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To: Maine Immunization Program Providers
From: Maine Immunization Program
Subject: RSV Vaccine Information
Date: August 23, 2023
Background
Respiratory syncytial virus (RSV) is a highly contagious virus that usually causes mild, cold-like symptoms; however, RSV can be serious, especially in infants and older adults. In adults it can cause pneumonia and infections of the bronchioles and can exacerbate chronic lung disease. RSV circulation is seasonal, typically starting during the fall and peaking in the winter. According to the Centers for Disease Control and Prevention (CDC), each year in the U.S. RSV leads to approximately 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 years of age and older.
Updates
In May 2023, two RSV vaccines were approved by the FDA for adults aged 60 and older to prevent lower respiratory tract disease. These vaccines are RSVPreF3/Arexvy (from GSK) and RSVPreF/Abrysvo (from Pfizer).
In June 2023, the Advisory Committee on Immunization Practices (ACIP) voted on and endorsed the use of RSV vaccines for older adults and recommended that adults aged ≥ 60 years may receive a single dose of RSV vaccine, using shared clinical decision-making.
For RSV vaccination, the decision to vaccinate a patient should be based on a discussion between the health care provider and the patient, which might be guided by the patient’s risk for severe disease; their values and preferences; and the provider’s clinical discretion.
Epidemiologic evidence indicates that persons aged ≥60 years who are at highest risk for severe RSV disease and who might be most likely to benefit from vaccination include:
- Persons with chronic medical conditions such as lung diseases, including chronic obstructive pulmonary disease and asthma
- Persons with cardiovascular diseases such as congestive heart failure and coronary artery disease
- Persons with moderate or severe immune compromise (either attributable to a medical condition or receipt of immunosuppressive medications or treatment)
- Persons with diabetes mellitus
- Persons with neurologic or neuromuscular conditions
- Persons with kidney disorders
- Persons with liver disorders and hematologic (blood) disorders
- Persons who are frail
- Persons of advanced age
- Persons with other underlying conditions or factors that the provider determines might increase the risk for severe RSV-associated respiratory disease.
- Persons who are residents of nursing homes and other long-term care facilities
Timing of Vaccine
Vaccination is approved and recommended as a single dose and should be offered as soon as possible. Providers should continue to offer vaccination to eligible adults who remain unvaccinated. For the 2023–24 season, clinicians should offer RSV vaccination to adults aged ≥60 years using shared clinical decision-making as early as vaccine supply becomes available and, ideally, before the RSV season.
Coadministration of Vaccine
Co-administration of the RSV vaccine and other adult vaccines during the same visit is acceptable. Data are lacking on the safety of coadministration with other vaccines that might be recommended for persons in this age group, such as COVID-19 vaccines; pneumococcal vaccines; adult tetanus, diphtheria, and pertussis vaccines; and the recombinant zoster vaccine (the recombinant zoster vaccine and GSK’s RSV vaccine contain the same adjuvant).
When deciding whether to co-administer other vaccines with an RSV vaccine, providers should consider whether the patient is up to date with currently recommended vaccines, the feasibility of the patient returning for additional vaccine doses, risk for acquiring vaccine-preventable disease, vaccine reactogenicity profiles, and patient preferences. When administering more than one vaccine at the same clinical visit, providers should separate injection sites by at least 1 inch if possible and consider administering vaccines that are associated with an enhanced local reaction in separate limbs.
Precautions and Contraindications
As a precaution, RSV vaccines should be delayed for persons experiencing moderate or severe acute illness with or without fever. RSV vaccines are contraindicated for and should not be administered to persons with a history of severe allergic reaction, such as anaphylaxis, to any component of the vaccine.
Adverse Events after Vaccination
Adverse events should be reported to the Vaccine Adverse Event Reporting System (VAERS). Reporting is encouraged for any clinically significant adverse event even if it is uncertain whether the vaccine caused the event. Information on how to submit a report to VAERS is available at the VAERS website or by telephone at 1-800-822-7967
Additional Information on RSV for Infants and Pregnant Individuals
On July 17, 2023, the FDA approved Beyfortus (nirsevimab-alip), a monoclonal antibody, for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
On August 21, 2023, the FDA approved Abrysvo for use in pregnant individuals between 32 and 36 weeks of pregnancy. This is the first and only U.S. approval of a maternal vaccine to help protect infants at birth through six months of life from lower respiratory tract disease (LRTD) and severe LRTD due to RSV.
The CDC's Advisory Committee for Immunization Practices (ACIP) is scheduled to meet from October 25-27 when they will decide on the recommended use of Beyfortus for infants and Abrysvo for pregnant women.
Resources:
Press release from CDC announcing recommendation for RSV vaccine
CDC’s RSV General Information Page
RSV Vaccine Information Statements
Arexvy website with prescribing information
Abrysvo site with prescribing information
Beyfortus site with prescribing information
Morbidity and Mortality Review (MMWR) “Use of Respiratory Syncytial Virus Vaccines in Older Adults: Recommendations of the Advisory Committee on Immunization Practices – United States, 2023” published on July 21, 2023
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