Licensed vaccine product
Abrysvo: side effects, ingredients & package insert
Pfizer Inc. · RSV vaccine · recombinant protein · intramuscular · 0.5 mL
Abrysvo ingredients (FDA package insert, Section 11)
Per-dose composition as stated in the prescribing information; verified 2026-07-09. Click an ingredient for every vaccine that contains it.
| Role | Ingredient | Amount per dose |
|---|---|---|
| Antigen | RSV prefusion F (bivalent: subgroup A and B) | 60 mcg each antigen (120 mcg total) |
| Preservative | None (preservative-free) | Single-dose presentation; label states no preservative. |
| buffer | Tromethamine / tromethamine hydrochloride | label quantity |
| stabilizer | Sucrose | label quantity |
| stabilizer | Mannitol | label quantity |
| surfactant | Polysorbate 80 | label quantity |
| buffer | Sodium chloride | label quantity |
Note: Unadjuvanted protein subunit RSV vaccine (contrast Arexvy AS01E).
Source: FDA package insert. Formulations change — re-verify before clinical use.
Abrysvo side effects: where the data is
Reported reactions for Abrysvo and the other RSV products are compiled on the RSV vaccine page: pre-licensure trial reactogenicity, VAERS report counts, and international databases (Canada Vigilance, EudraVigilance, Lareb, VigiAccess). Those counts are spontaneous reports with no denominator — a report does not establish that the vaccine caused the event.
Abrysvo lot number lookup
This site does not yet hold lot-level VAERS counts for RSV vaccines. Any lot can still be searched in the lot explorer; a lot number is printed on the vaccination record and the vial.
Abrysvo vs Arexvy
All licensed RSV vaccine products side by side. Differences in platform, adjuvant and route are the usual reasons one is chosen over another; efficacy and safety comparisons belong to the trial and surveillance sections of the RSV vaccine page.
| Product | Manufacturer | Platform | Adjuvant | Route | |
|---|---|---|---|---|---|
| Abrysvo | Pfizer Inc. | recombinant protein | none | intramuscular | |
| Arexvy | GlaxoSmithKline Biologicals | recombinant protein | AS01E | intramuscular | page |
Schedule and age range
Licensed ages and the recommended series for RSV vaccines are on the RSV vaccine page; how 31 countries schedule it is on RSV schedule by country. Always confirm the product-specific age range in the current package insert.
Common questions about Abrysvo
What are the side effects of Abrysvo?
Common reactions listed in the Abrysvo package insert are injection-site pain, redness or swelling and short-lived systemic symptoms such as fever, tiredness or irritability. Rarer events and the reported counts from VAERS and international databases are on the RSV vaccine page; counts are reports, not rates, and do not prove the vaccine caused the event.
What is in Abrysvo?
Abrysvo contains RSV prefusion F (bivalent: subgroup A and B) as antigen; adjuvant: none; it is preservative-free. Excipients: Tromethamine / tromethamine hydrochloride, Sucrose, Mannitol, Polysorbate 80, Sodium chloride. Amounts per dose are in the table above, taken from Section 11 of the FDA package insert (verified 2026-07-09).
Where is the Abrysvo package insert?
The FDA-licensed prescribing information for Abrysvo is published by Pfizer Inc. and the FDA; the source used for this page is https://www.fda.gov/vaccines-blood-biologics/vaccines/abrysvo. Formulations change, so re-verify the current insert before clinical use.
How does Abrysvo compare with Arexvy?
Abrysvo (Pfizer Inc.) uses a recombinant protein platform with adjuvant none, given intramuscular; Arexvy (GlaxoSmithKline Biologicals) uses recombinant protein with adjuvant AS01E. Both are licensed RSV vaccines; the comparison table above lists every product.
Reviewed 2026-10-08 · Matthew Thomas J Halma, Founder, Open Source Medicine Foundation. Informational, not medical advice.