Maternal RSV Vaccination

Frequently Asked Questions

• What is respiratory syncytial virus (RSV)?

  Respiratory syncytial virus is a common respiratory virus that usually causes mild cold-like symptoms. Most people recover in a week or two, but RSV can cause a serious illness in some groups, including infants and older adults. Here are some key data points:

  • Respiratory syncytial virus is one of the most common causes of childhood respiratory illness.
  • Respiratory syncytial virus is the leading cause of hospitalization for infants in the United States. An estimated 58,000–80,000 children under 5 years old, most of them infants under 6 months old, are hospitalized each year nationwide because of RSV infection.
  • Each year, an estimated 100–300 children younger than 5 years old die because of RSV in the United States.
• Which RSV vaccine can be administered to pregnant patients?

  Currently, the only RSV vaccine product approved and recommended for use in pregnant individuals is Pfizer’s RSVpreF vaccine (Abrysvo).

  The following vaccines are not approved for use in pregnancy: GSK’s RSV vaccine Arexvy and Moderna’s RSV vaccine MRESVIA.

• Should I recommend the RSV vaccine to my pregnant patients?

  Yes, patients should be counseled about both the RSV vaccine during pregnancy and the monoclonal antibody, nirsevimab or clesrovimab, for the baby after birth as safe and effective options for the prevention of RSV lower respiratory tract infections in infants younger than 6 months old. (See below for more information on counseling patients.)

• When should pregnant patients receive the RSV vaccine?

  The American College of Obstetricians and Gynecologists (ACOG) and the Centers for Disease Control and Prevention (CDC) recommend a single dose of Pfizer’s RSV vaccine (Abrysvo) for eligible pregnant individuals between 32 0/7 and 36 6/7 weeks of gestation who do not have a planned delivery within 2 weeks, using seasonal administration, to prevent RSV lower respiratory tract infection in infants.

  A monoclonal antibody product, either nirsevimab or clesrovimab, is recommended for newborns and young infants whose mothers did not receive the RSV vaccine during the current or any previous pregnancy or who were born within 14 days of maternal receipt of the RSV vaccine. There is no preferential recommendation for the use of clesrovimab versus nirsevimab.

• Who is eligible to receive the maternal RSV vaccine?

  Eligible individuals are those who are currently pregnant, if they are between 32 0/7 and 36 6/7 weeks of gestation this respiratory virus season, who do not have a planned delivery within 2 weeks, and who did not receive the maternal RSV vaccine during RSV season.

  It is currently not recommended that pregnant patients who received the maternal RSV vaccine during the previous RSV season receive an additional dose during the next respiratory virus season. For patients vaccinated in a previous pregnancy, their infants should receive a monoclonal antibody during the respiratory virus season.

• How do I counsel my patients about the importance of the RSV vaccine?

  Pregnant patients should be counseled about RSV and the risk of infection to their newborns and young infants. All infants are recommended to be protected from severe RSV disease by either the maternal RSV vaccine or infant monoclonal antibody for the RSV season. Clinicians should counsel patients about the benefits of maternal RSV vaccination as a safe and effective way to prevent severe lower respiratory tract illness caused by RSV in newborns through infants aged 6 months. Clinicians should also counsel patients regarding the use of a monoclonal antibody, either nirsevimab or clesrovimab, as a safe and effective option for newborns if the maternal RSV vaccine is not received during pregnancy or if the patient was previously vaccinated during pregnancy. There is no preferential recommendation for the use of clesrovimab versus nirsevimab.

  Clinicians might receive questions about the U.S. Food and Drug Administration (FDA)’s January 2025 requirement for safety labeling changes to the Prescribing Information for Abrysvo describing an increased risk of Guillain-Barré syndrome (GBS). It is important to explain to patients that this safety labeling update is due to the results of an observational study suggesting an increased risk of GBS during the 42 days following vaccination in a population of people aged 65 years and older only. The FDA has determined that the benefits of vaccination with Abrysvo continue to outweigh its risks.

  Clinicians should also explain the difference between RSV, influenza, and COVID-19 and the need for different vaccines to protect against each of these infections.

  See ACOG’s Practice Advisory for additional counseling considerations.

• Is the RSV vaccine safe to administer during pregnancy?

  Yes, the RSV vaccine is a safe option during pregnancy for the prevention of RSV lower respiratory tract infection in infants.

  The clinical trial for the RSV vaccine (the MATISSE trial) was a multi-country randomized clinical trial comparing the RSVpreF vaccine to placebo administered in pregnancy in over 7,000 participants. Vaccine recipients in the study experienced typical side effects, including pain at the injection site, headache, muscle pain, and nausea. A numerical imbalance in preterm births in vaccine recipients (5.7%) occurred compared to those who received placebo (4.7%). This imbalance was not statistically significant and was seen most often in trial participants residing in low- to middle-income countries. Thus, the available data are insufficient to establish or exclude a causal relationship between maternal RSV vaccination and preterm birth. However, to mitigate the theoretical risk of preterm birth, RSV vaccine should be administered to pregnant individuals at 32 through 36 weeks of gestation.

  A post-marketing observational study suggested an increased risk of GBS (an estimated nine excess cases of GBS per million doses of Abrysvo) during the 42 days following vaccination among people 65 years of age and older. However, available evidence is insufficient to establish a causal relationship. In January 2025, the FDA required safety labeling changes to the Prescribing Information for Abrysvo to include this information. The FDA has determined that the benefits of vaccination with Abrysvo continue to outweigh its risks. The FDA has also required the manufacturer of Abrysvo to conduct a study to assess the risk of GBS following administration of Abrysvo in pregnant individuals.

  There are conflicting data on whether there is a slight increase in hypertensive disorders of pregnancy for women who received the RSV vaccine during pregnancy compared to those who did not receive the vaccine. The CDC has reaffirmed the warning that the RSV vaccine may be associated with an increase in hypertensive disorders of pregnancy. This finding may be related to residual confounding variables, and further studies are needed to determine if this is a causal link.

• Can a newborn receive a monoclonal antibody if the pregnant person was vaccinated?

  Most infants born to people who were vaccinated during pregnancy do not need to receive a monoclonal antibody immunization, nirsevimab or clesrovimab. There are some exceptions, and infants may receive a monoclonal antibody based on the health care professional’s clinical judgment and patient preferences if …

  • The pregnant person received the maternal RSV vaccine during the previous RSV season.
  • The pregnant person’s RSV vaccine status during the current pregnancy is unknown.
  • The pregnant person delivers within 14 days of receipt of maternal vaccination.
  • The infant might have experienced loss of transplacentally acquired antibodies (eg, those who have undergone cardiopulmonary bypass or extracorporeal membrane oxygenation).
  • The infant has substantially increased risk for severe RSV disease.
  • The pregnant person may not mount an adequate immune response to vaccination (eg, people with immunocompromising conditions) or has conditions associated with reduced transplacental antibody transfer (eg, people living with HIV infection).

  RSV vaccination or declination during pregnancy should be clearly documented in the patient’s medical chart and communicated to the newborn’s clinician.

• How do I counsel my patients about receiving the maternal RSV vaccine versus a monoclonal antibody for their newborn?

  There are no head-to-head studies comparing the efficacy of maternal vaccination to the efficacy of newborn or infant monoclonal antibody immunization. Each prevention measure has been shown to be safe and effective in their respective clinical trials. Thus, the decision to receive the vaccine or wait for a monoclonal antibody after birth should be based on patient preference after a conversation between the patient and health care professional. Considerations to discuss include the following:

  • Patient’s vaccination status with the maternal RSV vaccine
  • The availability of the monoclonal antibody nirsevimab or clesrovimab*
  • The availability of the maternal RSV vaccine
  • The patient’s preference for maternal vaccination or monoclonal antibody immunization
  • The patient’s current health conditions and circumstances

  See ACOG’s Practice Advisory for additional counseling considerations.

  *If there is a limited supply of nirsevimab or clesrovimab at any point during the season, discussions concerning the benefit of maternal vaccination should occur.

• Can I administer RSV vaccine at the same time as other vaccines?

  Yes. It is critically important that pregnant patients receive all recommended vaccines. Maternal RSV vaccine can be safely administered at the same time as other vaccines routinely recommended during pregnancy, including influenza, Tdap (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis), and COVID-19 vaccines.

• Is the RSV vaccine recommended during subsequent pregnancies?

  It is currently not recommended that pregnant patients who received the maternal RSV vaccine during the previous RSV season receive an additional dose during a subsequent pregnancy. For patients vaccinated in a previous pregnancy, their infants should receive a monoclonal antibody during the current respiratory virus season. There are currently no safety or efficacy data to inform recommendations related to RSV vaccination in subsequent pregnancies. Data are needed to determine whether additional seasonal doses during subsequent pregnancies are necessary and safe, and as these data become available, the Advisory Committee on Immunization Practices may update recommendations.

• Should newborns from a multiple pregnancy receive the monoclonal antibody even if the pregnant person was vaccinated?

  Only singleton pregnancies were included in the clinical trials for RSV vaccine. However, assuming the babies are born at least 14 days after maternal receipt of the RSV vaccine and no other risk factors are present, the monoclonal antibody should not be necessary.

• Can a pregnant individual receive the RSV vaccine if they recently had an RSV infection?

  Yes. Recent RSV infection is not a contraindication to vaccination. There is no specific length of time that pregnant patients need to wait after having RSV exposure or infection before pregnant people can receive an RSV vaccine within the indicated window.

• What is the storage and administration recommendation for the maternal RSV vaccine?

  ACOG encourages clinicians to stock and, ideally, administer all recommended vaccines in their offices. Studies show that immunization rates are higher when a trusted clinician can strongly recommend, offer and administer the vaccine during the same visit, as opposed to recommending vaccination and referring the patient elsewhere to receive the vaccine. Influenza and Tdap vaccines are routinely offered and administered by a majority of practices, while other vaccines are not as commonly stocked, leaving significant gaps in coverage (CDC 2024, O’Leary 2019). When clinicians make immunizations an integral part of their practice and routinely recommend and administer indicated vaccine, they help to increase vaccination rates for pregnant people.

  Many obstetrician–gynecologists also perceive a lack of reimbursement as a major barrier to including immunization services in their practices (Leddy 2009). However, with proper documentation and coding, these services can be reported to third-party payers and reimbursement can be received. The practice should adhere to basic coding principles when billing for immunization services. In general, the appropriate vaccine product code should always be reported along with the appropriate Current Procedural Terminology (CPT) vaccine administration code.

  For more information on documentation and coding, please visit Immunization Coding for Obstetrician–Gynecologists and Obtain Maximum Reimbursement for the Maternal Respiratory Syncytial Virus (RSV) Vaccine (Abrysvo): Administration, Storage and Coding Tips for Obstetricians.

• Will the RSV vaccine be covered by insurance?

  In most cases, yes.

  • Medicaid is required to cover the RSV vaccine in all states with no out-of-pocket costs for nearly all full-benefit adult beneficiaries with traditional Medicaid.
  • Pregnant patients eligible for the Vaccines for Children (VFC) program will be covered with no out-of-pocket costs but must receive the vaccine from a participating VFC health care professional. Check with local pharmacies to confirm if they participate in the VFC program before scheduling a vaccine appointment.
  • Most private insurers are required to cover the vaccine. This barrier should be minimal, given it is at least 1 year since the original recommendation.
  • Patients should check with their insurance plan about vaccine coverage. If planning to receive the vaccine at a pharmacy, they should confirm the pharmacy is in-network to minimize out-of-pocket costs.
  • To facilitate access to Abrysvo during the RSV maternal vaccination season, ensure patients meet eligibility requirements (gestational age and seasonal window). Include all required codes on the claim (eg, gestational age, CPT for visit, and administration of Abrysvo) and confirm billing requirements with payers, as they may vary.

  For more information on RSV vaccine coverage, please visit Respiratory Syncytial Virus (RSV) Vaccine (Abrysvo) Administration, Storage and Coding Tips for Obstetricians.

• Can pregnant individuals receive the RSV vaccine at a pharmacy?

  Yes. Many pharmacies are offering the RSV vaccine to pregnant patients. If you are referring your patient to a pharmacy, here are some key considerations and tips:

  • Identify nearby pharmacies that carry Pfizer’s RSVpreF vaccine, Abrysvo, so you can ensure patients are sent to a location with the correct vaccine. The other RSV vaccine products, Arexvy and mResvia, are not approved for use in pregnant people.
  • Encourage patients to check their pharmacy’s website to see if an appointment is recommended for vaccine visits. For most pharmacies, vaccine appointments are strongly recommended, but walk-ins are usually accommodated.
  • Pharmacists’ authority to administer different types of vaccines varies by state.
  • Remind patients to confirm they are between 32 0/7 and 36 6/7 weeks of gestation when presenting to the pharmacy. Clinicians can provide patients with an after-visit summary with this information.

  Most states do not require a prescription for vaccines administered to adults at pharmacies. However, it is helpful to check if local pharmacies require a prescription for the maternal RSV vaccine.

  • You can find information on pharmacist authority, including prescription requirements, through the American Pharmacists Association’s Immunization Center webpage.
  • If a prescription is required, include the indication “due to pregnancy” on the prescription, confirm the patient is between 32 0/7 and 36 6/7 weeks of gestation, and specify “Pfizer Abrysvo.”
• Why is it important to provide patients with written documentation about RSV vaccination administration and encourage them to share this information with their pediatricians?

  Documentation of vaccine receipt or declination is an essential component of any immunization program. All vaccines received or declined should be documented in the patient’s chart and state immunization information system.

  This is particularly important for maternal RSV vaccination because most infants of people who received the maternal RSV vaccine are not recommended to receive nirsevimab or clesrovimab.

  As such, clinicians should document receipt or declination of maternal RSV vaccination in the patient’s medical chart and encourage the patient to share this information with their child’s pediatrician during their first visit. One tip is to encourage the parent to take a photo of the document for later sharing. Hospitals and pediatric care professionals will need to know the maternal RSV vaccination status to counsel patients appropriately about the monoclonal antibody, nirsevimab or clesrovimab, for the newborn.

  The CDC recommends that all newborns under the age of 8 months receive RSV immunization if the gestational parent’s RSV vaccine status is unknown. Sharing documentation will help infants avoid an unnecessary immunization.

  For more information on documentation and coding, please see ACOG’s New CPT Codes for RSV Vaccine Administration and Immunization Coding for Obstetrician–Gynecologists.