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