Latex in Vaccine Packaging
Appendix B
Latex in Vaccine Packaging
"Immediate-type allergic reactions due to latex allergy have been described after vaccination, but such reactions are rare. If a person reports a severe anaphylactic allergy to latex, vaccines supplied in vials or syringes that contain natural rubber latex should be avoided if possible. If not, if the decision is made to vaccinate, providers should be prepared to treat immediate allergic reactions due to latex, including anaphylaxis. The most common type of latex hypersensitivity is a delayed-type (type 4, cell-mediated) allergic contact dermatitis. For patients with a history of contact allergy to latex, vaccines supplied in vials or syringes that contain dry natural rubber or natural rubber latex may be administered."
(ACIP General Best Practice Guidelines for Immunization)
Vaccine (Trade Name)
Package Insert Date
Latex (Yes/No)(a)
Adenovirus Anthrax (Biothrax) BCG (Tice) Cholera (Vaxchora) Dengue (Dengvaxia) DT (Sanofi) DTaP (Daptacel) DTaP (Infanrix) DTaP-IPV (Kinrix) DTaP-IPV (Quadracel) DTaP-HepB-IPV (Pediarix) DTaP-IPV/Hib (Pentacel) DTaP-IPV-Hib-HepB (Vaxelis) Ebola Zaire (ERVEBO) Hib (ActHIB) Hib (Hiberix) Hib (PedvaxHIB) Hep A (Havrix) Hep A (Vaqta) Hep B (Engerix-B) Hep B (Recombivax) Hep B (Heplisav-B) Hep A/Hep B (Twinrix) HPV (Gardasil 9) Influenza (Afluria) Quadrivalent(c) Influenza (Fluad) Quadrivalent(c) Influenza (Fluarix) Quadrivalent(c) Influenza (Flublok) Quadrivalent(c) Influenza (Flucelvax) Quadrivalent(c) Influenza (Flulaval) Quadrivalent(c) Influenza (Fluzone) Quadrivalent(c) Influenza (Fluzone) High Dose(c) Influenza (FluMist) Quadrivalent(c) IPV (Ipol)
10/2019 11/2015 02/2009 06/2016 06/2019 06/2018 01/2021(b) 01/2021(b) 01/2021(b) 02/2021 01/2021(b) 12/2019 10/2020 01/2021(b) 05/2019 04/2018 01/2021(b) 01/2021(b) 01/2021(b) 01/2021(b) 12/2018 05/2020 01/2021(b) 08/2020 03/2021 03/2021 2021 03/2021 10/2021(b) 2021 2021 2021 08/2021 01/2021(b)
No
Yes
No
No
No
No
No
Yes ? Syringe, No ? Vial
Yes ? Syringe, No ? Vial
No
Yes
No
No
No
No
No
Yes
Yes ? Syringe , No ? Vial
Yes ? Syringe, Yes ? Vial
Yes ? Syringe, No ? Vial
Yes ? Syringe, Yes ? Vial
No
Yes
No
No
No
No No
B
No
No
No
No
No
No
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Appendix B
Vaccine (Trade Name)
Japanese Encephalitis (Ixiaro) MenACWY (Menactra) MenACWY(MenQuadfi) MenACWY (Menveo) MenB (Bexsero) MenB (Trumenba) MMR (M-M-R II) MMRV (ProQuad) (Frozen: Recombinant Albumin) PCV13 (Prevnar 13) PPSV-23 (Pneumovax) Rabies (Imovax) Rabies (RabAvert) Rotavirus (RotaTeq) Rotavirus (Rotarix) Smallpox (Vaccinia) (ACAM2000) Td (Tenivac) Td (TDVAX) Tdap (Adacel) Tdap (Boostrix) Typhoid (Typhim Vi) Typhoid (Vivotif Ty21a) Varicella (Varivax) Frozen Yellow Fever (YF-Vax) Zoster (Shingles) (Shingrix)
Package Insert Date
09/2018 04/2018 01/2021(b) 07/2020 01/2021(b) 2018 12/2020 01/2021(b) 08/2017 09/2020 10/2019 2018 01/2021(b) 01/2021(b) 03/2018 11/2019 09/2018 12/2020 09/2020 03/2020 09/2013 01/2021(b) 02/2019 01/2021(b)
Latex (Yes/No)(a)
No No No No Yes No No No No No No No No Yes No Yes ? Syringe, No ? Vial No Yes(d) ? Syringe, No ? Vial Yes ? Syringe, No ? Vial No No No No No
Abbreviations: DT = diphtheria and tetanus toxoids; DTaP = diphtheria and tetanus toxoids and acellular pertussis; Hep A = Hepatitis A; Hep B = Hepatitis B; Hib = Haemophilus infuenzae type b; HPV = human papillomavirus; IPV = inactivated poliovirus; LAIV = live, attenuated infuenza vaccine; MenACWY = quadrivalent meningococcal conjugate vaccine; MenB = serogroup B meningococcal vaccine; MMR = measles, mumps, and rubella; MMRV = measles, mumps, rubella, varicella; PCV13 = pneumococcal conjugate vaccine; PI = Package Insert; PPSV23= pneumococcal polysaccharide vaccine; Td = tetanus and diphtheria toxoids; Tdap = tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis.
(a)All information was extracted from manufacturers' package inserts. The date shown in the Date column of the table is the edition date of the PI is use in February 2020. If in doubt about whether a PI has been updated since this table was prepared, check the FDA's website at:
(b)The PI was not dated and this is the date the PI was reviewed for this table.
(c) All infuenza vaccine in this table are 2021-2022 northern hemisphere formulation.
(d)The most current PI (12/2020) indicates no latex in any presentation of Adacel. Previous PIs indicate tip caps of some lots of Adacel preflled syringes contain latex while others do not. Check the package insert that came with your vaccine, if necessary.
November 2021
B
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