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A summary of presentations from the weekly Summit partner webinars

July 20, 2023 – The latest Summit Summary

Flu Surveillance Update – Katie Tastad (CDC)

Katie Tastad, MPH, Influenza Division – Domestic Surveillance Team, CDC, gave a flu surveillance update.

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U.S. Influenza Surveillance (Link)

Virologic Surveillance – Percent Positive for Influenza

  • Influenza A was the dominant flu type for the 2022–23 season
  • Influenza B became slightly more prominent in the spring and summer
  • Activity is low, which is typical for this time of year

Virologic Surveillance – Virus Characteristics

  • Influenza A H3 predominance followed by the H1 strains
  • There was no Influenza B Yamagata reported during the season

Outpatient Respiratory Illness – people resenting to outpatient urgent care, primary practice, or emergency department for fever and cough or sore throat

  • This past season peaked earlier than the past five influenza seasons
  • Since about week nine, the nation has been below baseline; activity has been low for a while and still decreasing/plateauing

Preliminary Estimates for 2022–2023 season in the U.S. Influenza has caused:

  • At least 27 million symptomatic illnesses
  • At least 12 million medical visits
  • At least 300,000 hospitalizations
  • At least 19,000 deaths

CDC is providing three new resources to display influenza, RSV, and COVID-19 data together:

Respiratory Virus Laboratory Emergency Department Network Surveillance (RESP-LENS)

  • Interactive dashboard that tracks emergency department visits for laboratory-confirmed COVID-19, flu, and RSV
    • Shows all three viruses at the national level
    • Data can be pulled out by virus or region
    • Data shows that RSV peaked earlier than flu and COVID-19 in the past fall season 

National Emergency Department Visits for COVID-19, flu, and RSV

  • Provides combined view of emergency department visit data for multiple respiratory conditions as tracked by the National Syndromic Surveillance Program (NSP)
    • Uses diagnosis discharge codes for COVID-19, flu, and RSV
    • Can see all three trends in one snapshot
    • Can be broken down by age and region to get more detailed look

Respiratory Virus Hospitalization Surveillance Network (RESP-NET)

  • This site comprises three platforms that conduct population-based surveillance for laboratory-confirmed hospitalizations associated with COVID-19, RSV, and flu among children and adults

Mortality

  • Looking at the combination of pneumonia, influenza, and COVID-19 (PIC) deaths
    • Coming down to typical baseline
    • Mortality was along the lines of a more typical flu season
  • Influenza-associated pediatric deaths
    • 162 reports
    • 152 of the deaths were due to influenza and ten due to influenza-like viruses
QUESTIONS

Q: We may start to change how providers do testing, how much testing they’re doing, and which viruses they’re testing as we transition from the pandemic. Were patients with certain syndromes or sets of symptoms routinely tested as opposed to testing just based on the provider’s discretion?

 

Katie Tastad: I would have to ask our ILI colleagues to find out more about how those testing practices work.

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Immunize.org webinar: Hepatitis B-Gone! Implementing universal adult screening and vaccination. Your practical questions answered. – Kelly L. Moore (Immunize.org)

Kelly L. Moore, MD, MPH, CEO, Immunize.org, gave an overview of the most recent Immunize.org webinar.

Hepatitis B-Gone! Implementing universal adult screening and vaccination. Your practical questions answered

  • Last week’s webinar had nearly 1,000 participants
  • Discussion between
    • org experts:
      • Kelly L. Moore, MD, MPH, President and Chief Executive Officer, Immunize.org
      • J Tan, PhD, MS, Chief Policy and Partnership Officer, Immunize.org
    • Carolyn Wester, MD, MPH, Director of CDC’s Division of Viral Hepatitis, National Center for HIV, Viral Hepatitis, STD, and TB prevention, CDC
  • Highlighted the interest in needing to understand more about the implementation of universal adult hepatitis B vaccination and screening recommendations
  • Wester talked about vaccination and universal screening recommendations for hepatitis B that involve screening for hepatitis B antibody, surface antigen, and core antibody—three tests that are recommended by CDC to be done once in a lifetime for every adult age 18+
  • Discussed how clinics should approach thinking about hepatitis B vaccination and screening of adults and to understand that these new recommendations are an important opportunity to prevent severe disease caused by hepatitis B, as well as an opportunity to eliminate hepatitis B at a faster pace than ever before
    • Tremendous success with pediatric vaccination programs
    • Acute hepatitis B infections among adults age 30–50 can be turned around
  • Discussed how new generations of vaccines demonstrate increased protection for older adults
    • Vaccines are available on 2- or 3-dose schedule
    • Many options for vaccination available
  • Webinar showed that many questions remain about the recommendations
  • Video and slides can be found on Immunize.org
  • org is in process of developing resources to be available before the end of July that will be shared on Immunize.org and announced in IZ Express
    • One-pager intended for patients titled, “Hepatitis B Vaccination and Screening of Adults – Simple Steps to Protect Yourself from Serious Liver Disease,” outlines the information patients need to know about screening and vaccination
    • Q&A intended for healthcare professionals that will go through all of the questions that were covered in the webinar, as well as some additional points that were not covered

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ACIP Update – Melinda Wharton (CDC)

Melinda Wharton, MD, MPH, Associate Director for Vaccine Policy, NCIRD, CDC gave an ACIP update on the sessions related to adult vaccinations.

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RSV Vaccines – Older Adults (Vote)

  • Two RSV vaccines were licensed in May
  • RSV vaccinations have the potential to prevent considerable mortality from RSV disease among older adults, particularly those with chronic underlying medical conditions and those who are frail
  • Both vaccines–Pfizer’s bivalent RSVpreF and GSK’s adjuvanted RSVPreF3—demonstrate significant efficacy against lower respiratory tract illness caused by RSV among older adults over at least two seasons
    • Trials did not include sufficient numbers of the oldest adults and adults who were frail to confirm that the efficacy was equally strong in those groups
    • Trials were not powered to show efficacy against RSV hospitalization
      • Efficacy against symptomatic illness may indicate efficacy against more severe disease
    • There were a number of cases of inflammatory neurological events within 42 days after vaccination in clinical trials of the vaccines
    • Clinical trials weren’t powered to determine whether or not the small number of cases occurred due to random chance
      • Important to have post-licensure surveillance for both safety and efficacy to look at adverse events and document real-world performance of the vaccines
    • Discussion about the health economics
      • RSV vaccine for older adults could be a cost-effective intervention
        • Not all patients who are eligible will receive the vaccine
      • Uncertainty in the net societal costs of an RSV vaccination program for older adults is driven by uncertainties in:
        • Vaccine acquisition costs:
          • Current assumption
            • $200 Pfizer RSVpreF
            • $270 GSK RSVPreF3
          • Incidence of RSV illness
          • Duration of protection from RSV vaccination (assumption: 2 RSV seasons)
        • Vaccination of older age groups would be more cost-effective than younger age groups

FINAL RECOMMENDATION: Adults age 60 years and older may receive a single dose of RSV vaccine using shared clinical decision-making.

Polio Vaccines (Vote)

  • Problem with polio:
    • S. remains at risk as long as there are unvaccinated in the world
      • Cases have been documented in U.S. recently
    • Unvaccinated and incompletely vaccinated adults are susceptible to paralytic polio if exposed
  • Questions that arose around the 2000 statement on IPV vaccination for adults
    • The statement focused on adults at increased risk of poliovirus exposure
    • Uncertainty in how to think about increased risk when there is circulating vaccine-derived polio in the U.S.
    • Unclear guidance for unvaccinated adults with unknown increased exposure risk
    • Uncertainty about vaccinated adults and if/when a booster needed
  • Committee voted on February 2 on these issues
    • Adults age 18 and older with known or suspected to be unvaccinated or incompletely vaccinated against polio should complete primary IPV vaccination.
      • Point: Even if they don’t have access to their childhood vaccine records, most people are vaccinated if they grew up in the U.S.
    • Adults who have received primary series of trivalent OPV (tOPV) or IPV in any combination and who are at increased risk of poliovirus exposure may receive another dose of IPV. Available data do not indicate the need for more than a single lifetime booster dose with IPV for adults.
      • Similar language to that in the 2000 recommendation

Influenza Vaccines (Vote)

  • Proposed Recommendations
    • Vaccination of all people age 6 months and over who do not have contraindications continues to be recommended
    • Recommendations regarding timing of vaccination are unchanged from last season
      • Most people who need only one dose of flu vaccine for the season should be vaccinated during September or October
      • Vaccination should continue after October and throughout flu season as long as flu viruses are circulating and unexpired vaccine is available
      • Vaccination during July and August is not recommended for most people
        • It might be possible to start vaccinating earlier for some adults, children, and pregnant people
      • Changes:
        • Updated U.S. flu vaccine composition for season 2023–2024
          • Includes update to the H1N1 component
        • Changes to the recommendations for vaccination for persons with acute egg allergy
      • Current ACIP recommendations on people with egg allergy
        • People with a history of egg allergy of any severity should get the flu vaccine
        • Any licensed, recommended flu vaccine can be used
        • For people with previous reactions to eggs, involving symptoms other than urticaria:
          • “If a vaccine other than ccIIV4 or RIV4 is used, the selected vaccine should be administered in an inpatient or outpatient medical setting, including but not necessarily limited to hospitals, clinics, health departments, and physician offices. Vaccine administration should be supervised by a health care provider who is able to recognize and manage severe allergic reactions.”
        • No specific observation period is recommended
      • Available evidence concerning the safety of influenza vaccines in persons with a history of egg allergy favored routine vaccination without additional safety measures, regardless of severity of previous allergic reaction to egg

VOTE: All people age 6 months and older with an egg allergy should receive influenza vaccine. Any influenza vaccine (egg based or non-egg based) that is otherwise appropriate for the recipient’s age and health status should be used.

Dengue Vaccines

  • Dengvaxia: ACIP recommendation in June 2021
    • Three doses of the vaccine are indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3, and 4 in people 9–16 years old with:
      • Laboratory confirmation of previous dengue infection
      • AND living in endemic areas
    • Presentations to ACIP on TAK-003
      • October 2022:
        • Dengue epidemiology
        • Review of Sanofi dengue vaccine and ACIP recommendation
      • February 2023
        • Takeda dengue vaccine safety and efficacy presentation
        • Workgroup summary and interpretation
      • June 2023
        • Policy questions
        • Cost-effective analysis
        • Partial evidence to recommendations (EtR)
      • Introduction of new vaccine to Puerto Rico
        • Applied for FDA licensure for vaccine with broader age range
        • Potentially be used for travelers
        • In the June meeting, there was a discussion about cost-effectiveness and comparison of cost-effectiveness models along with a review of part of the evidence to recommendations framework
        • July 11 there was an announcement that the BLA application was withdrawn by Takeda

Chikungunya Vaccines

  • In February 2023, the FDA accepted Valneva’s chikungunya vaccine BLA for and granted priority review
  • Licensure in August 2023
  • No chikungunya vaccine ever licensed globally
  • No existing chikungunya vaccine recommendations
  • Chikungunya vaccines work group is developing options for ACIP’s consideration among U.S. people at risk
    • Travelers
    • Lab workers
      • 44 reports of disease, four over the last eight years
      • Transmission include aerosol and percutaneous route
      • Likelihood of disease vs. asymptomatic infection probably high
    • Residents of U.S. territories and states with at risk transmission
  • Chikungunya can occur in explosive outbreaks such as in Paraguay in 2022–2023
    • EAt the end of 2022, the outbreak explosive and extensive
      • Beginning of June almost 170,000 cases reported
    • Older adults, infants (highest fatality), and people with comorbidities are at risk for severe disease,
    • Impact high on health services from patient load and sick staff 

RSV Vaccines – Pediatric/Maternal

  • EtR Framework policy question: Should vaccination with Pfizer RSVPreF vaccine be recommended for pregnant people (24–36 weeks gestation) to prevent RSV disease in infants?
  • Work group interpretations
    • Effective vaccine that can prevent RSV lower respiratory tract infection in young adults
    • Concern that Pfizer trial was underpowered to detect a 20% difference in preterm births between vaccine and placebo recipients
      • Data may be insufficient to determine safety
      • Vaccine can provide benefit by preventing RSV lower respiratory tract infection in infants and the difference in preterm births was not statistically significant
    • Imbalance in preterm birth:
      • Most prominent in South Africa
      • Not seen in high-income countries
      • Still present but less pronounced when compared to the prevalence of low birth weight
      • Most preterm births were more than 30 days post-vaccination
    • Work group discussed:
      • Support of narrower dosing window
        • In opposition to that, risk of severe RSV disease unprotected in preterm infants at high risk
      • Alignment of RSV vaccine with Tdap to improve feasibility
      • All members endorsed the importance of post-introduction vaccine safety monitoring
    • Draft clinical considerations:
      • Either maternal vaccination with RSVpreF or nirsevimab (licensed mid-July) is recommended to prevent RSV disease, but both products are not needed for most infants
      • Risks and benefits of both should be considered when deciding on maternal vaccination
      • If the mother is vaccinated, nirsevimab can be considered if the infant is considered to have insufficient protection from vaccine or is at high risk of severe disease
    • Nirsevimab will be discussed on August 3

Mpox Vaccines

  • February 2023 ACIP meeting the vote passed for the use of Jynneos during outbreaks. ACIP recommends the 2-dose Jynneos vaccine series for people age 18 and older who are at risk of mpox during an mpox outbreak
  • June 2023 the previous recommendation was discussed and updates were given about vaccine effectiveness and safety
  • In October 2023, ACIP will consider the need for longer term vaccination strategy for 2-dose Jynneos vaccination

COVID-19 Vaccines

  • There was an update to COVID-19 in pregnant people and infants
    • Pregnancy continues to be a risk factor for severe maternal disease
    • COVID-19 vaccination improves outcomes for pregnant people and their infants
    • Evidence that mRNA vaccines are safe during pregnancy
    • Uptake is low among pregnant people – 23% received the updated dose
    • Pregnant people should receive recommended COVID-19 vaccine
    • Continue to review data and evaluate COVID-19 recommendations for pregnant people
  • Infection-induced and hybrid immunity
    • Hybrid immunity provides better protection than infection or vaccination alone
    • Protection influenced by factors:
      • Vaccine doses
      • Number of times infected
      • Timing of most recent vaccination or infection
      • How closely circulating variant matches the vaccine or prior infection
    • Protection wanes over time
    • Receipt of updated vaccine dose can provide additional protection and restore protection after waning
  • Recommendation of updated vaccine timeline
    • June 15, 2023, FDA VRBPAC met to discuss fall strain composition
    • VRBPAC unanimously voted composition to be updated monovalent COVID-19 vaccine with XBB-lineage of Omicron variant
    • FDA advised manufacturers to develop vaccine with monovalent XBB.1.5 variant
    • Vaccine doses expected in fall
    • Following updated vaccine authorization, ACIP will review evidence to inform updated recommendations
  • Fall 2023
    • Commercial marketplace COVID-19 vaccine in fall
    • Most Americans will pay nothing out-of-pocket with insurance
    • Twenty-five million uninsured will lose access
      • Bridge Access Program for COVID-19 Vaccines and Treatment – public-private partnership to prevent loss of under- and uninsured adult access to COVID-19 vaccine and treatment at no cost after insurance
    • Summary for COVID-19 vaccines
      • COVID-19 continues to cause morbidity and mortality especially in older adults and immunocompromised people
      • Vaccination most effective preventive tool
      • Vaccination is important for pregnant people to protect themselves and infants
      • Most of population hasn’t gotten the bivalent booster dose
      • Review of data is ongoing
      • Anticipated increases in cases over the winter
      • ACIP to discuss future recommendations at upcoming meetings
QUESTIONS

Q: When with the (adult) RSV vaccines become available and will they be covered by insurance?

Melinda Warton: My understanding is that there will be some availability soon but I don’t know how fast things will roll out. The exact timing of the insurance coverage will depend on the individual plan. There is a requirement that most insurers cover ACIP recommended vaccines but that coverage doesn’t necessarily start immediately. I think it will be available in pharmacies quite soon. As far as doctor’s offices, it will depend on when they order it.

L.J Tan: Even though this vaccine is a shared clinical decision-making recommendation, it will be covered under the Affordable Care Act.

 

Q: Is nirsevimab being classified as a vaccine?

Melinda Warton: ACIP is planning on convening to make recommendations for the product. AAP has long made recommendations for antibody products that are used in conjunction with vaccines. In this particular case this is a long acting monoclonal antibody that is being used in the same type of way we would use the vaccine. It feels like this is much more like a vaccine than the usual antibody product. It was really left as being a policy decision about how this would be handled. This is a therapeutic agent even though its used for the prevention of infectious diseases. There will be lots of complications about implementation because of that. There’s potential for a lot of benefits to infants so hopefully it can be figured out so it can be implemented.

 

Q: Does the preferential recommendation for older adults for high-dose adjuvanted vaccines apply again this year?

Melinda Warton: That was a new recommendation last year and it is unchanged this year. We still have the preferential recommendation for high-dose adjuvanted or recombinant influenza vaccine for people age 65 and older.

 

Q: We heard that CVS and Walgreens are the only pharmacies in the Bridge program. Can you confirm that?

L.J Tan: There is a third pharmacy called E True North that is also a part of the three that have been contracted as part of the Bridge program. But we will get a more definitive answer as we move further forward in the program.

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Announcements
  • During the summer, our weekly meetings become monthly meetings. Beginning in September, we will resume our weekly schedule. The next meetings will be on August 17 and 31.
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