Loading ...None of the vaccines have been proven safe or tested safe in humans.They just had a law suit on that.
I have to stop this because it went on and on so you can get a idea of the toxins they put in them and imagine giving all these to a new born to adulthood, most wouldn’t subject themselves to all this as a adult let alone a baby. Parents aren’t informed either.
2014 CDC Vaccine Schedule from Birth to Adult (1)
Hepatitis B- Given at Birth, 2 months, 6-18 months, 3 doses at 19-65+ if high risk, given to pregnant women at high risk
Rotavirus (RV)- Given at 2 months, 4 months, 6 months
Diphtheria, Pertussis, Tetanus (DtaP)- Given at 2 months, 4 months, 6 months, 15-18 months, 4-6 years
Haemophilus influenzae type b (Hib)- Given at 2 months, 4 months, 6 months, 12-15 months, 1 or 3 doses at 19-65 if high risk
Pneumococcal conjugate (PCV13)- Given at 2 months, 4 months, 6 months, 12-15 months, 4-6 years, 6-18 years if high risk, 1 dose at 19-65 if a high risk
Pneumococcal polysaccharide (PPSV23)- Given at 19-64 if high risk, 65+
Influenza (yearly)- Starting at 6 months and up, also given to pregnant women
Measles, Mumps, Rubella (MMR)- Given at 12-15 months, 4-6 years, 1 or 2 doses at 19-50
Chickenpox (Varicella)- Given at 12-15 months, 4-6 years, 2 doses at 19-65+
Hepatitis A- Given at 12-23 months (2 doses), 6-18 if high risk, 2 doses at 19-65+ if high risk
Diphtheria, Pertussis, Tetanus (Tdap or Td) -Given at 11-12 years, at 19-65+ Substitute 1-time dose of Tdap for Td booster; then boost with Td every 10 yrs, also given to pregnant women
Human papillomavirus (HPV)- Given at 11-26 years (3 doses)
Meningococcal (MCV4)- Given at 11-12 years, 16 years, 1 or more doses at 19-65+ if high risk
Shingles (Herpes Zoster)- Given at 60-65+
Polio (IPV-Ipol)- Given at 2 months, 4 months, 6 months, 12-15 months
Dr. Bob Sears selective vaccine schedule (2)
2 months- Dtap, Rotavirus
3 months- Pc, Hib
4 months- Dtap, Rotavirus
5 months- Pc, Hib
6 months- Dtap, Rotavirus
7 months- Pc, Hib
15 months Pc, Hib
7 years- Tetanus booster
10 years- Blood tests for measles, mumps, rubella, chickenpox, and hep a immunity. Consider vaccinating if not immune.
Dr. Bob Sears delayed vaccine schedule
Starting vaccines at 6 months:
6 months- Dtap
7 months- Pc, Hib
8 months- Dtap
9 months- Pc, Hib
10 months- Dtap, Polio
Starting vaccines at 12 months:
12 months- Dtap, Polio
13 months- Pc, Hib
14 months- Dtap, Polio
15 months- Pc, Hib
18 months- Dtap, Polio
20 months- MMR
Starting vaccines at 2 years:
24 months- Dtap, Polio
25 months- Pc, Hib
26 months- Dtap, Polio
28 months- MMR
30 months- Dtap
34 months- Chickenpox
36 months- Hep B
37 months- Hep B
42 months- Hep B
Dr. Stephanie Cave and Deborah Mitchell selective vaccine schedule (150)
Birth- Hep B only if mom is hepatitis b positive
4 months- Hib, IPV
5 months- Dtap
6 months- Hib, IPV
7 months- Dtap
8 months- Hib
9 months- Dtap
15 months- Measles
17 months- Hib, IPV
18 months- Dtap
24 months- Prevnar (1 dose only)
27 months- Rubella
30 months- Mumps
4 years- varicella (if not already immune)
4-5 years- Hep B series
4-5 years- Test titers for MMR and do not give unless not immune.
Vaccine Recommendations
• Do not vaccinate child if he/she:
• is having fever (even low-grade), or runny nose/ diarrhea/constipation, or any other illness, or still recovering from an infection, or on antibiotics for other reasons. You may postpone vaccination on another day.
• had any bad reaction or deterioration in health after previous vaccination.
• had any past history of immune system disorder, severe allergies, convulsions or neurological disorders, vaccine reactions.
• Always have full information on the vaccine’s side effects.
• Ask the doctor on how to identify a vaccine reaction.
• Know the vaccine manufacturer’s name and lot number.
• Report any side effect to the doctor, NVIC, and VAERS.
• Always ask for single dose, mercury-free (no thimerosal) vaccines.
• Ask for separate vials of measles, mumps, and rubella, and give them separately, months apart.
Ask the doctor to check vaccine titers to check for immunity before giving boosters.
If you have to vaccinate, give the following:
• Vitamin A (cod liver oil) 1 tbsp for three days before and on the day of the shot.
• Vitamin C 100 mg twice daily for infants and 300mg twice daily for toddlers for three days before and on the day of the shot.
**NOTE: They no longer make single MMR vaccines. If you choose to go with this schedule you should choose when you feel comfortable giving the MMR.
Vaccine Ingredients (3)
Dtap (Infanrix)- formaldehyde, glutaraldehyde, aluminum hydroxide, polysorbate 80, Fenton medium (containing bovine extract), modified Latham medium (derived from bovine casein), modified Stainer-Scholte liquid medium
Dtap (Daptacel)- aluminum phosphate, formaldehyde, glutaraldehyde, 2- phenoxyethanol, Stainer-Scholte medium, modified Mueller’s growth medium, modified Mueller-Miller casamino medium (without beef heart infusion), dimethyl-1-beta-cyclodextrin, ammonium sulfate
Dtap+IPV (Kinrix)- formaldehyde, glutaraldehyde, aluminum hydroxide, vero (monkey kidney) cells, calf serum, lactalbumin hydrolysate, polysorbate 80, neomycin sulfate, polymyxin B, Fenton medium (containing bovine extract), modified Latham medium (derived from bovine casein), modified Stainer-Scholte liquid medium
Dtap+Hep B+IPV (Pediarix)- formaldehyde, glutaraldehyde, aluminum hydroxide, aluminum phosphate, lactalbumin hydrolysate, polysorbate 80, neomycin sulfate, polymyxin B, yeast protein, calf serum, Fenton medium (containing bovine extract), modified Latham medium (derived from bovine casein), modified Stainer-Scholte liquid medium, Vero (monkey kidney) cells
Dtap+IPV+Hib (Pentacel)- aluminum phosphate, polysorbate 80, formaldehyde, glutaraldehyde, bovine serum albumin, 2-phenoxyethanol, neomycin, polymyxin B sulfate, Mueller’s growth medium, Mueller-Miller casamino acid medium (without beef heart infusion), Stainer-Scholte medium (modified by the addition of casamino acids and dimethyl-beta-cyclodextrin), MRC-5 (human diploid) cells, CMRL 1969 medium (supplemented with calf serum), ammonium sulfate, medium 199
Hib (ActHIB)- ammonium sulfate, formalin, sucrose, modified Mueller and Miller medium
Hib (Hiberix)- formaldehyde, lactose, semi- synthetic medium
Hib (PedvaxHIB)- aluminum hydroxyphosphate sulfate, ethanol, enzymes, phenol, detergent, complex fermentation medium
Hib+Hep B (Comvax)- yeast (vaccine contains no detectable yeast DNA), nicotinamide adenine dinucleotide, hemin chloride, soy peptone, dextrose, mineral salts, amino acids, formaldehyde, potassium aluminum sulfate, amorphous aluminum hydroxyphosphate sulfate, sodium borate, phenol, ethanol, enzymes, detergent
Hep A (Vaqta)- amorphous aluminum hydroxyphosphate sulfate, bovine albumin, formaldehyde, neomycin, sodium borate, MRC-5 (human diploid) cells
Hep A (Havrix)- aluminum hydroxide, amino acid supplement, polysorbate 80, formalin, neomycin sulfate, MRC-5 cellular proteins
Hep A+Hep B (Twinrix)- formalin, yeast protein, aluminum phosphate, aluminum hydroxide, amino acids, phosphate buffer, polysorbate 20, neomycin sulfate, MRC-5 human diploid cells
Hep B (Engerix-B)- aluminum hydroxide, yeast protein, phosphate buffers
Hep B (Recombivax)- yeast protein, soy peptone, dextrose, amino acids, mineral salts, potassium aluminum sulfate, amorphous aluminum hydroxyphosphate sulfate, formaldehyde
HPV (Cervarix)- vitamins, amino acids, lipids, mineral salts, aluminum hydroxide, sodium dihydrogen phosphate dihydrate, insect cell and viral protein, 3-0-desacyl-4′ Monophosphoryl lipid
HPV (Gardasil)- yeast protein, vitamins, amino acids, mineral salts, carbohydrates, amorphous aluminum hydroxyphosphate sulfate, L-histidine, polysorbate 80, sodium borate
Influenza (Fluzone: standard, high dose)- formaldehyde, octylphenol ethoxylate (Triton X-100), gelatin (standard trivalent formulation only), thimerosal (multi-dose vial only), egg protein, phosphate buffers, sucrose
Influenza (Fluvirin)- nonylphenol ethoxylate, thimerosal (multi-dose only in prefilled syringe), polymyxin, neomycin, beta-propiolactone, egg proteins
Influenza (Flulaval)- thimerosal, a-tocopheryl hydrogen succinate, polysorbate 80, formaldehyde, sodium deoxycholate, ovalbumin
Influenza (Flumist)- ethylenediaminetetraacetic acid (EDTA), monosodium glutamate, hydrolyzed porcine gelatin, arginine, sucrose, dibasic potassium phosphate, monosodium potassium phosphate, gentamicin sulfate, egg protein
Live virus vaccine that has the potential to shed.
Meningococcal (MCV4-Menactra)- formaldehyde, phosphate buffers, Mueller Hinton agar, Watson Scherp media, modified Mueller and Miller medium
Meningococcal (MCV4- Menceo)- formaldehyde, amino acids, yeast extract, Franz complete medium, CY medium
Meningococcal (MPSV4- Menomune)- thimerosal (multi-dose vial only), lactose, Mueller Hinton casein agar, Watson Scherp media, detergent, alcohol
MMR (MMR-II)- recombinant human albumin, neomycin, sorbitol, hydrolyzed gelatin, chick embryo cell culture, WI-38 human diploid lung fibroblasts, Medium 199, minimum essential medium, phosphate
Live virus vaccine that has to potential to shed.
MMRV (ProQuad)- sucrose, hydrolyzed gelatin, sorbitol, monosodium L-glutamate, sodium phosphate dibasic, human albumin, sodium bicarbonate, potassium phosphate monobasic, potassium chloride, potassium phosphate dibasic, neomycin, bovine calf serum, chick embryo cell culture, WI-38 human diploid lung fibroblasts, MRC-5 cells
Live virus vaccine that has the potential to shed.
Pneumococcal (PCV13- Prevnar 13)- casamino acids, yeast, ammonium sulfate, polysorbate 80, succinate suffer, aluminum phosphate
Pneumococcal (PPSV-23-Pneumovax)- isotonic saline solution, phenol
Polio (IPV- Ipol- 2-phenoxyethanol, formaldehyde, neomycin, streptomycin, polymyxin B, monkey kidney cells, Eagle MEM modified medium, calf serum protein
Rotavirus (RotaTeq)- sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, fetal bovine serum, vero cells [DNA from porcine circoviruses (PVC) 1 and 2 has been detected in RotaTeq. PCV-1 and PCV-2 is not known to cause disease in humans]
Live virus vaccine that has the potential to shed.
Rotavirus (Rotarix)- amino acids, dextran, sorbitol, sucrose, calcium carbonate, xanthan, Dulbecco’s modified Eagle Medium (DMEM) [Porcine circovirus type 1 (PCV-1) is present in Rotarix. PCV-1 is not known to cause disease in humans]
Live virus vaccine that has the potential to shed.
Tdap (Boostrix)- formaldehyde, glutaraldehyde, aluminum hydroxide, polysorbate 80 (tween 80), Latham medium derived from bovine casein, Fenton medium containing a bovine extract, Stainer-Scholte liquid medium
Tdap (Adacel)- aluminum phosphate, formaldehyde, glutaraldehyde, 2-phenoxyethanol, ammonium sulfate, Stainer-Scholte medium, dimethyl-beta cyclodextrin, modified Mueller’s growth medium, Mueller-Miller casamino acid medium (without beef heart infusion)
Varicella (Varivax)- sucrose, phosphate, glutamate, gelatin. Monosodium L-glutamate, sodium phosphate dibasic, potassium phosphate monobasic, EDTA, residual components of MRC-5 cells including DNA and protein, neomycin, fetal bovine serum, human diploid cell cultures
Live virus vaccine that has the potential to shed.
Zoster (Shingles-Zostavax)- sucrose, hydrolyzed porcine gelatin, monosodium L-glutamate, sodium phosphate dibasic, potassium phosphate monobasic, neomycin, potassium chloride, residual components of MRC-5 cells including DNA and protein, bovine calf serum
Live virus vaccine that has the potential to shed.
Adverse Reactions from the package inserts (4)
Dtap (Infanrix)- Bronchitis, cellulitis, respiratory tract infection, Lymphadenopathy, thrombocytopenia, anaphylactic reaction, hypersensitivity, encephalopathy, headache, hypotonia, syncope, ear pain, cyanosis, apnea, cough, angioedema, erythema, pruritus, rash, urticaria, fatigue, injection site induration, injection site reaction, Sudden infant death syndrome (SIDS)
Dtap (Daptacel)- temp above 105 degrees within 48 hours, collapse or shock-like state, persistent/ inconsolable crying lasting more than 3 hours, seizures with or without fever, Guillain- Barre syndrome, anorexia, drowsiness, vomiting, lymphadenopathy, cyanosis, nausea, diarrhea, injection site pain/ swelling/ module/ mass/ cellulitis/ abscess, hypersensitivity, allergic reaction, anaphylactic reaction, convulsions, febrile convulsions, partial seizures, syncope, screaming
Dtap+IPV (Kinrix)- temp above 105 degrees, collapse or shock-like state, persistent/ inconsolable crying lasting more than 3 hours, seizures with or without fever, cellulitis, constipation, foreign body trauma, injection site vesicles, syncope, anaphylactoid reactions, anaphylaxis, angioedema, urticaria, apnea, lymphadenopathy, thrombocytopenia
Dtap+Hep B+IPV (Pediarix)- pyrexia, gastroenteritis, bronchiolitis, Sudden infant death syndrome (SIDS), convulsive disorder, congenital immunodeficiency with sepsis, neuroblastoma, By chance alone some cases of SIDS can be expected to follow receipt of pertussis- containing vaccines. Chronic illness, asthma, febrile and afebrile seizures, infantile spasms, jaundice, meningitis, lichen planus
Dtap+IPV+Hib (Pentacel)- dehydration, gastroenteritis, asthma, pneumonia, death due to suffocation, head trauma, sudden infant death syndrome (SIDS), neuroblastoma, cyanosis, vomiting, nausea, meningitis, rhinitis, viral infection, decreased appetite, depressed level of consciousness, screaming, apnea, cough, erythema, skin discoloration, pallor
Hib (ActHIB)- Erythema, high fever, drowsiness, anorexia, diarrhea, vomiting, persistent crying, unusual crying, urticaria, seizures, hives, renal failure, Guillain- Barre syndrome
Hib (Hiberix)- extensive swelling of the vaccinated limb, allergic reaction (including anaphylactic and anaphylactoid reactions), angioedema, convulsions (with or without fever), somnolence, syncope, apnea, rash, fever, fussiness, loss of appetite, sleepiness, diarrhea, vomiting
Hib (PedvaxHIB)- Guillain- Barre syndrome, lymphadenopathy, hypersensitivity, angioedema, febrile seizures, sterile injection site abscess
Hib+Hep B (Comvax)- irritability, somnolence, crying (unusual, high pitched, prolonged for more than 4 hours), anorexia, vomiting, fever over 103 degrees, diarrhea, upper respiratory infection, rash, rhinorrhea, respiratory congestion, cough, anaphylaxis, angioedema, urticaria, seizures, pruritus, edema, syncope, arthritis
Hep A (Havrix)- anorexia, nausea, fatigue, fever, pharyngitis, upper respiratory tract infection, lymphadenopathy, insomnia, dysgeusia, hypertonia, photophobia, vertigo, abdominal pain, diarrhea, vomiting, pruritus, rash, urticaria, arthralgia, myalgia, injection site hematoma, creatine phosphokinase increased, rhinitis, hepatitis, jaundice, angioedema, erythema, multiforme, congenital anomaly, musculoskeletal stiffness
Hep A (Havrix)- anorexia, nausea, fatigue, fever, upper respiratory infection, insomnia, vertigo, diarrhea, vomiting, rash, rhinitis, thrombocytopenia, convulsions, dizziness, multiple sclerosis, myelitis, neuropathy, hepatitis, jaundice, chills, influenza-like symptoms
Hep A+Hep B (Twinrix)- headache, fatigue, diarrhea, nausea, fever, vomiting, upper respiratory tract infection, anorexia, agitation, insomnia, dizziness, migraine, paresthesia, somnolence, syncope, vertigo, erythema, rash, sweating, back pain, myalgia, lymphadenopathy, dysgeusia, photophobia, hypotension, herpes zoster, meningitis, Bell’s palsy, convulsions, Guillain- Barre syndrome, multiple sclerosis, neuritis, earaches, tinnitus, palpitations, hepatitis, jaundice, eczema, lichen planus, arthritis, chills
Hep B (Engerix-B)- herpes zoster, meningitis, thrombocytopenia, anaphylaxis, hypersensitivity syndrome, encephalitis, encephalopathy, migraine, multiple sclerosis, neuritis, neuropathy, Guillain- Barre syndrome, Bell’s palsy, optic neuritis, seizures, syncope, earaches, tinnitus, vertigo, palpitations, asthma, eczema, alopecia, lichen planus, purpura, arthritis, muscular weakness, abnormal liver function tests, anorexia, insomnia
Hep B (Recombivax)- fatigue, weakness, high fever, nausea, diarrhea, pharyngitis, upper respiratory infection, sweating, chills, diminished appetite, rhinitis, influenza, cough, vertigo/ dizziness, paresthesia, pruritus, rash, angioedema, myalgia, back pain, lymphadenopathy, insomnia, earaches, dysuria, hypotension, elevation of liver enzymes, constipation, Guillain- Barre syndrome, multiple sclerosis, seizures, febrile seizures, herpes zoster, encephalitis, eczema, arthritis, extreme pain, lupus-like syndrome
HPV (Cervarix)- extreme pain, headache, nasopharyngitis, influenza, dizziness, upper respiratory infection, dysmenorrhea, chlamydia infection, pharyngitis, injection site bruising, vaginal infection, back pain, UTI, arthritis, celiac disease, dermatomyositis, diabetes, hyperthyroidism, hypothyroidism, inflammatory bowel disease, psoriasis, death, allergies, vitiligo, seizures
HPV (Gardasil)- headache, fever, nausea, arthritis, death, autoimmune thyroiditis, celiac disease, inflammatory bowel disease, multiple sclerosis, nephritis, pigmentation disorder, diabetes, chills, fatigue, malaise, autoimmune disease, seizures, cellulitis, deep venous thrombosis
Influenza (Fluzone: High dose)- myalgia, malaise, headache, fever, thrombocytopenia, lymphadenopathy, anaphylaxis, ocular hyperemia, Guillain- Barre syndrome, convulsions, Bell’s palsy, brachial neuritis, syncope (shortly after vaccination), dizziness, rhinitis, cough, wheezing, chest pain, vomiting, nausea, diarrhea, chills
Influenza (Fluvirin)- pain, headache, fatigue, fever, sweating, arthralgia, myalgia, malaise, sore throat, chills, nausea, cough, wheezing, stroke, hypersensitivity reactions, vasculitis, loss of appetite, confusion, febrile seizures, Guillain- Barre syndrome, urticaria, rash, cellulitis, encephalopathy
Influenza (Flulaval)- Guillain- Barre syndrome, syncope (fainting), headache, fatigue, malaise, sore throat, cough, chills, facial swelling, diarrhea, lymphadenopathy, eye pain, photophobia, dysphagia, chest pain, allergies, anaphylaxis, angioedema, rhinitis, laryngitis, cellulitis, arthritis, dizziness, tremors, seizures, limb paralysis, insomnia, bronchospasm, throat tightness
Influenza (FluMist)- wheezing, runny nose, decreased appetite, lethargy, chills, high fever, pericarditis, genetic disorders, nausea, vomiting, diarrhea, hypersensitivity, Guillain- Barre syndrome, Bell’s Palsy, meningitis, vaccine- associated encephalitis, rash
Meningococcal ( MCV4-Menactra)- diarrhea, drowsiness, anorexia, arthralgia, fever, rash, vomiting, seizure, headache, chills, hypersensitivity reactions such as anaphylaxis/ anaphylactic reaction, wheezing, difficulty breathing, upper airway swelling, urticaria, erythema, pruritus, hypotension, Guillain- Barre syndrome, paraesthesia, vasovagal syncope, dizziness, convulsion, facial palsy, acute disseminated encephalomyelitis, transverse myelitis, myalgia
Meningococcal (MCV4- Menveo)- irritability, sleepiness, persistent crying, change in eating habits, vomiting, diarrhea, rash, fever, appendicitis, pneumonia, staphylococcal infection, inguinal hernia, abdominal pain, labor pneumonia, viral hepatitis, hearing impaired, vertigo, hypersensitivity, vaccination site cellulitis, tonic convulsions
Meningococcal (Menomune)- injection site pain, irritability, diarrhea, headache, fatigue, anorexia, vomiting, seizures, rash, chills, fever, vasovagal syncope, Guillain- Barre syndrome, myalgia, arthralgia, urticaria, pruritus, dyspnea, dizziness, paresthesia
MMR (MMRII)- Panniculitis, atypical measles, fever, syncope, headache, dizziness, malaise, irritability, vasculitis, pancreatitis, diarrhea, vomiting, parotitis, nausea, diabetes belitus, thrombocytopenic, purpura, regional lymphadenopathy, leukocytosis, anaphylaxis, anaphylactoid, pneumonia such as angioneurotic edema, bronchospasm, arthritis, arthralgia, myalgia, encephalitis, encephalopathy, measles inclusion body encephalitis (MIBE), subacute sclerosing panencephalitis (SSPE), Guillain- Barre syndrome, febrile seizures, febrile seizures, ataxia, polyneuritis, polyneuropathy, ocular palais, paresthesia, ear nerve deafness, death
MMRV (Proquad)- fever, irritability, measles-like rash, varicella-like rash, rash, upper respiratory infection, viral exanthema, diarrhea, rubella-like rases, rhinorrhea, atypical measles, candidiasis, cellulitis, herpes zoster, infection, influenza, measles, respiratory infection, varicella (vaccine strain), anaphylaxis, pneumonia, afebrile seizures, aseptic meningitis, Bell’s Palsy, dizziness, ear pain, nerve deafness, bronchial spasms, eczema, death
Pneumococcal (PCV13- Prevnar13)- bronchiolitis, gastroenteritis, pneumonia, sudden infant death syndrome (SIDS), fever, decreased appetite, irritability, increased or decreased sleep, diarrhea, vomiting, rash, inconsolable crying, hypersensitivity, seizures, urticaria, anaphylactic/ anaphylactoid reaction including shock, apnea
Pneumococcal (PPSV-23-Pneumovax)- cellulitis, malaise, fever above 102, decreased limb mobility, nausea, vomiting, lymphadenitis, lymphadenopathy, leukocytosis, anaphylactoid reactions, serum sickness, angioneurotic edema, arthritis, paresthesia, radiculoneuropathy, Guillain- Barre syndrome, febrile seizures, rash, urticaria, back pain, upper respiratory infection, chills, myalgia, headache, angina pectoris, heart failure, chest pain, ulcerative colitis, depression, cerebrovascular accident, lumbar radiculopathy, pancreatitis/ myocardial infarction resulting in death
Polio (IPV-Ipol)- Ipol vaccine is contraindicated in persons with a history of hypersensitivity to any component of the vaccine, including 2-phenoxyethanol, formaldehyde, neomycin, streptomycin, and polymyxin B. Deaths have been reported in temporal association with the IPV vaccine. High fever, irritability, anorexia, vomiting, persistent crying, GBS, lymphadenopathy, agitation, injection site mass, type 1 hypersensitivity including allergic reaction, anaphylactic reaction, anaphylactic shock, arthralgia, myalgia, convulsions, febrile convulsions, headache, paraesthesia, somnolence, rash, urticaria
Rotavirus (RotaTeq)- bronchiolitis, gastroenteritis, pneumonia, fever, UTI, sudden infant death syndrome (SIDS), hematochezia, seizures, kawasaki disease, vomiting, diarrhea, irritability, anaphylactic reaction, intussusception (including death), urticaria, angioedema, “RotaTeq has not been evaluated for its carcinogenic or mutagenic potential or its potential to impair fertility.”
Rotavirus (Rotarix)- fussiness, cough/ runny nose, fever, loss of appetite, vomiting, diarrhea, death mostly caused by pneumonia, kawasaki disease, intussusception (including death), recurrent intussusception (including death), hematochezia, gastroenteritis with vaccine trial shedding in infants with severe combined immunodeficiency disease (SCID)
Tdap (Boostrix)- hypersensitivity, anaphylaxis, coma, decreased level of consciousness, prolonged seizures, Guillain- Barre syndrome, brachial neuritis, syncope, progressive or unstable neurologic disorders, Arthus- type hypersensitivity, headache, fatigue, gastrointestinal symptoms, fever, lymphadenitis, allergic reaction such as anaphylactic and anaphylactoid reactions, myocarditis, injection site mass, back pain, convulsions (with and without fever), encephalitis, facial palsy, loss of consciousness
Tdap (Adacel)- headache, body ache, tiredness, chills, sore and swollen joints, nausea, lymph node swelling, diarrhea, vomiting, rash, anaphylactic reaction, hypersensitivity reaction, Guillain- Barre syndrome, brachial neuritis, facial palsy, convolutions, syncope, myositis, myocarditis, pruritus, extensive limb swelling
Varicella (Varivax)- fever, varicella-like rash, anaphylaxis (including anaphylactic shock), pneumonia, facial edema, necrotizing, retinitis, aplastic anemia, thrombocytopenia, varicella (vaccine strain), encephalitis, Guillain- Barre syndrome, Bell’s palsy, non- febrile seizures, aseptic meningitis, dizziness, paresthesia
Zoster (shingles-Zostavax)- injection pain/ swelling, erythema, pruritus, congestive heart failure, deaths caused by cardiovascular disease, nausea, herpes zoster (vaccine strain), rash, arthralgia, myalgia, respiratory infection, fever, rhinitis, skin disorder, diarrhea
Vaccine ingredient descriptions and effects
2-Phenoxyethanol- “The major hazards encountered in the use and handling of 2-phenoxyethanol stem from its toxicologic properties. Toxic by all routes (inhalation, ingestion, and dermal contract). Exposure to this faintly aromatic, colorless, oily liquid may occur from its use as a fixative for cosmetics, perfumes and soaps; as a bactericide and insect repellant; as a solvent for cellulose acetate, dyes, stamp pads, ball point, and specialty inks.” (5) “It has the ability to inhibit phagocytic activity, meaning toxic to all cells. The phenol the 2-PE is capable of disabling the immune system’s primary response mechanism. It can also cause systemic poisoning, headache, shock, weakness, convulsions, kidney damage, cardiac failure, kidney failure, or death” (6) Included in Polio (IPV), Dtap (Daptacel), Dtap+IPV+Hib (Pentacel), Tdap (adacel)
3-0-desacyl-4′ Monophosphoryl lipid- “The invention pertains to adjuvant and vaccine compositions of monophosphoryl lipid A, sugar and optionally an amine based surfactant, which when frozen and thawed or lyophilized and reconstituted reform a colloidal suspension having a light transmission of greater than or equal to 88 % as measured spectrophotometrically.” (7) “Adjuvant System 04 (AS04) consisting of MPL (3-O-desacyl-4′-monophosphoryl lipid A) adsorbed onto a particulate form of aluminum salt is one of these new generation adjuvants now licensed for use in humans” (8) Included in HPV (Cervarix)
A-tocopheryl hydrogen succinate- “A natural tocopherol and one of the most potent antioxidant tocopherols. It exhibits antioxidant activity by virtue of the phenolic hydrogen on the 2H-1-benzopyran-6-ol nucleus. It has four methyl groups on the 6-chromanol nucleus. The natural d form of alpha-tocopherol is more active than its synthetic dl-alpha-tocopherol racemic mixture.” (9) “Vitamin E is the name given to a group of water-insoluble, plant-derived substances. There are eight naturally-occurring isomers and a number of semisynthetic or synthetic homologues. The naturally-occurring d- (or RRR) alpha-tocopherol is the most biologically active form and vitamin E activity is traditionally expressed in terms of equivalents of this isomer (mg alpha-tocopherol equivalents or a-TE). Other tocopherols such as gamma-tocopherol also have vitamin E activity. There are four tocopherol homologues (d-a-, d-ß-, d-?- and d-d-) and four tocotrienols. Other forms of vitamin E occur in lower amounts in foods and are less active in animal bioassay. The usual form in supplements is synthetic dl- (or all-rac) a-tocopherol that consists of a mixture of active and inactive stereoisomers, because natural vitamin E from wheat germ oil is expensive.” (10) Included in Influenza (Flulaval)
Alcohol- “Alcohol is a chemical class as well as a discrete substance name. In chemistry, a hydroxyl group ( -OH ) added to a molecule of carbon structure is called an ‘alcohol’. So add an -OH to a benzene ring and get phenol. Drink that and you die quickly. Phenol is really what is used when people think formaldehyde is being used. It is an alcohol but it isn’t “alcohol”. Alcohol, a term standing alone without something else modifying it means booze – Ethyl alcohol. Eth means two carbons.” “Alcohol is a good chemical defatting agent . Rub it on your hands and see how chafed they get. That last feature is what we use alcohol for. Fat removal. It is used in window cleaning agents for that chemical trait.Nerves come in two main sorts, those with fat envelopes and those without. The fat insulation speeds up the nerve transmission chemistry by insulating it from the general circulating milieu, the part with chloride and sodium and potassium and calcium ions just itching to pour through neural pores. Fat covered nerves conduct faster by controlling that conduction specific milieu and focusing the ion current to receptive nodes.If there is a nerve that, innocent as it may be, is carrying way too much data as inappropriate bursts of spastic overly repetitive pulses, then placing a speed bump on that nerve can reduce the ill of that overactivity.Alcohol injected right on the nerve directly, strips off the fat from that location and slows conduction there. Multiple speeding impulses pile up and come through as one single impulse. So a stream of impulses such as :gogogogogogogogog—–gogogogogogo—– comes through the block area as:
go—–go—–go—–go—– Engineers call this a low pass filter. When a muscle gets hit with a single “go” it responds. When it gets hit with a barrage of gogogogogogogogog it gets thrown into tetany, a rigid hard to undo contractile state. Worse, it screams for help over feed back circuits which (in spasticity) are mistakenly linked into the motor circuits by reflex spinal pathways.” (11) Included in Meninagococcal (MPSV4-Menomune)
Aluminum hydroxide- “Aluminum hydroxide is used for the relief of heartburn, sour stomach, and peptic ulcer pain and to promote the healing of peptic ulcers. Aluminum hydroxide is also used sometimes to decrease the amount of phosphate in the blood of patients with kidney disease. Side effects include constipation, loss of appetite, confusion, unusual tiredness or discomfort, and muscle weakness” (12) Included in Tdap (Boostrix), Dtap (Infranix), Hep B (Engerix-B), HPV (Cerverix), Dtap+IPV (Kinrix), Dtap+Hep B+IPV (Pediarix), Hep A (Havrix), Hep A+Hep B (Twinrix)
Aluminum hydroxyphosphate sulfate- same as amorphous aluminum hydroxyphosphate sulfate. Included in Hib (PedvaxHIB)
Aluminum phosphate- “Aluminum phosphate mixture is a slow acting antacid used similarly to aluminum hydroxide mixture. Unlike aluminum hydroxide, it does not interfere with phosphate absorption and is used when a high-phosphporus diet cannot be maintained or if there is diarrhea or a deficiency of pancreatic juice. It is also used as an adjuvant in adsorbed vaccines. The mixture is given in doses of 5 to 15 ml and dried aluminum phosphate in doses of 400 to 800 mg. Aluminum is ubiquitous, it is the most abundant metal in the earth’s crust. The majority of human exposure comes from food. It is present in some pharmaceuticals, primarily antacids, analgesics, antacids, antidiarrheals, astringents and as adjuvants for vaccines. In industry it is widely used in construction materials and packaging. Aluminum inhibits bone remodeling, causing osteomalacia. It is believed to inhibit erythropoiesis, causing anemia.Acute toxicity is rare. Most cases of aluminum toxicity in humans are in one of two categories: patients with chronic renal failure, or people exposed to aluminum in the workplace. Soluble forms of aluminum (such as aluminum chloride (AlCl(3+)), aluminum fluoride (AlF(3)), aluminum sulfate (Al(SO4)3) and aluminum citrate (AlC(6)H(8)O(7))) have greater potential for toxicity than insoluble forms (such as aluminum hydroxide(AlOH(3))), due to their greater absorption. Patients with renal failure are prone to aluminum toxicity, either from aluminum in the dialysate or other exogenous sources, especially aluminum-containing phosphate binders and antacids. Signs and symptoms may include dementia, memory loss, aphasia, ataxia, seizures, altered EEG, and osteomalacia. Encephalopathy has been reported in patients with renal failure. This may range from mild personality changes and speech disorders to severe obtundation, seizures,coma and death. Fatal encephalopathy with status epilepticus has occurred after the use of aluminum-containing bone cement in vestibular neurectomies. Aluminum has also been linked to the histopathology of Alzheimer disease. Occupational exposure to aluminum has been associated with cognitive deficits and delayed reaction times. Aluminum in drinking water has been linked to central nervous system birth defects. Some aluminum compounds have proven teratogenic in laboratory animals; however, overall, aluminum is not considered teratogenic.” (13) Included in Pneumococcal (PVC13-Prevnar13), Dtap (Daptacel), Dtap+Hep B+IPV (Pediarix), Dtap+IPV+Hib (Pentacel), Hep A+Hep B (Twinrix), Tdap (Adacel)
Amino acids- “An amino acid is any monecule that contains both amino and carborylic acid functional groups. Amino acid is any one of the calss of simple organic compounds comtaining carbon, hydrogen, oxygen, nitrogen, and incertain cases, sulfer. Theses compounds are the building blocks of proteins.” (14) “The side effects of taking too much amino acids depend largely on the kind of amino acid that is being taken. Most are practically harmless and offer many benefits, while others (such as tyrosine) have been reported to cause restlessness, anxiety, and rapid heart beat at higher doses in rare cases.” (15) Included in Hep B (Recombivax), HPV (Cerverix), HPV (Gardasil), Hib+Hep B (Comvax), Hep A (Havrix), Hep A+Hep B (Twinrix), Meninagococcal (MCV4-Menveo), Rotavirus (Rotarix)
Ammonium sulfate- “The chemical compound ammonium sulfate is primarily used in fertilizers but is important in other industries as well. While it isn’t considered highly hazardous to humans, there are some important precautions to take if you’re using it. Ammonium sulfate, also called diammonium sulfate or sulfuric acid diammonium salt, is a white crystalline solid with no smell. It tastes salty. The compound dissolves easily in water but will not dissolve in alcohol or acetone. It readily absorbs water, so if it’s exposed to moist air, it will “scab” on the damp surfaces. When ammonium sulfate reacts with alkaline substances, it gives off ammonia gas. Finally, ammonium sulfate is a fertilizer that’s sometimes used in making homemade explosives. Ammonium sulfate is used most commonly as an artificial fertilizer for alkaline soils. When introduced into damp soil, an ammonium ion is released. This creates a small amount of acid, which lowers the pH balance of the soil. It also contributes nitrogen, which aids in plant growth. It dissolves relatively slowly, which makes it cheaper than some other artificial fertilizers. Ammonium sulfate is also used as an herbicide because it will burn the leaves of plants and either kill them outright or at least weaken them for easy removal. This compound is used in the production of printed circuit boards. It’s also in flame retardant materials because it lowers the combustion temperature and increases the production of residues or chars. Ammonium sulfate activates yeast, so it helps to get industrially produced bread to rise, and it’s also a general-purpose food additive. Finally, it plays an important role in developing vaccines during the purification process. The DTap vaccine, which protects children from diphtheria, tetanus, and whooping cough, uses ammonium sulfate for this purpose. Ammonium sulfate is potentially dangerous to both people and the environment, so it requires care in its use. It can cause severe irritation and inflammation of the respiratory tract if inhaled. Eating or drinking ammonium sulfate will cause irritation in the gastrointestinal tract like nausea, vomiting, and diarrhea, although it isn’t toxic unless consumed in large quantities. Contact with the skin or eyes will cause irritation, redness, itching, and pain. It may also be a neurotoxin, meaning it can cause confusion and behavioral changes.” (16) Included in Hib (ActHIB), Pneumococcal (PCV13-Prevnar13), Dtap (Daptacel), Dtap+TPV+Hib (Pentacel), Tdap (Adacel)
Amorphous aluminum hydroxyphosphate sulfate- “Merck Aluminum Adjuvant (AAHS) is a proprietary aluminum hydroxyphosphate sulfate formulation that is both physically and functionally distinct from traditional aluminum phosphate and aluminum hydroxide adjuvants. At a macromolecular level, AAHS is structurally related to aluminum phosphate as it forms an amorphous mesh like structure. AAHS bears a nearly zero charge at neutral pH”(17) “The amount of aluminum in the recommended individual dose of a biological product shall not exceed 1.250mg. However, infants are exceeding the maximum recommended dose depending on which vaccine is given, and how many vaccines are being given in one day. This far exceeds the FDA’s safety limit on aluminum. “The FDA determined that babies should not get more than about 25 to 50 micrograms of aluminum in any one day,” Dr. Sears says. “If too much aluminum is injected all at once, it can find its way into the brain, bones and body organs and cause damage. This was discovered many years ago in hospitalized patients who were receiving IV solutions containing too much aluminum.” Aluminum neurotoxicity has been recognized in experimental animals, in individuals with renal failure, and links to neurodegenerative disorders to aluminum exposure. Also, aluminum content in infant formulas, and in intravenous solutions for home parenteral nutrition, has been associated with neurological consequences and metabolic bone disease, characterized by low-bone formation rate.Symptoms of mild to moderate acute aluminum phosphide toxicity may include nausea, agitation and chills, restlessness, abdominal pain, tightness in chest, and excitement. Symptoms of aluminum toxicity may include disorientation, colic, memory loss, headaches, learning difficulty, mental confusion, heartburn, loss of coordination, and flatulence. More severe symptoms of toxicity may include tachycardia (rapid pulse), diarrhea, respiratory failure, cyanosis, dizziness and/or death, difficulty breathing, pulmonary edema, and hypotension (low blood pressure). Convulsions have been to occur in lab animals exposed to high concentrations of phosphine. Severe exposure may indicate kidney damage. Pathological examination of exposed laboratory animal tissue and results of post-mortem examinations of phosphine poisoning in people generally indicate hypoxia, along with evidence of local trauma in the gastrointestinal tract or lungs, liver, kidneys and central nervous system. The antigen presenting cells can cause problems. Dendritic cells that present antigen for too long will allow abnormal antibodies to be produced; also known as autoantibodies. Antigen presenting cells from vaccines promote a better immune response and aluminum ensures this abnormal response.When macrophages cross the blood brain barrier they take aluminum with them and are thus affected by aluminum as well. They can become loaded with aluminum particles and disrupt their function. Aluminum can integrate into molecular functions but it is also a neurotoxin. It alters permeability of the blood-brain barrier making the brain more accessible to other toxins in the body, just as Thimerosal can. Aluminum hydroxide when used in vaccines is injected through the skin right to the tissue where it is absorbed and enters the brain. Myelin is the protective protein which coats neurons and covers the spinal cord. Damage to this protein is referred to as demyelination. Multiple Sclerosis, Acute Disseminated Encephalomyelitis, Autism, Transverse Myelitis, and Optic Neuritis are examples of demyelinating diseases when damage to myelin causes neurological dysfunction. So, Aluminum interacts directly with DNA. Exogenous aluminum interacts via membrane contact and with cell signaling events. Both mechanisms take place and around 30 genes can be affected. Seven of which are significantly up-regulated or in other words, genes that are primarily pro-inflammatory or pro-apoptotic: apoptosis means cell suicide. The consequences for brain development are still unknown since there has not been enough research done to date. However, it is known that aluminum in vaccines is sufficient to induce abnormal gene expression in the brain. ” (18) Included in Hep A (Vaqta), Hep B (Recombivax), HPV (Gardasil), Hib+Hep B (Comvax)
Arginine- “L-arginine is an amino acid commonly sold in supplement form and obtained naturally in the diet. L-arginine-rich foods include plant and animal proteins, such as dairy products, meat, poultry, fish, and nuts. It may help with health problems such as angina, erectile dysfunction, congestive heart failure, boost immune system, colds, and high blood pressure. There are a number of side effects including indigestion, nausea, headache, bloating, diarrhea, gout, blood abnormalities, allergies, airway inflammation, worseing of asthma, and low blood pressure. Higher doses can increase stomach acid, so it may also worsen heartburn, ulcers, or digestice upset caused my medication. Due to saftey concers, L-arginine should be avoided by diabetes patients, people who have suffered heart attack and pregnant or nursing women” (19)
Beta-propiolactone- “beta-Propiolactone is used for vaccines, tissue grafts, surgical instruments, and enzymes, as a sterilant of blood plasma, water, milk, and nutrient broth, and as a vapor-phase disinfectant in enclosed spaces. Acute (short-term) inhalation exposure to beta-propiolactone causes severe irritation of the eyes, nose, throat, and respiratory tract in humans. Acute dermal exposure may cause irritation of the skin, blistering, or burns in humans. Contact with the eyes may cause permanent corneal opacification. Burns of the mouth and stomach may occur in humans following acute exposure via ingestion. No information is available on the chronic (long-term), reproductive, developmental, or carcinogenic effects of beta-propiolactone in humans. Squamous cell carcinomas of the forestomach have been reported in orally exposed rats. In dermally exposed rodents, skin tumors have been observed. The International Agency for Research on Cancer (IARC) has classified beta-propiolactone as a Group 2B, possible human carcinogen. Acute inhalation exposure beta-propiolactone causes severe irritation of the eyes, nose, throat, and respiratory tract in humans. Acute dermal exposure may cause irritation of the skin, blistering, or burns in humans. Contact with the eyes may cause permanent corneal opacification. Burns of the mouth and stomach may occur in humans following acute exposure via ingestion. Acute oral exposure has been observed to result in muscular spasms, respiratory difficulty, and convulsions at high levels in rats. In rats acutely exposed intravenously, liver and kidney tubular damage has been reported. In mice, hamsters, and guinea pigs dermally exposed, skin tumors have been observed. EPA has not classified beta-propiolactone for carcinogenicity. IARC has classified beta-propiolactone as a Group 2B, possible human carcinogen.” (20) Included in Influenza (Fluvirin)
Bovine albumin (bovine extract)- “Bovine serum albumin (BSA) is commonly used in cell culture protocols, particularly where protein supplementation is necessary and the other components of serum are unwanted. In cell culture, its main role is as a carrier of small molecules. Because of its negative charge, Bovine Serum Albumin binds water, salts, fatty acids, vitamins and hormones, then carries these bound components between tissues and cells.” (21) When the BSA is attached to an antibody, the complex may deposit in the membrane of the kidney. This leads to inflammation and breakdown of the filter membrane barrier, allowing it to leak imoprtant bodily proteins, clotting factors, immune globulins, etc. that normally would be held back in the selective filteration process. Some diseases that are “nephrotic” include idopatic membranous nephropathy, minimal charge nephropathy (most common in children). Protein-losing nephropathies like theses result in several other problems in the body, namly high blood pressure, high cholesterol and kidney insufficiency. They can also lead to clotting disorders from loss of anitithrombin, infections die to loss of important immune globuins, and vitamin D deficiency due to loss of vitamin D binding proteins among other things. (22) Included in Hep A (Vaqta), Dtap+IPV+Hib (Pentacel), Dtap (Infrarix), Tdap (Boostrix), Dtap+IPV (Kinrix), Dtap+Hep B+IPV (Pediarix)
Calcium carbonate- “Calcium carbonate is a dietary supplement used when the amount of calcium taken in the diet is not enough. Calcium is needed by the body for healthy bones, muscles, nervous system, and heart. Calcium carbonate also is used as an antacid to relieve heartburn, acid indigestion, and upset stomach. Side effects include upset stomach, vomiting, stomach pain, belching, constipation, dry mouth, increased urinatin, decreased appetite, metallic taste.” (23) “Calcium carbonate, or CaCO3, comprises more than 4% of the earth’s crust and is found throughout the world. Its most common natural forms are chalk, limestone, and marble, produced by the sedimentation of the shells of small fossilized snails, shellfish, and coral over millions of years. Although all three forms are identical in chemical terms, they differ in many other respects, including purity, whiteness, thickness and homogeneity. Calcium carbonate is one of the most useful and versatile materials known to man.” (24) Included in Rotavirus (Rotarix)
Calf Serum Protein (fetal bovine serum)- “Serum is the liquid fraction of clotted blood from fetal calf, depleted of cells, fibrin and clotting factors, but containing a large number of nutritional and macromolecular factors essential for cell growth. Bovine serum albumin is the major component of the fetal bovine serum. Very important is the myriad of growth factors in fetal bovine serum, which are essential for the maintenance and growth of cultured cells. Fetal bovine serum also contains small molecules like amino acids, sugars, lipids, and hormones. FBS is used in cell culture of eukaryotic cells, and has a wide range of applications. For example, it’s used in the research, manufacture, and control of human and veterinary vaccines and of biotech drugs.” (25) For more information about extraction and effects on the human body see fetal bovin serum. Included in Polio (IPV-Ipol), Dtap+IPV (Kinrix), Dtap+Hep B+IPV (Pediarix), MMRV (ProQuad), Zoster (Shingles-Zostavax), Rotavirus (RotaTaq), Varicella (Varivax)
Carbohydrates- “Carbohydrates are one of the three macronutrients in our diet (fat and protein being the others). They exist in many forms and are mainly found in starchy foods such as bread, pasta, and rice, as well as in some beverages, e.g. fruit juices and sugar-sweetened drinks. Carbohydrates represent the most important source of energy for the body, and are vital for a varied and balanced diet. The building blocks of all carbohydrates are sugars and they can be classified according to how many sugar units are combined in one molecule. Glucose, fructose and galactose are prominent examples among the single unit sugars, also known as monosaccharides. Double units are called disaccharides, with sucrose (table sugar) and lactose (milk sugar) being the most widely known.” (26) Included in HPV (Gardasil)
Casamino acids- “Amino acid mixture obtained through the hydrolysis of caseine and used in bacteriology as a culture medium” (27) “Casein is a protein that is found in milk and used independently in many foods as a binding agent. Technically, it is part of a group called phosphoproteins, collections of proteins bound to something containing phosphoric acid. It may also be called caseinogen, particularly in European foods. Casein has also been linked to negative effects in people with autism. While in most people, this protein is easily broken down by the digestive system into peptides known as casomorphins, and then further processed into basic amino acids, some evidence suggests that in autistics, this process does not occur fully. The resulting casomorphins, which fail to break down completely, may have an effect on the body similar to that of morphine or other opiates. For this reason, some experts on autism recommend that people suffering from autism avoid products containing this protein.” (28) Included in Pneumococcal (PCV13-Prevnar13)
Cell culture media- “Animal or plant cells, removed from tissues, will continue to grow if supplied with the appropriate nutrients and conditions. When carried out in a laboratory, the process is called Cell Culture. It occurs in vitro (‘in glass’) as opposed to in vivo (‘in life’). The culture process allows single cells to act as independent units, much like a microorganism such as a bacterium or fungus. The cells are capable of dividing, they increase in size and, in a batch culture, can continue to grow until limited by some culture variable such as nutrient depletion.Cultures normally contain cells of one type although mixed cultures, especially of bacteria, are common in food sciences and wastewater treatment related studies. The cells in culture may be genetically identical (homogenous population) or may show some genetic variation (heterogeneous population). A homogenous population of cells derived from a single parental cell is called a clone. Therefore all cells within a clonal population are genetically identical.” (29) Included in Rotavirus (RotaTeq)
Chick embryo cell culture (egg protein)- “The paper below shows that vaccines cultured in chick embryos (such as measles and mumps) contain “retroviruses” that show potential for replicating (and causing cancer) in the host (human). Researchers have detected “reverse transcriptase” activity in vaccines. Reverse transcriptase is a DNA polymerase enzyme that transcribes single-stranded RNA into double-stranded DNA. ‘BACKGROUND: A recent publication reporting the presence of low levels of reverse transcriptase (RT) activity in certain vaccines for human use necessitated that regulatory agencies address the issue of whether this RT activity presented a risk to humans. Detection of low levels of RT activity corresponding to fewer than ten virions became possible with the development of highly-sensitive polymerase chain reaction (PCR)-based RT (PBRT) assays. Variations of the PBRT assay were developed in three laboratories. These assays were reported as being at least one million-fold more sensitive than conventional RT assays. OBJECTIVE: To ascertain the sensitivity and reliability of PBRT assays in different laboratories and to determine which vaccine samples possessed RT activity. STUDY DESIGN: Coded panels of licensed vaccines together with positive and negative controls was assembled at the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) and distributed to five cooperating laboratories as well as to our laboratory at CBER. Each laboratory carried out their version of the PBRT assay and submitted the results to the coordinator at CBER. RESULTS: Results of the PBRT analyses carried out in the six laboratories are presented. Five of the six laboratories reported results that were highly consistent. RT activity was detected in live attenuated vaccines that were prepared in chick embryo cells (mumps, measles and yellow fever), but very low or undetectable RT activity was found in vaccines produced in mammalian cells (rabies and rubella). influenza vaccines from several manufacturers included in the panel displayed the most variability, with different products of this inactivated vaccine having differing amounts of RT activity. CONCLUSIONS: Only vaccines produced in chick embryo cells had significant RT activity. Because RT activity was present in the allantoic fluid of uninfected chick embryos and culture medium from chick embryo fibroblasts, the RT activity arises from the cell substrate used for vaccine production. The PBRT assays were reliably able to detect the low levels of RT activity in chicken-derived vaccines.’ -Maudru T, Peden KW. Laboratory of Retrovirus Research, Food and Drug Administration, Bethesda, MD 20892, USA. Analysis of a coded panel of licensed vaccines by polymerase chain reaction-based reverse transcriptase assays: a collaborative study.Clin Virol. 1998 Jul 24;11(1):19-28.” (30) Included in MMR (MMRII), MMRV (ProQuad), Influenza (Fluvirin), Influenza (Flumist), Influenza (Fluzone:high dose)
CMRL 1969 medium (supplemented with calf serum)- “An improved tissue culture basal medium, CMRL-1969, supplemented with serum, has been evaluated by measuring the growth responses of primary cultures of trypsin-dispersed monkey kidney cells (PMKC) and of an established culture of a human diploid cell strain (HDCS). Medium H597, an early modification of medium 199 which has been used successfully in the preparation of poliomyelitis vaccine for 15 years, was used for comparison. In addition, parallel testing was done with Basal Medium Eagle (BME) widely used for the growth of HDCS. The improvements in basal medium CMRL-1969 are attributed to changes in amino acid concentrations, in vitamin composition, and, in particular, to enhanced buffering capacity. The latter has been achieved by the use of free-base amino acids and by increasing the dibasic sodium phosphate.” (31) For more information see calf serum, monkey kindey cells, and human dipliod cells. Included in Dtap+IPV+Hib (Pentacel)
Complex fermentation medium- “Yeast extract (YE) is commonly used as a key component in the complex media for industrial fermentations. However, the lot-to-lot variation of this raw material frequently requires extensive “use testing” of many lots to identify only the few that support desired fermentation performance. Through extensive fermentation studies and chemical analyses, we have identified adenine and two metabolizable carbon sources, trehalose and lactate, as the principle components in YE that affect the production of a recombinant protein antigen by a yeast strain. Adenine is required for culture growth and the relationship between biomass and measured adenine can be expressed by a Michaelis-Menten model, while the slowly metabolized trehalose serves to maintain the energy supply to the continued antigen synthesis. The rapidly utilized lactate exerts an indirect positive effect by sparing some of the accumulated ethanol from being consumed for growth to being utilized in the product formation. The effects of these YE components are mutually dependent. Based on the database generated from 40 lots at laboratory scale, a relatively high level of carbon sources in YE (trehalose plus lactate, >9.5% w/w) and an intermediate level of adenine (0.14-0.24% w/w) appear to be the minimal requirement of a good lot for this recombinant yeast fermentation. Many poor lots were improved in lab fermenters by rational supplementation of trehalose, lactate, or adenine to compensate for their insufficiencies. At the large production scale, predictions based on adenine and trehalose/lactate contents in various YE lots used correlated reasonably well with culture growth and antigen yield, illustrating the feasibility of such a simple chemical/biochemical analysis as a rapid and reliable initial screening tool. Without incurring any compositional change to an established manufacturing medium, this study demonstrates an effective approach to achieve consistency in fermentations employing complex nutrients and to improve fermentation productivities supported by suboptimal lots of raw material.” (32) Included in Hib (PedvaxHIB)
CY medium- “Casitone…………………5.0 g
Yeast extract…………….1.0 g
Distilled water…………..1.0 L (33)
For more informatin see yeast. Included in Meningococcal (MCV4-Menveo)
Detergent- There are many different detergents used in vaccines. Some examples are Trinton X-100 or octylphenol ethorylate, sodium deoxycholate, polysorbate 20, sodium taurochenodeoxycholate. (34) “Cytotoxic; detergents cause cells to leak or explode by weakening their walls. This catastrophically mimics the membrane attack complex (MAC) Octoxynol 9 (or 10) and Triton X-100 typically contain traces of the toxicants ethylene oxide, dioxane, C9 phenols, or glycol ether. Sodium Deoxycholate causes cell death and symptoms such as burning, redness, and swelling. It has been shown to weaken the blood-brain-barrier (BBB) and subsequently activate seizures. It is also known to promote tumor growth. It demonstrates synergistic toxicity — notably with Amphotericin B, the antifungal listed above. Sodium Taurodeoxycholate has been observed to promote tumor growth in the throat, pancreas, colon and other tissues. By increasing cell permeability it also increases drug uptake showing that exposed cells become more vulnerable to toxic insult.” (35)(36)(37)(38)(39) Included in Hib (PedavaxHIB), Hib+Hep B (Comvax), Influenza (Fluzone:high dose), Meninagococcal (MPSV4-Menomune), Influenza (Fluvirin), Influenza (Flulaval), Hep B+Hep A (Twinrix)
Dextran- “The physical and chemical properties of purified dextrans vary depending on the microbial strains from which they are produced and by the production method. Dextrans have high water solubility and the solutions behave as Newtonian fluids. Solution viscosity depends on concentration, temperature, and molecular weight, which have a characteristic distribution. The hydroxyl groups present in dextran offer many sites for derivatization, and these functionalized glycoconjugates represent a largely unexplored class of biocompatible and environmentally safe compounds.”(40) Included in Rotavirus (Rotarix)
Dextrose- “Dextrose is the commercial name used for the crystalline glucose produced from starch. If the crystallized dextrose (glucose) contains no water, it is listed as “dextrose anhydrous” or “anhydrous dextrose” in an ingredient statement. If the crystallized dextrose contains one molecule of water, it will be listed as “dextrose” or “dextrose monohydrate” in an ingredient statement. The majority of the dextrose listed in food ingredient statements began as cornstarch. Food manufacturers may list dextrose produced from cornstarch as “corn sugar” in an ingredient statement. If the dextrose comes from another source like rice or wheat, the ingredient list would read “rice sugar” or “wheat sugar,” respectively. Dextrose is used in many baking products like cake mixes and frostings, snack foods like cookies, crackers and pretzels, and desserts like custards and sherbets. Dextrose is also used as a filler in the single-serve, table-top packets of the common artificial sweeteners.” (41) “When used in small doses, no common side effects have been reported with this product. Seek medical attention right away if any of these severe side effects occur while taking glucose (the active ingredient contained in Dextrose) Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).” (42) Included in Hib+Hep B (Comvax), Hep B (Recombivax)
Dibasic potassium phosphate- “Dipotassium Phosphate is a stable chemical compound used in various manufactured products (mostly food). It comes as an odorless, white crystal powder with a shelf life of about 12 months. It is deliquescent when exposed to moist air. Used as additive in the coffee creamers substitute and as nutrient in various powdered materials (stabilizer (emulsifier) in non-dairy creamers, bodybuilding drinks). Its function is to prevent protein coagulation, and also to prevent its precipitation. It is a humectant. Also included in foods where low Sodium is specified, like low Sodium cheeses. It helps control the pH in food processing applications. Used as nutrient in microorganism cultures to produce antibiotics, and as a buffering agent in certain pharmaceuticals. Put into antifreeze solutions as a buffer and sequestrate, used as a dispersion medium in liquid detergents and as an additive in cheese processes. It’s an ingredient in non-toxic antifreeze. Used as a high efficient, compound fertilizer preparation for special purposes and as additive in the paper industry.” (43) “As well as its needed effects, potassium phosphate may cause unwanted side effects that require medical attention. Side effects include burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings, chest pain or discomfort, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fast, slow, or irregular heartbeat, muscle cramps in the hands, arms, feet, legs, or face, no muscle tone or movement, numbness and tingling around the mouth, fingertips, or feet, pounding or rapid pulse, shortness of breath, unusual tiredness or weakness, weakness and heaviness of the legs” (44) Included in Influenza (Flumist), MMRV (ProQuad)
Dimethyl-1-beta-cyclodextrin- “Cyclic structure oligomers of glucose ( called cyclodextrins) are obtained from the starch digests of the bacteria Bacillus macerans. The individual glucose units are connected by 1,4 bonds. The most abundant cyclodextrins are alpha, beta and gamma cyclodextrin which have 6,7 and 8 glucose units respectively. The interior cavity is hydrophobic and the outside of the molecule is hydrophilic. The enhanced of characteristics such as stability, aqueous solubility, and reduced volatility, can be modified through propoxylation reactions of them. Potential applications of cyclodextrins include water-soluble pharmaceuticals, prolonged drug release, tabletting and herbicides and pesticides.” (45) “CDs offer an additional tool for the formulator to overcome some of the formulation and delivery limitations of problematic drugs. As with any new tool, they have both strengths and weaknesses. Their major strengths are the specific nature of how they interact with drug molecules and their ability to deliver safely a number of intractable drug molecules. The specific nature of their interaction is also a weakness in that only molecules with the right size, geometry, and intrinsic solubility properties benefit from their use. Whereas both α-CD and β-CD and a number of alkylated CDs are known to be renally toxic and disruptive of biological membranes, γ-CD and some of its derivatives, as well as HP-β-CD and SBE-β-CD, appear to be much safer. As more products using CDs are approved or undergo evaluation by regulatory agencies for use in food and pharmaceuticals, concerns about their safety will be clarified.” (46) “Mitochondrion-based MTT test was a more sensitive indicator of cytotoxicity than the plasma membrane-based propidium iodide test.” (47) “The products of the bvgAS locus coordinately regulate expression of the Bordetella pertussis virulence regulon in response to environmental signals. Transcription of bvgAS-activated genes is nearly eliminated by several modulating conditions, including the presence of sulfate anion or nicotinic acid and growth at low temperature. We have isolated spontaneous mutations that result in the constitutive synthesis of multiple bvg-regulated loci. Several of these mutations have been analyzed and were found to result from single-nucleotide substitutions within bvgS, in a region encoding a 161-amino-acid segment which links the transmembrane sequence with cytoplasmic domains that appear to be involved in signaling events. The effect of signal transduction mutations in Escherichia coli was determined by measuring the expression of an fhaB-lacZYA transcriptional fusion, and that in B. pertussis was determined by measuring expression of both fhaB-cat and ptxA3201-cat fusions. The constitutive mutations have little effect on fhaB-cat or fhaB-lacZYA expression in the absence of modulating signals but result in a nearly complete insensitivity to MgSO4, nicotinic acid, or growth at low temperature. Furthermore, insertion and deletion mutations in bvgS sequences encoding the periplasmic domain eliminate activity of the wild-type product, whereas constitutive mutants remain active. In B. pertussis cultures grown in Stainer-Scholte broth, expression of ptxA3201-cat differed from that of fhaB-cat in several respects. In combination with a wild-type bvgS allele, ptxA3201-cat expression required the addition of heptakis-(2,6-O-dimethyl)-beta-cyclodextrin, and this requirement was eliminated by the presence of the constitutive mutations.” (48) Included in Dtap (Daptacel), Tdap- (Adacel)
Dulbercco’s modified Eagle medium (DMEM)- There are many different additives that go into different formulas of this medium. “The most basic formulation offered. This formulation is used by investigators who want to start with the essential components of DME, and have the flexibility to optimize the formula for their own application. Powder, Without L-glutamine, glucose, phenol red, sodium pyruvate and sodium bicarbonate, Supplement with 0.584 gm/L of L-glutamine; 1.0 gm/L glucose; 3.7 gm/L of sodium bicarbonate, Formulated at 8.3 grams of powder per liter of medium , Cell culture tested. Liquid form of the original Dulbecco’s formulation, offered as D 5523, with one key exception. Pyridoxal, which is an aldehyde, has been replaced with pyridoxine. This modification has been shown to improve the stability of the medium. Liquid, With 1000 mg/L glucose and sodium bicarbonate, Without L-glutamine, With pyridoxine (substitutes pyridoxine HCl for pyridoxal Hcl), cell culture tested, endotoxin tested, sterile-filtered.” (49) Included in Rotavirus (Rotarix)
Eagle MEM modified medium- Minimum Essential Medium (MEM) is a modification of Basal Medium Eagle (BME). It was developed by Harry Eagle to meet the specific nutritional requirements of certain subtypes of HeLa cells and normal mammalian fibroblasts. MEM includes higher concentration of amino acids so as to closely approximate the protein composition of cultured mammalian cells.
Composition :
Ingredients mg/L
INORGANIC SALTS
Calcium chloride dihydrate 265.000
Magnesium sulphate anhydrous 97.720
Potassium chloride 400.000
Sodium bicarbonate 2200.000
Sodium chloride 6800.000
Sodium dihydrogen phosphate anhydrous 122.000
AMINO ACIDS
L-Arginine hydrochloride 126.000
L-Cystine dihydrochloride 31.300
L-Histidine hydrochloride monohydrate 42.000
L-Isoleucine 52.000
L-Leucine 52.000
L-Lysine hydrochloride 72.500
L-Methionine 15.000
L-Phenylalanine 32.000
L-Threonine 48.000
L-Tryptophan 10.000
L-Tyrosine disodium salt 51.900
L-Valine 46.000
VITAMINS
Choline chloride 1.000
D-Ca-Pantothenate 1.000
Folic acid 1.000
Nicotinamide 1.000
Pyridoxal hydrochloride 1.000
Riboflavin 0.100
Thiamine hydrochloride 1.000
i-Inositol 2.000
OTHERS
D-Glucose 1000.000
Phenol red sodium salt 11.000 (50) Included in Polio (IPV-Ipol)
Egg proteins- “Egg allergy is one of the most common food allergies of childhood, with a prevalence of 1% to 3% in children under 3 years of age. It is often associated with eczema in infants and asthma in young children. As most children outgrow their egg allergy, the prevalence in adulthood is much lower and is estimated at 0.1%. The most common egg allergy is to egg white. Cross-sensitivity with egg yolk and chicken protein has been described. Vaccines that contain small quantities of egg protein can cause hypersensitivity reactions in some people with allergies to eggs. In Canada, there are several vaccines manufactured by processes involving hens’ eggs or their derivatives, such as chick cell cultures.” (51) For more information see chick embryo cell culture. Included in Incluenza (Fluvirin), Influenza (Flumist), Influenza (Fluzone: high dose), MMR (MMRII), MMRV (ProQuad)
Enzymes- “Enzymes are proteins that initiate change. The enzymes found in the human body are naturally occurring. They catalyze, or accelerate, all normal biochemical reactions in the body. Enzymes are responsible for all metabolic functions and many are absolutely vital for life itself. These proteins are highly specific regarding what they do and under what conditions they do it. Like a glove and a hand, the enzyme and substrate must fit correctly in order to work.” (70) Included in Hib (PedvaxHIB), Hib+Hep B (Comvax)
Ethanol- “Ethanol is a grain alcohol that can be blended with gasoline and used in motor vehicles. Many gasoline stations provide a blended fuel, which typically is 10 percent ethanol and 90 percent gasoline. Ethanol can be fermented from many sources of starch, including corn, wheat, grain sorghum, barley, and potatoes, and from sugar crops such as sugar cane and sweet sorghum. Because there has been has been an abundant supply of corn, most of the ethanol made in the United States is from corn.” (71) For effects on the body see alcohol description. Included in Hib (PedvaxHIB), Hib+Hep B (Comvax)
Ethylenediamine tetraacetic acid (EDTA)- “Chelation therapy is a treatment that involves repeated intravenous (IV) administration of a chemical solution of ethylenediaminetetraacetic acid, or EDTA. It is used to treat acute and chronic lead poisoning by pulling toxins (including heavy metals such as lead, cadmium, and mercury) from the bloodstream. The word chelate comes from the Greek root chele, which means “to claw.” EDTA has a claw like molecular structure that binds to heavy metals and other toxins.” (52) “EDTA is a chemical that binds and holds on to (chelates) minerals and metals such as chromium, iron, lead, mercury, copper, aluminum, nickel, zinc, calcium, cobalt, manganese, and magnesium. When they are bound, they can’t have any effects on the body and they are removed from the body. EDTA is safe when used as a prescription medicine, as eye drops, and in small amounts as a preservative in foods. EDTA can cause abdominal cramps, nausea, vomiting, diarrhea, headache, low blood pressure, skin problems, and fever. It is unsafe to use more than 3 grams of EDTA per day, or to take it longer than 5 to 7 days. Too much can cause kidney damage, dangerously low calcium levels, and death. Nebulizer solutions containing disodium EDTA as a preservative can cause the breathing tubes to narrow in some people with asthma. The size of the dose determines the amount of the narrowing. EDTA might make heart rhythm problems worse. It might interfere with blood sugar control because it can interact with insulin. It can decrease serum calcium levels, making hypocalcemia worse. It can bind with potassium and increase the amount of potassium that is flushed out in the urine. This might cause potassium levels to drop too low, especially in people who have low levels to begin with. If you have this problem, don’t use EDTA. It can bind with magnesium and increase the amount of magnesium that is flushed out in the urine. This might cause magnesium levels to drop too low, especially in people who have low levels to begin with. If you have this problem, don’t use EDTA. EDTA might make liver disease worse. Avoid using EDTA if you have a liver condition. EDTA can harm the kidney and might make kidney disease worse. EDTA doses should be reduced in patients with kidney disease. Avoid using EDTA if you have severe kidney disease or kidney failure.There is some concern that EDTA might increase the risk of seizure in people with epilepsy or in people who tend to have seizures.It can cause severe decreases in blood levels of calcium, and this can cause a seizure. Tuberculosis is a lung infection that is caused by particular bacteria. Sometimes the body is able to “wall off” pockets of infection, making the infection inactive. The bacteria remain alive behind the wall of scar tissue, but they can’t get out to cause illness or infect other people. This scar tissue frequently contains calcium. There is some concern that EDTA might be able to bind the calcium in the scar tissue, causing the “walls” to give way and release bacteria. Don’t use EDTA if you have active TB or had TB in the past.” (53) Included in Influenza (Flumist), Varicalla (Varivax)
Fenton medium (containing a bovine extract)- Fenton medium is well hidden. No inserts or ingredients list. All I could find is that it contains bovine extract. For more information see discription of fetal bovine serum. Included in Dtap (Infanrix), Tdap (Boostrix), Dtap+IPV (Kinrix), Dtap+Hep B+IPV (Pediarix)
Fetal bovine serum- “After slaughter and bleeding of the cow at an abattoir, the mother’s uterus containing the calf fetus is removed during the evisceration process (removal of the mother’s internal organs) and transferred to the blood collection room. A needle is then inserted between the fetus’s ribs directly into its heart and the blood is vacuumed into a sterile collection bag. This process is aimed at minimizing the risk of contamination of the serum with micro-organisms from the fetus and its environment. Only fetuses over the age of three months are used otherwise the heart is considered too small to puncture. Once collected, the blood is allowed to clot at room temperature and the serum separated through a process known as refrigerated centrifugation. It remains questionable as to whether or not fetuses have already died from anoxia (deprivation of oxygen) prior to serum collection. Nevertheless, no anesthesia is given, despite their possible ability to experience pain and discomfort. Serum is a major source of viral contaminants which once present, are almost impossible to remove from cultures. It can contain viruses, prions (a protein that can transform into a rogue agent) and mycoplasma (considered to be a primitive form of bacteria),each of which can skew the outcome of scientific experiments. Many substances present in FCS have not yet been identified, and of the substances which have been, the function of the cultured cells is not always clear. Serum can suppress cell spreading, attachment and embryonal tissue differentiation, which is the process by which embryonic cells develop into specialized cells for particular functions. Critically, this can actually prevent an objective of cell growth research especially when we talk about growing new organs and limbs.” (54) Nearly 100% of all commercially avalable fetal bovine serum is contaminated with viruses, there are no clean cultures. The viruses that are known to be contained are bovine diarrhea virus, bovine leukiema virus, bovine immunosuppresive virus, bovine herpes virus and mycoplasma. Mycoplasma causes changes in cell growth characterstics, inhibition of cell growth metabolism, disruption of nucleic acid synethesis, chromosomal aberrations, altered transfaection rates and virus suseptibility. Dr. Charles Engel stated at an NIH meeting on Feb. 7th, 2000: “I am now of the view that the probable cause of chronic fatigue syndrome and fibromyalgia is the mycoplasma…” (55) Included in Rotavirus (RotaTeq), Varicella (Varivax), Dtap+IPV (Kinrix), MMRV (ProQuad), Zoster (Shingles-Zostavax), Polio (IPV-Ipol)
Formaldyhyde- “Formaldehyde is a commonly used chemical compound that exists in various forms and at room temperature, is a colorless, distinctive, strong and even pungent smelling, flammable and gaseous substance. Formaldehyde has been used in a number of industries for various purposes such as: for the manufacturing of building materials – like pressed wood products (mostly as an adhesive resin), fiber board, plywood, cigarette smoke, fuel burning appliances and kerosene space heaters. Additional uses in household products include: additive for permanent –press, an ingredient in glues, and as a preservative in medical laboratories – as embalming fluid, and as a sterilizer. Since Formaldehyde is a by-product of combustion and other inherent processes, it can be found in significant concentrations and in various environments. It is also critical to note that the “11th report on carcinogens” classifies formaldehyde as “reasonably anticipated to be a human carcinogen”. In recent years, the health effects associated with elevated levels of exposure have brought to light the dangers from prolonged and repeated contact with chemical. The major exposure risks associated with formaldehyde come from occupants inhaling contaminated air. Exposure to elevated levels of this substance should be avoided whenever possible as exposures to high levels of formaldehyde can trigger asthma attacks, nausea, watery and/or burning eyes, difficulty breathing, headaches, respiratory irritation, sensitization. Formaldehyde has been shown to cause cancer in animals and according to the Department of Health and Human Services (DHHS), formaldehyde may “reasonably be anticipated to be a carcinogen”.” (56)
“Formaldehyde has been classified as a known human carcinogen (cancer-causing substance) by the International Agency for Research on Cancer and as a probable human carcinogen by the U.S. Environmental Protection Agency. Research studies of workers exposed to formaldehyde have suggested an association between formaldehyde exposure and several cancers, including nasopharyngeal cancer and leukemia.” (57) “Formaldehyde ingestion results in severe corrosive damage to the gastrointestinal tract followed by CNS depression, myocardial depression, circulatory collapse, metabolic acidosis and multiple organ failure. The toxic effects of formaldehyde in experimental animals include irritation, cytotoxicity, and cell proliferation in the upper respiratory tract, ocular irritation, pulmonary hyperreactivity, bronchoconstriction, gastrointestinal irritation, and skin sensitization. Other reported effects include oxidative stress, neurotoxicity, neurobehavioral effects, immunotoxicity, testicular toxicity, and decreased liver, thyroid gland, and testis weights” (58)
Included in Dtap (Infanrix), Hep A (Vaqta), Influenza (Flulaval), Meningococcal (MCV4-Menactra), Polio (IPV-Ipol), Tdap (Boostrix), Hep B (Recombivax), Tdap (Adacel), Dtap (Daptacel), Dtap+IPV (Kinrix), Dtap+Hep B+IPV (Pediarix), Dtap+IPV+Hib (Pentacel), Hib (Hiberix), Hib+Hep B (Comvax), Influenza (Fluzone: high dose), Meningococcal (MCV4-Menveo)
Formalin- “Formalin is a solution in water of the gas formaldehyde (CH2O). A saturated solution contains about 40% by volume — or 37% by weight — of the gas, plus a small amount of a stabilizer, usually 10-12% methanol; this prevents polymerization. The liquid is used as an embalming fluid and for the preservation of animal specimens and tissue samples. It is also used, generally in a much more dilute form, as a disinfectant, and anti-bacterial wash and in aquariums for treating parasitic infections in fish. The disinfectant properties of the solution are due to the presence of formaldehyde, which also gives it a pungent, irritating smell. There are a number of hazards associated with the use of formalin. It readily releases formaldehyde gas, which is both toxic and highly flammable. Accidental spillage of the solution can quickly raise the concentration of this gas to dangerous levels, posing a direct threat to health and the risk of fire or explosion. If swallowed, the solution has a corrosive effect on the mouth, tongue and esophagus, causing pain, vomiting and bleeding. Other symptoms include kidney failure, effects on the central nervous system and coma. The lethal dose for humans may be around 1 oz (30 ml). People are more likely to suffer ill effects through inhalation of the vapor. At low levels, it is irritating to the eyes and nose and can cause headaches. At higher levels, inhalation can lead to bronchitis and accumulation of fluid in the lungs. Contact with the skin may cause irritation or dermatitis. Eye contact with very dilute solutions causes irritation, but higher concentrations may damage the cornea and cause loss of vision.” (59) “The results of this investigation may be summarized as follows:
1. The inhalation of formaldehyde gas in even small quantities is followed by bronchitis and pneumonia. Pneumonia is due to the inhalation of the gas and not to secondary infection.
2. Formalin belongs to that rare group of poisons which are capable of producing death suddenly when swallowed.
3. The introduction of formalin into the stomach is followed by the production of a gastritis which varies greatly in character. The duodenum and upper jejunum may also be involved in the inflammatory process.
4. Intraperitoneal injections of formalin cause peritonitis of a fibrino-haemorrhagic character. A definite reaction is obtained when very dilute formalin (1–1000) is employed. In the peritoneal cavity formalin exercises a destructive action upon all organs (pancreas, liver, peritoneal fat, Fallopian tubes, etc.) with which it comes in contact and causes inflammation in these organs.
5. The lethal dose of formalin when injected intraperitoneally into guinea pigs is approximately 2 cc. of 1–1000 formalin for each 100 grm. of body weight.
6. The injection of formalin into the lungs is followed by pneumonia and bronchitis.
7. The inflammation which follows subcutaneous injections of formalin is characterized by intense exudation.
8. The injection of formalin into the muscles produces myositis.
9. The injection of formalin into the anterior chamber of the eye causes the accumulation of an exudate containing leucocytes and fibrin. When formalin is dropped into the conjunctival sac iritis follows and may be severe enough to destroy the eye.
10. Formalin in whatever way introduced into the body is absorbed, and is then capable of producing lesions in the parenchymatous organs.
11. Changes in the liver after absorption of formalin consist of mild or severe grade of cloudy swelling accompanied by vacuolation of the protoplasm, changes in the nuclei and leucocytic infiltration. Focal necrosis may result. Similar changes follow the inhalation of formaldehyde.
12. The injection of formalin or the inhalation of the vapors of formaldehyde produces cloudy swelling of the parenchyma of the kidney. Focal necrosis may result.
13. Pneumonia and bronchitis are found in all animals after the injection of formalin.
14. The leucocytic infiltration which follows the introduction of formalin into an organ has these general characteristics: The eosinophiles are the first leucocytes to appear; these are followed by the other polynuclear leucocytes; last appear the large and small mononuclear leucocytes. Similar phenomena occur in the trachea, bronchi and lungs of animals subjected to formaldehyde inhalations.
15. Formalin is, directly or indirectly, chemiotactic for leucocytes. The tissues which are not infiltrated with leucocytes after the injection of formalin are those which have been so injured by the chemical that an inflammatory reaction is impossible.
1 Animals subjected to chronic poisoning with formalin administered by intraperitoneal injection develop fibrinous peritonitis, associated with marked eosinophilia. The changes in the kidneys and liver consist of cloudy swelling, fatty degeneration, focal necrosis and leucocytic infiltration.” (60) Included in Hib (ActHIB), Hep A (Havrix), Hep A+ Hep B (Twinrix), Dtap (Infarnix)
Franz complete medium- “The invention relates to a medium for culturing pathogenic bacteria to produce an immunogenic factor. The medium comprises non-animal derived proteinaceous material. The invention also relates to the use of the medium to cultivate pathogenic bacteria, obtaining immunogenic factors from the bacteria being cultivated and preparing vaccines using the immunogenic factors. Culture medium with yeast or soybean extract as aminoacid source and no protein complexes of animal origin.” (61) For more information see yeast protein and/or soy protein.Included in Meningococcal (MCV4-Menveo)
Gelatin- “Gelatin is a protein obtained by boiling skin, tendons, ligaments, and/or bones with water. It is usually obtained from cows or pigs. Gelatin is used in shampoos, face masks, and other cosmetics; as a thickener for fruit gelatins and puddings (such as Jell-O); in candies, marshmallows, cakes, ice cream, and yogurts; on photographic film; and in vitamins as a coating and as capsules, and it is sometimes used to assist in “clearing” wines. Gelatin is not vegan.” (62) “Gelatin is likely safe for most people in food amounts and possibly safe in the larger amounts used as medicine. There’s some evidence that gelatin in doses up to 10 grams daily can be safely used for up to 6 months. Gelatin can cause an unpleasant taste, sensation of heaviness in the stomach, bloating, heartburn, and belching. Gelatin can cause allergic reactions in some people. There is some concern about the safety of gelatin because it comes from animal sources. Some people are worried that unsafe manufacturing practices might lead to contamination of gelatin products with diseased animal tissues including those that might transmit mad cow disease (bovine spongiform encephalopathy). Although this risk seems to be low, many experts advise against using animal-derived supplements like gelatin.” (63) Included in Varicella (Varivax), Influenza (Fluzone: highdose)
Gentamicin Sulfate- “This medication is used to prevent or treat a wide variety of bacterial infections. Gentamicin belongs to a class of drugs known as aminoglycoside antibiotics. It works by stopping the growth of bacteria. Nausea, vomiting, stomach upset, or loss of appetite may occur. Pain/ irritation/ redness at the injection site may infrequently occur. This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Gentamicin may cause live bacterial vaccines (such as typhoid vaccine) not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor.” (64) Included in Influenza (Flumist)
Glutamate- “Prolonged excitation is toxic to nerve cells. Neurobiologists recognize that the nerve cell messenger, glutamate, can cause harm when its messages are overwhelming. Normally glutamate is swiftly cleared from the nerve cell junctions to keep the messages brief. Molecules called transporters aid in keeping glutamate in proper concentrations around nerve cells. Abundant evidence points to glutamate as a destructive factor in ALS and investigators are working to find out how this can be changed. Gene therapy approaches are under investigation to deliver glutamate transporters to cells affected by ALS. Other avenues towards control of glutamate in ALS are also under active investigation. Nerve cells pass signals to each other and to their target organs by releasing messenger molecules, called transmitters. Many are simple amino acids such as the one called glutamate.
The message is intended to tell the recipient neuron whether to fire off its own neurotransmitters. As with all neurotransmitters, glutamate docks at specific recognition molecules on the receiving neuron. Glutamate is then swiftly cleared from the nerve cell junctions to keep the message brief. Prolonged excitation is toxic to nerve cells, and neurobiologists recognize that glutamate can cause harm when the messages are overwhelming, as in stroke or epilepsy. Glutamate’s toxicity is apparently due to calcium flooding the cell. Calcium is supposed to briefly enter the neuron with each signal and triggers the cell to fire off its own signals and adjust its own activities accordingly. But prolonged calcium inside the cell evidently can do damage, and will even activate programmed cell death.” (65) Included in Varicella (Varivax)
Glutaraldehyde- “Glutaraldehyde is a colorless glass-like crystal that is usually in a 2% to 50% water solution. It is used for cold sterilization of dental and medical equipment and as a preservative, biocide, hardener, and tanning agent. Glutaraldehyde is on the Right to Know Hazardous Substance List because it is cited by ACGIH, DOT and NIOSH. Glutaraldehyde can affect you when inhaled and by passing through the skin. Contact with the liquid and vapor can severely irritate and burn the skin and eyes. Inhaling Glutaraldehyde can irritate the nose, throat and lungs causing coughing, wheezing and/or shortness of breath. Glutaraldehyde can cause headache, nausea and vomiting. Glutaraldehyde may cause a skin allergy and an asthma- like allergy.” (66) “Glutaraldehyde is a hazardous chemical used for cold sterilization of medical and dental equipment. Glutaraldehyde based products are effective sterilants and disinfectants for medical devices that cannot be steam sterilized, are particularly heat-sensitive, for lensed instruments that are commonly subjected to high-level disinfection between patient uses. It is a colorless, oily liquid with a pungent odor. As a cold sterilizer it is commonly used as a 2%-4% aqueous solution, and it is found in Ultizyme. Glutaraldehyde has also been used as a preservative in chemical products such as fabric softeners, antiperspirants and fixatives for biological specimens.” (67) Included in Dtap (Daptacel), Dtap+IPV (Kinrix), Dtap+Hep B+IPV (Pediarix), Dtap+IPV+Hib (Pentacel), Tdap (Adacel), Tdap (Boostrix)
Hemin Chloride- “Treating symptoms of certain blood disorders (porphyria). It may also be used for other conditions as determined by your doctor. Hemin is an enzyme inhibitor made from red blood cells. It works by correcting certain types of heme deficiency in the liver. May cause mild fever; pain, redness, or swelling at the injection site. 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); change in the amount of urine; unusual bleeding; unusual tiredness.” (68) “Hemin chloride, a heme oxygenase 1 inducer, is a porphyrin complex that is derived from erythrocytes. At a concentration of 20 mM Hemin chloride demonstrated the significance of heme in myotube maturation by increasing size, number, cross-striations, and contraction frequency and strength of myotubes. The compound has been observed to induce cGMP formation through induction of guanylate cyclase. Hemin chloride has been noted to stimulate calcium-dependent K+ channels and modulate fluid transport and Na+ in the loop of henle in rat studies. Hemin has also been documented to give rise to active chloride secretion in Caco-2 cells. In cadmium injured rat testes, hemin chloride demonstrated anti-apoptotic, antiinflamatory and antioxidant properties. Derived from procine.” (69) Included in Hib+Hep B(Comvax)
Human albumin- “Treating a variety of conditions, including shock due to blood loss in the body, burns, low protein levels due to surgery or liver failure, and as an additional medicine in bypass surgery. It may be used for certain conditions as determined by your doctor. Albumin (human) is a concentrate of plasma proteins from human blood. It works by increasing plasma volume or serum albumin levels. Side effects include:Anaphylactoid reactions, fever, chills, rash, nausea, vomiting, tachycardia, hypotension. Dermatologic side effects have included urticaria, skin rash, pruritus, edema, and erythema.Nervous system side effects have included headache, chills, and febrile reactions. Cardiovascular side effects have included hypotension. Gastrointestinal side effects have included nausea, vomiting and increased salivation. Respiratory side effects have included bronchospasm.” (72) Included in MMRV (ProQuad) MMR (MMR-II)
Human diploid cell cultures- “In fact, some vaccines are grown in cell cultures that were originally obtained from two human fetuses. In addition, the rubella virus used to make rubella vaccine was isolated from a third human fetus. Two different strains of human diploid cell cultures made from fetuses have been used extensively for vaccine production for decades. One was developed in the United States in 1961 (called WI-38) and the other in the United Kingdom in 1966 (called MRC-5). WI-38 came from lung cells from a female fetus of 3-months gestation and MRC-5 was developed from lung cells from a 14-week-old male fetus. Both fetuses were intentionally aborted, but neither was aborted for the purpose of obtaining diploid cells. The fetal tissues that eventually became WI-38 and the MRC-5 cell cultures were removed from fetuses that were dead. The cellular biologists who made the cell cultures did not induce the abortions. These two cell strains have been growing under laboratory conditions for more than 35 years.” (73) For more information on effects on the body see WI-38 and MRC-5 descriptions. Included in Varicella (Varivax), Dtap+IPV+Hib (Pentacel), Hep A+Hep B (Twinrix), Hep A (Havrix), MMRV (ProQuad), Zoster (Shingles-Zostavax), Hep A (Vaqta), MMR (MMR-II)
Hydrolyzed gelatin (hydrolyzed collagen)- “Hydrolyzed collagen refers to enzymatically or chemically processed collagen derived from marine life, though it can also be taken from bovine, ox, pig skin, and bone. It is water soluble and contains peptides like amino acids as well as glycine, proline, hydroxyproline, and glutamic acid. Hydrolyzed collagen is normally used to benefit nails and skin due to the presence of the amino acids. It is also used to regenerate cells for the body’s lean muscle mass, benefit arthritis, and even help the body burn off fat and enhance weight loss. Hydrolyzed collagen side effects from topical use may trigger dermatitis or inflammation of the skin. Initially, a mild rash may develop. Since dermatitis is an allergic reaction, the reaction may therefore depend on the person using the cream and doesn’t affect every user. Before taking any supplement orally, you should check with your physician for any allergies to animal products. While marine collagen is very much safe, people might have allergic reactions to animal or plant hydrolyzed collagen. Some hydrolyzed collagen supplements are now being made from chicken. While no studies yet show any bad effects from chicken based hydrolyzed collagen, other chicken based supplements aside from collagen have been known to cause mild cases of nausea, heartburn, diarrhea, constipation, drowsiness, skin reactions, and headache.” (74) For more information see gelatin description. Included in MMR (MMR-II), MMRV (ProQuad)
Hydrolyzed porcine gelatin- Gelatin made from pork. For more information see gelatin or hydrolyzed gelatin. Included in Influenza (Flumist), Zoster (Shingles-Zostavax)
Insect cell and viral proteins- “Insect cells (IC) and particularly lepidopteran cells are an attractive alternative to mammalian cells for biomanufacturing. Insect cell culture, coupled with the lytic expression capacity of baculovirus expression vector systems (BEVS), constitutes a powerful platform, IC-BEVS, for the abundant and versatile formation of heterologous gene products, including proteins, vaccines and vectors for gene therapy. Such products can be manufactured on a large scale thanks to the development of efficient and scalable production processes involving the integration of a cell growth stage and a stage of cell infection with the recombinant baculovirus vector. Insect cells can produce multimeric proteins functionally equivalent to the natural ones and engineered vectors can be used for efficient expression. Insect cells can be cultivated easily in serum- and protein-free media.” (75) “Insect cell culture is a common choice for heterologous protein expression. For large scale production or basic research, insect cells are able to express large quantities of protein with complex post-translational modifications.” (76) “Sf9 (Cat. no. B825-01) and Sf21 (Cat. no. B821-01) cell lines are the traditional cell lines used with baculovirus and originated at the USDA Insect Pathology Laboratory. The cell lines are also suitable for use in the InsectSelect™ System. These two cell lines originated from the IPLBSF-21 cell line, derived from the pupal ovarian tissue of the fall armyworm, Spodoptera frugiperda (O’Reilly et al., 1992; Vaughn et al., 1977). When working with recombinant or wild-type viral stocks (e.g.,infecting cells),
always maintain separate media bottles for cell culture and for virus work. Baculovirus particles can survive and be maintained in media at 4°C, and will contaminate your stock cultures if introduced to culture plates or flasks during passaging. The following section summarizes the most common problems associated with insect cell culture. Morphological changes in the cells or changes in the growth rate can indicate an underlying problem with the culture. Keeping a good record of cells (i.e. ,cell density, viability, and detailed notes on the health of the cells) will help in troubleshooting potential problems that may arise. Information below may be used as a guideline to help troubleshoot common problems observed in culturing insect cells.” (77) “Baculoviruses are arthropod‐specific, enveloped viruses with circular, supercoiled double‐stranded DNA genomes. They infect Lepidoptera (butterflies and moths), Hymenoptera (sawflies) and Diptera (mosquitoes).. While many viruses are studied because of their damaging effects, the study of baculoviruses was stimulated by their potential utility to control insect pests. Later, the utility of baculovirus as gene expression vectors was evidenced and a new research area emerged. A major step forward was the development of bacmid technology (the construction of bacterial artificial chromosomes containing the genome of the baculovirus) which allows the manipulation of the baculovirus genome in bacteria. With this technology, foreign genes can be introduced into the bacmid by site‐ directed recombination or by transposition. Baculoviruses have been used to explore fundamental questions in molecular biology such as the nature of programmed cell‐death. Moreover, the ability of baculoviruses to transduce mammalian cells led to the consideration of their use as gene therapy and vaccine vectors. Strategies for genetic engineering of baculoviruses have been developed to meet the requirements of new application areas, and the establishment of new genetic modification systems is still necessary when an unexplored experimental system is to be addressed. The aim of this chapter is to detail the areas of application of the baculovirus in basic molecular biology and applied biotechnology and the strategies used to generate genetically modified baculoviruses according to each area of study.” (78) “A new vaccine for influenza has hit the market, and it is the first ever to contain genetically-modified (GM) proteins derived from insect cells. According to reports, the U.S. Food and Drug Administration (FDA) recently approved the vaccine, known as Flublok, which contains recombinant DNA technology and an insect virus known as baculovirus that is purported to help facilitate the more rapid production of vaccines.
According to Flublok’s package insert, the vaccine is trivalent, which means it contains GM proteins from three different flu strains. The vaccine’s manufacturer, Protein Sciences Corporation (PSC), explains that Flublok is produced by extracting cells from the fall armyworm, a type of caterpillar, and genetically altering them to produce large amounts of hemagglutinin, a flu virus protein that enables the flu virus itself to enter the body quickly. So rather than have to produce vaccines the “traditional” way using egg cultures, vaccine manufacturers will now have the ability to rapidly produce large batches of flu virus protein using GMOs, which is sure to increase profits for the vaccine industry. But it is also sure to lead to all sorts of serious side effects, including the deadly nerve disease Guillain-Barre Syndrome (GSB), which is listed on the shot as a potential side effect.
“If Guillain-Barre Syndrome (GBS) has occurred within six weeks of receipt of a prior influenza vaccine, the decision to give Flublock should be based on careful consideration of the potential benefits and risks,” explains a section of the vaccine’s literature entitled “Warnings and Precautions.” Other potential side effects include allergic reactions, respiratory infections, headaches, fatigue, altered immunocompetence, rhinorrhea, and myalgia. According to clinical data provided by PSC in Flublok’s package insert, two study participants actually died during trials of the vaccine. But the company still insists Flublok is safe and effective, and that it is about 45 percent effective against all strains of influenza in circulation, rather than just one or two strains.” (79) Included in HPV (Cervarix) and Influenza (Flublock)
L-Histidine- “Histidine is an amino acid. Amino acids are the building blocks of protein in our bodies. People use histidine as medicine. Histidine is used for rheumatoid arthritis, allergic diseases, ulcers, and anemia caused by kidney failure or kidney dialysis. Histidine is involved in a wide range of metabolic processes in the body. Histidine might be safe for most people. Doses of up to 4 grams per day have been used in research without causing noticeable side effects. Not enough is known about the use of histidine during pregnancy and breast-feeding. Stay on the safe side and avoid use.” (80) Included in HPV (Gardasil)
Lactalbumin hydrolysate- “Lactalbumin Hydrolysate (LAH) Solution Concentrate (50X) is a peptone frequently utilized as a nutritional supplement for preparing bacterial, insect and mammalian cell culture, especially as a rich source of amino acids. Lactalbumin Hydrolysate (LAH) is a supplement utilized with Grace’s Insect Cell Culture Medium for Baculovirus protein expression systems to assist in increasing biomass production. It is also an overlay for the protein expression. LAH may also be utilized, aside from other cell or tissue culture or microbiological applications/formulations, for the production of vaccines of viral origin.” (81) For more information see insect cells. Included in Dtap+IPV (Kinrix), Dtap+Hep B+IPV (Pediarix)
Lactose- “Lactose or milk sugar occurs in the milk of mammals – 4-6% in cow’s milk and 5-8% in human milk. It is also a by product in the the manufacture of cheese. The galactose and glucose units are joined by an acetal oxygen bridge in the beta orientation. Lactose intolerance is the inability to digest significant amounts of lactose, the predominant sugar of milk. This inability results from a shortage of the enzyme lactase, which is normally produced by the cells that line the small intestine. Lactase breaks down the lactose, milk sugar, into glucose and galactose that can then be absorbed into the bloodstream. When there is not enough lactase to digest the amount of lactose consumed, produce some uncomfortable symptoms. Some adults have low levels of lactase. This leads to lactose intolerance. The ingested lactose is not absorbed in the small intestine, but instead is fermented by bacteria in the large intestine, producing uncomfortable volumes of carbon dioxide gas. While not all persons deficient in lactase have symptoms, those who do are considered to be lactose intolerant. Common symptoms include nausea, cramps, bloating, gas, and diarrhea, which begin about 30 minutes to 2 hours after eating or drinking foods containing lactose. The severity of symptoms varies depending on the amount of lactose each individual can tolerate.” (82) Included in Hib (Hiberix), Meningococcal (MPSV4-Menomune)
Latham medium (derived from bovine casein)- “Composition of the Modified Latham Medium (per 1 liter of the medium):
Polypeptone 20 g
Bovine heart extract 10 g
Glucose 8.0 g
Sodium chloride 2.5 g
Magnesium sulfate (heptahydrate) 0.1 g
Cystine 0.125 μg
Calcium pantothenate 1.0 mg
Uracil 1.25 mg
Nicotinic acid 0.25 mg
Thiamine 0.25 mg
Riboflavin 0.25 mg
Pyridoxine 0.25 mg
Biotin 2.5 μg
Vitamin B12 0.05 μg
Folic acid 100 μg
Iron(III) chloride (hexahydrate) 32 mg
Iron sulfate (heptahydrate) 0.2 g
(The pH was adjusted to 7.0 using 7N NaOH)” (83) Included in Dtap (Infanrix), Tdap (Boostrix), Dtap+IPV (Kinrix), Dtap+Hep B+IPV (Pediarix)
Lipids- “All Lipids are hydrophobic: that’s the one property they have in common. This group of molecules includes fats and oils, waxes, phospholipids, steroids (like cholesterol), and some other related compounds.” (84) Included in HPV (Cervarix)
Medium 199- “Medium 199 was originally developed for nutritional studies of chick embryo fibroblasts. It has broad species applicability, particularly for cultivation of non-transformed cells. Medium 199 is widely used in virology, vaccine production, and in vitro cultivation of primary explants of mouse pancreatic epithelium, and rat lens tissues. The complete formulation is available.
Compared to other basal media, Medium 199 contains unique components, including adenine, adenosine, hypoxanthine, thymine, and additional vitamins. Medium 199 is available with Earle’s salts for use in a CO2 incubator, or with Hank’s salts for use without CO2.” (85) Included in Dtap+IPV+Hib (Pentacel), MMR (MMR-II)