Maternal RSV Vaccination Recommendations and Implementation in Pharmacies

Thank you for joining this presentation on Maternal RSV Vaccination Recommendations and Implementation in Pharmacies. My name is Alicia Hall, and I'm the Deputy Chief Medical Officer in the Immunization Services Division at CDC. Today, I'm going to talk about Maternal RSV Vaccination Recommendations, including why vaccination this season is so critical, what the recommendations are, key implementation considerations for pharmacies, and resources to help facilitate vaccination in your pharmacy. RSV is just one of three seasonal respiratory diseases for which we have immunizations to help protect ourselves. Before we dive into Maternal RSV vaccination specifically, I'll start by putting this recommendation in the context of the overall 2023-2024 fall-winter vaccination recommendations. Flu, COVID-19, and RSV are circulating, and the time to immunize patients who haven't yet been immunized to protect them against fall-winter respiratory viruses this season is now. CDC expects a similar number of hospitalizations this season as last year nationally, but likely more than pre-pandemic years. Even a moderate season of flu, COVID-19, and RSV co-circulation could place more significant strain on our healthcare system than a severe season of just flu and RSV co-circulation alone. Some healthcare systems are already reporting strain. Taking a look at where we are now in December of this season, viral respiratory season has arrived and is expected to worsen over the next several weeks in much of the country. This season, there are more ways than ever to protect the health of our patients. There are safe, updated vaccines for influenza, COVID-19, and RSV. Treatments are available for flu and COVID-19 that can reduce severe illness, hospitalization, and death. Rapid antigen tests are available to quickly detect respiratory viruses so there are no delays in getting treatment. And we have everyday actions we can take, like frequent hand-washing, to help prevent the spread of respiratory viruses. Now let's dive into immunization recommendations to protect patients from respiratory diseases. First, for COVID-19, most people ages 5 years and older need one dose of the COVID-19 vaccine. The one exception is people ages 12 years and older who have not previously received any COVID-19 vaccine doses and choose to receive Novavax should receive an initial series of two doses. Children 6 months through 4 years and immunocompromised patients may need more than one dose to complete their initial series. And finally, immunocompromised patients may get additional doses. For influenza, for people ages 6 months through 8 years, one or two doses is recommended depending on vaccination history. For people ages 9 through 64 years, one dose is recommended. And finally, for people ages 65 years and older, one dose of a high-dose inactivated, recombinant, or adjuvanted inactivated vaccine is preferred. If one of these vaccines is not available, don't miss the opportunity to vaccinate. Another age-appropriate vaccine should be used. And finally, for RSV, immunization is recommended to protect children, infants, and older adults. Maternal RSV vaccination at 32 through 36 weeks gestation from September through January or nursevimab for infants less than 8 months born during or who are entering their first RSV season is recommended. Some children ages 8 through 19 months at increased risk for severe RSV should get nursevimab in their second RSV season. And finally, for those ages 60 years and older, one dose of RSV vaccine is recommended if indicated based on shared clinical decision-making. Now we'll specifically dive into maternal RSV vaccination, a new vaccine introduced this year to protect infants from severe RSV disease. It is critical to protect infants from severe RSV disease. RSV accounts for approximately 1.5 million outpatient visits among children younger than 5 years old, over 500,000 emergency department visits, and tens of thousands of hospitalizations and hundreds of deaths each year. There are two options to protect infants and young children from RSV. First is maternal RSV immunization, or second is nursevimab, a monoclonal antibody for infants and young children. Either maternal vaccination or use of nursevimab in the infant is recommended to prevent RSV lower respiratory tract infection, but administration of both products is not needed for most infants. Only abrisvo from Pfizer is recommended for use in pregnant people. An additional RSV vaccine, orexvi from GSK, is not recommended for use in pregnant people. Neither abrisvo or orexvi are approved for infants. In pharmacies, we're really only dealing with maternal RSV vaccine, but it's good to be aware there's an infant recommendation because this emphasizes the importance of regular processes when giving a vaccination. For instance, providing the pregnant person with documentation when they get vaccinated to make it easier in determining whether the infant needs nursevimab at birth. For these products, we have new ACIP recommendations this season. So as mentioned, either maternal vaccination with Pfizer's abrisvo vaccine or use of nursevimab is recommended, but both products are not needed for most infants. Again, orexvi is not recommended for pregnant people and neither abrisvo or orexvi is licensed in infants. Maternal vaccine is recommended for pregnant people during 32 through 30 weeks gestation with seasonal administration. So this means administering during September through January in most of the continental US. In jurisdictions where seasonality differs from most of the continental US, for example, Alaska, or jurisdictions with tropical climates, providers should follow state, local, or territorial guidance on timing of administration. Maternal Pfizer vaccine can be simultaneously administered with other indicated vaccines. Now let's go into some implementation considerations for pharmacies. As mentioned, there are two RSV vaccines. Two are approved for people 60 years and older, but there is only one for pregnant people, and that is Pfizer's vaccine abrisvo. Some pharmacies might have both vaccines, some may only have GSK's vaccine orexvi, and some may only have Pfizer's vaccine abrisvo. For those sites not carrying the maternal RSV vaccine, if there are state or local resources that help identify availability of Pfizer's vaccine abrisvo, providing those resources can help patients get vaccinated. These vaccines have similar names and abbreviations. So given the potential for mixups between these vaccines, it's critical to put procedures in place to avoid vaccine administration errors. In the next few slides, I'll cover some specific procedures that you can put in place to help avoid errors. So first, there are some storage practices that can be put in place. You encircle important information on the packaging to emphasize the difference between vaccines. Separate vaccines into bins or other containers according to type and formulation. Use color-coded identification labels on vaccine storage containers. Store look-alike vaccines in different areas of the storage unit. Consider using name alert or look-alike stickers on packaging in areas where these vaccines are stored. Next, when integrating the name of the vaccine into your systems and processes, you could include the manufacturer name with the vaccine abbreviation and brand wherever possible in orders, medical screens, etc. And not list vaccines with look- or sound-alike names sequentially on computer screens. Order forms or medical records whenever possible. Next, some preparation and administration practices. Establish do-not-disturb or no-interruption areas or times when vaccines are being prepared or administered. Prepare vaccines for patients one at a time. Once prepared, label the syringe with vaccine name and manufacturer. Do not administer vaccines prepared by someone else. And finally, triple-check work before administering a vaccine, and you could always ask another staff member to check as well. And finally, integrate vaccine administration training into orientation and other appropriate education requirements. And provide education when new products are added to inventory or recommendations are updated. Now switching gears to another implementation consideration, it is critically important to document receipt of maternal RSV vaccines, as most infants of vaccinated mothers are not recommended to receive Nirsevimab. You can document in the immunization information systems, the electronic health record, and give written documentation to the patient. In terms of insurance coverage for the RSV vaccine, for Medicaid, it is covered with no-cost sharing for nearly all full-benefit adult beneficiaries with traditional Medicaid beginning October 1, 2023. It varies by state for other types of Medicaid coverage. For the Vaccines for Children's Program, or VFC, it is covered for patients under age 19 years who are eligible for the program. And finally, for private insurance, most private insurance plans are required to cover, but they have one year to do so. RSV vaccines may not be covered under all private plans this season, including the maternal RSV vaccine. Finally, there are some practices that pharmacists can implement, where allowed by state law, to help reduce barriers for pregnant people getting vaccine. First, none of these suggested practices supersede state law. You should always follow state law for requirements for vaccination, whether this is a prescriber order or prescription, a protocol, or having no additional requirements. Avoid practices that present additional barriers for patients when not required by state law. So, for example, avoiding requiring physician prescription orders and avoiding requiring documentation of pregnancy or gestational age. And promote practices that can enable vaccination, where allowed by state law. This includes implementing standing orders, accepting self-attestation of pregnancy and gestational age. So, this just means accepting the patient's word that they are pregnant and they are at the correct 32 through 36 weeks without requiring documentation proving that. Removing any requirements for physicians or for physician prescriptions or orders. And now I'll wrap up with some resources. This slide lists resources for RSV, including a provider toolkit that is a one-stop shop for fall and winter virus resources, as well as multiple web pages on RSV immunization. This slide links to the RSV vaccine information statement for the maternal RSV vaccine and the RSV immunization information sheet for Nercevimab. On this slide is a link for RISPO standing orders, which can help to facilitate vaccination. And finally, this slide provides a link to CDC's health advisory, describing interim recommendations to provide options for clinicians to protect infants from RSV in the context of a limited supply of Nercevimab. Thank you for joining this webinar today on maternal RSV vaccination and implementation considerations.