RESPIRATORY SYNCYTIAL VIRUS VACCINE
Each year in the
United States, respiratory syncytial virus (RSV) causes increased
hospitalizations and deaths in infants and older adults. In most regions of
the United States and other areas with similar climates, RSV season typically
starts during the fall and peaks in the winter. Immunization administration
schedules may be adjusted based on the local RSV activity in the community due
to the variability of the timing of the onset, peak, and decline of RSV within
a region.
US FEDERAL DRUG ADMINISTRATION (FDA) APPROVAL
On June 7,
2024, respiratory syncytial virus
vaccine, adjuvanted (Arexvy) was approved by the US FDA for the prevention of
lower respiratory tract disease caused by respiratory syncytial virus in
individuals 50 years of age and older.
On June 14, 2024,
respiratory syncytial virus vaccine (Mresvia) was approved by the FDA for the
prevention of lower respiratory tract disease caused by respiratory syncytial
virus in individuals 60 years of age and older.
ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) RECOMMENDATIONS
On June 26, 2024,
ACIP updated its RSV recommendations. ACIP recommends a single dose of the
RSV vaccine for individuals 60 to 74 years of age who are at increased risk of severe
RSV disease. ACIP recommends a single dose of the RSV vaccine for individuals
75 years of age and older.
PNEUMOCOCCAL 21-VALENT CONJUGATE VACCINE
Pneumococcal vaccine
provides protection against Streptococcus pneumoniae, which can cause
sinusitis, acute otitis media (AOM), bacteremia, meningitis, pneumonia, and
death. Pneumococcal 21-valent conjugate
(PCV21) vaccine is purified capsular polysaccharides from S. pneumoniae
serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B (de-O-acetylated prior to
conjugation), 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B
individually conjugated to CRM197 carrier protein.
US FDA APPROVAL
On June 17, 2024,
PCV21 was approved by the US FDA for the prevention of invasive disease caused by
S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A,15B,
15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 18
years of age and older.
ACIP RECOMMENDATIONS
On June 27, 2024,
ACIP recommended PCV21 as an option for adults aged 19 years of age or older
who currently have a recommendation to receive a dose of PCV.
RESPIRATORY SYNCYTIAL VIRUS VACCINE
MEDICALLY NECESSARY
Routine/Preventive Vaccines
Retroactively effective to June 26, 2024, RSV vaccine (i.e., respiratory
syncytial virus vaccine, adjuvanted [Arexvy], respiratory syncytial virus
vaccine [Abrysvo], or respiratory syncytial virus vaccine [mRESVIA]) is considered
medically necessary and, therefore, covered as a preventive service as a one-time dose
regimen for the following:
- Individuals 60-74 years of age who are at increased risk of severe RSV disease.
- Risk factors include, but are not
limited to:
- Chronic cardiovascular disease
- Chronic lung disease
- Advanced chronic kidney disease
- Diabetes mellitus with end-organ
damage
- Severe obesity
- Immunocompromising conditions
- Neurologic or neuromuscular
conditions
- Liver disorders
- Hematologic conditions
- Frailty
- Residence in a nursing home or other
long-term care facility
- Individuals 75 years of age and
older.
Non-routine/Non-preventive Vaccines
Retroactively effective to June 7, 2024, respiratory syncytial virus vaccine, adjuvanted
(Arexvy) is considered medically necessary and, therefore, covered as
a one-time dose regimen for individuals 50 to 59 years of
age.
EXPERIMENTAL/INVESTIGATIONAL
Retroactively effective to June 7, 2024, respiratory syncytial virus vaccine, adjuvanted
(Arexvy) is considered experimental/investigational and, therefore, not
covered for individuals younger than 50 years of age.
PNEUMOCOCCAL 21-VALENT CONJUGATE
VACCINE
MEDICALLY NECESSARY
Routine/Preventive Vaccines
Retroactively effective to June 17, 2024, PCV21 is considered medically
necessary and, therefore, covered as a preventive service for individuals 19
years of age and older who currently have a recommendation to receive a dose of
PCV.
Non-routine/Non-preventive Vaccines
Retroactively effective to June 17,
2024, PCV21 vaccine is considered medically necessary and, therefore,
covered for individuals 18 years of age
and older.
EXPERIMENTAL/INVESTIGATIONAL
Retroactively effective to June 17, 2024, PCV21 vaccine is considered experimental/investigational and, therefore, not covered for individuals younger than 18 years of age.
