Also known as: Tween 80, polyoxyethylene sorbitan monooleate
Polysorbate 80
Sourced from FDA-approved package inserts (DailyMed). Last verified: 2026-07-07.
What It Is & Why It's in Vaccines
Polysorbate 80 is a nonionic surfactant and emulsifier widely used in pharmaceuticals, foods, and cosmetics. In vaccines, it functions as a stabilizer that prevents aggregation and surface adsorption of antigens during manufacturing, storage, and handling.
Stabilizer/emulsifier — prevents protein aggregation and maintains the homogeneity of the vaccine suspension. It is also used in some vaccine manufacturing processes to extract antigens from cell membranes.
Dose-in-Context
Per-Dose Quantity
≤0.1 mg per dose (varies by product, typically 10–100 mcg)
Reference Comparison
Polysorbate 80 is an FDA-approved food additive (GRAS — Generally Recognized As Safe) found in ice cream, baked goods, and many processed foods. Daily dietary intake can reach hundreds of milligrams. A vaccine dose containing ≤0.1 mg represents a fraction of typical daily dietary exposure.
Source: FDA 21 CFR 172.840 (Polysorbate 80 as a food additive). WHO Food Additives Series 5: Toxicological evaluation of polysorbate 80.
Route-of-Administration Note
The principal safety consideration for polysorbate 80 in vaccines is not toxicity but potential cross-reactivity with polyethylene glycol (PEG) hypersensitivity. Polysorbate 80 contains a PEG-like structural moiety, and individuals with confirmed PEG allergy may also react to polysorbate 80 — this is a labeled warning on some mRNA COVID-19 vaccine products and is relevant to other polysorbate/PEG-containing vaccines.
Documented Adverse Effects
Cross-reactive hypersensitivity with PEG has been documented: individuals with confirmed PEG allergy may react to polysorbate 80. This is a labeled consideration on products containing either ingredient.
Isolated case reports of anaphylactoid reactions to polysorbate 80 in parenteral products exist, but the incidence is extremely low and confounded by the presence of other potential triggers. No large-scale epidemiological evidence of vaccine-specific polysorbate 80 hypersensitivity beyond the PEG cross-reactivity signal.
Vaccines Containing Polysorbate 80
Hepatitis B — Heplisav-B (Dynavax Technologies)
DTaP/Tdap — Infanrix (GlaxoSmithKline Biologicals)
HPV — Gardasil 9 (Merck Sharp & Dohme LLC)
COVID-19 — Nuvaxovid (Novavax COVID-19 Vaccine, Adjuvanted) (Novavax, Inc.)
Protein subunit + Matrix-M adjuvant — no mRNA, no LNP.
Rotavirus — RotaTeq (Merck Sharp & Dohme LLC)
PCV (Pneumococcal) — Prevnar 20 (Pfizer Inc.)
Shingles — Shingrix (GlaxoSmithKline Biologicals)
RSV — Arexvy (GlaxoSmithKline Biologicals)
RSV — Abrysvo (Pfizer Inc.)
Unadjuvanted protein subunit RSV vaccine (contrast Arexvy AS01E).
ⓘ Methodology Disclaimer: Ingredient lists are sourced from official FDA-approved package inserts for the specific branded products named on each vaccine page. Formulations can change between manufacturing lots and over time — always verify against the current package insert before making a clinical decision. The presence of a substance in a vaccine does not by itself indicate harm; toxicology is dose-, route-, and context-dependent. Comparisons to reference exposure levels are provided with their sources where available, and are approximate — see the cited source for full methodology.