Frequently Asked Questions About RSVpreF (Abrysvo) Vaccine for Pregnant People

To protect infants from RSV-associated LRTI, either the pregnant person should receive RSVpreF (Abrysvo) vaccine during pregnancy, or their infant should receive RSV monoclonal antibody, nirsevimab (Beyfortus) within 1 week after birth. Pregnant people and their health care providers should discuss the relative advantages and disadvantages of each product and consider patient preferences when deciding which product is best for them.

Pregnant people who prefer to receive RSVpreF (Abrysvo) vaccine should be vaccinated during weeks 32 through 36 of pregnancy. In most of the continental United States, pregnant people should receive RSVpreF (Abrysvo) vaccine from September through January so that their babies are protected against RSV-associated LRTI in the first months of life while RSV is circulating. 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 maternal RSVpreF vaccination.

No. There is no preferential recommendation for using RSVpreF (Abrysvo) vaccine during pregnancy or administering RSV monoclonal antibody, nirsevimab (Beyfortus) to the infant after birth.

No studies have directly compared the two products. However, both products have been shown to provide significant protection against RSV-associated LRTI in infants entering their first RSV season.

Health care providers should inform pregnant people about both maternal vaccination with RSVpreF (Abrysvo) vaccine during pregnancy and infant immunization with RSV monoclonal antibody, nirsevimab (Beyfortus). Providers should consider patient preferences when determining whether to vaccinate the pregnant patient or to administer nirsevimab to the infant after birth.

Currently no data are available on the effectiveness of the first lifetime dose during subsequent pregnancies or on the safety of additional doses given in subsequent pregnancies. More data are needed to determine whether additional doses should be given in subsequent pregnancies. CDC will continue to evaluate the data and may update recommendations prior to the 2024-25 RSV season.

A single 0.5 mL dose of RSVpreF (Abrysvo) vaccine should be administered intramuscularly (preferably deltoid region of the upper arm). Sufficient evidence does not exist at this time to determine the need for additional doses.

In accordance with CDC’s General Best Practices Guidelines for Immunization, RSVpreF (Abrysvo) vaccine can be administered to pregnant persons with other recommended vaccines, such as tetanus, diphtheria, and pertussis (Tdap), influenza, and COVID-19 vaccines, without regard to timing. This includes simultaneous administration (i.e., same clinic day) or at any interval between vaccine products.

Data are only available for coadministration of RSV and influenza vaccines in adults 60 years and older. Administering RSV vaccine with one or more other vaccines at the same visit might increase local or systemic reactogenicity, however, evidence is mixed. In older adults, influenza antibody titers were somewhat lower with coadministration of RSVpreF; however, the clinical significance of this is unknown.

Data are lacking on the safety of coadministration with other vaccines recommended for pregnant women, such as COVID-19 vaccines and Tdap vaccine. In non-pregnant women ages 18-49 years, coadministration of Tdap and Pfizer RSVpreF led to decreased immune response to pertussis components. The clinical significance of lower immune responses for pertussis components is unclear.

When deciding whether to coadminister other vaccines with an RSV vaccine, providers should consider whether the patient is up to date with currently recommended vaccines, the likelihood of the patient returning for additional vaccine doses, risk for acquiring vaccine-preventable disease, vaccine reactogenicity profiles, and patient preferences.

No. Only Pfizer’s RSVpreF (Abrysvo) vaccine is approved and recommended for use in pregnant people. GSK’s RSVpreF3 (Arexvy) is NOT approved or recommended for use in pregnant people and should NOT be used in pregnant people.

In most of the continental United States, pregnant people should receive RSVpreF (Abrysvo) vaccine from September through January to provide protection against RSV-associated LRTI in the recipient’s baby for up to 6 months after birth. The protection provided to the baby wanes over time.

However, RSV seasons can vary in different parts of the United States. 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 maternal RSVpreF vaccination. The timing of maternal RSVpreF vaccination might vary in these jurisdictions because the historic timing of RSV circulation differs from the rest of the United States. Because maternal RSVpreF vaccination should start 1–2 months before the anticipated start of the RSV season and continue through 2–3 months before the anticipated end of the RSV season, it is not feasible to change maternal RSVpreF vaccination timing based on year-to-year variations in RSV circulation. Thus, in most of the continental United States, maternal RSVpreF vaccination should be given from September through January, regardless of year-to-year variation in RSV circulation.

Seasonal administration is recommended for RSVpreF (Abrysvo) vaccine to provide protection against RSV-associated LRTI in the first months of life when infants are most at risk.

RSVpreF (Abrysvo) vaccine should be administered to pregnant persons from September through January in most of the continental United States to target vaccine to pregnant persons whose infants will be in their first months of life, when protection from maternal vaccination would be at its highest, during the RSV season. Administering RSVpreF (Abrysvo) vaccine starting in September (1–2 months before the anticipated start of the RSV season) and continuing through January (2–3 months before the anticipated end of the RSV season) will maximize cost-effectiveness and benefits. Administering the RSVpreF (Abrysvo) vaccine outside that period is not recommended because protection will likely begin to wane before the peak of the RSV season.

However, RSV season can begin and end at different times in different parts of the United States. 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 maternal RSVpreF vaccination. The timing of maternal RSVPreF vaccination might vary in these jurisdictions because the historic timing of RSV circulation differs from the rest of the United States. As maternal RSVPreF vaccination should start 1–2 months before the anticipated start of the RSV season and continue through 2–3 months before the anticipated end of the RSV season, it is not feasible to change maternal RSVpreF vaccination timing based on year-to-year variations in RSV circulation. Thus, in most of the continental United States, maternal RSVPreF vaccination should be given in September–January, regardless of year-to-year variation in RSV circulation.

RSVpreF (Abrysvo) vaccine should be administered from 32 weeks 0 days through 36 weeks 6 days of pregnancy. Pregnant people who are less than 32 weeks should not be vaccinated, as the vaccine is not approved for less than 32 weeks because of a potential risk of preterm birth. Pregnant people who are more than 36 weeks 6 days pregnant should not be vaccinated, as it is unlikely there will be enough time for the antibodies to cross the placenta and protect the infant. Instead, their newborn should receive RSV monoclonal antibody, nirsevimab (Beyfortus).

Maternal RSVpreF vaccine (Abrysvo, Pfizer) should be administered to pregnant persons only during September–January in most of the continental United States* to target vaccine to pregnant persons whose infants will be in their first months of life, when protection from maternal vaccination would be at its highest, during the RSV season. Administering maternal RSVpreF vaccine starting in September (1–2 months before the anticipated start of the RSV season) and continuing through January (2–3 months before the anticipated end of the RSV season) will maximize cost-effectiveness and benefits.

*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 maternal RSVpreF vaccination.

RSV vaccine is given in anticipation that the infant will be born when RSV activity is still high. After January 31, in most of the continental U.S., infants will be born when RSV activity is expected to be lower, and there is less benefit relative to the cost of vaccine. If infants are expected to be born during low periods of RSV transmission, nirsevimab is recommended because it can be timed so that maximum protection is aligned with the period of high RSV transmission.

*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 maternal RSVpreF vaccination.

Yes, even if vaccination occurs after January 31^st*, the dose is considered valid. Nirsevimab is not recommended for the infant after they are born. Either maternal RSVpreF vaccination during pregnancy or nirsevimab administration to the infant is recommended to prevent severe RSV disease but both are not needed for most infants.

*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 maternal RSVpreF vaccination.

No, administration after January 31^st is not considered a vaccine administration error. The recommendation to administer maternal RSVpreF (Abrysvo, Pfizer) vaccination during September through January in most of the continental United States is meant to maximize cost-effectiveness and benefits. However, jurisdictions with RSV seasonality that differs from most of the continental United States administration timing may vary.

If you are a vaccine provider who serves ONLY pregnant people, follow the guidance below for storing and handling Abrysvo (Pfizer) vaccine after January 31st. Providers who see adults 60 years and over may continue to administer RSV vaccine based on shared clinical decision-making (SCDM).

1. February 1: Check the expiration date(s) of vaccine and diluent in your vaccine inventory.

• If the vaccine and diluent has not expired:
  • Continue to store between 2° C and 8° C (36° F and 46° F).
  • Mark the vaccine or its container “Do NOT use until September”.
• Discard any expired vaccine and diluent. If the vaccine was purchased with public funds, contact your immunization program and/or the vaccine manufacturer for guidance before discarding.

2. May – August: Prepare for September by checking the current RSV inventory and ordering additional vaccine as needed.
3. End of August: Check the expiration date for Abrysvo (Pfizer) vaccine and diluent in the current inventory.

• If the vaccine and diluent has not expired, store between 2° C and 8° C (36° F and 46° F).
• Remove guidance indicating not to use the vaccine.
• Place storage labels on containers, bins or attach directly to shelf where vaccine is placed to better identify the vaccine in the storage unit, for example, CDC vaccine storage labels. Vaccines Storage and Handling Toolkit | CDC
• Discard expired vaccine and diluent. If the vaccine was purchased with public funds, contact your immunization program and/or the vaccine manufacturer for guidance before discarding.

People who are 32 through 36 weeks pregnant September through January should get one dose of maternal Abrysvo (Pfizer) RSV vaccine to protect their babies from severe RSV. RSV season can vary around the country. In jurisdictions where seasonality differs from most of the continental United States, such as Alaska, southern Florida, Guam, Hawaii, Puerto Rico, the U.S.-affiliated Pacific Islands, and the U.S. Virgin Islands, healthcare providers should follow state, local, or territorial guidance on timing of administering the RSV vaccine Abrysvo (Pfizer) for pregnant people.

Providers who see adults 60 years and over will continue administering RSV vaccine to patients 60 years and older based on SCDM and not seasonal administration.

The Pfizer RSV vaccine (Abrysvo) is the only RSV vaccine recommended for pregnant people.

The GSK RSV vaccine (Arexvy) is not approved for use in pregnancy. If a pregnant person receives the GSK RSV vaccine (Arexvy) in error, healthcare providers are encouraged to report this event to the Vaccine Adverse Event Reporting System (VAERS), even if there is no adverse health event associated with the error. Healthcare providers are encouraged to report any adverse events after RSV vaccination to VAERS regardless of which vaccine is used and even if it is not clear that the vaccine caused the adverse event.

Additionally, the following guidance is provided:

• For pregnant people who have received the GSK RSV vaccine (Arexvy) in error, do not give the pregnant person a dose of the Pfizer RSV vaccine (Abrysvo).
• Inform the recipient of the vaccine administration error.
• Experts suggest no special monitoring for the pregnant person beyond routine prenatal care is needed.
• The pregnant person may experience local and systemic reactions after the GSK RSV vaccine (Arexvy). The most common reactions reported in both pregnant people and adults aged ≥60 years after any RSV vaccine were injection site pain, fatigue, muscle pain, headache, joint pain, and nausea.
• If GSK RSV vaccine (Arexvy) is given in error to a pregnant person, the infant after birth should receive nirsevimab shortly before or during their first RSV season (at age less than 8 months) for RSV prevention.
• Providers should consult with the state immunization program and/or immunization information system (IIS) to determine how the dose should be entered into the IIS.
• Determine how the error occurred and implement strategies to prevent it from happening again. A discussion about strategies to prevent errors can be found in the “Vaccine Administration” chapter of Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book). Additional resources, including a job aid for preventing errors, can be found on CDC’s vaccine administration web page.

A statistically significant imbalance in preterm births was observed in a pre-licensure study of an unadjuvanted version of GSK’s RSV vaccine. For additional information see Package Insert – AREXVY (fda.gov).

RSVpreF (Abrysvo; Pfizer) vaccine can be given to pregnant people who have had RSV infection in the past. People who are moderately or severely ill with or without fever, including those who have known current RSV infection, should defer RSV vaccination until recovery from the acute illness.

The RSVpreF (Abrysvo; Pfizer) vaccine clinical trial did not include testing for RSV infection in pregnant participants or exclude people with known previous RSV infection. Pregnant people with past and recent RSV infection were therefore likely included in the trial, and the reported trial efficacy reflects the protection when vaccinating pregnant people both with and without recent RSV infection.

RSV vaccine given to pregnant people is intended to protect their infants. For most younger or middle-aged adults, RSV is a mild illness with cold-like symptoms. However, it can be much more severe for infants and older adults.

Some vaccines given during pregnancy are given to protect the baby from getting very ill after birth; this includes Tdap and RSV. Other vaccines, like COVID-19 and influenza vaccines, can prevent serious illness in both pregnant people and their infants after they are born.

In the clinical trials, more preterm births were observed among RSVpreF (Abrysvo) vaccine recipients than among placebo recipients, although the differences were not statistically significant. It is unclear whether preterm birth was caused by the vaccine or simply due to chance. Available data are insufficient to establish or exclude a causal relationship between preterm birth and RSVpreF (Abrysvo). To reduce the potential risk of preterm birth when administering maternal RSV vaccine, FDA approved the vaccine for use from 32 through 36 weeks of pregnancy.

FDA is requiring the manufacturer to do additional studies that will look more closely at the potential risk of preterm births. Additionally, CDC will monitor the safety of maternal RSV vaccination using multiple systems (i.e., VAERS, v-safe and the Vaccine Safety Datalink).

For more information: 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 (cdc.gov)

In the full clinical trial population, more hypertensive disorders of pregnancy (including preeclampsia) were observed in persons administered the vaccine rather than the placebo; these differences were not statistically significant. For example, preeclampsia occurred among 1.8% of vaccine recipients and in 1.4% of placebo recipients, but this difference was not statistically significant.

Although not statistically significant, low birth weight (meaning less than 5.5 lbs) and neonatal jaundice occurred more frequently in infants born to mothers who received the RSV vaccine compared to infants born to mothers who received a placebo. Low birth weight and neonatal jaundice are more common among infants born preterm than among infants born at term.

In the clinical trials for use of RSVpreF (Abrysvo) vaccine in older adults aged ≥60 years, 3 cases of Guillain-Barre Syndrome or other neurological events were recorded among 20,255 vaccine recipients. While the RSVpreF (Abrysvo) vaccine is the same for both older adults and pregnant people, there were no cases of inflammatory neurologic events among pregnant people in the clinical trials.

While the RSVPreF (Abrysvo) vaccine is the same for both older adults and pregnant people, there were no cases of atrial fibrillation among pregnant people in the clinical trials. In the clinical trials including 36,862 participants for use of RSVpreF (Abrysvo) vaccine in older adults, 10 cases in the vaccine group and 4 cases in the placebo group reported atrial fibrillation as an unsolicited event within the 30 days after injection. Among participants who reported atrial fibrillation, a medical history of atrial fibrillation was reported by six of 10 vaccine recipients and two of four placebo recipients.