Last year, an estimated 1 million infants were protected from RSV either through infant receipt of nirsevimab or through vaccination of pregnant people. However, as with many newly available products, we experienced some collective growing pains, including the identification of several important administration errors. The Centers for Disease Control and Prevention (CDC) reported that as of Jan. 17, 2024, the Vaccine Adverse Event Reporting System (VAERS) received RSV immunization-related error reports regarding 25 children less than 2 years of age and 128 pregnant people. While errors are frustrating for the practices where they occurred, we can all learn from each other — making us better together! So, this month, we wanted to focus on the areas identified for improvement in the upcoming (second) season of availability of these products.
First, a brief refresher
RSV prevention products available in the United States for protecting infants include:
- One protein subunit vaccine (Abrysvo) for pregnant people, indicated at 32 through 36 weeks gestation from September through January.
- One monoclonal antibody, nirsevimab (Beyfortus), for all infants in their first RSV season as well as high-risk infants entering their second RSV season. Palivizumab (Synagis) is a monoclonal antibody that remains available for high-risk infants.
Importantly, although not a focus of this piece, the RSV subunit vaccine used during pregnancy (Abrysvo) and two additional RSV vaccines (Arexvy and mResvia) are also available for older adults. (Check the September feature article for more information about RSV prevention in adults.)
Many of the errors during the first RSV season included administration of the wrong product to the wrong patient, so immunization providers should have standard processes in place to ensure the various products are used correctly. This reduces the likelihood of errors while also creating a common process for identifying areas for improvement.
Preventing errors
- Train healthcare providers and other clinical staff on the different indications for each RSV prevention product.
- Be sure staff always checks product labels at least three times before administration to verify that the correct product is being administered to the patient in front of them.
- Consider implementing systemic safeguards (e.g., electronic alerts) to prevent administration errors. For example, the electronic health record can be programed to alert the provider if they erroneously order Beyfortus for a patient older than 19 months or at the wrong time of year.
- Facilities that stock both the RSV vaccine and the RSV monoclonal antibody should put systems and procedures in place to prevent interchanging the products, including using clear and instructive labeling and systematic approaches to storage in units for related products. Adding warning labels that remind staff to double check which product they are grabbing at a given point can also help. CDC’s job aid titled, “Vaccine Administration: Preventing Vaccine Administration Errors,” is useful for training.
Reporting errors
While the goal is to be error-free, from time to time, mistakes happen. Make sure a process is in place so that everyone knows steps to take if a situation occurs:
- Be sure that staff feel the work environment is supportive for reporting any errors that are made.
- Ensure that one of the steps includes the process for informing the family of the error.
- Regardless of the type, all errors should be reported.
- Errors involving administering vaccine incorrectly should be reported to the Vaccine Adverse Event Reporting System (VAERS). If the antibody was administered at the same visit as vaccines, CDC strongly encourages reporting this medication error and any suspected adverse events following the error to VAERS as well.
- If antibody only was administered, report the incident to MedWatch or the FDA at 1-800-FDA-1088.
Fixing errors clinically
An important and, sometimes complex, part of addressing administration errors is knowing what to do for the patient. Each clinical scenario below is adapted from Immunize.org’s “Ask the Experts: RSV.” Like other pages in this section of the Immunize.org website, responses are designed to give readers the “need-to-know” highlights. You can also reach out to your local health department, the CDC, or the manufacturer for assistance in resolving the issue.
Clinical scenario #1
An adult patient of mine received a dose of nirsevimab, the RSV monoclonal antibody for infants. What should I do?
Administer the RSV vaccine as recommended because the infant dose of the monoclonal antibody is not likely to protect an adult. There is no defined waiting period after monoclonal antibody administration for vaccine administration.
Clinical scenario #2
The mother of a newborn I care for was given Arexvy (GSK) during the pregnancy. I am aware that for the prevention of RSV-associated lower respiratory tract disease in infants younger than 6 months old, only Abrysvo (Pfizer) is licensed for use during pregnancy (during 32 through 36 weeks and 6 days’ gestation). Given the vaccine error, what needs to be done to protect the infant?
As Arexvy (GSK) is not licensed or recommended for use in pregnancy, if Arexvy is inadvertently given during pregnancy, do NOT administer a dose of Abrysvo. Instead, the infant (if younger than 8 months) should receive nirsevimab during RSV season. Essentially, treat the infant in the same manner as an infant born to a mother who did not receive RSV vaccination during pregnancy.
Clinical Scenario #3
Should I give nirsevimab to an infant who inadvertently got an RSV vaccine?
In this case, tell the family that the safety and effectiveness of an RSV vaccine has not been studied in infants, and the infant still needs protection from RSV. Give nirsevimab according to CDC recommendations, ideally within 72 hours of the error. Administer the nirsevimab in a different anatomic site than the RSV vaccination site.
Tracking and learning from errors
Track errors within your practice to help drive improvement. At the time of the error, review your practice processes. It’s important to understand if there was deviation from a standard process and if you can implement changes to your internal processes to decrease the likelihood of it occurring again. Alternatively, you may need to develop a new process to better prevent future errors.
Resources
- Clinician Outreach and Communication Activity (COCA Now) update, Information on Respiratory Syncytial Virus (RSV) Vaccine Administration Errors in Young Children and Pregnant People – CDC, January 22, 2024
- RSV (Respiratory Syncytial Virus) Clinical Resources – Immunize.org
- CDC Cautions Against RSV Immunization Errors, Offers Guidance – AAP News, Jan. 23, 2024
- Vaccine Adverse Event Reporting System: Information for Health Care Providers
Contributed by: Sharon G. Humiston, MD, MPH, FAAP
Last year, an estimated 1 million infants were protected from RSV either through infant receipt of nirsevimab or through vaccination of pregnant people. However, as with many newly available products, we experienced some collective growing pains, including the identification of several important administration errors. The Centers for Disease Control and Prevention (CDC) reported that as of Jan. 17, 2024, the Vaccine Adverse Event Reporting System (VAERS) received RSV immunization-related error reports regarding 25 children less than 2 years of age and 128 pregnant people. While errors are frustrating for the practices where they occurred, we can all learn from each other — making us better together! So, this month, we wanted to focus on the areas identified for improvement in the upcoming (second) season of availability of these products.
First, a brief refresher
RSV prevention products available in the United States for protecting infants include:
- One protein subunit vaccine (Abrysvo) for pregnant people, indicated at 32 through 36 weeks gestation from September through January.
- One monoclonal antibody, nirsevimab (Beyfortus), for all infants in their first RSV season as well as high-risk infants entering their second RSV season. Palivizumab (Synagis) is a monoclonal antibody that remains available for high-risk infants.
Importantly, although not a focus of this piece, the RSV subunit vaccine used during pregnancy (Abrysvo) and two additional RSV vaccines (Arexvy and mResvia) are also available for older adults. (Check the September feature article for more information about RSV prevention in adults.)
Many of the errors during the first RSV season included administration of the wrong product to the wrong patient, so immunization providers should have standard processes in place to ensure the various products are used correctly. This reduces the likelihood of errors while also creating a common process for identifying areas for improvement.
Preventing errors
- Train healthcare providers and other clinical staff on the different indications for each RSV prevention product.
- Be sure staff always checks product labels at least three times before administration to verify that the correct product is being administered to the patient in front of them.
- Consider implementing systemic safeguards (e.g., electronic alerts) to prevent administration errors. For example, the electronic health record can be programed to alert the provider if they erroneously order Beyfortus for a patient older than 19 months or at the wrong time of year.
- Facilities that stock both the RSV vaccine and the RSV monoclonal antibody should put systems and procedures in place to prevent interchanging the products, including using clear and instructive labeling and systematic approaches to storage in units for related products. Adding warning labels that remind staff to double check which product they are grabbing at a given point can also help. CDC’s job aid titled, “Vaccine Administration: Preventing Vaccine Administration Errors,” is useful for training.
Reporting errors
While the goal is to be error-free, from time to time, mistakes happen. Make sure a process is in place so that everyone knows steps to take if a situation occurs:
- Be sure that staff feel the work environment is supportive for reporting any errors that are made.
- Ensure that one of the steps includes the process for informing the family of the error.
- Regardless of the type, all errors should be reported.
- Errors involving administering vaccine incorrectly should be reported to the Vaccine Adverse Event Reporting System (VAERS). If the antibody was administered at the same visit as vaccines, CDC strongly encourages reporting this medication error and any suspected adverse events following the error to VAERS as well.
- If antibody only was administered, report the incident to MedWatch or the FDA at 1-800-FDA-1088.
Fixing errors clinically
An important and, sometimes complex, part of addressing administration errors is knowing what to do for the patient. Each clinical scenario below is adapted from Immunize.org’s “Ask the Experts: RSV.” Like other pages in this section of the Immunize.org website, responses are designed to give readers the “need-to-know” highlights. You can also reach out to your local health department, the CDC, or the manufacturer for assistance in resolving the issue.
Clinical scenario #1
An adult patient of mine received a dose of nirsevimab, the RSV monoclonal antibody for infants. What should I do?
Administer the RSV vaccine as recommended because the infant dose of the monoclonal antibody is not likely to protect an adult. There is no defined waiting period after monoclonal antibody administration for vaccine administration.
Clinical scenario #2
The mother of a newborn I care for was given Arexvy (GSK) during the pregnancy. I am aware that for the prevention of RSV-associated lower respiratory tract disease in infants younger than 6 months old, only Abrysvo (Pfizer) is licensed for use during pregnancy (during 32 through 36 weeks and 6 days’ gestation). Given the vaccine error, what needs to be done to protect the infant?
As Arexvy (GSK) is not licensed or recommended for use in pregnancy, if Arexvy is inadvertently given during pregnancy, do NOT administer a dose of Abrysvo. Instead, the infant (if younger than 8 months) should receive nirsevimab during RSV season. Essentially, treat the infant in the same manner as an infant born to a mother who did not receive RSV vaccination during pregnancy.
Clinical Scenario #3
Should I give nirsevimab to an infant who inadvertently got an RSV vaccine?
In this case, tell the family that the safety and effectiveness of an RSV vaccine has not been studied in infants, and the infant still needs protection from RSV. Give nirsevimab according to CDC recommendations, ideally within 72 hours of the error. Administer the nirsevimab in a different anatomic site than the RSV vaccination site.
Tracking and learning from errors
Track errors within your practice to help drive improvement. At the time of the error, review your practice processes. It’s important to understand if there was deviation from a standard process and if you can implement changes to your internal processes to decrease the likelihood of it occurring again. Alternatively, you may need to develop a new process to better prevent future errors.
Resources
- Clinician Outreach and Communication Activity (COCA Now) update, Information on Respiratory Syncytial Virus (RSV) Vaccine Administration Errors in Young Children and Pregnant People – CDC, January 22, 2024
- RSV (Respiratory Syncytial Virus) Clinical Resources – Immunize.org
- CDC Cautions Against RSV Immunization Errors, Offers Guidance – AAP News, Jan. 23, 2024
- Vaccine Adverse Event Reporting System: Information for Health Care Providers
Contributed by: Sharon G. Humiston, MD, MPH, FAAP