12/15/2023
Vaccination During Pregnancy for Prevention of Severe RSV Disease in Newborns
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Respiratory Syncytial Virus (RSV) is the leading cause of hospitalization among U.S. infants; 2% to 3% of young infants will be hospitalized for RSV disease. RSV-associated hospitalization rates are highest in infants aged <6 months, with hospitalization peaking at age 1 month.
The CDC’s Advisory Committee on Immunization Practices recommends RSVpreF vaccine (Abrysvo™, Pfizer Inc.) for pregnant persons as a one-time dose during 32 0/7 through 36 6/7 weeks gestation using seasonal administration (September through January in most of the continental United States) to prevent RSV-associated lower respiratory tract infection in infants aged <6 months. This vaccine is not to be confused with an existing RSV vaccine (Arvexy, GSK) which is not approved for use during pregnancy.
Key points for providers and patients:
- Abrysvo™ is a recombinant protein vaccine, so vaccine recipients will not develop an infection.
- It should be given at 32 0/7 through 36 6/7 weeks gestation, from September-January in the continental United States, except southern Florida.
- Studies showed that it decreased both medical visits and hospitalizations for RSV lower respiratory tract infection in infants by over 50% through 180 days after birth.
- While not statistically significant, vaccine recipients showed a trend toward more hypertensive disorders in pregnancy, low birthweight infants, infants with neonatal jaundice, and preterm birth (most of which occurred at 36 WGA).
In jurisdictions with RSV seasonality that differs from most of the continental United States (including Alaska, southern Florida, Guam, Hawaii, Puerto Rico, U.S.-affiliated Pacific Islands, and U.S. Virgin Islands) providers should follow state, local, or territorial guidance on timing of vaccination with Abrysvo™ during pregnancy. Vaccination during pregnancy with Abrysvo™ can be administered with other vaccines, such as tetanus, diphtheria, and pertussis (Tdap), influenza, and COVID-19 vaccines, including simultaneous vaccination at different injection sites on the same day.
There are 2 available options to prevent RSV lower respiratory tract infection in infants through passive immunization: Abrysvo™ and a long-acting monoclonal antibody, nirsevimab (Beyfortus™). Either vaccination with Abrysvo™ during pregnancy or nirsevimab immunization for infants aged <8 months born during or entering their first RSV season is recommended to prevent RSV-associated lower respiratory tract infection in infants, but administration of both products is not needed for most infants. No data are available directly comparing the efficacy of nirsevimab and vaccination with Abrysvo™ during pregnancy in preventing RSV-associated lower respiratory tract infection in infants. Clinicians who care for pregnant persons should discuss the relative advantages and disadvantages of both maternal Abrysvo™ vaccination and nirsevimab.
As with all vaccines, vaccination with Abrysvo™ should be delayed for persons experiencing moderate or severe acute illness with or without fever (precaution). RSV vaccines are contraindicated for persons with a history of severe allergic reaction, such as anaphylaxis, to any component of the vaccine. Adverse events after vaccination should be reported to the Vaccine Adverse Event Reporting System (VAERS: https://vaers.hhs.gov/index.html or 1-800-822-7967).
Further Reading:
ACOG Practice Advisory, Maternal Respiratory Syncytial Virus Vaccination, September 2023. Available at: https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2023/09/maternal-respiratory-syncytial-virus-vaccination. Last accessed: November 2023.
Fleming-Dutra KE, Jones JM, Roper LE, Prill MM, et al., Use of the Pfizer Respiratory Syncytial Virus Vaccine During Pregnancy for the Prevention of Respiratory Syncytial Virus-Associated Lower Respiratory Tract Disease in Infants: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023. MMWR Morb Mortal Wkly Rep. 2023 Oct 13;72(41):1115-1122. doi: 10.15585/mmwr.mm7241e1. PMID: 37824423; PMCID: PMC10578951.
Jones JM, Fleming-Dutra KE, Prill MM, et al. Use of Nirsevimab for the Prevention of Respiratory Syncytial Virus Disease Among Infants and Young Children: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023. MMWR Morb Mortal Wkly Rep. 2023 Aug 25;72(34):920-925. doi: 10.15585/mmwr.mm7234a4. PMID: 37616235; PMCID: PMC10468217.
Initial Publication December 2023.
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