FDA approves two RSV vaccines in older adults
In May 2023 the Food and Drug Administration (FDA) approved two RSV vaccines, for use in adults ages 60 and over, within a month of each other - Arexvy® and Abrysvo®.
Together, these vaccines represent a breakthrough in preventing RSV infection. The Centers for Disease Control and Prevention (CDC) estimates that 60,000-160,000 older adults in the US are hospitalized each year due to RSV infections, and approximately 6000-10,000 older adults die each year from RSV-related illness.[59]
Abrysvo® is a bivalent RSV prefusion F (RSVpreF) protein-based vaccine. In contrast, Arexvy® is a recombinant RSV-specific antigen glycoprotein F stabilized in the prefusion conformation (RSVPreF3), combined with the AS01E adjuvant system. Both vaccines have proven to be effective with comparable safety profiles in large randomized controlled trials.
The CDC's Advisory Committee on Immunization Practices (ACIP) is expected to meet in June 2023 to discuss recommendations for the appropriate use of these vaccines in older adults.
Summary
Definition
History and exam
Key diagnostic factors
- exposure to RSV
- infants at high risk for RSV infection
- winter season
- older adult age
- immune deficit
- rhinorrhea/congestion
- tachypnea
- increased work of breathing
- cough
- wheeze
- poor feeding
- cyanosis
- rales
- apnea
Other diagnostic factors
- fever
Risk factors
- exposure to RSV
- hemodynamically significant congenital heart disease
- history of prematurity
- immune deficit
- chronic lung disease
- high-risk infants with no recent immunoprophylaxis against RSV
- infants aged <6 months
- winter season
- older adult age
- smoke exposure
- family history of asthma
- Down syndrome
Diagnostic investigations
1st investigations to order
- pulse oximetry
Investigations to consider
- chest x-ray
- hydration status
- direct fluorescent antibody staining of respiratory specimen (e.g., nasopharyngeal aspirate)
- reverse transcriptase polymerase chain reaction of respiratory specimen (e.g., nasopharyngeal aspirate)
- viral culture of respiratory specimen (e.g., nasopharyngeal aspirate)
Treatment algorithm
mild or self-limited illness
moderate illness
severe illness
Contributors
Authors
Giovanni Piedimonte, MD, FAAP, FCCP
Vice President for Research
Professor of Pediatrics, Biochemistry, & Molecular Biology
Tulane University School of Medicine
New Orleans
LA
Disclosures
GP declares that he has no competing interests.
Margot Anderson, MD
Assistant Professor of Clinical Pediatrics
Section of Infectious Diseases and Hospital Medicine
Tulane University School of Medicine
Tulane University
New Orleans
LA
Disclosures
MA will be the principal investigator for a phase 3 trial to evaluate the safety, efficacy, and pharmacokinetics of MK-1654 in infants and children at increased risk for severe respiratory syncytial virus disease, based at Tulane University School of Medicine. Merck will reimburse Tulane University for participation.
Acknowledgements
Dr Giovanni Piedimonte and Dr Margot Anderson would like to gratefully acknowledge Dr Frank Esper and Dr Melvin L. Wright, previous contributors to this topic.
Disclosures
FE is on an advisory board for Procter and Gamble. MLW declares that he has no competing interests.
Peer reviewers
Leonard R. Krilov, MD
Chief
Pediatric Infectious Disease
Vice Chairman
Department of Pediatrics
Children's Medical Center
Winthrop University Medical Center
Mineola
Professor of Pediatrics
School of Medicine
Stony Brook University Medical Center
Stony Brook
NY
Disclosures
LRK has participated as an investigator in multiple clinical research trials supported by grants from MedImmune. LRK has also served as a consultant to MedImmune on medical advisory boards and is a member of their speakers' bureau.
Robert Welliver, MD
Professor of Pediatrics
Women and Children's Hospital
Buffalo
NY
Disclosures
RW declares that he has no competing interests.
Jennifer Handforth, MB ChB, MRCPCH, DTM&H
Consultant Paediatrician
Croydon University Hospital
Croydon
UK
Disclosures
JH declares that she has no competing interests.
Differentials
- Human metapneumovirus
- Influenza virus
- Parainfluenza virus
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