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A summary of presentations from the weekly Summit partner webinars

October 19, 2021 – The latest Summit summary

Flu Surveillance Update – Alicia Budd (CDC)
Update on CDC COVID-19 vaccine safety monitoring systems: V-safe and VAERS– Tanya Myers (CDC)
Adaptive Vaccine Solutions – Emily Pallien (Sanofi Pasteur)
Announcements

Flu Surveillance Update – Alicia Budd (CDC)

Alicia Budd, MPH, Influenza Division, CDC, gave a presentation on influenza activity in the United States 2021–2022 season and CDC’s FluView flu surveillance for week 40 (week ending October 9, 2021), the first week of weekly influenza surveillance.

National Influenza Surveillance in the U.S.: 2021–22

The National Influenza Surveillance System looks different this season than it has in the past. Surveillance components that are the same this year include virological surveillance, outpatient illness, FluSurvNet hospitalization, mortality, and pediatric mortality. New surveillance components include HHS Protect hospitalization and laboratory-confirmed flu cases in long-term care (LTC) facilities. This year the geographic spread map from the state territorial epidemiologist report, “the brown map,” has been retired due to the ongoing COVID-19 pandemic’s impact on the data systems.

Revised Summary Section of FluView

The summary section at the top of the FluView webpage has been reformatted to include the new components, to remove the retired component, and has improved readability.

Influenza Virologic Surveillance – United States, May 23, 2021–October 9, 2021

Looking at the virologic data from the clinical labs, flu activity in week 40 is lower than usual for this time of year. The percent of positive cases is still at 0.1%, where it typically is between 1–2% positive. This is not for lack of testing; testing numbers are as high if not higher this year than last year.

Public health labs have much lower numbers in week 40 compared to prior years, as well. There were 13 positive cases, where there are typically more than 100 positive cases during week 40.

Moving further into the season when there are more viruses circulating, FluView will be reporting virus characterization data (genetic/antigenic and antiviral resistance), as well.

Percentage of Outpatient Visits for Influenza-Like Illness (ILI), ILINet, U.S.

The outpatient Influenza-like Illness Surveillance Network (ILINet) monitors outpatient visits for influenza-like illness (ILI). ILI is not strictly related to influenza virus activity, but refers to someone who has a fever and cough or sore throat. These are symptoms that are found with many respiratory illnesses that are often circulating at the same time of year. ILI cases are not laboratory confirmed cases of influenza.

For week 40, all ages combined, the percent ILI is 1.9%, which is slightly higher than is typically seen this time of year, however there are more respiratory viruses circulating than is typical, such as with COVID-19 and RSV. When broken down into age groups, children around the age of four currently have the highest ILI.

ILI Activity Level, Determined by Data Reported to ILINet Week Ending October 9, 2021 (Week 40)

The ILI activity level map is based off the same ILI outpatient data but reflects intensity of ILI activity and not the extent of the geographic spread. This compares data from the providers that reported that week to baseline data for the same providers to compare and see whether they are seeing gradations of ILI activity. The ILI Activity Indicator Map displays state-specific and core-based statistical area (CBSA) specific activity levels by week for multiple seasons and allows a visual representation of relative levels of ILI activity from state to state.

In week 40 ILI activity increased but not due to influenza, instead it was due primarily to RSV, COVID-19, rhinoviruses, and enteroviruses.

Percent of Long-Term Care Facilities (LTCF) with at least One Confirmed Influenza Case among Residents, Reported to CDC National Healthcare Safety Network (NHSN), National Summary, May 24, 2021 – October 10, 2021

A new component of FluView is the percentage of LTCFs with at least one confirmed influenza case among residents, which is reported to CDC’s National Healthcare Safety Network’s (NHSN). This model supports the COVID-19 response but contains several flu questions related to lab-confirmed flu cases among residents and personnel in the reporting facilities. Currently there are more than 15,000 LTCFs across the country reporting to this network each week.

As of week 40, there are a reported 0.1% flu positive cases among residents, which is very low for this time of year. Since this is a new system there is no historical data to compare this year’s data to, but this number is expected to increase substantially when influenza virus is circulating across the country.

Influenza Hospitalizations in the United States

There are two influenza hospitalization components reported in FluView:

Influenza Hospitalization Surveillance Network (FluSurv-Net): This component conducts population-based surveillance for laboratory-confirmed flu-related hospitalizations. This data will start to be reported later in the season when there are enough cases to get stable rates.

NEW! HHS Protect National Summary: This piggybacks off of some work that was set up for the COVID-19 response. All hospitals are required to report data on COVID-19 and flu and because of this, the CDC is getting information on previous admissions with lab-confirmed cases of flu, hospital admissions due to lab-confirmed flu, and ICU information on patients with lab-confirmed flu. This is a new system as of March of 2020, so there is no historical data to compare to. As of week 40, the numbers are very low.

Influenza-Related Mortality in the United States

The two mortality-related components of FluView have not been changed.

National Center for Health Statistics (NCHS) Mortality Surveillance Data: This looks at the death certificate data from state vital statistics offices for all the deaths in the U.S. with pneumonia, flu, or COVID-19 listed as the cause of death. Since COVID-19 emerged, the percentage of deaths due to these three causes has been well above the weekly epidemic threshold, and that holds true for week 40. Flu does not seem to be contributing to morbidity or mortality right now.

Influenza-Associated Pediatric Mortality Surveillance System: This system monitors flu-related deaths of children under the age of 18 years. Currently, there have not been any pediatric deaths with flu as the cause of death so far this flu season.

International Influenza Activity – Influenza Positives Reported to WHO’s FluNet

WHO’s F luNet offers information on surveillance of flu on a global level. As of week 40, flu activity is similar to what was seen last year––much lower than expected. In the northern hemisphere, there is a mixture of influenza B (Victoria lineage) and influenza A (H3) right now, and in the southern hemisphere, the numbers are lower, and the majority of the strains are influenza B (Victoria lineage), influenza A (H3), influenza A (H1), and influenza A (H1N1).

Additional Information

Influenza Activity

Other Respiratory Virus Activity

Questions

Question

You mentioned that flu is a little lower than what we see traditionally. Do you anticipate a return of the flu, or do you anticipate it circulating less this season like last year?

Alicia Budd

We just don’t know which way this season is going to go. We haven’t seen a lot of seeding of viruses in the southern hemisphere and we also don’t know what COVID-19 measures will come into play. This could be an especially concerning season for young children as their bodies have not seen the flu for a while. There are many more unknowns this year and we will just have to wait and see.

Question

The Summit partners are interested in the messaging of the season this year. There is concern about crying wolf about promoting flu vaccines with the message of a “twindemic” when it may turn out like last year. If this happens for a second year, are you concerned about what this messaging could do?

Alicia Budd

That is a real concern. But we would be doing people a bigger disservice by not pushing the vaccine and having a worse season. I think that we will see some level of flu activity this season, more than last year, but to what degree? I’m not sure.

Question

What resources remain at the federal level to observe the geographic spread of flu?

Alicia Budd

There is state level data publicly available on FluView Interactive. If you are interested in sub-state level data, you will need to look at the local state health department websites. We only present state level data, which could tell you if there is an outbreak of disease and could give you an indication that you need to dig a little deeper by going to state-specific websites.

Update on CDC COVID-19 vaccine safety monitoring systems: V-safe and VAERS– Tanya Myers (CDC)

Tanya Myers, v-safe Team Co-Lead, 2019 Novel Coronavirus Response, CDC, gave an update presentation on CDC COVID-19 vaccine safety monitoring systems: v-safe and VAERS.

U.S. CDC Vaccine Safety Contributions to COVID-19 Vaccine Program

Since v-safe rolled out in conjunction with the beginning of COVID-19 vaccine distribution in the U.S., CDC has published a number of manuscripts and given presentations for the ACIP that included v-safe data as part of the broader look at what was going on with the surveillance systems. Recently CDC published reactogenicity reported after an additional dose of the COVID-19 vaccine, for example.

CDC Vaccine Safety Monitoring

There are a number of vaccine safety surveillance systems in the U.S., and as part of the preparations for the COVID-19 rollout, CDC added the v-safe system. V-safe in addition to existing systems such as VAERS, VSD, and CISA Project, have yielded the most intensive vaccine safety monitoring effort in U.S. history. This allows the CDC to get a full picture of what people are experiencing with COVID-19 vaccines. The CDC offers a full list of U.S. COVID-19 vaccine safety monitoring systems that are in use on the CDC website for more information.

V-safe Smartphone-based Active Safety Monitoring

V-safe is a CDC smartphone-based monitoring program for COVID-19 vaccine safety that became available in December of 2020 with the initial rollout of COVID-19 vaccines. The program uses text messaging and web-based surveys to check-in with vaccine recipients. It also allows recipients to report how they feel after each dose of vaccine, including the new 3^rd dose for immune compromised people and for booster doses. And now, parents can enter data on behalf of adolescents who have been vaccinated.

CDC wants people to report even if they have no symptoms, because this helps to give a complete picture of what vaccine recipients are experiencing, rather than just collecting adverse events. This information also helps clinicians prepare patients for what to expect and to be able to reassure them that side effects are transient.

Within the program, recipients are also able to report medically attended health impact events that can be captured in a VAERS report after an interaction with a healthcare professional.

New V-safe Features for Existing Participants

New features in v-safe include the option to enter a third dose and the option to register a dependent. Parents and guardians can now enroll on behalf of their children, and all outreach goes to parent or guardian rather than the child. That’s been helpful and will become more important for younger ages to be included in V-safe.

New V-Safe Participants

New v-safe participants can register after any dose and begin reporting information to CDC. If coming in after the first dose, the program will allow the participants to enter data retrospectively if desired, as well as enter information on other vaccines given at the time of the COVID-19 injection. CDC plans to look at participant data from last flu season to analyze data about COVID-19 and flu shot co-administration.

Promoting V-safe in Practice

CDC has materials for promoting v-safe in the clinical setting that talk about the importance of v-safe at vaccination and encourage enrollment in the program.

Your Participation in V-safe Helps Protect All Americans from COVID-19; Here’s How:

It’s important to register and share each vaccination experience with v-safe because your data along with millions of other participants’ data in the U.S. are combined and analyzed by the CDC to help understand the health experiences people are having post-vaccination.

V-safe also offers a way for the CDC to communicate with the participants and offers unvaccinated Americans additional information about the safety profile of the COVID-19 vaccines so that they can feel more confident in getting vaccinated.

VAERS IS the Nation’s Early Warning System for Vaccine Safety

VAERS is a nation-wide system that can rapidly detect potential safety problems and rare adverse events from vaccinations. VAERS accepts all reports from everyone regardless of the plausibility of the vaccine causing the event or the clinical seriousness of the event. VAERS gives the CDC very useful and rapid information that can be used to follow up on potential signals from other systems like the Vaccine Safety Datalink system. However, VAERS has limitations including incomplete reporting, incomplete information, and biases in reporting. VAERS data cannot determine cause and effect through the data acquired.

VAERS reporting information can be found at Vaers.hhs.gov.

For help you can call: 1-800-822-7967

Email: info@VAERS.org

Video instructions YouTube video that walks through how to complete a VAERS report: https://youtu.be/sbCWhcQADFE

EUA Requirements for Healthcare Providers to Report Adverse Events to VAERS Following COVID-19 Vaccine

For healthcare providers there are requirements to report an adverse event to the VAERS system. Events to report to VAERS include:

Vaccine administration errors (whether or not associated with an adverse event)
Serious adverse events regardless of causality, including:
- Death
- Life threatening adverse event
- Inpatient hospitalization or prolongation of existing hospitalization
- A persistent or significant incapacity or disruption of the ability to conduct normal life functions
- A congenital anomaly/birth defect
- An important medical event based on appropriate medical judgement that may jeopardize the individual and may require medical intervention to prevent one of the outcomes listed above
Cases of Multisystem Inflammatory Syndrome
Cases of COVID-19 that result in hospitalization or death

People participating in v-safe are can also report to VAERS, and the event will be matched to the VAERS report provided by a medical professional.

Your Role

COVID-19 vaccine safety gets stronger with your participation and promotion. Healthcare providers need to encourage their patients to participate in v-safe and encourage adolescent enrollment and addition of booster dose reporting. Healthcare providers also need to continue to report adverse events and to respond to requests from VAERS.

Questions

Question

Do you have a question in v-safe about whether someone has had COVID-19 prior to vaccination?

Tanya Myers

This is not a current question on v-safe, however, the CDC is working on data for a study after reaching back out to people who had COVID-19 prior to the vaccine. This study was set up because there have been anecdotal reports of enhanced reactogenicity of people who had COVID-19 prior to being vaccinated. Those results are likely to be published in the coming months.

Adaptive Vaccine Solutions – Emily Pallien (Sanofi Pasteur)

Emily Pallien, Product Manager, US Influenza Vaccines, Sanofi Pasteur, gave a presentation on Sanofi Pasteur ‘s new clinic development guidebook – Adaptive Vaccine Solutions – which provides guidance for alternative solutions to delivering vaccines in a clinic. This guidebook takes into account best practices that were developed as a result of the COVID-19 pandemic.

COVID-19 Has Increased Vaccine Literacy and Opportunities for Flu and Other Immunizations as More Consumers Learn about Vaccination

Due to COVID-19, people have an increased vaccine literacy that they have not had in the past, and in the last season, more people sought out vaccinations than normal due to the fear of the “twindemic” and the fear of the unknown with both COVID-19 and flu circulating. This year things are returning to what was seen in the 2019–2020 flu season in terms of social interaction, etc, which allows an opportunity this year to draw flu vaccine recipients back in from last year that may not have gotten a flu vaccine in the past.

Last year there was a huge gap in people over age 65 who received a flu shot (70%) and those who received a COVID-19 shot (95%). How might those people who may not have gotten the flu vaccine in previous years, but did last year, be convinced to come back and get a flu shot this year?

Adaptive Vaccination Solutions Overview

Adaptive Vaccination Solutions (AVS) is a comprehensive clinic kit that empowers healthcare providers to focus on protecting patients through alternative and adaptive immunization approaches. AVS was developed as a solution to help providers not miss an opportunity to immunize against vaccine-preventable diseases as a result of the pandemic and aims to drive vaccinations by overcoming vaccination fatigue. AVS makes sure that healthcare providers have what they need to plan their influenza season and provide patient educational materials in a timely and relevant manner. It also helps ensure that patients are protected from both flu and COVID-19. This year, it is imperative that we share timely updates on coadministration guidance to help protect as many patients as possible against both the flu and COVID-19.

There are three parts to AVS:

Plan: Walk-Thru and Drive-Thru Clinic Planning Tools

In an effort to help and take the burden away from healthcare providers, Sanofi developed a blueprint for drive- and walk-through clinics so that providers can focus on disease education and making sure their patients are protected.

Prepare: Patient Outreach Communications

Scripts and media are available for offices to help get the word out about flu vaccinations, as well as to talk about the importance of all vaccinations for all ages in general. The information provided will help assure patients that it’s safe to come into the office and that plans need to be made for vaccination.

Perform: Solutions for HCPs and Patient Education Resources

FLUency is a campaign that Sanofi rolls out every year. This campaign focuses on disease education for all ages and helps healthcare providers with unbranded educational materials so that they have the tools to facilitate conversations around the importance of vaccinations. This campaign also includes information on the co-administration of COVID-19 and flu vaccines, as well as guidance on boosters.

AVS guidebook

ANNOUNCEMENTS

L.J Tan (IAC)

1. We have moved all of our communications to Mailchimp, so please add NAIIS: info@izsummitpartners.org to your contacts to receive all future communications.

2. Part 4 of the COVID-19 Vaccine Developers Panel is rescheduled for November 8 at 1:00 p.m. (CT)/2:00 p.m. (ET). During this call, COVID-19 vaccine developers discuss future directions for the COVID-19 vaccine.

3. The Immunization Action Coalition (IAC), with funding support from Seqirus, is offering a limited quantity of FREE Flu Vaccine buttons and stickers in English and Spanish to support your flu vaccine promotion efforts this season. Order the flu buttons and stickers.

4. IAC hosted two influenza webinars this September that can now be viewed online.

5. We would like to welcome having more NAIIS member organizations to add their support to the Call to Action on adult immunization. Access the call to action and click on the top righthand button to add your organization.