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A summary of presentations from the weekly Summit partner webinars

 

July 1, 2021

VRBPAC Pediatric COVID-19 Meeting Update – 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, provided a presentation on FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on June 10.

CDC Overview

During the meeting, CDC provided an overview of the COVID-19 epidemiology as it relates to children. The highlights are as follows:

  • Children are susceptible to SARS-CoV-2, but younger children have fewer respiratory symptoms compared to adults.
  • Studies demonstrated that SARS-CoV-2 infection rates are similar to all age groups and children can transmit the virus to others.
  • MIS-C, a severe, rare inflammatory syndrome complication with varying clinical presentations is highest in African American and Hispanic children.

CDC noted that routine adolescent vaccination rates for 2020 are down.  And as of June 16, provider orders for vaccines other than influenza vaccine are down by 12 million doses compared to that of 2019. HPV and Tdap vaccinations are down by 18% and meningitis vaccinations are down by 12%. The operational approach discussed for vaccinating adolescents with the COVID-19 vaccine specifically involves augmenting existing vaccination with primary care doctors, pharmacists, HRSA-funded healthcare centers, and school-based vaccination programs.

FDA Overview of Post-Authorization Surveillance Activities

The initial results of the post-mRNA vaccination reports of myocarditis or pericarditis indicate that it occurs primarily in males younger than 30 years old.  CDC reviewed preliminary VAERS data which shows that myocarditis post-vaccination predominately occurs in males in younger age groups especially after the second dose of mRNA vaccines, with a rate of 16 cases/million after the second dose. In most cases, people with myocarditis or pericarditis had full recovery.   Several recent publications in JAMA Cardiology provide details about COVID-19 vaccine-associated myocarditis/pericarditis.

Considerations regarding possible future EUA and BLA for COVID-19 Vaccine Use in Pediatric Populations

The FDA discussed considerations on data needed to support additional emergency use authorizations (EUA) or future biologics license applications (BLA) for COVID-19 vaccines for use in pediatric populations.

The law requires vaccine manufactures seeking licensure of COVID-19 vaccines for children 6-months–17-years to submit assessments of vaccine safety and effectiveness. The FDA presented to VRBPAC discussion topic questions for consideration:

  • Is there sufficient evidence of COVID-19 vaccine effectiveness for children 6-months–<12 years, and what safety data , including database size, duration, and follow-up, are needed to support either EUA or BLA?
  • Is there sufficient evidence of COVID-19 vaccine effectiveness for adolescents 12–17-years, and what safety data including database size, duration, and follow-up are needed to support either EUA or BLA?
  • What safety studies are needed following EUA or BLA for further evaluation and monitoring of safety and effectiveness of COVID-19 vaccines in different pediatric age groups?

The FDA asked VRBPAC to focus on vaccine safety, as effectiveness has been well-established already.

Discussion

VRBPAC members expressed strongly that they felt that children should be offered vaccination against COVID-19  because children get infected and transmit the disease just as adults do and herd immunity is not possible without vaccinating children. In addition, children can also have severe disease.  Fewer children die from influenza and varicella each year compared to the number of children who died from COVID-19 thus far, but we still vaccinate children routinely. The notion that kids don’t need COVID-19 vaccination is simply wrong.

Points for consideration brought up by committee members:

  • Vaccine safety for children is paramount and there needs to be 12–18-month follow-up before BLA can be granted for use of COVID-19 vaccines among children younger than 12 years.
  • Dose-ranging studies and follow-up are needed to minimize potential adverse events. Follow-up is needed for at least 2 months after the second dose for consideration for EUA and at least 6-months after the second dose for consideration for a BLA. Increasing the length of follow-up is not necessary due to the fact that rare adverse events might not be seen.
  • The number of participants to assess safety should be around 3,000–5,000. More participants are needed as the age decreases.
  • We need to pay close attention to dosing for children. There should be strong consideration for looking at different dose-interval options and single dose options. One dose might offer adequate protection for children.
  • Post-vaccine fevers should be monitored very closely given its association with inflammatory responses.
  • Evaluation of breakthrough disease in children that got the vaccine and came down with COVID-19 needs to be a part of follow-up.

More information about the meeting can be found on the FDA website.

COVID-19 Epidemiology Surveillance Update – Katie Fullerton (CDC)

Katie Fullerton, MPH, Centers for Disease Control and Prevention (CDC), co-lead, Integrated Analytics & Visualization, CDC COVID-19 Response, provided a presentation on the most recent COVID-19 epidemiology surveillance data.

COVID-19 Summary, June 30, 2021

There have been over 33 million total cases with a 7-day moving average of about 11,000 cases/day, which is a 3.2% increase over the previous 7-day period. For the 7-day daily average, there were 1,795 hospitalizations and 286 deaths per day.   On average there are 574,316 COVID-19 tests per day, which is around a 15% decrease over the previous week. The cumulative percent positivity over the length of the pandemic is 7.6% and over the 7-day period, 1.9%.

The above data can be found on CDC’s COVID-19 Data Tracker website.

Level of Community Transmission in the United States

Another way to look at COVID-19 activity across the U.S. is by the level of community transmission, which can be found on the Data Tracker website by using the COVID-19 Integrated County View. This looks at two different metrics: incidence (total new cases/100,000 people in the past seven days) and the percentage of nucleic acid amplification (NAAT) tests that are positive during the past seven days. The data is put into four categories of community transmission: high, substantial, moderate, and low.

For the time period of June 22–28, 80% of the counties in the U.S. are at moderate (44%) or low (36%) levels of transmission and fewer than 10% are in the high transmission category.

COVID-19 State Profile Report

The COVID-19 State Profile Report (SPR) – Combined Set on HHS website, healthdata.gov, gives the best picture on a weekly basis of what’s happening across the country, at the state level, and at the county level. This report comes out twice a week and shows four national graphs: new cases/week per 100,000 population, new deaths/week per 100,000 population, NAAT viral (RT-PCR) lab test positivity, and new hospital admissions per 100 inpatient beds.

National data from June 18–24 shows that there was movement towards fewer counties with the number of new cases, hospital admissions, and NAAT positivity rates in the “red” zones.

SARS-CoV-2 Variants

Multiple variants of SARS-CoV-2 are circulating globally and within the U.S. The CDC COVID Data Trackers offers tracking of the variant proportions in the U.S. The biweekly data of the proportions of the most common SARS-CoV-2 lineages are based on 175,000 sequences collected through CDC’s national genomic surveillance since December of 2020. Data are grouped into two-week intervals and are subject to change over time.

Currently there are five variants of concern (VOC) in the U.S.: B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), B.1.427/B.1.429 (Epsilon), and B.1.617.2 (Delta). Our most prevalent variant right now is alpha, however over the last 14 weeks delta and gamma have increased across the U.S.

National Picture, Vaccinations as of June 30, 2021

The data for the National Picture on the CDC COVID Data Tracker is updated from 4–6 p.m. (ET) every day. On June 30, 154.9 million people were fully vaccinated across the U.S. There have been 381,949,830 doses delivered and 326,521,526 doses administered. The number of doses being administered has moved from a peak in March of around 3.5 million a day to below one million a day.

In the integrated county view, data also shows that in most counties, 70% of those 65+ years of age have been vaccinated and that percentage decreases with age.

Vaccination Data by Demographic

CDC’s COVID Data Tracker offers information on vaccination by demographic trends by age group, race/ethnicity, and sex.  An important caveat to the data on race/ethnicity is that a high percentage of vaccinations reported have missing data on race/ethnicity.  Thus, proportions of persons vaccination appear to be lower due to about 32-38% of vaccinees having missing data.

As of June 30, the highest ethnicity both vaccinated with one dose and fully vaccinated are the American Indian/Alaska Native, Non Hispanic/Latino. But, as above, this information is difficult to interpret due to large numbers of vaccinees with missing information on race/ethnicity.

Vaccination Data by Age

Under the demographic trends map, there is an option to look at the data by age and also by sex. Currently, those 65+ years of age have the highest rate of vaccination in the U.S., and the percentage vaccinated is lower as age decreases.

Recent MMWR Publications Related to COVID-19 Vaccinations

Below are CDC’s most recent MMWR publications. There are more articles and summaries of the MMWRs in the presentation slides.

June 25, 2021

June 18, 2021

June 11, 2021

June 4, 2021

COVID Data Tracker Weekly Review

CDC’s COVID Data Tracker Weekly Review is the best place to get the most up to date COVID data in the U.S. The review is an interpretive summary of some of the data released each week. You can subscribe for the weekly newsletter on the website.

Questions

Q: Do children have less severe myocarditis and pericarditis from the vaccine than as a result of COVID-19 infection?

David

This question wasn’t specifically addressed during the VRBPAC meeting, but it’s been mentioned that the risk of myocarditis and pericarditis from COVID-19 infection is significantly higher than the risk that stems from mRNA vaccination. That information is generally available.

JAMA: Myocarditis Occurring after Immunization with mRNA-Based COVID-19 Vaccines (6/29/21)

Q: Do you have any additional data showing reduction in disease burden relative to COVID-19 vaccination?

Katie

One of the June MMWRs looks specifically at that question.

What is the feeling about incentives? Do they help or do they hurt?

Carolyn Bridges (IAC)

Incentives have been shown to help increase vaccination rates based on reviews of evidence-based interventions for improving vaccination rates reported in the Community Guide to Preventive Health Services. One recently demonstrated effective incentive was having employers give employees time off from work to get vaccinated and to recuperate from vaccine side effects.  Employers who encourage vaccination see higher vaccination rates in their workplaces.

Kaiser Family Foundation: Workers Are More Likely to Get a COVID-19 Vaccine When Their Employers Encourage It and Provide Paid Sick Leave, Though Most Workers Don’t Want Their Employers to Require It (6/30/21)

David

Medical ethicists have concluded that incentives are justified, and they contextualize that by putting the efforts to vaccinate in the interest of the public good. In general, they do not see a conflict with offering monetary or other incentives to people so that they roll up their sleeves and get the vaccine.

Announcements

Kelly Moore, MD, MPH (IAC)

IAC has “I Got My COVID Vaccine” buttons and stickers in both Spanish and English for public health departments, nonprofit organizations, and all clinics promoting vaccination. Access this order form to request the FREE buttons and stickers for your outreach efforts. (This is a CDC supported activity.)

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