What Are the New RSV Vaccines and Who Should Get Them?

Name: What Are the New RSV Vaccines and Who Should Get Them?
Creator: David Kim, MS, CSCS
Published: 2026-02-12T19:50:55.260Z

Understanding the breakthrough RSV vaccines for older adults and infants approved in 2023-2024.

DKMC

Written by David Kim, MS, CSCS

MS in Exercise Science, CSCS

DJM

Reviewed by Dr. James Mitchell, MD, FACC

Board-Certified Cardiologist · Cleveland Clinic

Written Feb 12, 2026Reviewed Feb 12, 2026Fact-checked Feb 12, 20263 sources citedMedically Fact-Checked

What Should You Know About RSV Vaccines?

After decades of failed attempts, effective RSV prevention is now available for the first time. Two vaccines protect adults 60+, a maternal vaccine protects newborns, and a monoclonal antibody protects all infants. These represent a major breakthrough for one of the most significant remaining vaccine-preventable causes of severe respiratory disease.

Strong EvidencePhase 3 RCTs with tens of thousands of participants demonstrated robust efficacy for all RSV prevention products.

Respiratory syncytial virus (RSV) has been one of the last major respiratory pathogens without a vaccine since its discovery in 1956. A tragic vaccine trial in the 1960s that caused enhanced disease in immunized infants set the field back decades. Modern understanding of RSV F protein structure and stabilization in its prefusion conformation finally enabled effective vaccine development. The FDA approved both Arexvy (GSK) and Abrysvo (Pfizer) for adults 60+ in May-June 2023, and nirsevimab (Beyfortus) for infants in July 2023.

The CDC's Advisory Committee on Immunization Practices (ACIP) recommended RSV vaccination for adults 60+ through shared clinical decision-making, meaning healthcare providers and patients should discuss individual risk factors rather than vaccinating all older adults universally. This approach reflected the GBS safety signal and the relatively mild course of RSV in many older adults. For infants, nirsevimab is recommended for all babies entering their first RSV season.

Arexvy and Abrysvo were approved by FDA in May-June 2023 for adults 60+

How Do RSV Vaccines Work and How Effective Are They?

RSV vaccines target the fusion (F) protein stabilized in its prefusion form, generating antibodies that prevent the virus from entering cells. Adult vaccines showed 80-89% efficacy against severe RSV disease. Nirsevimab delivers pre-formed antibodies providing immediate 80% protection against RSV hospitalization in infants for approximately 5 months.

Strong EvidencePhase 3 RCTs (AReSVi-006, RENOIR, MELODY, HARMONIE) with robust sample sizes and confirmed by real-world effectiveness data.

The AReSVi-006 trial for Arexvy enrolled over 24,000 adults 60+ and demonstrated 82.6% efficacy against RSV lower respiratory tract disease and 94.1% efficacy against severe disease in the first season. The RENOIR trial for Abrysvo enrolled over 34,000 adults and showed 88.9% efficacy against severe RSV with two or more symptoms. Both vaccines are given as a single intramuscular injection. Second-season efficacy data showed some waning, and revaccination timing is still being determined.

For infants, the MELODY and HARMONIE trials demonstrated that nirsevimab reduced RSV-associated lower respiratory tract infections by approximately 80% and RSV hospitalizations by 77-83%. A single intramuscular injection before or during RSV season provides protection for 5+ months. Real-world data from France, Spain, and the US during the 2023-2024 RSV season confirmed the clinical trial results, with population-level reductions in infant RSV hospitalizations of 50-80% in areas with high uptake.

AReSVi-006 trial showed Arexvy 82.6% effective against RSV lower respiratory tract disease

HARMONIE trial showed nirsevimab reduced RSV hospitalizations by 83%

Frequently Asked Questions

Who should get the RSV vaccine?

Adults aged 60 and older should discuss RSV vaccination with their healthcare provider. The CDC uses 'shared clinical decision-making' rather than universal recommendation, meaning individual risk factors (chronic lung or heart disease, immunocompromised status, living in congregate settings) guide the decision. Pregnant women at 32-36 weeks gestation may receive Abrysvo. All infants are eligible for nirsevimab.

How effective are RSV vaccines?

Clinical trials showed Arexvy was 82.6% effective and Abrysvo was 88.9% effective against severe RSV lower respiratory tract disease in adults 60+. Nirsevimab reduced RSV-associated hospitalizations in infants by approximately 80%. Protection from adult vaccines may wane after one season; the need for revaccination is under study.

Is the RSV vaccine safe?

Clinical trials involving tens of thousands of participants demonstrated acceptable safety profiles. Common side effects include injection site pain, fatigue, muscle pain, and headache. A small potential signal for Guillain-Barré syndrome was noted with Arexvy (about 1 in 14,000), leading to the shared decision-making approach rather than universal recommendation. Post-marketing surveillance continues.

Can babies get the RSV vaccine?

Infants receive nirsevimab (Beyfortus), which is technically a monoclonal antibody rather than a traditional vaccine. It provides immediate passive protection by delivering pre-formed antibodies against the RSV F protein. A single dose protects for approximately 5 months. All infants entering their first RSV season and children under 20 months at increased risk entering their second season are eligible.

Is RSV dangerous?

RSV causes 60,000-120,000 hospitalizations and 6,000-10,000 deaths annually among US adults 65+. In infants, it is the leading cause of hospitalization, affecting 2-3% of infants in their first year. Most healthy adults experience mild cold-like symptoms, but older adults, immunocompromised individuals, and infants are at risk for severe disease including pneumonia and respiratory failure.

Sources

1.
FDA Approves First RSV Vaccines for Older Adults and Infant Prevention — US Food and Drug Administration (2023) Link
2.
Efficacy of RSVPreF Vaccine (Arexvy) in Older Adults: AReSVi-006 Trial — Papi A, Ison MG, Langley JM et al. New England Journal of Medicine (2023) DOI
3.
Nirsevimab for Prevention of RSV in Infants (HARMONIE) — Moline HL, Tannis A, Engel Tobin S et al. New England Journal of Medicine (2024) DOI

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