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Pediatric Vaccines in the Team-Based Care Model
1. Continuing Education Credits
In support of improving patient care, Community
Health Center, Inc. / Weitzman Institute is jointly
accredited by the Accreditation Council for
Continuing Medical Education (ACCME), the
Accreditation Council for Pharmacy Education
(ACPE), and the American Nurses Credentialing
Center (ANCC), to provide continuing education for
the healthcare team.
A comprehensive certificate will be sent after the
end of the series, December 2021.
2. Disclosures & Disclaimers
With respect to the following presentation, there has been no relevant (direct or indirect)
financial relationship between the faculty listed above or other activity planners (or spouse/partner)
and any for-profit company in the past 12 months which would be considered a conflict of interest.
The views expressed in this presentation are those of the faculty and may not reflect official
policy of Community Health Center, Inc. and its Weitzman Institute.
We are obligated to disclose any products which are off-label, unlabeled, experimental, and/or
under investigation (not FDA approved) and any limitations on the information that are presented,
such as data that are preliminary or that represent ongoing research, interim analyses, and/or
unsupported opinion.
This project is supported by the Health Resources and Services Administration (HRSA) of the
U.S. Department of Health and Human Services (HHS) as part of an award totaling $137,500 with 0%
financed with non-governmental sources. The contents are those of the author(s) and do not
necessarily represent the official views of, nor an endorsement, by HRSA, HHS, or the U.S.
Government. For more information, please visit HRSA.gov.
3. At the Weitzman Institute, we
value a culture of equity,
inclusiveness, diversity, and mutually
respectful dialogue. We want to
ensure that all feel welcome. If there
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please let us know.
11. Pediatric COVID Vaccinations
• Pfizer vaccine approvals:
– FDA authorized use for ages 5 through 11 years
– Advisory Committee on Immunization
Practices met on November 2…
• Moderna for younger ages:
– On hold
12. Pediatric COVID Vaccination
• Vaccination program for children aged 5 to 11 will
start “running at full strength”
– Second week of November, per the White House
• There are 28 million children aged 5 to 11
– Surveys indicate only ~1 in 3 parents will have kids
vaccinated immediately
– “We have more than enough vaccine for every
child 5 to 11.”
– Jeffrey D. Zients, the Pandemic Response Coordinator
17. Where are we now?
Kids don’t catch COVID-19.” Really?!
• Infection
– 1.9 million 5-11
year olds have
been infected
– 10.6% of cases
(they make up
8.7% of the
population)
18.
19. “Kids don’t get that sick from COVID.”
• Hospitalizations
– >8300 COVID-19
hospitalizations of 5-
11 year olds
• Over 30%, NO
underlying condition
• Starting in August, 5-
11 had their highest
rate since the
beginning of the
pandemic
• Once hospitalized,
1/3 of kids ended up
in the ICU
27. In for the Long Haul . . .
• Most common symptoms: fatigue, headache, insomnia,
trouble concentrating, muscle and joint pain, and cough
• Post-COVID conditions do occur in children
– Less common in children than in adults
– 7-8% of children with COVID-19 reported continued symptoms >12 weeks
– Can appear even after mild infections
• Can have significant impact on quality of life
– Limitations on physical activity
– Feeling distressed about symptoms
– Mental health challenges
– Decreased school attendance/participation
31. Show me the Data!
• 2,268 trial participants
(including 1,518 vaccine
recipients)
• A “safety expansion”
group of an additional
2,379 participants
(1,500 vaccine
recipients)
32. Does it work?
• Immunobridging
– Comparable antibody levels to older age group
• 90.7% efficacy
– 3 cases in vaccine group, 16 in placebo
• Worked well against delta variant
– Tested during high delta incidence
– Vaccinated sera effectively neutralized delta
33. Is it safe?
• Most common adverse events
– Fatigue (39%)
– Headache (28%)
– Muscle pain (12%)
34. Safety
• Two other adverse events linked to the vaccine:
– Lymphadenopathy: 13 vaccine participants vs. 1 placebo
participant
– Hypersensitivity rash
• 5 severe adverse events. None were linked to the vaccine:
– Ingestion of a penny (1 person in the vaccine group)
– Fractures (2 people in the vaccine group and 1 in the
placebo)
– Infective arthritis (one person in vaccine group)
• No cases of myocarditis, anaphylaxis or deaths
43. Vaccine After COVID
• Prior infection confers variable immunity
which wanes over time
– 2-5x higher risk of reinfection compared to
vaccine
• Significant boost in antibody levels
• Safe
56. Transportation
• Shipped on dry ice in thermal container
• Use insulated gloves!
• Note data logger
– “Stop delivery” button, press for 5 seconds
• Can transfer to ultra-cold freezer or fridge
• Temps must be monitored by a data logger
• Ancillary kit = diluent, needles, vaccine cards
57. Storage and Handling
• Ultra-cold freezer (-76F to -130F)
– > 6mo, until expired
• Pediatric vaccine cannot be stored in freezer
– Adult freezer up to 2 weeks
• Medical grade refrigerator (36F-46F)
– Pediatric – 10 weeks
– Adult – 1 month
• Protect from light, transport at 36-46F
58. Administration and Labeling
• Both vaccines require dilution; see ancillary kit
• Allow to warm to room temperature (~20 min) before diluted
• Do not shake! Rock back and forth gently before and after
dilution
• Pediatric vials: 1.3mL diluent. Adult vials: 1.8mL diluent
• Pediatric dose: 0.2mL = 10mcg. Adult dose: 0.3mL = 30mcg
• Once vial pierced, good for 6 hours for adult, 12 hours for
pediatric
• Pediatric vial = 10 doses. Adult vial = 6 doses
• May not refreeze
59.
60. Administration and Labeling
• Safety of concern when dealing with multiple types
of vaccines!
• Pediatric vaccine = orange cap, Adult vaccine =
purple cap
• Consider separate areas of vaccine preparation
– Amount of diluent different for each vaccine
• Label drawn up syringes to identify which vaccine it is
• Once vial pierced, draw up all doses from vial and
label
– Best practice is to not leave partially filled vials
– Consider separate areas for different vaccines
61. Post-Vaccine Observation Period
• 15 minute post-vaccine monitoring period
• Logistical considerations
– Volume/demand
– Vaccinators
– Spacing
– Other support staffing (greeters, registrars, etc.)
• Response (“code”) team considerations
63. Additional Resources
• AAP-AACAP-CHA Declaration of a National Emergency in Child
and Adolescent Mental Health
• Pediatricians, Child and Adolescent Psychiatrists and
Children’s Hospitals Declare National Emergency in Children's
Mental Health
Hinweis der Redaktion
11/2: Welcome everyone – today’s topic is Pediatric vaccines…
Before she died, Ailish Calloway said she wanted to be a doctor.
10/4/21: Here you can see from the map the ‘hot spots’ occurring around the country. The Darker colors mean more active infections: Alaska, the “Mountain West”, some parts of the midwest – Coal mining areas (W Virginia).
11/2: case levels are flat or falling in more than 40 states, though trouble spots continue to emerge in parts of the West. Alaska leads the country in recent cases per capita, while Colorado has the fastest rate of case growth.Florida, which experienced one of the worst summer surges, now has a lower recent case rate than every other state. Caseloads continue to fall rapidly across much of the South.
11/2/21
B.1.617.2 (India) – DELTA variant
-"like Covid on steroids," Andy Slavitt, former White House senior adviser for Covid-19 response
unclear what dosage of Moderna’s vaccine might be authorized for use as a booster for recipients of other vaccines
There are 15 million doses ready
11/2: up from 5.6% two weeks ago (total) and 14.6% for elderly (over 65)
11/2:
Connecticut now 70.8 up from 69.9% 2 weeks ago
Vermont: now 71.3 up from 70.6%
Puerto Rico – doing very well: 73.6 up from 72% immunized
Alaska – 52.7 up from 51.7%
Even though they make up 8.7% of the population).
There were exceedingly low (only 9) hospitalizations for flu during 2020-2021. At the same time, there were significantly higher COVID19 hospitalizations. Had mitigation measures (masks, closed schools) not been in place, these numbers would have been much higher.
But a reminder that 30% had no risk factors at all.
There have been 94 5-11 year olds that have died from COVID19. For context, this places COVID19 as the 8th leading cause of death for this age group. More recently (during Delta), COVID19 jumped to the 6th leading cause of death in this age group.
MIS-C (multisystem inflammatory syndrome in children) is highest among 5-11 year olds. There’s been 5,217 MIS-C cases reported as of October 4, 2021. 60-70% of patients are admitted to ICU and 1-2% died.
Post-COVID conditions do occur in children – Appears to be less common in children than in adults – A national survey in the UK found 7-8% of children with COVID-19 reported continued symptoms >12 weeks after diagnosis1 – Can appear after mild to severe infections, and after MIS-C
Kids also significantly contribute to the spread of the virus. Secondary transmission from young school age children can and does occur in both household and school settings
2,268 trial participants (including 1,518 vaccine recipients) followed for at least two months past the 2nd dose
A “safety expansion” group of an additional 2,379 participants (1,500 vaccine recipients) followed for a median of 2.4 weeks after the second dose. This was done per the FDAs request “to allow for more robust assessment of serious adverse events and other adverse events of interest”.
Among 86 million doses, there have been 9 reports of vaccine-induced myocarditis deaths. Among these 9 cases, 6 have been fully investigated thus far. Three deaths were confirmed as myocarditis. Importantly, all three were due to classic myocarditis (caused from infection of a bacteria/virus) and not due to the vaccine. No myocarditis deaths have been linked to the vaccine in the United States.
Myocarditis after vaccination in 5–11-year-old population likely lower than rates seen in 12–15-year-olds Underlying epidemiology of viral myocarditis varies greatly between children aged _____5–11 and 12–17 years: substantially lower in children 5–11 years of age Dose used in 5–11-year-olds (10µg) is a third of dose used in 12–15-year-olds (30µg)