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A summary of presentations from the weekly Summit partner webinars

 

July 15, 2021

Updates from the June 2021 ACIP Meeting – Jessica MacNeil, MPH (ACIP)

A CDC summary of information on votes during the June 2021 meeting and recommendations from ACIP are summarized as follows:

ACIP approved the following recommendations by majority vote at its June 24-25, 2021 meeting.

  • ACIP recommends 3-doses of Dengvaxia administered 6 months apart at month 0, 6, and 12, in persons 9-16 years of age with a laboratory confirmation of previous dengue infection and living in endemic areas.
  • ACIP affirms the updated MMWR Recommendations and Reports, “Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices—United States, 2021-22 Influenza Season.”
  • ACIP recommends a 2-dose [0, 7 days] intramuscular rabies vaccine series in immunocompetent persons <18 years of age for whom rabies vaccine pre-exposure prophylaxis (PrEP) is indicated.
  • ACIP recommends an intramuscular booster dose of rabies vaccine, as an alternative to a titer check, for immunocompetent persons <18 years of age who have sustained and elevated risk for only recognized rabies exposures (i.e., those in risk category #3 of rabies PrEP recommendations table). The booster dose should be administered no sooner than day 21 but no later than 3 years after the 2-dose PrEP series.

These recommendations have been adopted by the CDC Director and will become official once published in MMWR.

Jessica MacNeil, MPH, deputy executive secretary of the Advisory Committee on Immunization (ACIP) at the CDC, provided a presentation on the June 2021 ACIP meeting.

The June ACIP meeting began with COVID-19 presentations regarding safety and considerations for booster doses, and then focused on five different vaccine sessions, three with votes. This summary is of the five non-COVID-19 vaccine sessions, however, the entire June ACIP meeting slides can be viewed on CDC’s ACIP Meeting Information web page.

Dengue Vaccine Session (with vote)

The ACIP dengue vaccine workgroup has been meeting over the last several years to review available data on Dengvaxia and potential use of dengue vaccines in U.S. territories.

Since Dengvaxia was licensed by FDA in 2019, the workgroup has been focusing on several implementation considerations that are unique to this vaccine. For example, there is a need for a pre-vaccination screening test to identify those who are seronegative and seropositive before they get vaccinated.

The ACIP approved the following recommendation: 3-doses of Dengvaxia should be administered at months 0, 6, and 12, in persons 9–16 years of age with laboratory confirmation of previous dengue infection and living in an endemic area.

With the approved recommendation, the dengue workgroup is working to publish these recommendations in MMWR; they should be available in the next couple of months.

Influenza Vaccine Session (with vote)

A presentation during this session focused on the Flucelvax Quadrivalent (ccIIV4) Phase III immunogenicity and safety in children 6–47 months of age. The manufacturer presented data that showed that the vaccine met all of the predefined non-inferiority criteria for immunogenicity when compared to quadrivalent inactivated influenza vaccine (IIV4). This immunogenicity data was consistent across all four strains and ccIIV4 was shown to be well tolerated with similar rates of solicited and unsolicited adverse events between the two vaccine groups. This is consistent with previously reported data in older children.

The committee was asked to approve the updated 2021–22 ACIP Influenza Statement.

The core recommendation is unchanged: annual influenza vaccination is recommended for all persons aged 6 months and older who do not have contraindications.

The proposed key updates for this year include the following:

  • The influenza vaccine products expected to be available for the 2021–22 season
  • The U.S. influenza vaccine viral components for the 2021–22 season
  • Change in age indication for Flucelvax Quadrivalent (ccIIV4) from ≤4 to ≥2 years
  • Some changes to the timing of influenza vaccination language
  • The co-administration of influenza and COVID-19 vaccines
  • The contraindications and precautions concerning people with previous severe allergic reaction to influenza vaccines or their components.

This statement will be published and be available in an August MMWR.

Rabies Vaccine Session (with vote)

During the rabies session, the workgroup presented its final topic on pre-exposure prophylaxis (PrEP) for a vote and also began discussions on rabies post-exposure (PEP) prophylaxis. The proposed recommendations for the June ACIP vote included a change from a three-dose schedule to a two-dose (0, 7 days) schedule for immunocompetent people <18 years of age for whom rabies vaccine PrEP is indicated. The ACIP also recommends a booster dose after day 21 and no later than 3 years after the second dose as an alternative to a titer check.

The WHO recently changed its recommendations for the use of human rabies immunoglobulin (RIG) in the PEP vaccination schedule, so the workgroup has been considering whether to make any changes to the U.S. recommendation. During this presentation, the workgroup focused on and presented considerations for U.S. PEP for people who have not previously received PEP or PrEP.

The workgroup felt that considerations for PEP in the U.S. are very different from the rest of the world. They recommend that PEP regimen should be one dose of RIG at day 0 and four doses of rabies vaccine at day 0, 3, 7, and 14.

The workgroup will present at the October ACIP meeting and should be publishing an updated comprehensive summary of the rabies vaccine recommendations from the ACIP.

Pneumococcal Vaccine Session (no vote)

The pneumococcal vaccine session was an informational session and did not have a vote during the meeting.

The two current pneumococcal vaccines recommended by ACIP are the 23-valent pneumococcal polysaccharide vaccine (PPSV23) from Merck and the 13-valent pneumococcal conjugate vaccine (PCV13) from Pfizer. The two new vaccines are the 20-valent pneumococcal conjugate vaccine (PCV20) from Pfizer, which was licensed on June 8, 2021 for use in adults ≥18 years of age and the 15-valent pneumococcal conjugate vaccine (PCV15) from Merck. A Biologics License Application (BLA) was filed with FDA for PCV15 and licensure is anticipated in July 2021.

Policy questions that are under consideration by the workgroup are as follows:

  • Should PCV15 be routinely recommended in adults ≥50 or ≥65 years of age?
  • Should PCV15 be recommended in younger adults with underlying medical conditions?
  • Should PCV20 be routinely recommended in adults ≥50 or ≥65 years of age?
  • Should PCV20 be recommended in younger adults with underlying medical conditions?
  • Should recommendations be made for PCV15 and PCV20 alone or in series with PPSV23?

During the meeting, the workgroup presented a cost-effective analysis as well as a public health impact analysis for use of these new conjugate vaccines in U.S. adults. They also presented a GRADE/evidence to recommendations framework (EtR) for use of both the PCV15 and PCV20 in older adults. This is the first step in preparation for a potential ACIP vote in October.

The next step for the ACIP meeting in September will be to provide an additional cost-effective analysis (underway) and a GRADE analysis and EtR for risk-based recommendation for younger adults not targeted by the age-based recommendation. Following the September meeting, the work group will need to refine policy options on age- and risk-based recommendations on PCV15 and PCV20 use in adults for a vote at the October ACIP meeting. Both PCV15 and PCV20 will need to be reviewed separately.

Zoster Vaccine Session (no vote)

The zoster vaccine session was a session that did not have a vote at the June ACIP meeting.

The ACIP currently recommends (October 2017) that the recombinant zoster vaccine (RZV, Shingrix) be used in immunocompetent adults ≥50 years of age, including those taking low-dose immunosuppressive therapy, and those anticipating immunosuppression or who have recovered from an immunocompromising illness.

The workgroup is now considering the use of RZV in several different immunocompromised populations including hematopoietic stem cell transplant (HCT) recipients, patients with hematologic malignancies (HM), renal or other solid organ transplant (SOT) recipients, patients with solid tumor malignancies (STM), people living with HIV, and immunocompromised populations at increased risk of herpes zoster not covered in the previous groups.

During the session, the manufacturer presented some of the available immunogenicity and safety data for use of RZV in immunocompromised populations. The data helped to answer the policy question: Should vaccination with RZV be recommended for immunocompromised adults ≥19 years of age? They vaccinated a population of immunocompromised adults ≥19 years of age (split into 19–49 years and ≥50 years) with two doses of RZV given at least four weeks apart. They recorded the benefits vs. harms as the first step. Vaccine efficacy was evaluated among autologous hematopoietic stem cell transplant (HCT) recipients, and patients with hematologic malignancies (HM).

An additional RZV presentation is expected including a GRADE analysis and EtR framework for the policy question regarding vaccination of immunocompromised persons at the ACIP meeting in September. They will also need to lay the groundwork and prepare the committee for a potential vote in October.

Conclusions

Please visit the ACIP meeting information web page if you are interested in additional information on this meeting, past meetings, upcoming meetings, for materials, and for information on making a public comment.

There will be an ACIP meeting on COVID-19 on July 22 and there will be meetings in September and October.

HHS Notice of Funding Opportunity Announcement – David Kim, MD (HHS)

David Kim, MD, Director, Division of Vaccines, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), presented on the 2021 HHS Notice of Funding Opportunity (NOFO): Promoting Vaccine Confidence in Local Communities through Partnership with Regional Health Offices.

This goal of this NOFO is to identify innovative and effective vaccination policy strategies in local communities to increase confidence and uptake of vaccines that are routinely recommended for children and adults. This opportunity particularly focuses on programs that aim to promote vaccine uptake among racial and ethnic minorities and other disadvantaged or disenfranchised populations.

Anyone within the U.S. who has an interest in promoting vaccines is eligible to apply for this funding. What’s a little different about this NOFO than other efforts to promote vaccinations is that they are trying to leverage the HHS regional health offices’ collaboration and interest in immunization to get down to the neighborhood level where effective communication can be demonstrated.

The NOFO is a cooperative agreement and the maximum award is $125,000 for the first year and it’s renewable for up to two years, for a total of three years. This new three-year program will have an estimated annual budget of $750,000 and there will be 6–8 awards.

The application deadline for this NOFO is August 17 with the notification of the award on or around September 21. Please pass the word on to groups or advocates that might benefit from this kind of support. For any other questions about this NOFO, contact David Kim at David.kim@hhs.gov.

Question: The NOFO says if you are not a local government organization you should be partnered with one to apply. Is this correct?

David Kim
Yes, this is correct. For the applicants as well as for the health department immunization programs that link is crucial.

Question: Are rural populations included among the eligible groups that you are focusing on?

David Kim
Yes, we are looking to target any community that might be subject to disparities in immunization rates. Efforts to increase vaccination rates among rural populations or any population that can benefit from an increased emphasis on immunization and increase confidence in vaccines will be eligible.

Impact of the COVID-19 Pandemic on Adult HPV, Pneumococcal, and Zoster Vaccinations – Mawuli Nyaku, DrPH, MBA, MPH, (Merck)

Mawuli Nyaku, DrPH, MBA, MPH, from the Center for Observation and Real-World Evidence at Merck gave a presentation on the impact of the COVID-19 pandemic on adult HPV, pneumococcal, and zoster vaccinations.

Overview of Data Sources

To determine the impact of the pandemic on adult HPV, pneumococcal, and zoster vaccines, two data sources were used: IBM Truven Early View and TriNetX Dataworks.

IBM Truven Early View shows near real-time data with around a three-month lag. This data has over 245 million unique U.S. patients and data comes from large employers, electronic medical record (EMR) providers, Medicare, and Medicaid.

TriNetX Dataworks shows near real-time longitudinal EMR data from 26 healthcare organizations and 38 million U.S. patients. This data is constantly refreshed monthly to quarterly, however the data is limited to those individuals who have had a medical encounter.

For both databases, data is limited to patients or individuals in the U.S.

Methods

Analyses looks at metrics by month for both data sources from 2018–2020 (excluding 2021) shown in percent change for the year 2020.

IBM Truven Early View data covered individuals ≥19–45 years of age for HPV vaccines, ≥50 years of age for zoster vaccines (Shingrix and Zostavax), but did not cover individuals ≥65 years of age for pneumococcal vaccines.

TriNetX Dataworks data covered individuals ≥19–45 years of age for HPV vaccines, ≥50 years of age for zoster vaccines (Shingrix and Zostavax), and ≥65 years of age for pneumococcal vaccines (Prevnar 13 and Pneumovax 23), which was limited to individuals with a vaccine visit claim.

Data for HPV Vaccinations

The data is represented in the percent change in HPV vaccinations from January 2018–December 2020 with 2019 as a reference and the percent change mean of 2018 and 2019 compared to 2020.

IBM Truven Early View data shows a drop off in vaccinations from February to April 2020 at the lowest point, followed by a rebound in June and a slight drop off from July to August. Then there was a rebound in September followed by a drop off again in October and a plateau with vaccination rates remaining under pre-pandemic level for the rest of the year. When using 2018 to 2019 as a reference, vaccinations during the drop offs were trending below the pre-pandemic level and the loss in vaccine uptake was not made up with a rebound over the 2018-19 estimate.

TriNetX Dataworks data shows there was a drop off in February, a steep decline in April, and a rebound similar to what the IBM Truven Early View data suggested.

The two databases combined suggest generally the same trend.

Data for Zoster Vaccinations

IBM Truven Early View data shows a decline in vaccination in February until the lowest point in April, followed by a rebound in June, and then back to pre-pandemic levels. For the mean, the trends are more like the percent change in 2019–20 than to 2018–19, which had much lower rates to begin with and lower rates of vaccination overall.

TriNetX Dataworks data shows trends very similar to the IBM Truven Early View data. There was a drop off in February, with the lowest point in April, and then back up to around pre-pandemic rates.

The data is generally trending the same direction with both data sources and is like what can be seen with HPV vaccines.

Data for Pneumococcal Vaccinations

There is only data for the pneumococcal vaccinations from TriNetX Dataworks, which found a drop off in vaccinations around February, a low point in April, and a rebound to just below pre-pandemic levels. The percent change mean of both 2018 and 2019 to 2020 is very similar to the other vaccines assessed.

Conclusions

There were significant drop offs in 2020 for HPV, pneumococcal, and zoster vaccines, but levels are currently trending towards where they were pre-pandemic. However, there is still a significant number of missed doses of adult vaccines administered.

There is some data already for 2021, which shows these three vaccination rates to be a bit above pre-pandemic levels. However, we need to go way above pre-pandemic levels to make up for the deficit in vaccines administered. It could take several years to get to a level where we have made up for this deficit, and we need to communicate the importance of getting vaccine rates back up.

Question: Are you planning to look a bit more into the area under the curve to get more information on the remaining deficit that wasn’t made up? This is a big dip on top of the already very low adult immunization rates in general, so what is our actual deficit on the deficit? Are you able to look at that?

Mawuli Nyaku
The dip is serious because adult vaccinations were already low and the pandemic has pushed them way down. It’s going to take a lot to get beyond it and surpass it. We have some work to try to understand that area under the curve. It’s a combination of factors when it comes to why people aren’t getting their vaccines. Their reasons are all different. The challenge is trying to get those individuals to go back to get those vaccines. If we do have data to share, I will be happy to come back to the summit to present it.

Announcements

L.J Tan (IAC)

The American College of Physicians is holding a webinar called Covid-19 Recovery: Increasing Adult Vaccinations on August 4 at 12:00 p.m (ET).

The FDA held a webinar to discuss Guillain-Barré syndrome (GBS) association with the Janssen (Johnson & Johnson) COVID-19 vaccine. The FDA has updated the provider and patient fact sheets on the vaccine and GBS.

 

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