| CHECK BELOW FOR THE 83 VACCINES’ MANUFACTURERS’ INSERT INFORMATION (FOR PHYSICIANS) ON SECTION 13WHERE THEY STATE THAT…
NO vaccine has been evaluated for the potential to cause:
THE SOURCE OF THIS INFORMATION IS THE U.S. FOOD AND DRUG ADMINISTRATION – FDA) –http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093833.htm In addition, vaccine manufacturers are held to a lower standard than other pharmaceutical, and are not required to do double-blind placebo studies or long-term studies past 6 months, nor have they ever compared vaccinated populations with the unvaccinated! Meanwhile, every person who gets a vaccine is being injured by them. See VACCINE SUMMARY –http://www.healthalertphilly.org/Vaccines.htm NOTE: Beware of “patients inserts” are not the same as “physicians inserts” and may not contain the same information. SAMPLE VACCINE INSERT SECTION: Section 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility VAXCHORA has not been evaluated for the potential to cause carcinogenicity or genotoxicity, or to impair fertility.e |
Trade Name |
| 1. Adenovirus Type 4 and Type 7 Vaccine, Live, Oral Section 13, omittted |
No Trade Name |
| 2. Anthrax Vaccine Adsorbed 13. NONCLINICAL TOXICOLOGY The effect of BioThrax on embryo-fetal and pre-weaning development was evaluated in a developmental toxicity study using pregnant rabbits. One group of rabbits was administered BioThrax twice prior to gestation and during the period of organogenesis (gestation day 7). A second group of rabbits was administered BioThrax twice prior to gestation and on gestation day 17. BioThrax was administered at 0.5 ml/rabbit/occasion, by intramuscular injection. No adverse effects on mating, fertility, pregnancy, parturition, lactation, embryo-fetal or preweaning development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis noted in this study |
Biothrax |
| 3. BCG Live BCG VACCINE has not been evaluated for carcinogenic, mutagenic potentials or impairment of fertility. |
BCG Vaccine |
| 4. BCG Live TICE® BCG has not been evaluated for its carcinogenic, mutagenic potentials or impairment of fertility. |
TICE BCG |
| 5. Cholera Vaccine Live Oral VAXCHORA has not been evaluated for the potential to cause carcinogenicity or genotoxicity, or to impair fertility. |
Vaxchora |
| 6. Diphtheria & Tetanus Toxoids Adsorbed Diphtheria and Tetanus Toxoids Adsorbed has not been evaluated for carcinogenicity, mutagenic potential, or impairment of fertility. |
No Trade Name |
| 7. Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed Tripedia vaccine has not been evaluated for its carcinogenic or mutagenic potentials or impairment of fertility. |
Tripedia |
| 8. Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed INFANRIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility. |
Infanrix |
| 9. Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed DAPTACEL has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility. |
DAPTACEL |
| 10. Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed, Hepatitis B (recombinant) and Inactivated Poliovirus Vaccine Combined PEDIARIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility. |
Pediarix |
| 11. Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine KINRIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility. |
KINRIX |
| 12. Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine Quadracel has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility. |
Quadracel |
| 13. Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Pentacel vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility. |
Pentacel |
| 14. Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) Liquid PedvaxHIB has not been evaluated for carcinogenic or mutagenic potential, or potential to impair fertility. |
PedvaxHIB |
| 15. Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) ActHIB vaccine has not been evaluated for its carcinogenic or mutagenic potential or impairment of fertility. |
ActHIB |
| 16. Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) HIBERIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility. |
Hiberix |
| 17. Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) & Hepatitis B Vaccine (Recombinant) COMVAX has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility. |
Comvax |
| 18. Hepatitis A Vaccine, Inactivated HAVRIX has not been evaluated for its carcinogenic potential, mutagenic potential, or potential for impairment of fertility. |
Havrix |
| 19. Hepatitis A Vaccine, Inactivated VAQTA has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility. |
VAQTA |
| 20. Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine TWINRIX has not been evaluated for its carcinogenic or mutagenic potential, or for impairment of fertility. |
Twinrix |
| 21. Hepatitis B Vaccine (Recombinant) RECOMBIVAX HB has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility. |
Recombivax HB |
| 22. Hepatitis B Vaccine (Recombinant) ENGERIX-B has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility. |
Engerix-B |
| 23. Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant GARDASIL has not been evaluated for the potential to cause carcinogenicity or genotoxicity. GARDASIL administered to female rats at a dose of 120 mcg total protein, which is equivalent to the recommended human dose, had no effects on mating performance, fertility, or embryonic/fetal survival. The effect of GARDASIL on male fertility has been studied in male rats at an intramuscular dose of 0.5 mL/rat/occasion (120 mcg total protein which is equivalent to the recommended human dose). One group of male rats was administered GARDASIL once, 3 days prior to cohabitation, and a second group of male rats was administered GARDASIL three times, at 6 weeks, 3 weeks, and 3 days prior to cohabitation. There were no treatment-related effects on reproductive performance including fertility, sperm count, and sperm motility. There were no treatment-related gross or histomorphologic and weight changes on the testes. |
Gardasil |
| 24. Human Papillomavirus 9-valent Vaccine, Recombinant GARDASIL 9 has not been evaluated for the potential to cause carcinogenicity, genotoxicity or impairment of male fertility. GARDASIL 9 administered to female rats had no effects on fertility [see Pregnancy (8.1)]. |
Gardasil 9 |
| 25. Human Papillomavirus Bivalent (Types 16, 18) Vaccine, Recombinant CERVARIX has not been evaluated for its carcinogenic or mutagenic potential. Vaccination of female rats with CERVARIX, at doses shown to be significantly immunogenic in the rat, had no effect on fertility. |
Cervarix |
| 26. Influenza A (H1N1) 2009 Monovalent Vaccine Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor AFLURIA has been evaluated for carcinogenic or mutagenic potential or for impairment of fertility. |
No Trade Name |
| 27. Influenza A (H1N1) 2009 Monovalent Vaccine Neither Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal nor FluMist have been evaluated for carcinogenic or mutagenic potential or potential to impair fertility. |
No Trade Name |
| 28. Influenza A (H1N1) 2009 Monovalent Vaccine Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor FLULAVAL has been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility. |
No Trade Name |
| 29. Influenza A (H1N1) 2009 Monovalent Vaccine Neither FLUVIRIN nor the Influenza A (H1N1) 2009 Monovalent Vaccine have been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility. |
No Trade Name |
| 30. Influenza A (H1N1) 2009 Monovalent Vaccine Neither Fluzone vaccine nor Influenza A (H1N1) 2009 Monovalent Vaccine have been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility. |
No Trade Name |
| 31. Influenza Virus Vaccine, H5N1 (for National Stockpile) Influenza Virus Vaccine, H5N1, has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility. |
No Trade Name |
| 32. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted has not been evaluated for carcinogenic or mutagenic potential, or male infertility in animals. Vaccination of female rats with Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted had no effect on fertility [see 385 Pregnancy (8.1)]. |
No Trade Name |
| 33. Influenza Vaccine, Adjuvanted FLUAD has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. FLUAD did not affect female fertility in a rabbit reproductive and developmental toxicity study. |
FLUAD |
| 34. Influenza Vaccine AFLURIA QUADRIVALENT has not been evaluated for carcinogenic or mutagenic potential, or male infertility in animals. A developmental toxicity study conducted in rats vaccinated with AFLURIA (trivalent formulation) revealed no impact on female fertility (see Pregnancy [8.1]). |
AFLURIA QUADRIVALENT |
| 35. Influenza Vaccine FLUCELVAX QUADRIVALENT has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. Administration of Flucelvax vaccine (45 mcg HA/dose) did not affect female fertility in a rabbit reproductive and developmental toxicity study. |
Flucelvax Quadrivalent |
| 36. Influenza Virus Vaccine (Trivalent, Types A and B) AFLURIA has not been evaluated for carcinogenic or mutagenic potential, or male infertility in animals. A reproductive study of female rats vaccinated with AFLURIA revealed no impairment of fertility (see Pregnancy, 8.1). |
Afluria |
| 37. Influenza Virus Vaccine (Trivalent, Types A and B) FLULAVAL has not been evaluated for carcinogenic, mutagenic potential, or male infertility in 15 animals. Vaccination of female rats with FLULAVAL had no effect on fertility [see Use in Specific Populations (8.1)]. |
FluLaval |
| 38. Influenza Vaccine, Live, Intranasal (Trivalent, Types A and B)FluMist Quadrivalent has not been evaluated for its carcinogenic or mutagenic potential or its potential to impair fertility. |
FluMist |
| 39. Influenza Virus Vaccine (Trivalent, Types A and B) FLUARIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility. |
Fluarix |
| 40. Influenza Virus Vaccine (Trivalent, Types A and B) FLUVIRIN® has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility. |
Fluvirin |
| 41. Influenza Virus Vaccine (Trivalent, Types A and B) AGRIFLU has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility. |
Agriflu |
| 42. Influenza Virus Vaccine (Trivalent, Types A and B) Fluzone has not been evaluated for carcinogenic or mutagenic potential or for impairment of fertility. Fluzone High-Dose has not been evaluated for carcinogenic or mutagenic potential or for impairment of fertility. |
Fluzone, Fluzone High-Dose and Fluzone Intradermal |
| 43. Influenza Virus Vaccine (Trivalent, Types A and B) FLUCELVAX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. FLUCELVAX did not affect female fertility in a rabbit reproductive and developmental toxicity study. |
Flucelvax |
| 44. Influenza Vaccine (Trivalent) Flublok has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. A developmental toxicity study conducted in rats vaccinated with Flublok revealed no evidence of impaired female fertility (see Pregnancy [8.1]). |
Flublok |
| 45. Influenza Vaccine (Quadrivalent) Flublok Quadrivalent has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. A developmental toxicity study conducted in rats vaccinated with Flublok (trivalent formulation) revealed no evidence of impaired female fertility (see Pregnancy [8.1]). |
Flublok Quadrivalent |
| 46. Influenza Vaccine,Live, Intranasal (Quadrivalent, Types A and Types B) FluMist Quadrivalent has not been evaluated for its carcinogenic or mutagenic potential or its potential to impair fertility. |
FluMist Quadrivalent |
| 47. Influenza Virus Vaccine (Quadrivalent, Types A and Types B) FLUARIX QUADRIVALENT has not been evaluated for carcinogenic or mutagenic potential or male infertility in animals. Vaccination of female rats with FLUARIX QUADRIVALENT had no effect on fertility [see Use in Specific Populations (8.1)]. |
Fluarix Quadrivalent |
| 48. Influenza Virus Vaccine (Quadrivalent, Types A and Types B) Fluzone Quadrivalent has not been evaluated for carcinogenic or mutagenic potential. A reproductive study of female rabbits vaccinated with Fluzone Quadrivalent was performed and revealed no evidence of impaired female fertility [see Pregnancy (8.1)]. Fluzone Quadrivalent has not been evaluated for carcinogenic or mutagenic potential. A reproductive study of female rabbits vaccinated with Fluzone Quadrivalent was performed and revealed no evidence of impaired female fertility [see Pregnancy (8.1)]. For: Package Insert – Fluzone Quadrivalent – Southern Hemisphere formulation (PDF – 288KB)Section 13 omitted |
Fluzone Quadrivalent |
| 49. Influenza Virus Vaccine (Quadrivalent, Types A and Types B) FLULAVAL QUADRIVALENT has not been evaluated for carcinogenic, mutagenic potential, or male infertility in animals. Vaccination of female rats with FLULAVAL QUADRIVALENT had no effect on fertility [see Use in Specific Populations (8.1)]. |
FluLaval Quadrivalent |
| 50. Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed IXIARO has not been evaluated for carcinogenic or mutagenic potential. IXIARO was found to have no effect on fertility of female rats at intramuscular doses of up to 300-fold excess relative to the projected human dose (on a mg/kg basis) administered prior to and after mating [See Use in Specific Populations (8.1)]. The effect of IXIARO on male fertility has not been evaluated. |
Ixiaro |
| 51. Japanese Encephalitis Virus Vaccine Inactivated No studies have been performed to evaluate carcinogenicity, mutagenic potential, or impact on fertility. |
JE-Vax |
| 52. Measles and Mumps Virus Vaccine, Live
M-M-VAX has not been evaluated for carcinogenic or mutagenic potential, or potential to impair fertility. |
M-M-Vax |
| 53. Measles, Mumps, and Rubella Virus Vaccine, Live M-M-R II has not been evaluated for carcinogenic or mutagenic potential, or potential to impair fertility. |
M-M-R II |
| 54. Measles, Mumps, Rubella and Varicella Virus Vaccine Live ProQuad has not been evaluated for its carcinogenic, mutagenic, or teratogenic potential, or its potential to impair fertility. |
ProQuad |
| 55. Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine MENVEO has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility. |
Menveo |
| 56. Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine MENHIBRIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility. |
MenHibrix |
| 57. Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Menactra has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility. A developmental animal toxicity study showed that Menactra had no effects on female fertility in mice [see Pregnancy (8.1) ]. |
Menactra |
| 58. Meningococcal Group B Vaccine BEXSERO has not been evaluated for carcinogenic or mutagenic potential or impairment of male fertility. |
BEXSERO |
| 59. Meningococcal Group B Vaccine Trumenba has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility in males. |
TRUMENBA |
| 60. Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined Menomune – A/C/Y/W-135 vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility. |
Menomune-A/C/Y/W-135 |
| 61. Plague Vaccine | No trade name |
| 62. Pneumococcal Vaccine, Polyvalent— Section 13 omitted | Pneumovax 23 |
| 63. Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Prevnar® has not been evaluated for any carcinogenic or mutagenic potential, or impairment of fertility. |
Prevnar |
| 64. Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Prevnar 13 has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility. In a study in rabbits, no vaccine-related effects were found regarding reproductive performance including female fertility [see Use in Specific Populations (8.1)]. |
Prevnar 13 |
| 65. Poliovirus Vaccine Inactivated (Human Diploid Cell) – No link | Poliovax |
| 66. Poliovirus Vaccine Inactivated (Monkey Kidney Cell) CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Long-term studies in animals to evaluate carcinogenic potential or impairment of fertility have not been conducted. |
IPOL |
| 67. Rabies Vaccine (found no information on carcinogenesis, mutagenesis, or impairment of fertility | Imovax |
| 68. Rabies Vaccine Long-term studies with RabAvert have not been conducted to assess the potential for carcinogenesis, mutagenesis, or impairment of fertility. |
RabAvert |
| 69. Rabies Vaccine Adsorbed | No Trade Name |
| 70. Rotavirus Vaccine, Live, Oral ROTARIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility. |
ROTARIX |
| 71. Rotavirus Vaccine, Live, Oral, Pentavalent RotaTeq has not been evaluated for its carcinogenic or mutagenic potential or its potential to impair fertility. |
RotaTeq |
| 72. Smallpox (Vaccinia) Vaccine, Live Section 13 omitted |
ACAM2000 |
| 73. Tetanus & Diphtheria Toxoids Adsorbed for Adult Use No studies have been performed with MassBiologics’ Td to evaluate carcinogenicity, mutagenic potential, or impairment of fertility. |
No Trade Name |
| 74. Tetanus & Diphtheria Toxoids Adsorbed for Adult Use TENIVAC vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility. |
TENIVAC |
| 75. Tetanus Toxoid(Discontinued) No studies have been performed to evaluate carcinogenicity, mutagenic potential, or impact on fertility. |
No Trade Name |
| 76. Tetanus Toxoid Adsorbed Diphtheria and Tetanus Toxoids Adsorbed has not been evaluated for carcinogenicity, mutagenic potential, or impairment of fertility. |
No Trade Name |
| 77. Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed Adacel vaccine has not been evaluated for carcinogenic or mutagenic potential, or impairment of fertility. |
Adacel |
| 78. Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed BOOSTRIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility. |
Boostrix |
| 79. Typhoid Vaccine Live Oral Ty21a Long-term studies in animals with Vivotif have not been performed to evaluate carcinogenic potential, mutagenic potential or impairment of fertility. |
Vivotif |
| 80. Typhoid Vi Polysaccharide Vaccine Typhim Vi vaccine has not been evaluated for its carcinogenic potential, mutagenic potential or impairment of fertility. |
TYPHIM Vi |
| 81. Varicella Virus Vaccine Live| Section 13 is missing! Pregnancy: Do not administer VARIVAX to females who are pregnant; the possible effects of the vaccine on fetal development are unknown. Pregnancy should be avoided for 3 months following vaccination with VARIVAX. (4.4, 8.1, 17) See 17 for PATIENT COUNSELING INFORMATION and |
Varivax |
| 82. Yellow Fever Vaccine YF-VAX has not been evaluated for its carcinogenic or mutagenic potential or its effect on fertility. |
YF-Vax |
| 83. Zoster Vaccine, Live, (Oka/Merck)
ZOSTAVAX has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility |
Zostavax |