The Pentagon — A Voice of Reason on Vaccines and Autism?

The Pentagon — A Voice of Reason on Vaccines and Autism?

David Kirby

Recently, several documents have been brought to my attention which, when viewed together, suggest that the Department of Defense has legitimate concerns about vaccine injuries and their possible connection to autism, perhaps more so than other branches of the Federal Government.

These documents raise several questions that I am currently trying to get answered from DOD officials:

1) Autism may be an “adverse event” of Tripedia (DTaP) use

According to the website of the Vaccine Healthcare Centers Network, run by DOD and CDC, autism is listed as an “adverse event” associated with use of the Tripedia triple vaccine for diphtheria, tetanus and pertussis.

My questions are: Why does autism appear here? Does VHC consider autism to be a possible adverse event of DTaP use, or has it simply been reported that way by parents?

2) Patients who have bad vaccine reactions should avoid multiple vaccines in the future

According to this VHC slide, any patient who has a “Systemic Event” following immunization – defined as “symptoms and signs of illness after vaccination” and “any reaction that does not involve the injection site” – should avoid multiple vaccines in the future, if possible.

My questions are: Is that standard DOD policy? Is there an alternative schedule for these patients? Does this advice apply to children of service members as well? Why is this information not shared with civilian doctors and pediatricians?

3) Patients who develop serious neurological diseases might need vaccine exemptions in the future

This VHC slide says that a patient who develops a severe neurologic disease following vaccination might need temporary or permanent exemption from future vaccines. Such diseases include peripheral neuropathy, encephalopathy (including autism, presumably) Guillain-Barré syndrome and progressive focal neurologic disease. Such patients should be given temporary exemptions from future vaccinations.

Meanwhile, risks for recurrent reactions should be assessed before additional doses are given, and “permanent vaccine exemption may be required.”

Again, is this DOD policy? Are such exemptions given? Because autism is listed as a “severe neurological disease,” would those patients (ie, children of service members) also be exempt from future vaccinations? And, on a related note, does VHC consider autism to be a “neurological disease,” as opposed to a developmental/behavioral disorder?

4) Mercury, and possibly thimerosal may cause autism and dementia

According this slide (#22) on the vaccine preservative thimerosal, from the Armed Forces Institute of Pathology (AFIP), “exposure to mercury in utero and children may cause mild to severe mental retardation and mild to severe motor coordination impairment.” The slide also seems to indicate that autism and dementia might questionably be “health effects” of mercury or thimerosal exposure.

My question is: Why does autism appear on a list of health effects on a slide about thimerosal, even if it is followed by a question mark?

5) Alternative biomedical treatments may be prescribed for thimerosal exposure

The same slide says that “treatments” for thimerosal exposure include: “Methyl-B12, ointment DMPS, & glutathione (GSH).” These are all alternative (some would say fringe, radical and dangerous) treatments being used today by thousands of autism parents and their children’s physicians, with varying degrees of success (including reports of full recovery).

Methyl-B12 – has been shown to repair damage to the process of methylation, and to restore methionine and glutathione levels in patients with autism to within normal ranges.

DMPS – is a sulfur-based amino acid used in the process of chelation – in which sulfur molecules bind with heavy metals such as mercury, and eliminate them from the system.

Glutathione – is a sulfur-based protein that binds with heavy metals and eliminates them from the system. It is also a powerful anti-oxidant. Many children with autism show signs of glutathione depletion, heavy metal accumulation and oxidative stress.

My questions are: Was the speaker simply refering to treatments that some people have tried, or is the AFID endorsing these treatments for thimerosal toxicity and/or autism? On what evidence is this based? Are Methyl B-12 and GSH, like chelation, considered standard of care in the military for mercury toxicity? Can you explain why autism families in the military have these treatments covered, (at thousands of dollars a year), even if they also have an autism diagnosis? Is this why military insurance will pay for visits to doctors in the Defeat Autism Now network, which advocates the use of these non-traditional treatments?

I eagerly await the replies from VHC and AFID officials, and will update this blog as soon as I hear anything.

Meanwhile, regardless of the Pentagon’s positions on the above questions, we know for certain that DOD is concerned about the risk of injury from multiple vaccines.

In fact, it may even need to reconsider the practice.

“We have preliminary findings from one of our many on-going research studies that suggest a relationship between adverse events and multiple vaccinations exist,” US Army Colonel Renata J. M. Engler, MD, director of the VHC, (a “collaborative network” of the Defense Department and the CDC), wrote to Rep. Carolyn Maloney (D-NY). “These findings will require validation, but heighten our concern for the current clinical practice of multiple vaccinations.”

“The more drugs one is exposed to, the greater the likelihood of having an adverse event so as vaccine numbers increase, and (sic) we will see more people who have efficacy or safety issues,” Col. Engler said. “The standard of care (ie, in the context of mixing vaccines) is to minimize drug exposures because of the recognition that the more drugs being used, the greater the chance of a reaction and potentially a serious adverse event.”

I wonder when the CDC and America’s pediatricians will issue an equally thoughtful and cautionary statement, instead of their usual reassurance that small children can easily get 100,000 shots at once, without a single “serious adverse event” among them.

*update:

Age of Autism

VHCN  _the page that is now under revision you can view here.

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Encephalitis and Encephalopathy (part 1)

Encephalitis

headVaccines containing Pertussis and Measles can cause encephalitis. Per the VICP guidelines; onset of encephalitis from Pertussis-containing vaccines is 24-48 hours, and between day five and fifteen for the MMR, M, MR and R vaccines.  
 
 
This is what the Vaccine Injury Compensation Program stated in the late 1980’s: 
 
The neurologic signs and symptoms of encephalopathy may be temporary with complete recovery or may result in various degrees of permanent impairment.  
 
Signs and symptoms such as high-pitched and unusual screaming, persistent inconsolable crying, and bulging fontanel are compatible with an encephalopathy, but in and of themselves are not conclusive evidence of encephalopathy. Encephalopathy usually can be documented by slow wave activity on an electroencephalogram. 
 
Today it states: 
 
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.  

 

 

*This means it is no longer considered a contradiction to further vaccination.
 

An adverse reaction association does have a name and it is called: Crying Syndrome or Screaming Syndrome.  The scream is also known as cry-encephalitis. The cause is infection of the brain from the vaccine virus/bacteria. When the body is injected with virus/bacteria it can travel to the brain and cause encephalitis. Encephalitis can be a reaction to any vaccine but the DTP and DTaP is the most common.
 

What is interesting to note is that when encephalitis occurs following an illness, a doctor will treat it correctly. However, following a vaccination, a doctor will tell you it is a normal reaction to the vaccine and do nothing.

 

Workshop on neurologic complications of pertussis and pertussis vaccination
  

A multidisciplinary workshop held from September 29 to October 1, 1989, at Airlie House, Warrenton, Virginia, considered the neurologic complications of whooping cough and pertussis vaccine. Pertussis mortality in the U.S. in 2-3/1000 cases. Seizures occur in 1.9% of cases, and encephalopathy in 0.3%. Reviewing all data, it appears likely that a combination of one or more bacterial toxins, asphyxia, CO2 retention and loss of cerebral vascular autoregulation is responsible for neurologic symptoms. The timing of the encephalopathy suggests that it results from increased lysis of bacteria, and release of endotoxin. The encephalopathy is not confined to the paroxysmal phase. In evaluating side-reactions to the vaccine, the following must be kept in mind: 1. Vaccines are not standardized between manufacturers. 2. For a given manufacturer, vaccines are not standard from one batch to the next. 3. Unless the vaccine is properly prepared and refrigerated, its potency and reactivity varies with shelf life. In fact, the whole question of vaccine detoxification has never been systematically investigated. Listed in order of increasing severity, observed adverse reactions include irritability, persistent, unusually high pitched crying, somnolence, seizures, a shock-like “hypotensive, hyporesponsive” state, and an encephalopathy. Since the neurologic picture is not specific for pertussis vaccination, its temporal relationship to the vaccination is the critical variable for determining causation. Although the majority of seizures following pertussis vaccination are associated with fever, it was the consensus of the neurologists attending the workshop, that these do not represent febrile convulsions, but are non-benign convulsions. The incidence of post-vaccine encephalopathy is difficult to ascertain.

 

 Basically, the screaming is caused by the pain of the endotoxin in the vaccine getting into his brain. The screaming then causes a release of cortisol through the body which disrupts the immune system. It also causes the body temperature to rise. The intestines ph or acidity of changes, and bacteria called e-coli increases. If the amount gets high, that is when it can cause problems. The DTP is known to slow the function of the liver but it is not known which babies will be affected. Therefore, it becomes important to neutralize the curlin and take strain off the liver.

 

According to Drugs.com:

 

Diphtheria / Tetanus Toxoids / Acellular Pertussis Vaccine

( DTaP/Tdap ) Pronouncation: (diff-THEER-ee-uh/TET-ah-nus/ay-SELL-yoo-ler per-TUSS-uss vaccine) Class: Toxoid

 

Trade Names: 
Adacel(Tdap)

Active booster immunization against diphtheria, tetanus, and pertussis as a single dose in persons 11 to 64 yr of age.
– Injection 2 Lf units diphtheria toxoid, 5 Lf units tetanus toxoid, 3 mcg pertactin, 5 mcg filamentous hemagglutinin (FHA), 2.5 mcg detoxified pertussis toxins, 5 mcg fimbriae types 2 and 3 per mL.

 
Boostrix(Tdap)

Active booster immunization against diphtheria, tetanus, and pertussis as a single dose in persons 10 to 18 yr of age.
– Injection 2.5 Lf units diphtheria toxoid, 5 Lf units tetanus toxoid, 2.5 mcg pertactin, 8 mcg FHA, 8 mcg inactivated pertussis toxins per 0.5 mL
Daptacel
– Injection 15 Lf units diphtheria toxoid, 5 Lf units tetanus toxoid, 10 mcg pertussis toxoid, 5 mcg FHA, 3 mcg pertactin, 5 mcg fimbriae types 2 and 3 per 0.5 mL

 

Infanrix
– Injection 25 Lf units diphtheria, 10 Lf units tetanus toxoid, 25 mcg pertussis toxin, 25 mcg FHA, 8 mcg pertactin per 0.5 mL

 

Tripedia
– Injection 6.7 Lf units diphtheria toxoid, 5 Lf units tetanus toxoid, 46.8 mcg pertussis antigens (approximately 23.4 mcg each of inactivated pertussis toxin and FHA) per 0.5 mL

Daptacel , Infanrix , Tripedia (DTaP)

Active immunization against diphtheria, tetanus, and pertussis in infants and children 6 wk to 6 yr of age (prior to seventh birthday).

 

Per CDC, Tdap is for use in adults and children 10 yr of age and older, and DTaP is for use in infants and children younger than 7 yr of age.

Contraindications

Encephalopathy within 7 days of previous administration of DTP, Tdap, or DTaP that is not attributable to another cause; progressive neurologic disorders (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy), in addition, pertussis vaccine should not be administered to persons with these conditions until a treatment regimen has been established and condition has stabilized; hypersensitivity to any component of the vaccine; history of serious allergic reaction temporarily associated with a previous dose of vaccine or any component of the vaccine.

 

Daptacel , Infanrix , Tripedia

Use in adults or children 7 yr of age and older; if contraindication to pertussis vaccine component occurs, substitute diphtheria and tetanus toxoids for pediatric use (DT) for each remaining dose; defer elective immunization procedures during outbreak of poliomyelitis because of risk of provoking paralysis.

 

It is recommended that the same brand of DTaP ( Daptacel , Infanrix , Tripedia ) be given for all doses in the immunization series because no data exist on the interchangeability of DTaP vaccines. Tdap vaccines ( Adacel , Boostrix ) are not interchangeable with DTaP vaccines.

 

 

Anticoagulants

Give DTaP/Tdap with caution to patients on anticoagulant therapy.

 

Immunosuppressants

May reduce vaccine’s efficacy.

 Influenza vaccine

To attribute causality of adverse reactions, do not give influenza vaccine within 3 days of pertussis vaccination.

Laboratory Test Interactions

None well documented.

 

Adverse Reactions

Cardiovascular

Boostrix

Myocarditis (postmarketing).

Daptacel

Cyanosis (postmarketing).

Infanrix

Cyanosis (postmarketing).

CNS

Adacel

Headache (44%); tiredness (30%); hyposthesia, paresthesia, vasovagal syncope (postmarketing).

 

Boostrix

Headache (43%); fatigue (37%); convulsion, encephalitis, facial palsy, paresthesia (postmarketing).

 

Daptacel

Fussines (76%); fretfulness (40%); drowsiness (33%); anorexia (11%); convulsions, febrile convulsion, grand mal convulsion, hypotonia, hypotonic-hyporesponsive episode, partial seizures, somnolence, screaming (postmarketing).

 

Infanrix

Drowsiness (38%); anorexia (12%); fussiness (9%); convulsions, crying, encephalopathy, hypotonia, hypotonic-hyporesponsive episode, irritability, somnolence (postmarketing).

 

Tripedia

Drowsiness (29%); irritability (25%); anorexia (10%); fussiness (6%); autism, convulsion, encephalopathy, grand mal convulsion, hypotonia, neuropathy, somnolence (postmarketing).

Dermatologic

Adacel

Rash (3%); pruritus, urticaria (postmarketing).

 

Boostrix

Exanthem, Henoch-Schonlein purpura, rash (postmarketing).

 Infanrix

Erythema, pruritus, rash, urticaria (postmarketing).

GI

Adacel

Nausea (13%); diarrhea (10%); vomiting (5%).

 Boostrix

GI symptoms including abdominal pain, diarrhea, nausea, vomiting (26%).

 Daptacel

Vomiting (7%); diarrhea, nausea (postmarketing).

 Infanrix

Vomiting (7%); diarrhea, intussusception (postmarketing).

 Tripedia

Vomiting (5%).

Hematologic-Lymphatic

Adacel

Lymph node swelling (7%).

 

Boostrix

Lymphadenitis, lymphadenopathy (postmarketing).

 

Infanrix

Idiopathic thrombocytopenic purpura, lymphadenopathy, thrombocytopenia (postmarketing).

 

Tripedia

Idiopathic thrombocytopenic purpura (postmarketing).

Hypersensitivity

Boostrix

Anaphylactic reaction, arthus-type hypersensitivity.

 

Daptacel

Allergic reaction, anaphylactic reaction (edema, face edema, face swelling, generalized rash and other types of rash, pruritus), hypersensitivity (postmarketing).

 

Infanrix

Anaphylactic reaction, hypersensitivity (postmarketing).

 

Tripedia

Anaphylactic reaction (postmarketing).

Local

Adacel

Pain (78%); erythema (25%); swelling (21%); injection-site bruising, sterile abscess

(postmarketing).

 

Boostrix

Pain (75%); redness (48%); swelling (39%); increase in arm circumference (28%); induration, inflammation, local reaction, mass, nodule, warmth (postmarketing).

 

Daptacel

Tenderness (50%); increased arm circumference (30%); redness (17%); swelling (12%); cellulitis, injection-site abscess, injection-site mass, injection-site nodule, injection-site pain, injection-site rash.

 

Infanrix

Redness (59%); swelling (50%); pain (27%); injection-site reactions (postmarketing).

 

Tripedia

Redness (33%); swelling (28%); pain (21%).

Musculoskeletal

Adacel

Body ache or muscle weakness (30%); sore and swollen joints (11%); muscle spasms, myelitis, myositis (postmarketing).

 

Boostrix

Arthralgia, back pain, myalgia (postmarketing).

 

Infanrix

Limb swelling (postmarketing).

Miscellaneous

Adacel

Chills (15%); fever (5%).

 

Boostrix

Fever (14%); insulin-dependent diabetes mellitus (postmarketing).

 

Daptacel

Crying (59%); decreased activity (51%); fever (24%).

 

Infanrix

Fever (7%); cellulitis, ear pain, respiratory tract infection, sudden infant death syndrome (postmarketing).

 

Tripedia

Fever (25%); apnea, sudden infant death syndrome (postmarketing).

 

Pregnancy

Category C .

Lactation

Undetermined.

Children

Adacel

Safety and efficacy not established in children younger than 11 yr of age.

 Boostrix

Not indicated for use in patients younger than 10 yr of age or older than 18 yr of age.

 

Daptacel , Infanrix , Tripedia

Safety and efficacy in infants younger than 6 wk of age not established; contraindicated for persons 7 yr of age and older.

Elderly

Adacel

Safety and efficacy not established in individuals 65 yr of age and older.

Special Risk Patients

If any of the following occurs in temporal relation with receipt of either whole-cell pertussis DTP or DTaP, carefully consider decision to administer subsequent doses of vaccine containing pertussis component: temperature of at least 105°F within 48 h not caused by another identifiable cause; collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 h; persistent inconsolable crying lasting at least 3 h occurring within 48 h; or convulsions, with or without fever, occurring within 3 days. If the decision is made to withhold pertussis component, continue immunization with DT (Td if 7 yr of age and older). If Guillain-Barré syndrome occurs within 6 wk of receipt of prior vaccine containing tetanus toxoids, base decision to give subsequent doses of DTaP or any vaccine containing tetanus toxoids on potential benefits versus risks. Patients who experience serious Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoids usually have high serum tetanus antitoxin levels and should not be given Td or DTaP vaccines or even emergency doses of Td more frequently than every 10 yr, even if wound is neither clean nor minor.

Bleeding disorders

Use with caution in patients with bleeding disorders (eg, thrombocytopenia, hemophilia) or receiving anticoagulant therapy.

Convulsions/CNS disorders

Family history of seizures or other CNS disorders is not a contraindication to pertussis vaccine.

Febrile illness or acute infection

Defer immunization during course of illness. Minor respiratory illness, such as mild upper respiratory tract infection, is usually not a reason to defer immunization.

Immunodeficiency

May have diminished antibody response; defer immunization, if possible, until immunocompetency is restored.

Latex sensitivity

Stoppers for Daptacel and Tripedia vials, and tip cap and rubber plunger of Infanrix and Boostrix needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex-sensitive individuals.

 

Measles, Mumps, and Rubella (MMR) vaccine

Brand Names: M-M-R II

 

What should I discuss with my healthcare provider before receiving this vaccine?

You should not receive this vaccine if you are allergic to:

  • eggs;
  • gelatin;
  • neomycin (Mycifradin, Neo-Fradin, Neo-Tab); or
  • if you have ever had a life-threatening allergic reaction to any vaccine containing measles, mumps, or rubella.
  •  

You should also not receive this vaccine if you have:

  • a chronic disease such as asthma or other breathing disorder, diabetes, kidney disease, or blood cell disorders such as anemia;
  • severe immune suppression caused by disease (such as cancer, HIV, or AIDS), or by receiving certain medicines such as steroids, chemotherapy or radiation; or
  • if you are pregnant.
  •  

Before receiving this vaccine, tell the doctor if you have:

  • thrombocytopenia purpura (easy bruising or bleeding);
  • active tuberculosis infection;
  • a history of seizures;
  • a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine);
  • a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments;
  • if you have received an immune globulin or other blood product within the past year; or
  • if you have received a previous MMR vaccine within the past 28 days (4 weeks).
  •  

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

You should not receive a measles, mumps, and rubella vaccine if you are pregnant. Wait until after your child is born to receive the vaccine.

Avoid becoming pregnant for at least 3 months after receiving a measles, mumps, and rubella vaccine.

Do no not receive this vaccine without telling your doctor if you are breast-feeding a baby.

What should I avoid before or after receiving this vaccine?

Do not receive another “live” vaccine such as oral polio, yellow fever, or varicella (chickenpox) for at least 4 weeks after you have received the measles, mumps, and rubella vaccine. The other live vaccine may not work as well during this time, and may not fully protect you from disease.

Measles, mumps, and rubella vaccines side effects

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot. Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with measles, mumps, or rubella is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

 

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • problems with hearing or vision;
  • extreme drowsiness, fainting;
  • easy bruising or bleeding, unusual weakness;
  • seizure (black-out or convulsions); or
  • high fever (within a few hours or a few days after the vaccine).
  •  

Less serious side effects include:

  • redness, pain, swelling, or a lump where the shot was given;
  • headache, dizziness;
  • low fever;
  • joint or muscle pain; or
  • nausea, vomiting, diarrhea.
  •  

Side effects other than those listed here may also occur. Contact your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect measles, mumps, and rubella vaccine?

Before receiving this vaccine, tell the doctor about all other vaccines you have recently received.

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

  • an oral, nasal, inhaled, or injectable steroid medicine;
  • medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or
  • medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).
  •  

If you are using any of these medications, you may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

There may be other drugs that can affect this vaccine. Tell your doctor about all the prescription and over-the-counter medications you have received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

 

ProQuad -Measles, Mumps, Rubella, and Varicella Vaccine

Do NOT use ProQuad if:

  • you are allergic to any ingredient in ProQuad , including gelatin
  • you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to neomycin
  • you have a weakened immune system (eg, advanced HIV, AIDS, decreased gamma globulin levels, decreased white blood cell levels), blood problems, cancer affecting the blood or bone marrow (eg, leukemia), fever, or active or untreated tuberculosis (TB)
  • you are pregnant
  • you are taking an immunosuppressant (eg, cyclosporine) or a salicylate (eg, aspirin)

Contact your doctor or health care provider right away if any of these apply to you.

Before using ProQuad :

Some medical conditions may interact with ProQuad . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are planning to become pregnant or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you are allergic to eggs
  • if you have an infection, a tumor, HIV, low blood platelet levels, a history of seizures or head injury, or a family history of seizures or immune system weakness
  • if you have had a recent blood or plasma transfusion or have received immune globulin or a tuberculin test
  • if you have been exposed to measles, mumps, rubella, or chickenpox
  • if you have a history of tuberculosis

Some MEDICINES MAY INTERACT with ProQuad . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Corticosteroids (eg, prednisone) or immunosuppressants (eg, cyclosporine) because the effectiveness of ProQuad may be decreased
  • Salicylates (eg, aspirin) because the risk of side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if ProQuad may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Important safety information:

  • ProQuad may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to ProQuad . Using ProQuad alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
  • This medicine may decrease the effectiveness of tuberculin tests. If you are scheduled to have a tuberculin test within 6 weeks after receiving this vaccination, contact your doctor. You may need to reschedule your tuberculin test.
  • Avoid contact with individuals with weakened immune systems, pregnant women who have not had chickenpox, and newborns whose mothers have not had chickenpox for 6 weeks after receiving this vaccination.
  • Avoid use of salicylates (eg, aspirin) for 6 weeks after receiving this vaccination.
  • Keep written documentation of all vaccinations received to help avoid unnecessary doses. Be sure that your doctor knows the dates that you have received other vaccinations.
  • This vaccine may not guarantee protection against measles, mumps, rubella, or chickenpox. Discuss any questions or concerns with your doctor.
  • Adult women may experience joint pain 2 to 4 weeks after receiving this injection. This usually lasts only a short time. However, these symptoms have persisted for months or, rarely, years.
  • ProQuad contains albumin, which comes from human blood. There is an extremely rare risk of developing a viral disease, or a central nervous system disease called Creutzfeldt-Jakob disease. No cases of viral diseases or Creutzfeldt-Jakob disease from albumin have been identified.
  • Use ProQuad with extreme caution in CHILDREN younger than 12 months of age. Safety and effectiveness in this age group have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use ProQuad if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. After receiving ProQuad , do not become pregnant for at least 3 months without checking with your doctor. It is unknown if ProQuad is excreted in breast milk. Do not breast-feed while using ProQuad .

Possible side effects of ProQuad :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; fever; general unwell feeling; headache; irritability; mild rash; muscle or joint ache or pain; nausea; pain, tenderness, soreness, or swelling at the injection site; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; loss of coordination; mental or mood changes; numbness or tingling in the fingers or toes; red, swollen, blistered, or peeling skin; seizures; unusual bruising or bleeding; vision or hearing changes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

 

Encephalitis and Encephalopathy

 

 

Encephalitis is inflammation of the brain. The inflammation is caused either by an infection invading the brain (infectious); or through the immune system attacking the brain in error (post-infectious / autoimmune encephalitis).

Encephalitis is different from meningitis. Meningitis means inflammation of the protective layers that cover the brain. Sometimes patients have both meningitis and encephalitis and this is called meningoencephalitis.

 

Encephalopathy is a term for any diffuse disease of the brain that alters brain function or structure. Encephalopathy may be caused by infectious agent (bacteria, virus, or prion), metabolic or mitochondrial dysfunction, brain tumor or increased pressure in the skull, prolonged exposure to toxic elements (including solvents, drugs, radiation, paints, industrial chemicals, and certain metals), chronic progressive trauma, poor nutrition, or lack of oxygen or blood flow to the brain. The hallmark of encephalopathy is an altered mental state. Depending on the type and severity of encephalopathy, common neurological symptoms are progressive loss of memory and cognitive ability, subtle personality changes, inability to concentrate, lethargy, and progressive loss of consciousness. Other neurological symptoms may include myoclonus (involuntary twitching of a muscle or group of muscles), nystagmus (rapid, involuntary eye movement), tremor, muscle atrophy and weakness, dementia, seizures, and loss of ability to swallow or speak. Blood tests, spinal fluid examination, imaging studies, electroencephalograms, and similar diagnostic studies may be used to differentiate the various causes of encephalopathy.

 

 

  Pertussis vaccination and epilepsy–an erratic history, new research and the mismatch between science and social policy.

 

For over 50 years, concerns have been raised about the risk of pertussis vaccine-induced childhood encephalopathy and epilepsy. This article reviews the scientific literature, and the social and historical context in which the scientific, public health and societal views have not always been aligned. Large-scale studies of this issue have produced conflicting results, although the recent consensus is that the risk of vaccine-induced encephalopathy and/or epilepsy, if it exists at all, is extremely low. Risk estimates in the literature have included: risk of a febrile seizure 1 per 19,496 vaccinations; risk of an afebrile seizure 1 per 76,133 vaccinations; risk of encephalopathy after pertussis infection nil-3 cases per million vaccinations. A recent study showed that encephalopathy in 11 out of the 14 children studied, although previously attributed to vaccination, was in fact due an inherited genetic defect of the SCNIA gene that codes for the voltage gated neuronal sodium channel. This study is important because it provides a solid alternative explanation for the perceived pertussis vaccine-encephalopathy association. The interesting possibility is raised that the encephalopathy apparently due to pertussis itself may, in some cases, be due to an SCNIA mutation. It may also, by analogy, shed some light on the continuing debate about other serious long-term adverse effects of vaccination in general.

 

 To be continued…the autism connection, post-vaccinal encephalomyelitis, the rise in neurological disorders…

DTaP

If you’ve had Pertussis yourself, that means you also have naturally-acquired antibodies to pertussis, which would have been passed to your baby through the placenta in utero.

 

 In the Swedish study that initially determined the safety and efficacy of the DTaP vaccine, they tested a subset of babies before giving them any doses of DTaP and found “some prevaccination samples contained high levels of maternal antibodies against pertussis.” Obviously, some of these babies didn’t need the vaccine. It’s documented from other research on other diseases and vaccines that maternal antibodies prevent vaccines from working the way they are intended to. The antibodies themselves detect the vaccine and get rid of it before the immune system can respond. Meaning, vaccinating a young infant who very likely has maternal antibodies already is pointless.

Maternal antibodies are known to dissipate from around 6-12 months after birth. After 6 months of age pertussis is way less of a concern. Most deaths have been in infants younger than 4 months old.

The Swedish study Highlights:

1) only healthy infants were enrolled in the study–infants with any history of chronic illness, seizure, immunosuppressant, etc. were excluded, but in practice, all infants receive the vaccine. So it’s not safe or ethical to test a vaccine in a child with impaired health status, but those kids get the vaccine later anyway.

 

2) Children were contraindicated for receiving the vaccine if they had a fever or had received another vaccine recently. Children get shots regardless of fevers or other vaccines received.

3) Children were contraindicated for further doses and dropped from the study if they  had an adverse event such as persistent crying, high fever, shock, etc. This was a 2-year study to determine long-term safety and efficacy of a 3-shot series, but the children, who reacted worst, and soonest, are not represented in the final results.
4) The old whole-cell version of DPT, given until about 1997 in the US, was bad.  It had a high rate of serious reactions, and these researchers calculated its effectiveness at only around 48%. But for the previous 20 years, parents in the US were being told their children must have this vaccine. The real truth about a particular vaccine being kind of dangerous and ineffective doesn’t come out until the pharmaceuticals decide they have something better.

In 1993-the JAMA published reports of adverse reactions , including death , following pertussis vaccines. Journal of American Medical Association 101(3) (1993) pp 187-88. See also:

  • Cherry JD et al (1993). Pertussis immunization and characteristics related to first seizures in infants and children. J Pediatr 122(6):900-3 1993. Department of Pediatrics, University of California Los Angeles School of Medicine.
  • Blumberg DA, et al.    Severe reactions associated with diphtheria-tetanus-pertussis vaccine: detailed study of children with seizures, hypotonic-hyporesponsive episodes, high fevers, and persistent crying. Pediatrics. 1993 Jun;91(6):1158-65. PMID: 8502521; UI: 93275702.  
  • Nielsen AO, et al.    [Aluminum allergy caused by DTP vaccine]. Ugeskr Laeger. 1992 Jun 29;154(27):1900-1. Danish. PMID: 1509548; UI: 92376915.
  • Griffin MR et al (1990). Risk of seizures and encephalopathy after immunization with the diphtheria-tetanus-pertussis vaccine. JAMA 263(12):1641-5 1990. Department of Preventive Medicine, Vanderbilt University School of Medicine, Nashville, Tenn 37232-2637. Miller D, et al (1993). Pertussis immunisation and serious acute neurological illnesses in children. BMJ. 1993 Nov 6;307(6913):1171-6. PMID: 7504540; UI: 94072962.

In 1948 Pediatrics published reports of irreparable damage and death following pertussis vaccine inoculations. Pediatrics, 1(4), (1948) pp. 437-457

In 1950 Lancet published a report describing severe neurological complications, mental retardation and paralysis, following a combined pertussis-diphtheria vaccine.
Lancet , (March 25, 1950) pp537-39. See also: Medline

The British Medical Journal published several studies showing a connection between the polio , diphtheria ,measles , tetanus ,and smallpox vaccines , and the development of Multiple Sclerosis several years later. British Medical Journal , Vol.2,(1967) pp 210-213.

 

 A study in The Journal of Infectious Diseases confirms that the DPT injections induce polio. (The oral polio shot is given at the same time and the only known cases of polio have come from the shot since 1980).  The Journal of Infectious Diseases (March 1992) pp 444-449. Source Neil Z. Miller’s Vaccines : Theory vs. Reality.

 

The pertussis vaccine is used in animal experiments to create allergies in order to test allergy medicine.

 

New Zealand -Based on a study in VACCINE, decided to use the acellular vaccine which tested the most effective, which is the five component one, which supposedly had a 78% effectiveness rate. In the final year report from the health department public surveillance, they admitted that in reality it only has a 33% “effective” immunization rate.   (Source: Theor Biol. 2003 Sep 21;224(2):269-75. Estimation of effective vaccination rate: pertussis in New Zealand as a case study.
Korobeinikov A, Maini PK, Walker WJ. Centre for Mathematical Biology, Mathematical Institute, University of Oxford, Oxford, UK.)

 

In some cases vaccination is unreliable. For example vaccination against pertussis has comparatively high level of primary and secondary failures. To evaluate efficiency of vaccination we introduce the idea of effective vaccination rate and suggest an approach to estimate it. We consider pertussis in New Zealand as a case study. The results indicate that the level of immunity failure for pertussis is considerably higher than was anticipated.

“The obtained figures indicate that in New Zealand the effective vaccination rate against pertussis is lower than 50%, and perhaps even as low as 33% of the population. These figures contradict the medical statistics, which claim that more than 80% of the newborns in New Zealand are vaccinated against pertussis (Turner et al., 2000). This contradiction is due to the mentioned unreliability of the available vaccine.”

There are a lot of VICP death cases. Some are compensated, but more are dismissed because the deaths either did not fit the government’s onset timeline or rigid causation and/or doctors refused to testify, etc. Many deaths were initially ruled as SIDS by the coroner. When you look at the bacteriology, immunology, virology and toxicology reports, they point to clear indicators.

 

DTaP is effective in preventing Pertussis?

That depends on what you mean by effective. An effective vaccine would require only one dose to achieve immunity. The DTaP requires that you get up to five doses for an 80% chance at immunity. That’s the lowest efficacy of any vaccine on the market. And despite high vaccine coverage, the incidence of pertussis is increasing.

DTaP contains aluminum, a potent neurotoxin that enters the brain when injected as a vaccine adjuvant. The amount of aluminum injected in a single vaccine dose is sufficient to alter gene expression in the brain. These are things that will manifest adversely in the long-term: they are not included in the parameters of the vaccine safety studies that monitor only short-term effects.

There isn’t much data on the efficacy and protection from one or two doses of DTaP. Pertussis vaccine trials are difficult to do. Virtually everyone who has looked at this issue uses 3 doses as the benchmark. We know that if you get 3 doses into a child, you are looking at 80%-85% efficacy.
Information on efficacy studies, etc.

 

 Since 1991, seven studies conducted in Europe and Africa have evaluated the efficacy of eight DTaP vaccines administered to infants. The vaccines, produced by different manufacturers, contained a varying number and quantity of antigens. The derivation and formulation of the individual antigens also varied among vaccines (Table_1). Four doses of vaccine were administered in one study (Wyeth-Lederle Vaccines and Pediatrics, ACEL-IMUNE{Registered} package insert); the other six studies involved three doses (14,15,23-25). These studies also differed in other ways (Table_2)

 

The efficacy of three doses of acellular pertussis vaccines in preventing moderate to severe pertussis disease was within the range expected for most whole-cell DTP vaccines. Point estimates of efficacy ranged from 59% to 89%.

 

  This report supplements the statement from CDC’s Advisory Committee on Immunization Practices regarding use of acellular pertussis vaccines and summarizes data regarding reactogenicity of acellular pertussis vaccines when administered as the fourth and fifth consecutive doses. Increases in the frequency and magnitude of local reactions at the injection site with increasing dose number have occurred for all currently licensed DTaP vaccines. Extensive swelling of the injected limb, sometimes involving the entire thigh or upper arm, after receipt of the fourth and fifth doses of DTaP vaccines has been demonstrated for multiple products from different manufacturers.

 

 There are 3 types of DTaP:

 

Infanrix

Daptacel

Tripedia

TDaP

Adacel

Boostrix

 DTaP combo vaccines:

Pediarix

Pentacel

Trihibit

 

 Contradictions to all:

If the child is sick with something more serious than a mild cold, DTaP may be delayed until the child is better.

 

If the child has had any of the following after an earlier DTaP, consult with the health care provider before the child receives another injection of the vaccine:

 

  • seizures within 3 to 7 days after injection

  • any serious brain problem within 7 days after injection

  • worsening of seizures or other brain problem (at any time)

  • mouth, throat, or face swelling (serious allergy) within a few hours after injection

  • difficulty breathing (serious allergy) within a few hours after injection

  • temperature of 105 degrees F or higher within 2 days after injection

  • shock or collapse within 2 days after injection

  • persistent, uncontrolled crying that lasts for more than 3 hours at a time within 2 days after injection

 

 What is the difference between DTP and DTaP:

 

The DTaP is made by removing many of the poisons (toxins) found in the whole-cell B.Pertussis bacteria that are used in the DTP vaccine. What remains are just a few components of the bacteria rather than the whole organisms. These components are detoxified using formaldehyde, and then thimerosal and aluminum are added. This acelluar, rather than whole cell, version of the pertussis vaccine is then combined with the DT vaccine to create DtaP. Removing these toxins from Pertussis also significantly reduces but does not eliminate the number and potency of the adverse effects associated with the vaccine. (Source Stephanie Cave 2001)

 

*note- Thimerosal content to date in the US –

Thimerosal has been reduced to traces; however, some of the older vaccines may be on the shelves and used until as late as 2007.

 

 A Not-so-Perfect Vaccine :

The Diphtheria, Tetanus and Acellular Pertussis Vaccine: An Investigation

 

 The Disease

 

Pertussis or Whooping Cough is an acute infectious disease caused by Bordetella pertussis.  The disease has been described for centuries; the organism was first isolated in 1906. Whooping cough is transmitted through the respiratory route usually by droplets of secretions.

 

The incubation period is usually 7 to 14 days but may be as short as 5 days and as long as 21 days. The disease evolves in three phases. Patients are most contagious during the initial catarrhal stage consisting usually of minor cold symptoms and a slight nocturnal cough. During the paroxysmal stage, which may last for several weeks, the patient has the more characteristic coughing spells, which culminate in an inspiratory whoop and are often followed by vomiting. There is usually a marked leucocytosis (increased white count) and lymphocytosis (increased lymphocyte count). In newborns and young infants, whooping cough may present as apnea and cyanotic spells. During the convalescent stage, the paroxysms subside; the patient coughs less and clinical improvement becomes evident.

 

Erythromycin is the antibiotic of choice for the treatment of whooping cough. If given early, it shortens the course of the illness and reduces its severity. Because it also eradicates the organism from the secretions, it decreases spread and communicability.

Erythromycin or trimeththoprim-sulfamethoxazole prophylaxis is of value for close contacts and is recommended regardless of vaccination status.

 

 The following statements are true about whooping cough and whooping cough vaccination

 

  1. The incidence of whooping cough in the United States had decreased before the introduction of the pertussis vaccine.

  2. It has continued to decrease since the vaccine has been in use.

  3. Whooping cough may be a serious and potentially fatal illness in young and vulnerable infants. 

  4. DTP vaccination has been associated with many severe and permanent adverse events including encephalopathy, brain damage, seizures, and even death. The reactions have been attributed to the pertussis component.

The DTAP Vaccine

 

The Federal Drug Administration (FDA) approved the use of DTAP for booster doses in 1991 and for all doses in 1996. All DTP and DTAP products used in the US contained thimerosal, a mercury derivative. In 1999, the AAP and FDA recommended that thimerosal be removed from pediatric vaccines. 

 

Several acellular pertussis vaccines were developed and licensed in the United States. They contained different purified inactivated components of B. pertussis in varying concentrations and were always combined with diphtheria and tetanus toxoids. No single antigen pertussis vaccine has been available commercially for sometime. According to the CDC “Contraindications to further vaccination with DTP or DTAP are severe allergic reactions to a prior dose of vaccine or vaccine component and encephalopathy, not due to another identifiable cause, within 7 days of vaccination…Certain infrequent adverse events following pertussis vaccination will generally contraindicate subsequent doses of pertussis vaccine. These adverse events are: Temperature to 105°F within 48 hours, not due to another identifieable cause, Collapse or shock-like state (hypotensive-hyporesponsive episode) within 48 hours, Persistent, inconsolable crying lasting 3 hours or more and Convulsions with or without fever occurring within 3 days…Acellular pertussis vaccine should not be substituted in children who have a valid contraindication to whole cell pertussis vaccine. If a valid contraindication or precaution exists, DT should be used for the remaining doses on the schedule.” (9)

 

The manufacturer of one of the still available DTAP products lists the same contraindications as those of the CDC; specifically that encephalopathy (not due to other identifiable causes) within 7 days of vaccination is a contraindication for further pertussis vaccination. According to that manufacturer, encephalopathy consists of major alterations of consciousness, unresponsiveness, generalized or focal seizures that persist for more than a few hours and failure to recover within a few hours. (10)

 

Interestingly, and most unfortunately, as shown in the box below, filing for “on-table” vaccine compensation is allowed only if encephalopathy has occurred in the 72 hours following vaccination with a pertussis antigen-containing vaccine (11)

 

 

When DTP was used exclusively, many studies were published regularly to convince physicians and parents that the vaccine was quite safe. The fact is that the DTP vaccine was not safe and that it had to be replaced by the DTAP vaccine.

Now, the CDC and vaccine manufacturers consistently downplay the side effects of DTAP vaccination. Indeed, though minor reactions following DTAP are fewer than with DTP, more serious reactions occur in rather disturbing numbers. This is supported by a report that was issued by a committee of US Scientists and published in 1987 in the Journal of the American Medical Society (JAMA). In “Acellular and whole-cell pertussis vaccines in Japan. Report of a visit by US scientists”, the authors stated:

 

“Since the introduction of acellular pertussis vaccines in Japan late in 1981, more than 20 million doses have been administered, mostly to children 2 years of age and older. Clinical studies indicate that mild local and febrile reactions are less frequent after administration of acellular pertussis vaccines than after whole-cell vaccines. Serious adverse events with sequelae occurred in 2-year-old children at approximately the same low rate during the period 1975 through August 1981, when whole-cell vaccines were used, and during August 1981 through 1984, when acellular vaccines were used exclusively.” 

Clearly multiple reports of serious DTAP-associated reactions have been filed with VAERS. Again, one must keep in mind that less than 10% of adverse events after vaccination are ever reported.

 

Delaying DPT Vaccination May Reduce Incidence of Childhood Asthma 

Medscape News. Laurie Barclay, MD. April 14, 2008. J Allergy Clin Immunol. 2008;121:626-631.

  

Childhood asthma is reduced by half when the first dose of diphtheria, pertussis, and tetanus (DPT) is delayed by more than 2 months vs given during the recommended period, according to the results of a retrospective longitudinal study reported in the March issue of the Journal of Allergy & Clinical Immunology.

“Early childhood immunizations have been viewed as promoters of asthma development by stimulating a TH2-type immune response or decreasing microbial pressure, which shifts the balance between TH1 and TH2 immunity,” write Kara L. McDonald, MSc, from the University of Manitoba in Winnipeg, Manitoba, Canada, and colleagues. “Differing time schedules for childhood immunizations may explain the discrepant findings of an association with asthma reported in observational studies. This research was undertaken to determine whether timing of diphtheria, pertussis, tetanus (DPT) immunization has an effect on the development of childhood asthma by age 7 years.”

The investigators analyzed data from the complete immunization and healthcare records of a cohort of children born in Manitoba in 1995, from birth until age 7 years. Using multivariable logistic regression, they computed the adjusted odds ratio for asthma at age 7 years according to the timing of DPT immunization.

Among 11,531 children who received at least 4 doses of DPT, the risk for asthma was halved in children in whom administration of the first dose of DPT was delayed by more than 2 months. For children with delays in administration of all 3 doses, the likelihood of asthma was 0.39 (95% confidence interval [CI], 0.18 – 0.86).

“We found a negative association between delay in administration of the first dose of whole-cell DPT immunization in childhood and the development of asthma; the association was greater with delays in all of the first 3 doses,” the study authors write. “The mechanism for this phenomenon requires further research.”

Limitations of this study include possible ascertainment bias; findings not yet confirmed with the diphtheria, acellular pertussis, tetanus (DaPT) vaccine; and inability to refute the issue of early-life infections as an explanation for the association between delayed immunization and protection against the development of asthma.

“Further study is vital to gain a detailed understanding of the relationship between vaccination and allergic disease, because a perception that vaccination is harmful may have an adverse effect on the effectiveness of immunization programs,” the study authors conclude.

The Canadian Institutes of Health Research supported this study. Some of the authors have disclosed various financial relationships with the Western Regional Training Center for Health Services Research, the National Training Program in Allergy and Asthma, the Canadian Institutes of Health Research, Allergen, and/or Novartis.

Epidemiologic evidence linking DPT immunizations to childhood asthma is inconsistent. Some studies show an increased or decreased risk of developing asthma, whereas others show no association. This study assessed whether timing of DPT vaccination affects the risk of developing childhood asthma by age 7 years.

 

 

Pertussis-Epidemiology and Transmission of Disease

Epidemiology and Transmission of Disease

Pertussis infection is unique to humans. There are no animal reservoirs, and the organism cannot survive for a prolonged period in the environment. Localized to the respiratory tract, the organism is transmitted primarily by aerosol droplets from an infected person to a susceptible one. The infection is highly contagious, with attack rates ranging from 50% to 100%. The highest attack rates occur among persons with exposure within 5 feet of a coughing patient.[5]

In the pre-vaccine era, pertussis was predominantly an infection of children aged 1 to 5 years, with maternal immunity providing passive protection during an infant’s first year of life. At that time, an average of 175,000 US cases were reported per year (incidence of approximately 150 cases per 100,000 population).[6] The incidence of disease declined steadily over the two decades after introduction of whole-cell pertussis vaccine, reaching an all-time low of just over 1000 reported cases in 1976.[7,8] Since then, the incidence of infection has continued to rise, with almost 26,000 cases reported to the CDC in 2004 (Figure 1).[9]

 

 Pertussis is the only vaccine-preventable disease on the rise in the US and it is severely underreported. CDC estimates that, at best, one-third of cases are believed to be reported to the CDC;[10] other estimates place the reported cases at 1 in 10 to 1 in 20 of the true incidence.[11] Although pertussis incidence remains highest among young infants, rates are also on the rise in adolescents and adults and there may be significant under-reporting in these age groups, especially those with mild or atypical infection.[7] Compared with surveillance data from 1994 to 1996, the pertussis incidence rate among adolescents and adults increased 62% and 60%, respectively, from 1997 to 2000.[7]

Increased incidence of pertussis in adolescents and adults relates to waning immunity and, likely, to a combination of previous underreporting and recent improvements in reporting processes. The longer the duration since vaccination, the higher the attack rate (Figure 2).[12] Data from a seroprevalence study by Cattaneo et al showed a peak in antibody titers at 4 to 6 years of age, coinciding with DTaP booster dosing, followed by a decline, and a second peak between 13 and 17 years of age.[13] Similar findings were documented by the National Health and Nutrition Examination Survey (NHANES), which reported a protracted decline interrupted by a peak in persons aged 40 to 45 years.[14] Since no pertussis-containing vaccine had been given past the age of 6 years, these spikes in adolescents and older persons clearly represent natural pertussis exposure. These persons not only represent potential cases, but a reservoir of disease that puts those most susceptible to significant morbidity and mortality (ie, those at the extremes of age) at risk of exposure.

Pertussis has been estimated to account for up to 17% of prolonged cough illness in adults.[15,16] Among adults with cough illness, the incidence of confirmed pertussis has been estimated at 170 to 630 cases per 100,000.[17,18] The rates among adolescents were almost 2-fold higher. Data from a prospective acellular pertussis vaccine efficacy trial (APERT) extrapolate the burden of pertussis to be nearly 1 million US cases annually in persons 15 years old.[11]

Given the large disease burden in adolescents and adults estimated by these studies, the limited number of confirmed cases of pertussis (defined in Table 1 ) in older children, adolescents, and adults is striking. A large proportion of these cases may be atypical and undiagnosed. However, according to recent data from Bisgard et al,[19] in cases where the source of pertussis was identifiable, adolescents and adults were the primary source of infection for 20% and 56%, respectively, of infants with pertussis.

Contact with infected adolescents and adults is a common source of B. pertussis infection in infants and unprotected, young children. Widespread silent transmission of pertussis within families has been reported.[20] In a study of risk factors for pertussis-related hospitalizations, siblings were the most common source (53%), followed by parents (20%), other relatives (12%), neighbors (8%), and day-care contacts (3%).[21] In a case-control study, infants of adolescent mothers (aged 15 to 19 years) were 6-fold more likely to contract pertussis, compared with infants of older mothers (aged 20 to 29 years).[22]

Details of the pathogenesis of pertussis infection have been extensively reviewed elsewhere.[23] In brief, the development of pertussis infection begins with entry of B. pertussis into the respiratory tract of a susceptible host. The organism produces adhesion and bacterial surface attachment factors that allow its attachment to cilia in the respiratory mucosa. Tracheal cytotoxin and other toxins are produced and released into the local environment, damaging the cilia and respiratory epithelium. These changes disturb clearance of pulmonary secretions and probably result in development of the coryza and cough observed during the catarrhal phase of the illness. Even as local damage increases, attracting host immune cells, the actions of additional toxins probably inhibit phagocyte functions, thereby protecting the proliferating organisms from clearance. In some cases, the proliferation of B. pertussis continues until organisms reach the alveoli, resulting in pneumonia.

Pertussis symptoms are nonspecific in nature, making the clinical diagnosis challenging. The type and severity of symptoms that develop are highly variable, as is the time frame over which they appear and resolve. Adolescents and adults, as well as those partially protected by pertussis vaccine, frequently have mild clinical disease (or even asymptomatic disease) that goes undiagnosed. Although illness may be milder in adolescents and adults, they are a reservoir of infection and may transmit whooping cough to unimmunized or partially immunized infants. Of great concern, health care providers often do not recognize the varied clinical presentations and do not consider a pertussis diagnosis in patients with chronic cough.[17] Furthermore, management of pertussis is complicated by the fact that infected persons are most contagious early in their illness, before they become symptomatic.

Despite significant interpatient variability, generalizations can be made about the clinical course of illness ( Table 2 ).[5,24] Pertussis infection develops in four sequential stages, beginning with an incubation period during which infected individuals are asymptomatic followed by three stages of symptomatic illness. The incubation period of pertussis infection commonly lasts for 7 to 10 days, but can be as short as 4 days or as long as 21 days. The first stage in which symptoms can be observed is the catarrhal stage. This stage, which typically lasts 1 to 2 weeks, is characterized by the insidious onset of coryza, sneezing, low-grade fever, and a mild, occasional, nonspecific cough that gradually becomes more severe. In young infants, this stage is often characterized by excessive sneezing or “throat clearing.”

During the next stage, the paroxysmal stage, many pertussis patients have bursts, or paroxysms, of numerous, rapid coughs, apparently due to impaired mucociliary clearance. At the end of the paroxysm, a long inspiratory effort is oftentimes associated with a high-pitched whoop. Post-tussive vomiting and cyanosis can also occur. The paroxysmal attacks increase in frequency during the first 1 to 2 weeks, remain at the same level for 2 to 3 weeks, and then gradually decrease.

During the convalescent stage, which lasts for weeks to months, recovery is gradual, with cough becoming less paroxysmal and then disappearing.

The symptomatology of infants during the paroxysmal stage of infection is different from that in adolescents and adults. Although very young infants do experience paroxysms of coughing, they often do not “whoop.” Although the absent whoop in adolescents and adults is usually associated with milder disease, the whoop may be absent in infants because they lack sufficient musculature in the chest wall to take the deep inhalation that creates the whooping sound. The whoop may appear later in the disease as infants gain in size and strength. Infants may also exhibit clinical symptoms such as gagging, gasping, or eye bulging. Occasionally, they may also present with bradycardia or cyanosis. Pertussis is often ignored in the differential diagnosis of cough illness in young infants due to the absence of a “whoop” and the frequency of concomitant respiratory infections.

Life-threatening complications are most common in infants <3 months of age,[19,21] but infection can also be severe in some adult cases. Secondary bacterial pneumonia is diagnosed in up to one quarter of young infants with pertussis[21,25] and is the most common complication and the cause of most pertussis-related deaths across age groups. Data from 1997 to 2000 indicate that pneumonia occurred in up to 5.2% of all reported pertussis cases, and 11.8% of infants <6 months of age.[7] Other complications include seizures (0.8% of all cases, 1.4% of infants <6 months of age) and encephalopathy (0.1% of all cases, 0.2% of infants <6 months of age).

Death due to pertussis is rare (0.2%). The vast majority (90%) occurs in children younger than 6 months of age with no predisposing conditions.[2] Risk factors for death among infants include premature birth, Hispanic ethnicity, and having a young mother.[2,26] Pertussis has also been linked to sudden infant death (3% to 5%).[27,28] Other less severe complications in infants include otitis media, anorexia, and dehydration. Pressure effects of severe paroxysms may lead to pneumothorax, epistaxis, subdural hematomas, hernias, and rectal prolapse. Additional complications identified in adolescents and adults include urinary incontinence, rib fracture, unilateral hearing loss, herniated disk, and precipitation of angina pectoris.[5,24]

Laboratory confirmation of pertussis infection is not as straightforward as that of many other infectious diseases. Most local laboratories are not equipped to make the diagnosis of B. pertussis infection. The preferred approach is polymerase chain reaction (PCR) testing and a culture of the organism from a posterior nasopharyngeal specimen obtained using two separate Dacron swabs.[29] For proper collection, the swab must touch the epithelial cells of the posterior nasopharyngeal wall. Culture is the only method from which antibiotic susceptibilities can be measured and molecular typing determined. Isolation of the organism is compromised by recent antibiotic therapy effective against pertussis (ie, macrolide/azalide or trimethoprim-sulfamethoxazole), by delay in specimen collection beyond the first 2 weeks of illness, and in vaccinated persons.

Serologic testing for B. pertussis is limited by a lack of standardization and should not be obtained for clinical decision making.[30] However, because of its convenience, serology continues to be the most common method used to diagnosis pertussis, especially in the later stages of the infection, making it an important tool in our understanding of disease frequency.[31] Various enzyme-linked immunosorbent assay (ELISA) techniques are available in commercial laboratories, although there is little evidence of sensitivity or specificity relative to clinical infection.[32] None of the commercially available serologic tests for pertussis is FDA-licensed for the routine diagnosis of infection.[14] Direct fluorescent antibody (DFA) is no longer considered useful for diagnosis of pertussis due to low sensitivity and variable specificity.

Pertussis Vaccination of Children

DTaP vaccine, which contains purified, inactivated components of B. pertussis cells (along with tetanus and diphtheria toxoids), has been available in the United States for more than a decade. Since 1997, the CDC recommends DTaP for all doses of the vaccination series for infants and children <7 years of age. The primary immunization series consists of three doses given at 4- to 8-week intervals, beginning at 6 weeks to 2 months of age. A fourth dose is given 6 to 12 months after the third dose. Children who have received all four primary doses before the fourth birthday should receive a fifth (booster) dose before entering school. A fifth dose is not necessary if the fourth dose was administered on or after the fourth birthday.

Point estimates of vaccine efficacy across trials of infants ranged from 80% to 85%.[24] In comparative studies, the acellular pertussis vaccine was significantly more effective than the whole-cell DTP, which is no longer available in the United States. Local and systemic adverse reactions occurred less frequently among infants vaccinated with acellular pertussis vaccine than among those vaccinated with whole-cell pertussis.[34]

Pertussis Vaccination of Adolescents and Adults

The availability of a less reactogenic acellular pertussis vaccine combined with evidence of substantial pertussis infection among adolescents and adults led to reconsideration for the need for acellular pertussis boosters among older subgroups.

Specific formulations of Tdap for adolescents 10 to 18 years, Boostrix® (GlaxoSmithKline), and for adolescents and adults 11 to 64 years, Adacel® (sanofi pasteur), were recently licensed for use in the United States. They contain tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis. In a randomized, controlled, multicenter clinical trial, 10- to 18-year-olds were vaccinated with one dose of Boostrix or a US-licensed Td vaccine.[35] Each subject had completed his or her routine childhood vaccinations against diphtheria, tetanus, and pertussis according to the CDC recommended schedule. Boostrix was comparable to the Td vaccine based on immunogenicity. In both treatment groups, >99.9% of subjects had anti-diphtheria and anti-tetanus concentrations greater than 0.1 IU/mL, indicating seroprotection against these two diseases. In the Boostrix treatment group, anti-pertussis antibodies levels following primary immunization exceeded (by 1.9 to 7.4 times) those observed in infants, in whom efficacy against pertussis disease was previously demonstrated. The overall safety profile was comparable between the Boostrix and Td vaccine groups.

Adacel was evaluated in four principal clinical trials in which 7206 individuals (4185 adolescents and 3021 adults) who had not received tetanus or diphtheria toxoid-containing vaccines within 5 years were enrolled. The trials consisted of one randomized, controlled trial that compared Adacel vaccine to a licensed Td vaccine,[36] one lot consistency trial, and two concomitant administration trials (one with hepatitis B vaccine and one with influenza vaccine). Across trials, a total of 3393 adolescents and 2448 adults received Adacel vaccine and 792 adolescents and 573 adults received Td vaccine. In the largest Adacel trial, the seroprotection rate (of at least 0.1 IU/mL) for tetanus and diphtheria was 99.8% and 100%, respectively.[36] Pertussis antibody geometric mean titers (GMTs) following one dose of Adacel were 2.1- to 5.4-fold higher than those observed among infants following three doses of DTaP. Overall, Adacel vaccine was well tolerated, with local and systemic adverse reactions occurring at similar rates in the Adacel and Td vaccine groups. The ACIP recently revised its recommendations for pertussis vaccination. The immunization schedule now includes a Tdap booster dose for all adolescents at 11 to 12 years of age ( Table 3 ).[37,38] The ACIP also calls for catch-up vaccination of those aged 13 to 18 years who did not receive the Td booster. Finally, because of the importance of controlling pertussis, those in this age range who received the Td booster are encouraged to get the new Tdap vaccine after a suggested 5-year interval. This interval may be shortened to as little as 2 years in the presence of increased risk (eg, during outbreaks or periods of increased pertussis activity in the community).[7]

The ACIP also recommends a single dose of Tdap booster to replace the next scheduled dose of tetanus diphtheria vaccine among persons 19 to 64 years of age. In addition, adults who have or who anticipate having close contact with a vulnerable infant (ie, an infant who has not received two to three doses of DTaP) should receive a single dose of Tdap booster.[39]

In February 2006, the ACIP recommended a single dose of Tdap booster as soon as feasible for health care workers in hospital or ambulatory care settings who have direct patient contact. The Committee stated that priority should be given to vaccination of health care workers with direct contact with infants <12 months of age. Other health care workers should receive a single dose of Tdap booster according to the routine recommendation and interval guidance for use of Tdap among adults.[39]

Widespread administration of Tdap vaccination should have a substantial impact on pertussis. By way of example, adolescent pertussis immunization programs were recently implemented countrywide in Canada, but started earlier in the Northwest Territories and Newfoundland. Following introduction of an adolescent booster dose, pertussis incidence in the Northwest Territories decreased from 7.9 per 100,000 in the late 1990s to 0.2 per 100,000 in 2004.[40] In Newfoundland, no person vaccinated with the Tdap booster has been diagnosed with pertussis to date.[41]

Pertussis is an often serious, potentially deadly community-acquired illness in persons of all ages. Infected adolescents and adults may suffer substantial morbidity and also are a reservoir for disease transmission to infants. Newly available Tdap vaccines are safe and effective in preventing infection. The addition of a pertussis booster to the previously available tetanus and diphtheria booster will not only directly benefit vaccine recipients but may allow for greater control of the pertussis reservoir in adolescents and adults, potentially leading to decreased incidence in infants who are at highest risk for severe complications including death. If widely administered, Tdap vaccination should have a substantial impact on pertussis.

Epidemiology and Transmission of Disease

J Am Board Fam Med.  2006;19(6):603-611.  ©2006 American Board of Family Medicine.

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