Protocol · graded by use, three uses
RSV vaccination (respiratory syncytial virus), for older adults
RSV lung illness and RSV hospitalization, bivalent RSV prefusion F vaccine, adults aged 60 and older.
At a glance
RSV is a common virus that can cause serious lung illness in older adults. Three RSV shots were each tested against a dummy shot in adults 60 and older. Each cut RSV lung illness over one winter by about two thirds or more. One of them also cut RSV hospital stays in a large trial in Denmark. Protection seems to fade after the first winter. Sore arms and tiredness are common. A rare nerve illness was about 5 to 23 cases per million shots more common in the 6 weeks after.
- What was measured
- Hospital stays for RSV lung illness over one winter, in adults 60 and older in Denmark.
- How big
- 3 of 65,642 vaccinated people against 18 of 65,634 unvaccinated people were in hospital with RSV over one winter.Read from the summary of PMID PubMed ID: the permanent number the US National Library of Medicine gives a published paper. Each one links to that paper's record on PubMed. 40888695.
- Who it applies to
- Adults 60 and older given the bivalent protein RSV shot, for the first winter after the shot. The other two RSV shots each have one trial so far.
- Safety
- Sore arms and tiredness are common, more so after the adjuvanted and mRNA shots. A rare nerve illness, Guillain-Barré syndrome, was about 5 to 23 cases per million shots more common in the 6 weeks after.
- Compared with
- No vaccine.
- Certainty
- Grade A, resting on: Randomized placebo-controlled trials of three vaccines; a pragmatic randomized trial with registry outcomes for one.
- What would change this grade
- Could move down to B if this trial found no benefit: Large randomized trial of the bivalent RSV prefusion F vaccine against placebo An inactive substitute made to look like the real treatment, so participants cannot tell which one they received., run independently of the maker. Who: Adults aged 60 and older, including those with heart and lung disease. Measured: RSV lung illness confirmed by RT-PCR, or RSV hospitalization. Length: At least one full RSV season.
- Cost
- No price recorded yet.
- Sources
- 7 studies cited on this record, listed under Sources.
The A belongs to one of the three uses graded on this record. The other two carry their own letters.
This record carries a separate letter for each thing it has been measured on. The headline grade is the best of them, and it does not transfer to the others.
Walsh et al. (N Engl J Med, 2023; PMID 37018468), RENOIR: RSV lower respiratory tract illness with at least two signs or symptoms 1.19 against 3.58 per 1,000 person-years, efficacy 66.7%; with at least three, 85.7%. Lassen et al. (N Engl J Med, 2025; PMID 40888695), DAN-RSV: RSV hospitalization 0.11 against 0.66 per 1,000 participant-years, effectiveness 83.3%; hospital stays for respiratory disease of any cause 284 against 335. Laboratory-confirmed RSV disease prevented in two randomized trials run by different groups: A. Both were funded by Pfizer, the maker; under the replication The same finding reproduced by a separate research group. A result seen once can be chance or bias; a replicated one is harder to explain away. rule same-maker trials count, and the funding is stated here.
Papi et al. (N Engl J Med, 2023; PMID 36791160), AReSVi-006: RT-PCR-confirmed RSV lower respiratory tract disease 7 against 40 cases (1.0 against 5.8 per 1,000 participant-years), efficacy 82.6%; severe disease 94.1%; funded by GlaxoSmithKline, the maker. A laboratory-confirmed disease event in one trial: C under Rule 06 until another trial repeats it for this vaccine.
Wilson et al. (N Engl J Med, 2023; PMID 38091530), ConquerRSV: efficacy 83.7% against RSV lower respiratory tract disease with at least two signs or symptoms and 82.4% with at least three; local reactions 58.7% against 16.2%; funded by Moderna, the maker. One trial with a short median follow-up: C under Rule 06 until it is repeated.
Funding: Both randomized trials replicating this Grade A for RSV lung illness and RSV hospitalization, bivalent RSV prefusion F vaccine, adults aged 60 and older were funded by the maker of the product they tested, Pfizer. The funder's role in design and analysis is not stated here, because the full trial reports could not be read. The letter stands because each trial met the grading rules on its own; the funding is stated here so it can be weighed alongside it.
Three RSV vaccines have each been tested against placebo in adults aged 60 and older. Each lowered RSV lung illness over the first season. One of them, the bivalent prefusion F protein vaccine, also lowered RSV hospital stays in a second, independent trial. Protection appears to fade after the first season, and a rare nerve disorder, Guillain-Barré syndrome, is more common in the six weeks after two of the vaccines. Each vaccine is graded on its own.
Why this letter
Why this gradeThe reasoning, and what the grade does not cover.
Grade A on RSV lung illness and RSV hospitalization with the bivalent RSV prefusion F vaccine in adults aged 60 and older: the placebo-controlled trial found laboratory-confirmed RSV lower respiratory tract illness 66.7% less frequent (RENOIR; Walsh et al., 2023; PMID 37018468), and a second randomized trial in 131,276 Danish adults, run by a different group, found RSV hospital stays 83.3% less frequent (DAN-RSV; Lassen et al., 2025; PMID 40888695). A disease event confirmed in the laboratory, repeated by an independent group in a second trial, so A; both trials were funded by the maker, as the funding line beside the letter states. Grade C on RSV lung illness with the adjuvanted RSVPreF3 vaccine (Papi et al., 2023; PMID 36791160) and with the mRNA-1345 vaccine (Wilson et al., 2023; PMID 38091530): each has one placebo-controlled trial, and under Rule 03 a grade attaches to the form studied, so each stays at C until its own result is repeated.
WHAT THIS GRADE DOES NOT COVERprotection beyond the first season, which the trials suggest fades; death from any cause, which no trial has reported; adults under 60 and people with weakened immune systems; and vaccination in pregnancy, a different use with its own trials.
Shared endpoint The outcome a trial measures to decide whether the treatment worked, such as heart attacks, blood pressure or a symptom score.: Laboratory-confirmed RSV disease (lung illness, or hospitalization coded for RSV), adults aged 60 and older, first season
- RENOIR, multicenter, 7 countries (Walsh, University of Rochester): RSV lower respiratory tract illness 1.19 against 3.58 per 1,000 person-years, efficacy 66.7%, 34,284 adults. PMID 37018468 · Funding: manufacturer-funded (Pfizer)
- DAN-RSV, Denmark (Lassen, Copenhagen University Hospital): RSV hospitalization 3 against 18, effectiveness 83.3%, 131,276 adults. PMID 40888695 · Funding: manufacturer-funded (Pfizer)
What the replication does not cover: Different endpoints (laboratory-confirmed lung illness, and RSV hospital admission from registries); the Danish trial was open-label Everyone in the trial knows which treatment they are receiving, so expectations can shape the results, especially for symptoms people report themselves. against no vaccine. Both cover the first season only.
A grade describes the human evidence for a named use. It is not advice, and it is not a judgment on any individual prescription. How the letters are decided →
Who responds: this record's trial reading reports no subgroup that identifies who responds.
ClinicalTrials.gov, the public registry run by the U.S. National Library of Medicine, lists studies that are recruiting volunteers. The link below searches it for RSV Vaccine among studies recruiting now. EBL has no relationship with any listed study and receives no payment for this link.
Search recruiting studies of RSV Vaccine on ClinicalTrials.gov
Evidence notes: randomized trial, independently replicated, industry-sponsored
Endpoint graded: RSV lung illness confirmed by laboratory test, and RSV hospitalization, in adults aged 60 and older (hard)
Last reviewed: November 2026
Dose, form and timing
Measured outcome in the graded trials: RSV lower respiratory tract illness with at least two signs or symptoms, confirmed by RT-PCR, over the first season; in the Danish trial, hospital admission coded for RSV respiratory disease in national registries.
As studiedDose, form, population and duration for every use.
A grade describes the intervention that was tested. Where the product on the shelf differs from it, this says so.
Safety
Side effects are common and differ by vaccine. Local reactions followed the bivalent protein vaccine in 12% against 7% on placebo (PMID 37018468) and the mRNA vaccine in 58.7% against 16.2% (PMID 38091530); the adjuvanted vaccine was more reactogenic than placebo, mostly mild to moderate and short-lived (PMID 36791160). Serious adverse events were similar with vaccine and placebo in all three trials. After licensing, a study of 4,746,518 vaccine recipients in US health records found Guillain-Barré syndrome, a nerve disorder that causes weakness, in excess in the 42 days after vaccination: 5.2 extra cases per million doses of the adjuvanted vaccine and 18.2 per million of the bivalent vaccine, significant for the bivalent vaccine (Fry et al., JAMA Netw Open, 2025; PMID 40343698). England's program for adults aged 75 to 79 found 23 extra cases per million doses of the bivalent vaccine (Stowe et al., Nat Commun, 2025; PMID 41381510). VAERS, the US Vaccine Adverse Event Reporting System, held reports from 2,321 people aged 60 and older after the two protein vaccines, most often nerve, muscle and whole-body symptoms, with more injection-site reports after the adjuvanted vaccine (McLaughlin et al., Kans J Med, 2025; PMID 41450594). Anyone can file a VAERS report, reports are not verified, and the system does not know how many people were vaccinated, so a report does not show that the vaccine caused the event and the counts are not rates. Its role is to raise signals, which studies with a known number of vaccinated people then measure. The reports can be searched at the system's public site, vaers.hhs.gov.
Cautions documented in human studies. Each caution on this record, sorted by what it rests on.
- Local reactions: 12% against 7% (bivalent protein vaccine) and 58.7% against 16.2% (mRNA vaccine) in the placebo-controlled trials (PMID 37018468 PMID 38091530)
- Guillain-Barre syndrome: 5.2 to 23 extra cases per million doses in the 42 days after vaccination, highest after the bivalent protein vaccine (PMID 40343698 PMID 41381510)
- VAERS: reports from 2,321 people aged 60 and older after the protein vaccines, unverified reports that are not rates or proof of cause (PMID 41450594)
None recorded.
None recorded.
Does not apply: human harm data are listed above.
Grade history
How this letter has changedLatest: No. 419 · November 2026 · First graded.
RSV vaccination now has its own record, each vaccine graded on its own and shown with its harms. The bivalent RSV prefusion F vaccine lowered laboratory-confirmed RSV lung illness against placebo, Walsh et al. (N Engl J Med, 2023; PMID 37018468), and RSV hospital stays in 131,276 Danish adults, Lassen et al. (N Engl J Med, 2025; PMID 40888695): A, both funded by the maker. The adjuvanted vaccine, Papi et al. (N Engl J Med, 2023; PMID 36791160), and the mRNA vaccine, Wilson et al. (N Engl J Med, 2023; PMID 38091530), each have one trial: C. Harms: Guillain-Barre syndrome after vaccination, Fry et al. (JAMA Netw Open, 2025; PMID 40343698) and Stowe et al. (Nat Commun, 2025; PMID 41381510), and VAERS reports, McLaughlin et al. (Kans J Med, 2025; PMID 41450594), with their limits stated.PMID 37018468 PMID 40888695 PMID 36791160 PMID 38091530 PMID 40343698 PMID 41381510 PMID 41450594
Every change to a letter on this site is dated and published. The full evidence log →
Sources
- Citations
- Every paper cited on this page is matched to its PubMed record on every build.
- Retractions
- None of these papers is retracted or under a journal expression of concern. PubMed is checked again on every build.
- Read against the papers
- November 2026. By a language model (AI-assisted reading), not yet reviewed by a clinician.
- Outside review
- Not yet done. No reviewer outside EBL has checked this record.
What each of these checks can and cannot show: evidence integrity.
The evidence, in fullSeven papers, each linked to its PubMed record.
Walsh et al. (N Engl J Med, 2023; PMID 37018468), RENOIR: 34,284 adults aged 60 and older, one dose of bivalent RSV prefusion F vaccine (120 micrograms) or placebo; RSV lower respiratory tract illness with at least two signs or symptoms 11 against 33 cases (1.19 against 3.58 per 1,000 person-years), efficacy 66.7%; local reactions 12% against 7%; funded by Pfizer. Lassen et al. (N Engl J Med, 2025; PMID 40888695), DAN-RSV: 131,276 adults aged 60 and older in Denmark, the same vaccine or no vaccine, open-label, 2024-2025 winter, outcomes from national registries; hospitalization for RSV respiratory disease 3 of 65,642 against 18 of 65,634, effectiveness 83.3% (42.9 to 96.9); funded by Pfizer, run by Copenhagen University Hospital. Papi et al. (N Engl J Med, 2023; PMID 36791160), AReSVi-006: 24,966 adults aged 60 and older, AS01-adjuvanted RSVPreF3 vaccine or placebo; RT-PCR-confirmed RSV lower respiratory tract disease 7 against 40 cases, efficacy 82.6%; funded by GlaxoSmithKline. Wilson et al. (N Engl J Med, 2023; PMID 38091530), ConquerRSV: 35,541 adults aged 60 and older, mRNA-1345 vaccine or placebo; efficacy 83.7% against RSV lower respiratory tract disease with at least two signs or symptoms; local reactions 58.7% against 16.2%; funded by Moderna. Harms: Fry et al. (JAMA Netw Open, 2025; PMID 40343698), US health records, 4,746,518 vaccine recipients, Guillain-Barré syndrome 5.2 extra cases per million doses after the adjuvanted RSVPreF3 vaccine and 18.2 after the bivalent RSVpreF vaccine; Stowe et al. (Nat Commun, 2025; PMID 41381510), England's program for 2.5 million people aged 75 to 79, relative incidence 3.34, 23 extra cases per million doses after the bivalent vaccine; McLaughlin et al. (Kans J Med, 2025; PMID 41450594), VAERS reports from 2,321 people aged 60 and older after the two protein vaccines.
How EBL searched for the trials (1 search)
The search that was run, what it returned, and what was left out and why, so the absence of evidence can be checked as well as its presence.
(RSV[tiab] OR "respiratory syncytial virus"[tiab]) AND vaccin*[tiab] AND ("older adults"[tiab] OR aged[tiab] OR "60 years"[tiab]) AND (efficacy[tiab] OR effectiveness[tiab]) AND (randomized controlled trial[pt] OR pragmatic clinical trial[pt])PubMed watch: does a new study change the grade? (nothing new)
No new paper matching the search behind this grade has been added to PubMed since November 2026.
Last run November 2026. A letter on EBL moves only after a logged review. A new paper never moves a letter by arriving: it is read, the answer is written here, and any change to the letter is published in the evidence log.
Disclosure
Educational use only · Not medical advice · EBL grades published human evidence and does not recommend treatment. Stopping a prescription is a decision for your physician.
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