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A summary of presentations from the weekly Summit partner webinars

May 9, 2024 – The latest Summit Summary

Respiratory Syncytial Virus (RSV) Immunization Recommendations – Jefferson Jones, MD, MPH, FAAP, CDR, Centers for Disease Control and Prevention

Jefferson Jones, MD, MPH, FAAP, CDR, US Public Health Service, Co-Lead, ACIP Pediatric/Maternal RSV Work Group, Centers for Disease Control and Prevention, gave the update for RSV immunization recommendations.

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Respiratory Syncytial Virus (RSV) Immunization Recommendations
Maternal RSV Vaccine and Nirsevimab Recommendations
Two products are available to protect infants.

    • In the infant’s first season, either maternal vaccination or infant vaccinations are recommended – but usually not both
    • If the infant is receiving RSV protection in his/her second season, nirsevimab is recommended regardless of maternal RSV vaccination
      • Maternal Vaccine Recommendation
        • Recommended for pregnant people, 32-36 weeks, seasonally
        • Maternal Pfizer RSV vaccine can be simultaneously administered with other indicated vaccinations
        • Maternal Pfizer RSV vaccine is currently recommended as one-time dose; there is no, or not enough, data available for efficacy and safety in subsequent pregnancies for additional doses
        • The Pfizer maternal RSV vaccine is Abrysvo®: it is administered as a single dose,  and requires reconstitution. It is given as an intramuscular injection and is the ONLY RSV vaccine approved for pregnant people
        • Pfizer/Abrysvo® storage and handling requirements were described (details in presentation)
      • Nirsevimab Recommendations
        • Infants younger than 8 months born during or entering their first RSV season should get 1 dose of nirsevimab if no maternal vaccine was given during the mother’s pregnancy, if maternal RSV vaccination status is unknown, or if the infant is born with 14 days of maternal RSV vaccination
        • For infants ages 8-19 months at increased risk of severe RSV disease and entering their second RSV season, 1 dose of nirsevimab is recommended
        • The timing of administration and details of considerations for increased risk were detailed for each age group (details in presentation)
          • In general, nirsevimab should be given between October and March, with some exceptions for geographic location and seasonality
          • Nirsevimab is given intramuscularly
        • Storage, handling, preparation, and dosage of nirsevimab were described (details in presentation)

Both products (maternal RSV vaccine and nirsevimab) are safe and effective, and patient preference should be considered. Providers should give information about both, including the advantages and disadvantages of each.

Adult RSV Vaccine Recommendations

    • In June 2023, ACIP and CDC recommended the first two vaccines for older adults
    • Adults ages 60 and older may receive a single dose of the RSV vaccine using shared clinical decision making (i.e., no default decision to vaccinate)
      • The patient’s risk of severe RSV disease is a consideration and is affected by chronic medical conditions and other factors
      • The best time for vaccination is at the start of the upcoming 2024 RSV season (i.e., late summer, early fall)
    • At the next ACIP meeting in June 2024, additional policy issues, such as potential FDA approvals for additional RSV vaccines and the use of shared clinical decision making, will be addressed

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Respiratory Syncytial Virus Vaccine Administration Errors in Pregnant Persons and Young Children <2 Years Reported to VAERS During the 2023-2024 Respiratory Season – Anne Scheffey, MPH, MS, BSN, RN, Nurse, Immunization Safety Office, Centers for Disease Control and Prevention

Anne Scheffey, MPH, MS, BSN, RN, Nurse, Immunization Safety Office, Centers for Disease Control and Prevention, gave the update on RSV vaccine administration errors.

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Respiratory Syncytial Virus Vaccine Administration Errors in Pregnant Persons and Young Children <2 Years as Reported to VAERS During the 2023-2024 Respiratory Season
Some background on approvals, coverage, and VAERS was given (details in presentation).

  • Of the three approved RSV prevention products, ONLY Pfizer/Abrysvo® is approved for use during pregnancy, and ONLY nirsevimab is approved for all infants and some young children
    • RSV vaccination coverage estimates are as follows: 17.8% of pregnant persons, 41.3% of infants, 23.8% of adults aged 60 and older; as of January 2024, March 2024, and April 2024, respectively
  • Vaccine Adverse Event Reporting System (VAERS) is co-managed by CDC and FDA and receives info on errors and adverse events following vaccination
    • Accepts reports from everyone regardless of plausibility of relationship of vaccine to adverse event
    • Rapidly detects safety signals but cannot assess causality
    • A review of VAERS describing errors from 2000-2013 found a marked increase of errors with over 20,000 reports; 25% had an adverse health event and, of those, 8% had an adverse health event classified as serious
        • The author findings from the review included the following: the most common error groups were inappropriate schedule, storage and dispensing mistakes, and wrong vaccine administered

There were RSV vaccine administration errors reported during the 2023-2024 season, including reports of pregnant persons and children receiving the wrong RSV vaccine.

  • Total of 113 reports of pregnant persons receiving Arexvy® from August 2023 to January 2024 (this is the GSK vaccine recommended for 60 and older); the majority (61.9%) reported that the  administration happened in a pharmacy or drugstore; 91.2% reported no adverse event
  • Reasons for administration errors (note: over 80% of reports did not list a reason) were most commonly, insufficient knowledge about difference in vaccines, and Pfizer RSV vaccine not being available at the facility

There were RSV vaccine administration errors involving children younger than 2 years reported from August 2023 to March 2024.

  • There were a total of 34 reports and most reports involved infants aged younger than 8 months; 71% occurred in doctors’ offices
  • Most reports (79%) did not have an adverse event; there was one serious event
  • Half of the reports said patient received RSV vaccine instead of nirsevimab, 1 patient was to receive a routine childhood vaccine, and the remaining reports did not indicate intended vaccination product
  • Most did not indicate reasons for errors; of those that did, reasons included new staff, out of stock, wrong product pulled

There were RSV vaccination administration errors involving adults aged 60 years and older during the 2023-2024 season.

  • There were a total of 346 reports
  • Common errors included administration at inappropriate site, an extra dose given, and an incorrect route of administration
  • 18.5% of the reports indicated an adverse event

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CDC Recommendations and Tools to Prevent RSV Immunization Errors – Elisha Hall, PhD, RD, Deputy Chief Medical Officer, Immunization Services Division

Elisha Hall, PhD, RD, Deputy Chief Medical Officer, Immunization Services Division, Centers for Disease Control and Prevention, gave the update on recommendations and tools to prevent immunization errors.

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CDC Recommendations and Tools to Prevent RSV Immunization Errors
Preventing Vaccine (Immunization) Administration Errors
There was an overview of the process of reporting and handling nirsevimab errors.

  • Inquiries come from NIP-INFO and come from both health providers/professionals and the general public; responses are made by NIP-INFO based on CDC or ACIP guidance
  • There were 26 nirsevimab error inquiries from August 2023 to March 2024
  • Six different types of errors were noted:
    • a lower than indicated dose (50%) administered
    • the wrong population given nirsevimab
    • higher than indicated dose administered
    • two doses given in one RSV season
    • a lower than indicated dose administered
    • storage temperature excursion
  • Most errors occurred in infants
  • Clinical guidance has been provided by the CDC for errors in adults and pregnant people (details in presentation)

Tips and Tools for Preventing Vaccine Administration Errors
The following information about the prevention of errors was provided.

  • Administer the correct product:
    • ONLY give Abrysvo® to pregnant people; NOT Arexvy® to pregnant people
    • ONLY nirsevimab (Beyfortus®, Sanofi, AstraZeneca) is administered to infants and young children; NOT RSV vaccines (Abryvso® [Pfizer], Arexvy® [GSK])
  • Facilities should establish procedures to avoid vaccine administration errors
    • Take preventive actions to avoid mix-ups
      • Education and training:
      • Systems changes to reduce errors:
        • Include the manufacturer name with abbreviation
        • Never list similar names sequentially
        • Use standing orders
        • Automate prevention alerts in EHR systems
      • Storage and handling best practices:
        • Circle information on packaging
        • Separate vaccines in bins/containers according to type/formulation
        • Use color-coded labels
        • Store look-alike vaccines in different areas
        • Use name alert/look-alike stickers
      • Preparation and administration tips to avoid errors:
        • Establish do-not-disturb times
        • Prepare vaccines for one patient at a time (include label)
        • Do not administer vaccines prepared by someone else
        • Clearly identify diluents
        • Triple check before administration
      • Prevent errors involving wrong patient:
        • Check identity
        • Educate staff
        • Prep/administer to one patient at a time
      • Prevent documentation errors:
        • Avoid error-prone abbreviations
        • Use ACIP vaccine abbreviations
        • Change look-alike names or generic abbreviations on computers
      • Prevent storage errors:
        • Training
        • Vaccine stock rotations based on expiration
        • Remove expired vaccines/diluent
        • Isolate vaccines exposed to improper temps
      • Prevent scheduling errors:
        • Use standing orders
        • Obtain vaccination history
        • Train/educate staff
        • Schedule after child’s birthday
        • Post current vax schedules
        • Counsel patients re: recordkeeping

 
QUESTIONS

Q: It seems like some of the errors may have been in part due to the nirsevimab supply shortage resulting in people trying to substitute where they shouldn’t have. Can you give any update on supply issues that we may see going forward for the next fall season?

Elisha Hall (CDC): To our knowledge, we have not been informed of any supply issues for the public VFC side. They are just proactively going to implement ordering controls just to make sure things stay steady. But we have not yet heard of any supply concerns.

 
Q: And does that apply to both doses of the nirsevimab?

Elisha Hall (CDC): Yes, we have not heard of supply constraints with either the 50 or the 100. And we have not heard of any supply constraints with Pfizer’s Abrysvo® vaccine. Certainly, that’s already available, a little different situation than nirsevimab but wanted to mention that, as well.

 
Q: And Jefferson, you or Michael answered this already in the chat, but I thought I would just ask you if you could talk about this to the whole group. And that is a question from Elizabeth Sobczyk, who’s with AMDA. Elizabeth is asking about the seasonal recommendations for administration. So I’m wondering if you can talk about that with regards to the RSV vaccines. Elizabeth and her organization work with people in long-term care, so I think that’s part of her perspective. But, anyway, if you could talk a little bit about seasonal administration of the vaccines.

Michael Melgar (CDC): I’m here to answer questions on the adult RSV vaccine program. So, I can start there because I think that was the genesis of the question. But I’ll point out that this recommendation is not a formal seasonal recommendation, whereas the pediatric and maternal immunization recommendations are, in fact, seasonal. But with that said, the rationale for encouraging older adult RSV vaccination in the late summer and early fall is because that timing would maximize the balance of benefits and potential risks of vaccination. We have noted that, from the clinical trial data, the efficacy does look like it wanes over time. And although both manufacturers, GSK and Pfizer, have shown that efficacy from the vaccine lasts into the second RSV season after vaccination, the persons that are enrolled in the trial were vaccinated at the right time to optimize that protection during the second season. So if vaccination is given too early, like, hypothetically, right now in May, it’s not clear how well the vaccine efficacy would persist into that second RSV season. And when the recommendations were initially made, almost a year ago now in June of 2023, RSV seasonality was still unpredictable. So, it didn’t make a lot of sense to encourage a strict seasonal recommendation at that time, especially knowing that there was evidence of efficacy into the second season. But what we saw during the 2023-2024 season was a pretty close alignment of the RSV season to the pre-COVID, pre-pandemic norm. And that, along with the evidence that was reviewed at the February ACIP meeting on reports of Guillain Barre Syndrome after RSV vaccination, led CDC to encourage vaccination at a time when persons who are vaccinated would get the most benefit from that vaccine. It’s not a strict seasonal recommendation; there are several reasons why clinicians and patients, together, might decide that they would want to get an RSV vaccine during the “offseason.” And that might be because the patient has very intermittent access to healthcare or there’s concern that, if they don’t receive the vaccine now, they just won’t get one. So, kind of the take-every-opportunity-to-vaccinate perspective, or if the patient really expresses a concern about receiving multiple vaccines at the same time in the fall (bundling it with flu and with COVID-19 vaccination) and would rather get one now while they’re face-to-face with their clinician. Those are all valid reasons and can make up part of the shared clinical decision making discussion. I think the big take away is the rationale for that updated messaging from CDC is really to maximize the balance of benefits and risks of RSV vaccination.

 
Q: You brought up a couple of things that I’m wondering if we could also address and that is the safety aspect. Do you anticipate that there will be additional safety data, or data on duration of protection from that single RSV vaccination at the June meeting, or are we going to be waiting some time for those?

Michael Melgar (CDC): Well, the agenda for the ACIP meeting has not yet been finalized, so I can’t speak in too much detail about what might be available. But, the CDC has been working very hard to generate observational, real world vaccine effectiveness estimates against the meaningful outcomes, like hospitalization, using our vaccine effectiveness platforms. And we hope to be able to share that at the public ACIP meeting. But, by definition, that’s only going to be one season because these vaccines have only been on the market for one season. The manufacturers have already shared two seasons worth of vaccine efficacy and Pfizer’s trial is now complete. So, they will not have any more than two seasons of vaccine efficacy data. GSKs will continue into a third RSV season, and we don’t yet know whether they will have any information to share in June about the third RSV season-worth of efficacy. CDC is aiming to provide an update on vaccine safety at that same ACIP meeting, but I don’t have more details that I can share this time.

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Announcements
  • Registration is now open for the May 16 and May 23 webinars, which will start at 2:00pm ET -4:30pm ET. These are in lieu of in-person meetings typically in May. These will focus on viral respiratory vaccination season coming up.
  • The National Adult and Influenza Immunization Summit in-person meeting will be August 15-16 at the same hotel as the conference, Marriott Marquis in Atlanta, GA. The 2024 meeting is temporarily full, but there is a waitlist and anticipated openings: please email your interest to info@izsummitpartners.org.

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