complication or sequela (including death) of above events 4 Not applicable

VI. Polio live virus-containing vaccines (OPV)


A. Paralytic polio

* in a non-immunodeficient recipient

0-30 days

* in an immunodeficient recipient

0-6 months

* in a vaccine associated community case

Not applicable
B. Vaccine-strain polio viral infection 9

* in a non-immunodeficient recipient

0-30 days

* in an immunodeficient recipient

0-6 months

* in a vaccine associated community case

Not applicable
C. Any acute complication or sequela (including death) of above events 4 Not applicable

VII. Polio inactivated-virus containing vaccines (e.g., IPV)


A Anaphylaxis or anaphylactic shock 1


0-4 hours
B. Any acute complication or sequela (including death) of above event 4 Not applicable

VIII. Hepatitis B antigen-containing vaccines


A. Anaphylaxis or anaphylactic shock 1


0-4 hours
B. Any acute complication or sequela (including death) of above event 4 Not applicable

IX. Hemophilus influenzae (type b polysaccharide conjugate vaccines)


A. No condition specified for compensation



Not applicable

X. Varicella vaccine


A. No condition specified for compensation



Not applicable

XI. Rotavirus vaccine


A. No condition specified for compensation



Not applicable

XII. Pneumococcal conjugate vaccines


A. No condition specified for compensation


Not applicable

XIII. Any new vaccine recommended by the Centers for Disease Control and Prevention for routine administration to children, after publication by Secretary, HHS of a notice of coverageb c


A. No condition specified for compensation



Not applicable

aEffective date: November 10, 2008

bAs of December 1, 2004, hepatitis A vaccines have been added to the Vaccine Injury Table (Table) under this Category.
As of July 1, 2005, trivalent influenza vaccines have been added to the Table under this Category. Trivalent influenza vaccines are given annually during the flu season either by needle and syringe or in a nasal spray. All influenza vaccines routinely administered in the U.S. are trivalent vaccines covered under this Category. See Federal Register Notice: April 12, 2005

c As of February 1, 2007, meningococcal (conjugate and polysaccharide) and human papillomavirus (HPV) vaccines have been added to the Table under this Category.
Qualifications and Aids to Interpretation

(1) Anaphylaxis and anaphylactic shock mean an acute, severe, and potentially lethal systemic allergic reaction. Most cases resolve without sequelae. Signs and symptoms begin minutes to a few hours after exposure. Death, if it occurs, usually results from airway obstruction caused by laryngeal edema or bronchospasm and may be associated with cardiovascular collapse. Other significant clinical signs and symptoms may include the following: Cyanosis, hypotension, bradycardia, tachycardia, arrhythmia, edema of the pharynx and/or trachea and/or larynx with stridor and dyspnea. Autopsy findings may include acute emphysema which results from lower respiratory tract obstruction, edema of the hypopharynx, epiglottis, larynx, or trachea and minimal findings of eosinophilia in the liver, spleen and lungs. When death occurs within minutes of exposure and without signs ofrespiratory distress, there may not be significant pathologic findings.

(2) Encephalopathy. For purposes of the Vaccine Injury Table, a vaccine recipient shall be considered to have suffered an encephalopathy only if such recipient manifests, within the applicable period, an injury meeting the description below of an acute encephalopathy, and then a chronic encephalopathy persists in such person for more than 6 months beyond the date of vaccination.

(i) An acute encephalopathy is one that is sufficiently severe so as to require hospitalization (whether or not hospitalization occurred).

(A) For children less than 18 months of age who present without an associated seizure event, an acute encephalopathy is indicated by a “significantly decreased level of consciousness” (see “D” below) lasting for at least 24 hours. Those children less than 18 months of age who present following a seizure shall be viewed as having an acute encephalopathy if their significantly decreased level of consciousness persists beyond 24 hours and cannot be attributed to a postictal state (seizure) or medication.

(B) For adults and children 18 months of age or older, an acute encephalopathy is one that persists for at least 24 hours and characterized by at least two of the following:

(1) A significant change in mental status that is not medication related; specifically a confusional state, or a delirium, or a psychosis;
(2) A significantly decreased level of consciousness, which is independent of a seizure and cannot be attributed to the effects of medication; and
(3) A seizure associated with loss of consciousness.

(C) Increased intracranial pressure may be a clinical feature of acute encephalopathy in any age group.

(D) A "significantly decreased level of consciousness" is indicated by the presence of at least one of the following clinical signs for at least 24 hours or greater (see paragraphs (2)(I)(A) and (2)(I)(B) of this section for applicable timeframes):

(1) Decreased or absent response to environment (responds, if at all, only to loud voice or painful stimuli);
(2) Decreased or absent eye contact (does not fix gaze upon family members or other individuals); or
(3) Inconsistent or absent responses to external stimuli (does not recognize familiar people or things).

(E) The following clinical features alone, or in combination, do not demonstrate an acute encephalopathy or a significant change in either mental status or level of consciousness as described above: Sleepiness, irritability (fussiness), high-pitched and unusual screaming, persistent inconsolable crying, and bulging fontanelle. Seizures in themselves are not sufficient to constitute a diagnosis of encephalopathy. In the absence of other evidence of an acute encephalopathy, seizures shall not be viewed as the first symptom or manifestation of the onset of an acute encephalopathy.

(ii) Chronic encephalopathy occurs when a change in mental or neurologic status, first manifested during the applicable time period, persists for a period of at least 6 months from the date of vaccination. Individuals who return to a normal neurologic state after the acute encephalopathy shall not be presumed to have suffered residual neurologic damage from that event; any subsequent chronic encephalopathy shall not be presumed to be a sequela of the acute encephalopathy. If a preponderance of the evidence indicates that a child's chronic encephalopathy is secondary to genetic, prenatal or perinatal factors, that chronic encephalopathy shall not be considered to be a condition set forth in the Table.
(iii) An encephalopathy shall not be considered to be a condition set forth in the Table if in a proceeding on a petition, it is shown by a preponderance of the evidence that the encephalopathy was caused by an infection, a toxin, a metabolic disturbance, a structural lesion, a genetic disorder or trauma (without regard to whether the cause of the infection, toxin, trauma, metabolic disturbance, structural lesion or genetic disorder is known). If at the time a decision is made on a petition filed under section 2111(b) of the Act for a vaccine-related injury or death, it is not possible to determine the cause by a preponderance of the evidence of an encephalopathy, the encephalopathy shall be considered to be a condition set forth in the Table.
(iv) In determining whether or not an encephalopathy is a condition set forth in the Table, the Court shall consider the entire medical record.

(3) Seizure and convulsion. For purposes of paragraphs (b)(2) of this section, the terms, "seizure" and "convulsion" include myoclonic, generalized tonic-clonic (grand mal), and simple and complex partial seizures. Absence (petit mal) seizures shall not be considered to be a condition set forth in the Table. Jerking movements or staring episodes alone are not necessarily an indication of seizure activity.

(4) Sequela. The term "sequela" means a condition or event which was actually caused by a condition listed in the Vaccine Injury Table.

(5) Chronic Arthritis. For purposes of the Vaccine Injury Table, chronic arthritis may be found in a person with no history in the 3 years prior to vaccination of arthropathy (joint disease) on the basis of:

(A) Medical documentation, recorded within 30 days after the onset, of objective signs of acute arthritis (joint swelling) that occurred between 7 and 42 days after a rubella vaccination;
(B) Medical documentation (recorded within 3 years after the onset of acute arthritis) of the persistence of objective signs of intermittent or continuous arthritis for more than 6 months following vaccination:
(C) Medical documentation of an antibody response to the rubella virus.

For purposes of the Vaccine Injury Table, the following shall not be considered as chronic arthritis: Musculoskeletal disorders such as diffuse connective tissue diseases (including but not limited to rheumatoid arthritis, juvenile rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, mixed connective tissue disease, polymyositis/dermatomyositis, fibromyalgia, necrotizing vasculitis and vasculopathies and Sjogren's Syndrome), degenerative joint disease, infectious agents other than rubella (whether by direct invasion or as an immune reaction), metabolic and endocrine diseases, trauma, neoplasms, neuropathic disorders, bone and cartilage disorders and arthritis associated with ankylosing spondylitis, psoriasis, inflammatory bowel disease, Reiter's syndrome, or blood disorders.

Arthralgia (joint pain) or stiffness without joint swelling shall not be viewed as chronic arthritis for purposes of the Vaccine Injury Table.

(6) Brachial neuritis is defined as dysfunction limited to the upper extremity nerve plexus (i.e., its trunks, divisions, or cords) without involvement of other peripheral (e.g., nerve roots or a single peripheral nerve) or central (e.g., spinal cord) nervous system structures. A deep, steady, often severe aching pain in the shoulder and upper arm usually heralds onset of the condition. The pain is followed in days or weeks by weakness and atrophy in upper extremity muscle groups. Sensory loss may accompany the motor deficits, but is generally a less notable clinical feature. The neuritis, or plexopathy, may be present on the same side as or the opposite side of the injection; it is sometimes bilateral, affecting both upper extremities. Weakness is required before the diagnosis can be made. Motor, sensory, and reflex findings on physical examination and the results of nerve conduction and electromyographic studies must be consistent in confirming that dysfunction is attributable to the brachial plexus. The condition should thereby be distinguishable from conditions that may give rise to dysfunction of nerve roots (i.e., radiculopathies) and peripheral nerves (i.e., including multiple mononeuropathies), as well as other peripheral and central nervous system structures (e.g., cranial neuropathies and myelopathies).

(7) Thrombocytopenic purpura is defined by a serum platelet count less than 50,000/mm3. Thrombocytopenic purpura does not include cases of thrombocytopenia associated with other causes such as hypersplenism, autoimmune disorders (including alloantibodies from previous transfusions) myelodysplasias, lymphoproliferative disorders, congenital thrombocytopenia or hemolytic uremic syndrome. This does not include cases of immune (formerly called idiopathic) thrombocytopenic purpura (ITP) that are mediated, for example, by viral or fungal infections, toxins or drugs. Thrombocytopenic purpura does not include cases of thrombocytopenia associated with disseminated intravascular coagulation, as observed with bacterial and viral infections. Viral infections include, for example, those infections secondary to Epstein Barr virus, cytomegalovirus, hepatitis A and B, rhinovirus, human immunodeficiency virus (HIV), adenovirus, and dengue virus. An antecedent viral infection may be demonstrated by clinical signs and symptoms and need not be confirmed by culture or serologic testing. Bone marrow examination, if performed, must reveal a normal or an increased number of megakaryocytes in an otherwise normal marrow.

(8) Vaccine-strain measles viral infection is defined as a disease caused by the vaccine-strain that should be determined by vaccine‑specific monoclonal antibody or polymerase chain reaction tests.

(9) Vaccine-strain polio viral infection is defined as a disease caused by poliovirus that is isolated from the affected tissue and should be determined to be the vaccine-strain by oligonucleotide or polymerase chain reaction. Isolation of poliovirus from the stool is not sufficient to establish a tissue specific infection or disease caused by vaccine-strain poliovirus.

The CFR also requires that the preservative used

.hall be sufficiently non-toxic so that the amount present in the recommended dose of the product will not be toxic to the recipient, and in combination used it shall not denature the specific substance in the product to result in a decrease below the minimal acceptable potency within the dating period when stored at the recommended temperature. [21 CFR 610.15(a)]

The charts are easier to read at the link.

Food And Drug Administration

Thimerosal in Vaccines

See also "Mercury in Plasma-Derived Products"


Table of Contents

* Introduction
* Preservatives in Vaccines
* Thimerosal as a Preservative
* Guidelines on Exposure to Organomercurials
* Thimerosal Toxicity
* Recent and Future FDA Actions
* The Safety Review of Thimerosal-containing Vaccines and Neurodevelopmental Disorders Conducted by the Institute of Medicine
* Tables
o Table 1. Thimerosal Content of the Routinely Recommended Pediatric Vaccines
o Table 2. Preservatives in U.S. Licensed Vaccines
o Table 3. Thimerosal and Expanded List of vaccines
* References
* Bibliography

Introduction

Thimerosal is a mercury-containing organic compound (an organomercurial). Since the 1930s, it has been widely used as a preservative in a number of biological and drug products, including many vaccines, to help prevent potentially life threatening contamination with harmful microbes. Over the past several years, because of an increasing awareness of the theoretical potential for neurotoxicity of even low levels of organomercurials and because of the increased number of thimerosal containing vaccines that had been added to the infant immunization schedule, concerns about the use of thimerosal in vaccines and other products have been raised. Indeed, because of these concerns, the Food and Drug Administration has worked with, and continues to work with, vaccine manufacturers to reduce or eliminate thimerosal from vaccines.

Thimerosal has been removed from or reduced to trace amounts in all vaccines routinely recommended for children 6 years of age and younger, with the exception of inactivated influenza vaccine (see Table 1). A preservative-free version of the inactivated influenza vaccine (contains trace amounts of thimerosal) is available in limited supply at this time for use in infants, children and pregnant women. Some vaccines such as Td, which is indicated for older children (≥ 7 years of age) and adults, are also now available in formulations that are free of thimerosal or contain only trace amounts. Vaccines with trace amounts of thimerosal contain 1 microgram or less of mercury per dose.

In the following pages, a discussion of preservatives, the use of thimerosal as a preservative, guidelines on exposure to organomercurials (primarily methylmercury), thimerosal toxicity, recent and future FDA actions, and the conclusions of the Institute of Medicine's most recent review of thimerosal in vaccines are presented. This narrative on thimerosal contains references to the literature and links to other sites for readers who wish additional information; for quick reference, a number of frequently asked questions (FAQs) and answers are provided.

Table of Contents

Preservatives in Vaccines

To begin, we need to answer two questions-what are preservatives and why are they used in vaccines. For our purposes, preservatives may be defined as compounds that kill or prevent the growth of microorganisms, particularly bacteria and fungi. They are used in vaccines to prevent microbial growth in the event that the vaccine is accidentally contaminated, as might occur with repeated puncture of multi-dose vials. In some cases, preservatives are added during manufacture to prevent microbial growth; with changes in manufacturing technology, however, the need to add preservatives during the manufacturing process has decreased markedly.

The United States Code of Federal Regulations (the CFR) requires, in general, the addition of a preservative to multi-dose vials of vaccines; indeed, worldwide, preservatives are routinely added to multi-dose vials of vaccine. Tragic consequences have followed the use of multi-dose vials that did not contain a preservative and have served as the impetus for this requirement. One particularly telling incident from Australia is described by Sir Graham S. Wilson in his classic book, The Hazards of Immunization

In January 1928, in the early stages of an immunization campaign against diphtheria, Dr. Ewing George Thomson, Medical Officer of Health of Bundaberg, began the injection of children with toxin-antitoxin mixture. The material was taken from an India-rubber-capped bottle containing 10 mL of TAM. On the 17th, 20th, 21, and 24th January, Dr. Thomson injected subcutaneously a total of 21 children without ill effect. On the 27th a further 21 children were injected.Of these children .eleven died on the 28th and one on the 29th. (Wilson 1967)

This disaster was investigated by a Royal Commission and the final sentence in the summary of their findings reads as follows:

The consideration of all possible evidence concerning the deaths at Bundeberg points to the injection of living staphylococci as the cause of the fatalities.

From this experience, the Royal Commission recommended that biological products in which the growth of a pathogenic organism is possible should not be issued in containers for repeated use unless there is a sufficient concentration of antiseptic (preservative) to inhibit bacterial growth.

The U.S. requirement for preservatives in multi-dose vaccines was incorporated into the CFR in January 1968, although many biological products had contained preservatives, including thimerosal, prior to this date. Specifically, the CFR states:

Products in multi-dose containers shall contain a preservative, except that a preservative need not be added to Yellow Fever Vaccine; Polio-virus Vaccine, Live Oral; viral vaccine labeled for use with the jet injector; dried vaccines when the accompanying diluent contains a preservative; or to an Allergenic Product in 50 percent or more volume (v/v) glycerin. [21 CFR 610.15(a)]

The CFR also requires that the preservative used

.hall be sufficiently non-toxic so that the amount present in the recommended dose of the product will not be toxic to the recipient, and in combination used it shall not denature the specific substance in the product to result in a decrease below the minimal acceptable potency within the dating period when stored at the recommended temperature. [21 CFR 610.15(a)]

Preservatives cannot completely eliminate the risk of contamination of vaccines. The literature contains several reports of bacterial contamination of vaccines despite the presence of a preservative, emphasizing the need for meticulous attention to technique in withdrawing vaccines from multi-dose vials. (Bernier et al 1981; Simon et al. 1993). The need for preservatives in multi-dose vials of vaccines is nonetheless clear. Several preservatives are used in U.S. licensed vaccines, and these are listed in Table 2. It is important to note that the FDA does not license a particular preservative; rather, the product containing that preservative is licensed, with safety and efficacy data generally collected in the context of a license application for a particular product.

Table of Contents

Thimerosal as a Preservative

Thimerosal, which is approximately 50% mercury by weight, has been one of the most widely used preservatives in vaccines. It is metabolized or degraded to ethylmercury and thiosalicylate. Ethylmercury is an organomercurial that should be distinguished from methylmercury, a related substance that has been the focus of considerable study (see "Guidelines on Exposure to Organomercurials" and "Thimerosal Toxicity", below).

At concentrations found in vaccines, thimerosal meets the requirements for a preservative as set forth by the United States Pharmacopeia; that is, it kills the specified challenge organisms and is able to prevent the growth of the challenge fungi (U.S. Pharmacopeia 2004). Thimerosal in concentrations of 0.001% (1 part in 100,000) to 0.01% (1 part in 10,000) has been shown to be effective in clearing a broad spectrum of pathogens. A vaccine containing 0.01% thimerosal as a preservative contains 50 micrograms of thimerosal per 0.5 mL dose or approximately 25 micrograms of mercury per 0.5 mL dose.

Prior to its introduction in the 1930's, data were available in several animal species and humans providing evidence for its safety and effectiveness as a preservative (Powell and Jamieson 1931). Since then, thimerosal has been the subject of several studies (see Bibliography) and has a long record of safe and effective use preventing bacterial and fungal contamination of vaccines, with no ill effects established other than minor local reactions at the site of injection.

While the use of mercury-containing preservatives has declined in recent years with the development of new products formulated with alternative or no preservatives, thimerosal has been used in some immune globulin preparations, anti-venins, skin test antigens, and ophthalmic and nasal products, in addition to certain vaccines. Under the FDA Modernization Act of 1997, the FDA compiled a list of regulated products containing mercury, including those with thimerosal (Federal Register 1999). It is important to note that this list was compiled in 1999; some products listed are no longer manufactured and many products have been reformulated without thimerosal. Updated lists of vaccines and their thimerosal content can be found in Table 1 (routinely recommended pediatric vaccines) and Table 3 (expanded list of vaccines).

Table of Contents

Guidelines on Exposure to Organomercurials

Mercury is an element that is dispersed widely around the earth. Most of the mercury in the water, soil, plants and animals is found as inorganic mercury salts. Mercury accumulates in the aquatic food chain, primarily in the form of the methylmercury, an organomercurial. Organic forms of mercury are more easily absorbed when ingested and are less readily eliminated from the body than are inorganic forms of mercury. Humans are exposed to methylmercury primarily from the consumption of seafood (Mahaffey et al. 1997).

Methylmercury is a neurotoxin. The toxicity of methylmercury was first recognized during the late 1950s and early 1960s when industrial discharge of mercury into Minimata Bay, Japan led to the widespread consumption of mercury-contaminated fish (Harada 1995). Epidemics of methylmercury poisoning also occurred in Iraq during the 1970s when seed grain treated with a methylmercury fungicide was accidentally used to make bread (Bakir et al. 1973). During these epidemics, fetuses were found to be more sensitive to the effects of methylmercury than adults. Maternal exposure to high levels of methylmercury resulted in infants exhibiting severe neurologic injury including a condition resembling cerebral palsy, while their mothers showed little or no symptoms. Sensory and motor neurologic dysfunction and developmental delays were observed among some children who were exposed in utero to lower levels of methylmercury.

More recently, several epidemiological studies have examined the effect of low dose dietary exposure to methylmercury, with inconsistent results. Studies from the Faroe Islands reported that subtle cognitive deficits (e.g., performance on attention, language, and memory tests), detectable by sophisticated neuropsychometric testing, were associated with methylmercury levels previously thought to be safe (Grandjean et al 1997). Studies in the Seychelles, evaluating more global developmental outcomes, did not reveal any correlation between abnormalities and methylmercury levels (Davidson et al. 1998).

Various agencies have developed guidelines for safe exposure to methylmercury, including the U.S. Environmental Protection Agency (Mahaffey et al. 1997), U.S. Agency for Toxic Substances and Disease Registry (ATSDR 1999), the FDA (Federal Register 1979)1, and the World Health Organization (WHO 1996). These exposure levels range from 0.1 µg/kg body weight/day (EPA) to 0.47 µg/kg body weight/day (WHO)2. The range of recommendations is due to varying safety margins, differing emphasis placed on various sources of data, the different missions of the agencies and the population that the guideline is intended to protect. All guidelines, however, fall within the same order of magnitude. While these guidelines may be used as screening tools in risk assessment to evaluate the "safety" of mercury exposures, they are not meant to be bright lines above which toxicity will occur. However, as exposure levels increase in multiples of these guidelines, there is increasing concern on the part of the public health community that adverse health consequences may occur (Mahaffey 1999).

To address the issue of conflicting methylmercury exposure guidelines, Congress asked the National Academy of Sciences to study the toxicological effects of methylmercury and provide recommendations on the establishment of a scientifically appropriate methylmercury reference dose. Their report concluded that the EPA's current reference dose, the RfD, for methylmercury, 0.1 µg/kg/day is a scientifically justifiable level for the protection of human health. (See "Related Links" below for link to the report: "The National Academies Press: Toxicological Effects of Methylmercury.") The FDA is considering this and other data relevant to its exposure guideline for methylmercury.

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Thimerosal Toxicity

The various mercury guidelines are based on epidemiological and laboratory studies of methyl mercury, whereas thimerosal is a derivative of ethyl mercury. Because they are different chemical entities - ethyl- versus methylmercury - different toxicological profiles are expected. There is, therefore, an uncertainty that arises in applying the methylmercury-based guidelines to thimerosal. Lacking definitive data on the comparative toxicities of ethyl- versus methylmercury, FDA considered ethyl- and methyl-mercury as equivalent in its risk evaluation. There are some data and studies bearing directly on thimerosal toxicity and these are summarized in this Section.

Allergic responses to thimerosal are described in the clinical literature, with these responses manifesting themselves primarily in the form of delayed-type local hypersensitivity reactions, including redness and swelling at the injection site (Cox and Forsyth 1988; Grabenstein 1996). Such reactions are usually mild and last only a few days. Some authors postulate that the thiosalicylate component is the major determinant of allergic reactions (Goncalo et al. 1996). In a clinical setting, however, it is usually not possible to determine whether local reactions are caused by thimerosal or other vaccine components.

The earliest published report of thimerosal use in humans was published in 1931 (Powell and Jamieson 1931). In this report, 22 individuals received 1% solution of thimerosal intravenously for unspecified therapeutic reasons. Subjects received up to 26 milligrams thimerosal/kg (1 milligrams equals 1,000 micrograms) with no reported toxic effects, although 2 subjects demonstrated phlebitis or sloughing of skin after local infiltration. Of note, this study was not specifically designed to examine toxicity; 7 of 22 subjects were observed for only one day, the specific clinical assessments were not described, and no laboratory studies were reported.

Several cases of acute mercury poisoning from thimerosal-containing products were found in the medical literature with total doses of thimerosal ranging from approximately 3 mg/kg to several hundred mg/kg. These reports included the administration of immune globulin (gamma globulin) (Matheson et al. 1980) and hepatitis B immune globulin (Lowell et al. 1996), choramphenicol formulated with 1000 times the proper dose of thimerosal as a preservative (Axton 1972), thimerosal ear irrigation in a child with tympanostomy tubes (Rohyans et al. 1994), thimerosal treatment of omphaloceles in infants (Fagan et al. 1977), and a suicide attempt with thimerosal (Pfab et al. 1996). These studies reported local necrosis, acute hemolysis, disseminated intravascular coagulation, acute renal tubular necrosis, and central nervous system injury including obtundation, coma, and death. (IOM2)

Several animal studies have evaluated the toxicity of thimerosal. In 1931 Powell and Jamieson reported acute toxicity studies in several animal species. Maximum tolerated doses not associated with death of the animals were 20 mg thimerosal/kg (rabbits) and 45 mg/kg (rats). Blair evaluated the administration of thimerosal intranasally for 190 days and observed no histopathological changes in the brain or kidney (Blair et al. 1975). Magos et al. directly compared the toxicity of ethyl- versus methylmercury in adult male and female rats administered 5 daily doses of equimolar concentrations of ethyl- or methylmercury by gavage (Magos et al 1985). Magos concluded that ethylmercury, the mercury derivative found in thimerosal, is less neurotoxic than methylmercury, the mercury derivative for which the various guidelines are based.

One final piece of data regarding thimerosal is worth noting. At the initial National Vaccine Advisory Committee-sponsored meeting on thimerosal in 1999, concerns were expressed that infants may lack the ability to eliminate mercury. More recent NIAID-supported studies at the University of Rochester and National Naval Medical Center in Bethesda, MD examined levels of mercury in blood and other samples from infants who had received routine immunizations with thimerosal-containing vaccines. [Pichichero ME, et al. Lancet 360:1737-1741 (2002)] Blood levels of mercury did not exceed safety guidelines for methyl mercury for all infants in these studies. Further, mercury was cleared from the blood in infants exposed to thimerosal faster than would be predicted for methyl mercury; infants excreted significant amounts of mercury in stool after thimerosal exposure, thus removing mercury from their bodies. These results suggest that there are differences in the way that thimerosal and methyl mercury are distributed, metabolized, and excreted. Thimerosal appears to be removed from the blood and body more rapidly than methyl mercury. NIAID is sponsoring a follow-up study with larger numbers of infants in Buenos Aires where thimerosal-containing vaccines are still administered to children. See "Related Links" below to find a link to the NIH/NIAID vaccines/thimerosal web site.

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Recent and Future FDA Action

FDA has been actively addressing the issue of thimerosal as a preservative in vaccines. Under the FDA Modernization Act (FDAMA) of 1997, the FDA conducted a comprehensive review of the use of thimerosal in childhood vaccines. Conducted in 1999, this review found no evidence of harm from the use of thimerosal as a vaccine preservative, other than local hypersensitivity reactions (Ball et al. 2001).

As part of the FDAMA review, the FDA evaluated the amount of mercury an infant might receive in the form of ethylmercury from vaccines under the U.S. recommended childhood immunization schedule and compared these levels with existing guidelines for exposure to methylmercury, as there are no existing guidelines for ethylmercury, the metabolite of thimerosal. At the time of this review in 1999, the maximum cumulative exposure to mercury from vaccines in the recommended childhood immunization schedule was within acceptable limits for the methylmercury exposure guidelines set by FDA, ATSDR, and WHO. However, depending on the vaccine formulations used and the weight of the infant, some infants could have been exposed to cumulative levels of mercury during the first six months of life that exceeded EPA recommended guidelines for safe intake of methylmercury.

As a precautionary measure, the Public Health Service (including the FDA, National Institutes of Health (NIH), Center for Disease Control and Prevention (CDC) and Health Resources and Services Administration (HRSA) and the American Academy of Pediatrics issued two Joint Statements, urging vaccine manufacturers to reduce or eliminate thimerosal in vaccines as soon as possible (CDC 1999) and (CDC 2000). The U.S. Public Health Service agencies have collaborated with various investigators to initiate further studies to better understand any possible health effects from exposure to thimerosal in vaccines.

Available data has been reviewed in several public forums including the Workshop on Thimerosal held in Bethesda in August 1999 and sponsored by the National Vaccine Advisory Committee, two meetings of the Advisory Committee on Immunization Practices of the CDC, held in October 1999 and June 2000, and the Institute of Medicine's Immunization Safety Review Committee in July 2001 and May 2004. Through its Vaccine Safety Datalink, the CDC has examined the incidence of autism as a function of the amount of thimerosal a child received from vaccines. Preliminary results indicated no change in autism rates relative to the amount of thimerosal a child received during the first six months of life (from 0 micrograms to greater than 160 micrograms). A weak association was found with thimerosal intake and certain neurodevelopmental disorders (such as attention deficit hyperactivity disorder) in one study, but was not found in a subsequent study. Additional studies are planned in these areas.

Much progress has been made to date in removing or reducing thimerosal in vaccines. New pediatric formulations of hepatitis B vaccines have been licensed by the FDA, Recombivax-HB (Merck, thimerosal free) in August 1999 and Engerix-B (Glaxo SmithKline, thimerosal free) in January 2007. In March 2001 the FDA approved a second DTaP vaccine formulated without thimerosal as a preservative (Aventis Pasteur's Tripedia, trace thimerosal). Aventis Pasteur, Ltd was also approved to manufacture a thimerosal-free DTaP vaccine, Daptacel, in 2002. In September 2001 Chiron/Evans was approved for manufacturing a preservative-free formulation of their influenza vaccine, Fluvirin, that contained trace thimerosal. In September of 2002, Aventis Pasteur, Inc was approved to manufacture a preservative-free formulation of their influenza vaccine, Fluzone that contained trace thimerosal, and in December 2004, a thimerosal-free formulation of Fluzone was approved. Two Td vaccines are also available in preservative-free formulations, Aventis Pasteur Inc's Decavac, and Aventis Pasteur, Ltd's Td vaccine. Also, Aventis Pasteur Inc's DT vaccine is now available only in a preservative-free formulation. These changes have been accomplished by reformulating products in single dose vials that do not contain a preservative. At present, all routinely recommended vaccines for U.S. infants are available only as thimerosal-free formulations or contain only trace amounts of thimerosal (≤1 than micrograms mercury per dose), with the exception of inactivated influenza vaccine. Inactivated influenza vaccine for pediatric use is available in a thimerosal-preservative containing formulation and in formulations that contain either no thimerosal or only a trace of thimerosal, but the latter is in more limited supply; see Table 1. A more extensive tabulation of vaccines and thimerosal content may be found in Table 3.

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The Safety Review of Thimerosal-containing Vaccines and Neurodevelopmental Disorders Conducted by the Institute of Medicine

In 2001, the Institute of Medicine convened a committee (the Immunization Safety Review Committee) to review selected issues related to immunization safety. [For more information regarding this committee, their charge, and their reports, find the link to IOM's Web site in "Related Links" below.] The IOM has, to date, completed reviews in two areas. The first review by this committee focused on a potential link between autism and the combined mumps, measles, and rubella vaccine. The second review focused on a potential relationship between thimerosal use in vaccines and neurodevelopmental disorders (IOM 2001). This latter issue was brought to the fore primarily as the result of the hypothesis, formulated by S. Bernard and others from Cure Autism Now, that autism is a novel form of mercury poisoning (Bernard et al. 2001); this hypothesis, linking autism to mercury, was based on a comprehensive review of the scientific literature on mercury toxicity.

In its report of October 1, 2001, the IOM's Immunization Safety Review Committee concluded that the evidence was inadequate to either accept or reject a causal relationship between thimerosal exposure from childhood vaccines and the neurodevelopmental disorders of autism, attention deficit hyperactivity disorder (ADHD), and speech or language delay. Additional studies were needed to establish or reject a causal relationship. The Committee did conclude that the hypothesis that exposure to thimerosal-containing vaccines could be associated with neurodevelopmental disorders was biologically plausible.

The Committee believed that the effort to remove thimerosal from vaccines was "a prudent measure in support of the public health goal to reduce mercury exposure of infants and children as much as possible." Furthermore, in this regard, the Committee urged that "full consideration be given to removing thimerosal from any biological product to which infants, children, and pregnant women are exposed."

In 2004, the IOM's Immunization Safety Review Committee issued its final report, examining the hypothesis that vaccines, specifically the MMR vaccines and thimerosal containing vaccines, are causally associated with autism. In this report, the committee incorporated new epidemiological evidence from the U.S., Denmark, Sweden, and the United Kingdom, and studies of biologic mechanisms related to vaccines and autism since its report in 2001. The committee concluded that this body of evidence favors rejection of a causal relationship between thimerosal-containing vaccines and autism, and that hypotheses generated to date concerning a biological mechanism for such causality are theoretical only. Further, the committee stated that the benefits of vaccination are proven and the hypothesis of susceptible populations is presently speculative, and that widespread rejection of vaccines would lead to increases in incidences of serious infectious diseases like measles, whooping cough and Hib bacterial meningitis.

The FDA is continuing its efforts to reduce the exposure of infants, children, and pregnant women to mercury from various sources. Discussions with the manufacturers of influenza virus vaccines (which are now routinely recommended for pregnant women and children 6-23 months of age) regarding their capacity to potentially increase the supply of thimerosal-reduced and thimerosal-free presentations are ongoing. Discussions are also underway with regard to other vaccines. Of note, all hepatitis B vaccines for the U.S., including for adults, are now available only as thimerosal-free or trace-thimerosal-containing formulatons. In addition, all immune globulin preparations including hepatitis B immune globulin, and Rho(D) immune globulin preparations are manufactured without thimerosal. For additional information on the issue of thimerosal in vaccines, see Frequently Asked Questions (FAQs).

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Tables

Table 1. Thimerosal Content of Vaccines Routinely Recommended for Children 6 Years of Age and Younger - (updated 7/18/2005*)
*Since this update, a biologics license application was approved for Rotavirus Vaccine, Tradename-RotaTeq (Merck), that is thimerosal free and never contained thimerosal.
Vaccine Tradename
(Manufacturer) Thimerosal Status Concentration**(Mercury) Approval Date for Thimerosal Free or Thimerosal / Preservative Free (Trace Thimerosal)*** Formulation
DTaP Infanrix
(GlaxoSmithKline Biologicals) Free Never contained more than a trace of thimerosal, approval date for thimerosal-free formulation 9/29/2000
Daptacel
(Sanofi Pasteur, Ltd) Free Never contained Thimerosal
Tripedia
(Sanofi Pasteur, Inc) Trace(≤0.3 µg Hg/0.5mL dose) 03/07/01
DTaP-HepB-IPV Pediarix
(GlaxoSmithKline Biologicals) Free Never contained more than a Trace of Thimerosal, approval date for thimerosal-free formulation 1/29/2007
Pneumococcal conjugate Prevnar
(Wyeth Pharmaceuticals Inc) Free Never contained Thimerosal
Inactivated Poliovirus IPOL
(Sanofi Pasteur, SA) Free Never contained Thimerosal
Varicella (chicken pox) Varivax
(Merck & Co, Inc) Free Never contained Thimerosal
Mumps, measles, and rubella M-M-R-II
(Merck & Co, Inc) Free Never contained Thimerosal
Hepatitis B Recombivax HB
(Merck & Co, Inc) Free 08/27/99
Engerix B
(GlaxoSmithKline Biologicals) Free 03/28/00, approval date for thimerosal-free formulation 1/30/2007
Haemophilus influenzae type b conjugate (Hib) ActHIB
(Sanofi Pasteur, SA)
OmniHIB
(GlaxoSmithKline) Free Never contained Thimerosal
PedvaxHIB
(Merck & Co, Inc) Free 08/99
HibTITER, single dose
(Wyeth Pharmaceuticals, Inc.)1 Free Never contained Thimerosal
Hib/Hepatitis B combination Comvax
(Merck & Co, Inc) Free Never contained Thimerosal
Influenza Fluzone
(Sanofi Pasteur, Inc) 0.01% (12.5 µg/0.25 mL dose, 25 µg/0.5 mL dose)2
Fluzone
(Sanofi Pasteur, Inc)3
(no thimerosal) Free 12/23/2004
Fluvirin
(Novartis Vaccines and Diagnostics Ltd) 0.01% (25 µg/0.5 mL dose)
Fluvirin
(Novartis Vaccines and Diagnostics Ltd)
(Preservative Free) Trace (<1ug Hg/0.5mL dose) 09/28/01
Influenza, live FluMist
(MedImmune Vaccines, Inc) Free Never contained Thimerosal

** Thimerosal is approximately 50% mercury (Hg) by weight. A 0.01% solution (1 part per 10,000) of thimerosal contains 50 µg of Hg per 1 mL dose or 25 µg of Hg per 0.5 mL dose.
*** The term "trace" has been taken in this context to mean 1 microgram of mercury per dose or less.
1 HibTiITER was also manufactured in thimerosal-preservative containing multidose vials but these were no longer available after 2002.
2 Children 6 months old to less than 3 years of age receive a half-dose of vaccine, i.e., 0.25 mL; children 3 years of age and older receive 0.5 mL.
3 A trace thimerosal containing formulation of Fluzone was approved on 9/14/02 and has been replaced with the formulation without thimerosal.

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Table 2: Preservatives Used in U.S. Licensed Vaccines
Preservative Vaccine Examples (Tradename; Manufacturer)
Thimerosal TT (one)
Influenza (several)
Phenol Typhoid Vi Polysaccharide (Typhim Vi; Sanofi Pasteur, SA)
Pneumococcal Polysaccharide (Pneumovax 23; Merck & Co, Inc)
Benzethonium chloride (Phemerol) Anthrax (Biothrax; Emergent BioDefense Operations Lansing Inc.)
2-phenoxyethanol DTaP (Infanrix; GlaxoSmithKline Biologicals)
DTaP (Daptacel; Sanofi Pasteur, Ltd)
Hepatitis A/Hepatitis B (Twinrix; GlaxoSmithKline Biologicals)
IPV (IPOL; Sanofi Pasteur, SA)

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Table 3: Thimerosal and Expanded List of Vaccines - (updated 3/14/2008)
Thimerosal Content in Currently Manufactured U.S. Licensed Vaccines
Vaccine Trade Name Manufacturer Thimerosal Concentration1 Mercury
Anthrax Anthrax vaccine Emergent BioDefense Operations Lansing Inc. 0 0
DTaP Tripedia2 Sanofi Pasteur, Inc &#8804; 0.00012% &#8804; 0.3 µg/0.5 mL dose
Infanrix GlaxoSmithKline Biologicals 0 0
Daptacel Sanofi Pasteur, Ltd 0 0
DTaP-HepB-IPV Pediarix GlaxoSmithKline Biologicals 0 0
DT No Trade Name Sanofi Pasteur, Inc < 0.00012% (single dose) < 0.3 µg/0.5mL dose
Sanofi Pasteur, Ltd3 0.01% 25 µg/0.5 mL dose
Td No Trade Name MassBiologics &#8804; 0.00012% &#8804; 0.3 µg mercury/0.5 ml dose
Decavac Sanofi Pasteur, Inc &#8804; 0.00012% &#8804; 0.3 µg mercury/0.5 ml dose
No Trade Name Sanofi Pasteur, Ltd 0 0
Tdap Adacel Sanofi Pasteur, Ltd 0 0
Boostrix GlaxoSmithKline Biologicals 0 0
TT No Trade Name Sanofi Pasteur, Inc 0.01% 25 µg/0.5 mL dose
Hib ActHIB/OmniHIB4 Sanofi Pasteur, SA 0 0
HibTITER Wyeth Pharmaceuticals, Inc. 0 0
PedvaxHIB liquid Merck & Co, Inc 0 0
Hib/HepB COMVAX5 Merck & Co, Inc 0 0
Hepatitis B

Engerix-B
Pediatric/adolescent

Adult
GlaxoSmithKline Biologicals



0

0




0

0

Recombivax HB

Pediatric/adolescent

Adult (adolescent)

Dialysis
Merck & Co, Inc



0

0

0




0

0

0
Hepatitis A Havrix GlaxoSmithKline Biologicals 0 0
Vaqta Merck & Co, Inc 0 0
HepA/HepB Twinrix GlaxoSmithKline Biologicals < 0.0002% < 1 µg/1mL dose
IPV IPOL Sanofi Pasteur, SA 0 0
Poliovax Sanofi Pasteur, Ltd 0 0
Influenza Afluria CSL Limited 0 (single dose)
0.01% (multidose) 0/0.5 mL (single dose)
24.5 µg/0.5 mL (multidose)
Fluzone6 Sanofi Pasteur, Inc 0.01% 25 µg/0.5 mL dose
Fluvirin Novartis Vaccines and Diagnostics Ltd 0.01% 25 µg/0.5 ml dose
Fluzone (no thimerosal) Sanofi Pasteur, Inc 0 0
Fluvirin (Preservative Free) Novartis Vaccines and Diagnostics Ltd < 0.0004% < 1 µg/0.5 mL dose
Fluarix GlaxoSmithKline Biologicals < 0.0004% < 1 µg/0.5 ml dose
FluLaval ID Biomedical Corporation of Quebec 0.01% 25 µg/0.5 ml dose
Influenza, live FluMist MedImmune Vaccines, Inc 0 0
Japanese Encephalitis7 JE-VAX Research Foundation for Microbial Diseases of Osaka University 0.007% 35 µg/1.0mL dose
17.5 µg/0.5 mL dose
MMR MMR-II Merck & Co, Inc 0 0
Meningococcal Menomune A, C, AC and A/C/Y/W-135 Sanofi Pasteur, Inc 0.01% (multidose)
0 (single dose) 25 µg/0.5 dose
0
Menactra A, C, Y and W-135 Sanofi Pasteur, Inc 0 0
Pneumococcal Prevnar (Pneumo Conjugate) Wyeth Pharmaceuticals Inc 0 0
Pneumovax 23 Merck & Co, Inc 0 0
Rabies IMOVAX Sanofi Pasteur, SA 0 0
Rabavert Novartis Vaccines and Diagnostics 0 0
Smallpox (Vaccinia), Live ACAM2000 Acambis, Inc. 0 0
Typhoid Fever Typhim Vi Sanofi Pasteur, SA 0 0
Vivotif Berna Biotech, Ltd 0 0
Varicella Varivax Merck & Co, Inc 0 0
Yellow Fever Y-F-Vax Sanofi Pasteur, Inc 0 0
Table Footnotes

1. Thimerosal is approximately 50% mercury (Hg) by weight. A 0.01% solution (1 part per 10,000) of thimerosal contains 50 µg of Hg per 1 ml dose or 25 µg of Hg per 0.5 ml dose.
2. Sanofi Pasteur's Tripedia may be used to reconstitute ActHib to form TriHIBit. TriHIBit is indicated for use in children 15 to 18 months of age.
3. This vaccine is not marketed in the US.
4. OmniHIB is manufactured by Sanofi Pasteur but distributed by GlaxoSmithKline.
5. COMVAX is not licensed for use under 6 weeks of age because of decreased response to the Hib component.
6. Children under 3 years of age receive a half-dose of vaccine, i.e., 0.25 mL (12.5 µg mercury/dose.)
7. JE-VAX is distributed by Aventis Pasteur. Children 1 to 3 years of age receive a half-dose of vaccine, i.e., 0.5 mL (17.5 µg mercury/dose).

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References

1. Agency for Toxic Substances and Disease Registry. Toxicological profile for mercury. Atlanta, GA: Agency for Toxic Substances and Disease Registry;1999.
2. Axton JMH. Six cases of poisoning after a parenteral organic mercurial compound (merthiolate). Postgrad Med J 1972;48:417-421.
3. Bakir F, Damlugi SF, Amin-Zaki L, Murtadha M, Khalidi A, Al-Rawi NY, Tikriti S, Dhahir HI, Clarkson TW, Smith JC, Doherty RA. Methylmercury poisoning in Iraq. Science 1973;181:230-241.
4. Ball LK, Ball R, Pratt RD. An assessment of thimerosal use in childhood vaccines. Pediatrics 2001;1147-1154.
5. Bernard S, Enayati A, Redwood L, Roger H, and Binstock T. Med. Hypotheses 2001, 56: 462-471.
6. Bernier RH, Frank JA, Nolan TF. Abscesses complicating DTP vaccination. Am J Dis Child 1981;135:826-828.
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8. Centers for Disease Control and Prevention. Notice to Readers: Thimerosal in Vaccines: A Joint Statement of the American Academy of Pediatrics and the Public Health Service. Morb Mort Wkly Rep 1999;48:563-565.
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Bibliography

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8. Wozniak-Parnowska W, Krowczynski L. New approach to preserving eye drops. Pharmacy International 1981;2(4):91-94.

Table of Contents

1 FDA's guideline is based in part on a maximum tolerable daily intake of 30 µg/day of methylmercury from the diet; for purposes of comparison this would translate to approximately 0.43 micrograms/kg/day for a 70 kg adult. The FDA recommends that pregnant women, women of childbearing age who may become pregnant, nursing mothers and young children do not consume certain kinds of fish that may contain high levels of methylmercury (i.e., shark, swordfish, king mackerel, and tilefish); see http://www.cfsan.fda.gov/~lrd/tphgfish.html

2 The WHO guideline is expressed as 3.3 µg/kg/week and has been converted to a daily dose for purposes of comparison.

 

[RodISHI]

I'm looking for the needle in the haystack.

30,000+ children no vaccines, no autism.

Thank you for this fine example of bad science.

Thank for your perfect example of blind ignorance.

 

[Valerie]

>>

Thimerosal
Information about Thimerosal

Since 2001, with the exception of some influenza (flu) vaccines, thimerosal is not used as a preservative in routinely recommended childhood vaccines.

Thimerosal is a mercury-containing preservative used in some vaccines and other products since the 1930's. There is no convincing evidence of harm caused by the low doses of thimerosal in vaccines, except for minor reactions like redness and swelling at the injection site. However, in July 1999, the Public Health Service agencies, the American Academy of Pediatrics, and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines as a precautionary measure.

 

[L.K.Eder]

no matter what you try to interject, like general critique of the FDA and governmental agencies and science per se, you always come back to the special case of vaccines and autism and thimerosal.

do you have any comment on the now finally rejected wakefield study?

was that bad science that killed and injured?

or is wakefield one of the good scientists, rodishi?

 

[RodISHI]

>>

Thimerosal
Information about Thimerosal

Since 2001, with the exception of some influenza (flu) vaccines, thimerosal is not used as a preservative in routinely recommended childhood vaccines.

Thimerosal is a mercury-containing preservative used in some vaccines and other products since the 1930's. There is no convincing evidence of harm caused by the low doses of thimerosal in vaccines, except for minor reactions like redness and swelling at the injection site. However, in July 1999, the Public Health Service agencies, the American Academy of Pediatrics, and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines as a precautionary measure.

If you read the charts they do not all match to the 2001 time line, in some they do use it in some they don't in the 2007 updates. That is why I put it all in the quote.

A lengthy article along with comments, articles, research links, etc. It seems to be fairly detailed in the discussions. One can consider the studies on infant monkeys that show definite damage to the brains. Of course we don't kill baby humans with these neurological malformations to determine if these same areas of the brain are stunted as in the infant monkeys.

Only Vaccinated Amish Children Are Autistic - Share The Wealth


"What's needed is a total study of the sensibility of the vaccine program. Why would you want to vaccinate a baby on the first day of its life?"

The report is one of the first to look beyond mercury blood levels resulting from vaccines. Instead it examines both the amount and the type of mercury reaching the brain. It suggests health officials examined the wrong compound and failed to look far enough when assessing the danger of mercury in thimerosal.

 

[RodISHI]

no matter what you try to interject, like general critique of the FDA and governmental agencies and science per se, you always come back to the special case of vaccines and autism and thimerosal.

do you have any comment on the now finally rejected wakefield study?

was that bad science that killed and injured?

or is wakefield one of the good scientists, rodishi?

Put some links up to what it is you are talking about please.

 

[Valerie]

>

The Nobel Prize winning doctor Maurice Hilleman warned Merck about the dangers, like autism, from increased mercury in vaccines then pleaded with FDA, they ignored him and covered up the fraud.

Thimerosal
Information about Thimerosal

Since 2001, with the exception of some influenza (flu) vaccines, thimerosal is not used as a preservative in routinely recommended childhood vaccines.

Thimerosal is a mercury-containing preservative used in some vaccines and other products since the 1930's. There is no convincing evidence of harm caused by the low doses of thimerosal in vaccines, except for minor reactions like redness and swelling at the injection site. However, in July 1999, the Public Health Service agencies, the American Academy of Pediatrics, and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines as a precautionary measure.

CDC - Mercury and Thimerosal - Vaccine Safety


>>

Journal Retracts Controversial Study Linking MMR Vaccine, Autism
The Lancet's Decision Could Ease Parental Resistance to Vaccination

By David Mitchell
2/10/2010

The Lancet has fully retracted the 1998 study that linked autism to the measles, mumps and rubella, or MMR, vaccine after an independent panel recently concluded that the study was flawed and its lead author's conduct was "dishonest, irresponsible and misleading."

Journal Retracts Controversial Study Linking MMR Vaccine, Autism -- AAFP News Now -- American Academy of Family Physicians

>>

The medical journal The Lancet has retracted the 1998 article that was the first to link the MMR vaccine to autism. The withdraw comes hot on the heels of a hearing that found Dr. Andrew Wakefield, the author of that article, acted unethically during the experiments listed in the article.

Full retractions from journals are rare; it is tantamount to saying that the article should have never been published. With this move, The Lancet is effectively stating that the conclusions drawn in the article were incorrect. Put simply, they are saying the conclusion that the MMR vaccine is linked to the development of autism that the article claimed was not good science.



Journal withdraws the original MMR vaccine-autism study

Journal withdraws the original MMR vaccine-autism study

 

[Valerie]

Despite considerable publicity, there is no evidence linking MMR vaccination with the development of autism. The Centers for Disease Control and Prevention (CDC) website ( Vaccines: HOME page for Vaccines and Immunizations site ) provides further information.

The potential benefits from receiving the MMR vaccine far outweigh the potential risks. Measles, mumps, and rubella are all very serious illnesses, and each can have complications that lead to lifetime disabilities or even death.

MMR vaccine: MedlinePlus Medical Encyclopedia

 

[L.K.Eder]

no matter what you try to interject, like general critique of the FDA and governmental agencies and science per se, you always come back to the special case of vaccines and autism and thimerosal.

do you have any comment on the now finally rejected wakefield study?

was that bad science that killed and injured?

or is wakefield one of the good scientists, rodishi?

Put some links up to what it is you are talking about please.

are you only in this thread to drop atrocious gargantuan copypasta or do you read other posts, too?

http://www.usmessageboard.com/2038536-post4.html

and if you are interested in the autism-vaccine-thimerosal clusterfuck, the name wakefield could be familiar.

Fall of Andrew Wakefield, &lsquo;dishonest&rsquo; doctor who started MMR scare - Times Online

EDIT: link was working, now it isn't. a conspiracy?

another link

http://www.telegraph.co.uk/health/7...ield-dishonest-irresponsible-and-callous.html

 

[Si modo]

Yes, methyl mercury is a toxin. So is water.

One word: dose.

 

[Valerie]

no matter what you try to interject, like general critique of the FDA and governmental agencies and science per se, you always come back to the special case of vaccines and autism and thimerosal.

do you have any comment on the now finally rejected wakefield study?

was that bad science that killed and injured?

or is wakefield one of the good scientists, rodishi?

Put some links up to what it is you are talking about please.

are you only in this thread to drop atrocious gargantuan copypasta or do you read other posts, too?

http://www.usmessageboard.com/2038536-post4.html

and if you are interested in the autism-vaccine-thimerosal clusterfuck, the name wakefield could be familiar.

Fall of Andrew Wakefield, &lsquo;dishonest&rsquo; doctor who started MMR scare - Times Online

Yes, and just to be clear....It was already established science that there is no evidence of causation BEFORE this recent retraction.

Journal of American Medicine - 2001 :

"In conclusion, to date, published observations based on empirical evidence do not suggest that increased MMR immunization among young children is associated with secular increases in cases of autism," they conclude.

(Reference: JAMA. 2001; 285:1183-1185)

07-Mar-2001

No Link Found Between MMR Immunization And Autism

 

[L.K.Eder]

Put some links up to what it is you are talking about please.

are you only in this thread to drop atrocious gargantuan copypasta or do you read other posts, too?

http://www.usmessageboard.com/2038536-post4.html

and if you are interested in the autism-vaccine-thimerosal clusterfuck, the name wakefield could be familiar.

Fall of Andrew Wakefield, &lsquo;dishonest&rsquo; doctor who started MMR scare - Times Online

Yes, and just to be clear....It was already established science that there is no evidence of causation BEFORE this recent retraction.

Journal of American Medicine - 2001 :

"In conclusion, to date, published observations based on empirical evidence do not suggest that increased MMR immunization among young children is associated with secular increases in cases of autism," they conclude.

(Reference: JAMA. 2001; 285:1183-1185)

07-Mar-2001

No Link Found Between MMR Immunization And Autism

that it took "the lancet" so long to formally retract this POS study is remarkable.

 

[Dr Gregg]

Boy, Ro...you are ALL over the place. You need to focus a bit.

My comment about the FDA was in reference to drugs and their meeting the requirements without bribery involved. I have to wonder what the heck your Amish story has to do with that.

I mentioned the fact that claims that mercury-based preservatives cause autism and/or other disorders at the doses in vaccines is not backed up by any science and you bring up forced vaccinations? That has no relevance to my statement about the science at all.

And if you now want to discuss genetically engineered crops, I'll be pleased to do so. Just, try to use science for support, please.

Just ignore him, he just copy and paste conspiracy theory and misinformation regarding science./ How much you want to be he's benefitted from science, the FDA and drugs and medical technollogy out there, that he seems to rail against all the time

 

[Valerie]

"In the world of academic medicine, this is a rare and incredibly severe sanction," Temte told AAFP News Now. "The Lancet has, basically, removed this contribution from existence based on well-documented lapses in acceptable scientific conduct."

Temte said "extensive and well-done studies" that followed Wakefield's paper have found no link between vaccines and autism. However, he acknowledged that many parents who have been influenced by Wakefield's study are unlikely to be swayed by the retraction.

"This may be seen as a production of the medical-industrial complex," he said, "thus missing the larger issue of the significant and lingering consequences of poorly conducted research."

Alison Singer, president and co-founder of the Autism Science Foundation, was more optimistic that the retraction, which received widespread media coverage in the United States and abroad, will make a difference.

"I hope this is the point where more parents accept what the science is telling us," she said. "The science is clear on MMR and autism. Now that The Lancet paper has been retracted, parents won't have an unfounded fear based on that study."

Singer said medical journals must take responsibility for reviewing studies because parents make decisions based on what is published.

"It's a big responsibility," she said. "They need to make sure that these studies have the weight of evidence behind them because people will act based on what they publish. In this case, children died because of what was published."

Journal Retracts Controversial Study Linking MMR Vaccine, Autism -- AAFP News Now -- American Academy of Family Physicians

 

[Dr Gregg]

No, Ro. Here is the science on vaccines and autism, not anecdotes:

Autism and measles, mumps, and rubella vaccine: no epidemiological evidence for a causal association


ProfBrent Taylor FRCPCHa, Corresponding Author Contact Information, Elizabeth Miller FRCPathb, CPaddy Farrington PhDc, Maria-Christina Petropoulos MRCPa, Isabelle Favot-Mayaud MDa, Jun Li PhDa and Pauline A Waight BScb

aDepartment of Community Child Health, Royal Free Campus, Royal Free and University College Medical School, University College London, London NW3 2QG, UK

bImmunisation Division, Public Health Laboratory Service Communicable Disease Surveillance Centre, London

cDepartment of Statistics, Open University

Summary
Background

We undertook an epidemiological study to investigate whether measles, mumps, and rubella (MMR) vaccine may be causally associated with autism.
Methods

Children with autism born since 1979 were identified from special needs/disability registers and special schools in eight North Thames health districts, UK. Information from clinical records was linked to immunisation data held on the child health computing system. We looked for evidence of a change in trend in incidence or age at diagnosis associated with the introduction of MMR vaccination to the UK in 1988. Clustering of onsets within defined postvaccination periods was investigated by the case-series method.
Findings

We identified 498 cases of autism (261 of core autism, 166 of atypical autism, and 71 of Asperger's syndrome). In 293 cases the diagnosis could be confirmed by the criteria of the International Classification of Diseases, tenth revision (ICD10: 214 [82%] core autism, 52 [31%] atypical autism, 27 [38%] Asperger's syndrome). There was a steady increase in cases by year of birth with no sudden “step-up” or change in the trend line after the introduction of MMR vaccination. There was no difference in age at diagnosis between the cases vaccinated before or after 18 months of age and those never vaccinated. There was no temporal association between onset of autism within 1 or 2 years after vaccination with MMR (relative incidence compared with control period 0·94 [95% Cl 0·60–1·47] and 1·09 [0·79–1·52]). Developmental regression was not clustered in the months after vaccination (relative incidence within 2 months and 4 months after MMR vaccination 0·92 [0·38–2·21] and 1·00 [0·52–1·95]). No significant temporal clustering for age at onset of parental concern was seen for cases of core autism or atypical autism with the exception of a single interval within 6 months of MMR vaccination. This appeared to be an artifact related to the difficulty of defining precisely the onset of symptoms in this disorder.
Interpretation

Our analyses do not support a causal association between MMR vaccine and autism. If such an association occurs, it is so rare that it could not be identified in this large regional sample.

The Lancet

You can take those vaccines if you want. If you have kids you can have them piped full of it. What you do not have the right to do is make anyone else take them. Enough said.

You can be an ignorant fuck and have your kids die of small pox, rubella, whooping cough, TB, etc

 

[Dr Gregg]

The Amish and Autism: Can Mercury in Vaccines Cause Autism? Odd only a few cases of Autism in Amish children and two of these cases had been vaccinated, the other lived near an abandon Mercury mine, WOW!

After writing my last article about vaccines and autism, I decided to do a little research and look for a group of society that does not vaccinate. I not only found one, I found two. I discovered some interesting
information regarding autism among the Amish and mercury associated with Thermasol. I also found studies from another group of children that had not been vaccinated, and the results were stunningly similar: no vaccines, and no autism. Hmmm. But the testing paid for by the pharmaceutical companies seems to be conclusive that there is no connection between vaccines and autism..... continued at link....

the amish story is such bullshit. Man you don't know anything about science. Amish make their own food. THey farm,. don't have preservative laden foods that most people eat, or exposed to other environmental toxins most other peopel are exposed to.

Fact are vaccines does not CAUSE autism. Another person that doens't know that correlation does not mean causation