���Pediatric Vaccinations

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October 13, 2021

Marin County Schools

Public Health Speaker Panel for Parents and Guardians�

COVID-19 mRNA vaccines and children

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Theodore Ruel MD

Professor, Department of Pediatrics

Chief, Division of Pediatric Infectious Diseases and Global Health

University of California, San Francisco

Disclosures

• I have no financial relationships with a pharmaceutical or vaccine manufacturing company related to the content of this presentation
• I have not been involved with any of the vaccine trials

Questions

• How do vaccines work? What is different about mRNA vaccines?
• What do we know from trials of mRNA COVID19 vaccines in adults, adolescents and children?
• Lessons from the Delta surge

Vaccines stimulate an immune response to small or weakened parts of an disease-causing organism

https://www.who.int/news-room/feature-stories/detail/how-do-vaccines-work

Different kinds of vaccines

http://magazine.scientificmalaysian.com/wp-content/uploads/2016/05/Types-of-vaccines.jpg

How do “mRNA” vaccines work?

Rely on the same basic biology of most vaccines: use fragments of virus to stimulate immune response

Use normal human cell machinery to make more protein fragments … so you get a big vaccine response from a small injection

• Long history of development
• First ideas in 1970s
• Clinical trial for influenza in 2015

Dolgin, Nature, 597, September 16, 2021

https://covid-slides.idea.medicine.uw.edu

1) Package the mRNA into bubbles of liquid fat molecules (lipid nanoparticle, LNP)

3) Cells make pieces of the COVID-19 spike protein and put them on their surface, stimulating immune response

(Normal with vaccines and infection)

mRNA is a cell’s normal recipe for proteins. The vaccines sneak new recipes into a cell’s busy kitchen! The innovation is in this efficiency

2) Inject into arm, taken up by muscle cells

What are the results of Pfizer BNT162b2 vaccine studies in adults?

• Phase 2 study looked at safety and immunogenicity (antibody levels in recipients)
• Phase 3 randomized-controlled trial (RCT) designed to compare safety and efficacy

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Walsh et al, N Engl J Med 2020; 383:2439-2450, December 17, 2020

Polack et al, N Engl J Med 2020; 383:2603-2615, December 31, 2020

Standard multi-step development as for all vaccines and drugs

• > 21,000 adults in each arm
• Fever and headache common (>50%), but few sever events
• 94.8% efficacy after second dose against COVID-19

What are the results of Pfizer BNT162b2 vaccine studies in adolescents (12-15 yo)?

Frenck et al, N Engl J Med 2021; 385:239-250, July 15, 2021

• ~1,100 children in each arm (smaller #’s)
• Good antibody response!

(compared to 16-25 yo)

• Prevented infections

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• Used same dose as adults (30mcg)

What are the results of Pfizer BNT162b2 vaccine studies children 5-11 yo?

• Using smaller dose (10mcg)
• Designed to look at safety and immunogenicity, comparing to 16-25 yo (who got the 30 mcg)
• ~2,200 in each arm

• RESULTS NOT YET PUBLIC
• Press release on September 20, 2021 suggests looks good, generating good antibody response and similar side effects
• FDA scheduled to review on October 26^th

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results

Lessons from the 2021 delta surge …

Weekly cases in children reached new heights with Delta

https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/

Data from 49 states

Children represented 24.8% of all cases week ending 10/7

Some children get very sick from COVID19

• There have been 23,071 child hospitalizations cumulatively in the USA

https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/

https://covid.cdc.gov/covid-data-tracker/#demographics

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(as of 10/7/21)

The Pfizer vaccine works against Delta variant, especially for hospitalization and severe disease

MMWR, September 10, 2021 / 70(36);1249–1254

MMWR. September 10, 2021 / 70(36);1255–1260

ED visits and Hospitalizations were 4x higher in states with low population vaccine coverage

COVID-Net, 14 states, March 1, 2020 to August 14 2021.

Hospitalizations were 10x higher among unvaccinated vs vaccinated adolescents

The Pfizer vaccine protected adolescents against severe disease in this Delta past surge

From: Public Health England, SARS-CoV-2 variants of concern and variants under investigation in England. Technical briefing 18. 9 July 2021

Delta spreads efficiently in homes

(so vaccination of as many as possible in households is important)

COVID19 cases brought into schools leads to children missing more days of school …

COVID-19 Vaccine �Side Effects

Tara L Greenhow, MD, FPIDS

Regional Lead Pediatric Infectious Diseases

Kaiser Permanente Northern California

© 2018 The Permanente Medical Group

DISCLOSURES

• I have no financial relationships with a pharmaceutical or vaccine manufacturing company related to the content of this presentation
• I have not been involved with any of the vaccine trials

• Only Pfizer is licensed and approved for use in children in the United States
• In children 12-15 years old, side effects were similar to 16-25 year olds
• In children 5-11 years old, side effects reported to be comparable to those seen in teens and adults

SAFE with mild side effects 1-2 days after vaccine

• No blood clots or severe allergic reactions
• ≤0.4% had serious adverse events and none considered vaccine-related
• No deaths reported

Frenck et al, N Engl J Med 2021; 385:239-250, July 15, 2021; https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html

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RESULTS OF PFIZER COVID-19 VACCINE STUDY IN 12-15 YEAR OLD

• Most common side effects include
• Injection site pain
• Fever
• Fatigue (tired)
• Headache

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• Importance of placebo-controlled studies
• ¼ of children had fatigue and headache after placebo (saline) injection
• Rare events are detected through post rollout surveillance and reporting

Frenck et al, N Engl J Med 2021; 385:239-250, July 15, 2021; https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html

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RESULTS OF PFIZER COVID-19 VACCINE STUDY IN 12-15 YEAR OLD

SAFE with mild side effects 1-2 days after vaccine

RARE COVID-19 VACCINE SIDE EFFECTS

• Rate 5 cases per 1 million Pfizer vaccine doses
• Comparable to other vaccines

ANAPHYLAXIS (severe allergic reaction)

• 15 minutes observation after vaccine
• 30 minutes observation after vaccine for any child with a history of an immediate allergic reaction to a vaccine or a history of severe allergy
• If severe allergic reaction or an immediate allergic reaction of any severity to a vaccine component (e.g. polyethylene glycol), your child cannot receive the Pfizer COVID-19 vaccine 

https://www.cdc.gov/mmwr/volumes/70/wr/mm7002e1.htm

VERY RARE COVID-19 VACCINE SIDE EFFECTS

MYOCARDITIS

• Symptoms include chest pain, shortness of breath, and palpitations (heart beating too hard or too fast, skipping a beat, or fluttering)

• When “itis” is added to a medical term = inflammation
• Definition: inflammation of the heart muscle
• Viral infection is the most common cause of myocarditis

Occurs frequently in children and adults with COVID-19 infection

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Risk myocarditis: 1.5 / 1,000 COVID positive

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COVID-19 Infection

MIS-C

COVID-19 Vaccine

MYOCARDITIS

https://www.cdc.gov/mmwr/volumes/70/wr/mm7035e5.htm; https://www.cdc.gov/mmwr/volumes/70/wr/mm7027e2.htm

https://covid.cdc.gov/covid-data-tracker/#mis-national-surveillance; https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-08-30/03-COVID-Su-508.pdf

Occurs frequently in children and adults with COVID-19 infection

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Risk myocarditis: 1.5 / 1,000 COVID positive

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COVID-19 Infection

MIS-C

COVID-19 Vaccine

MYOCARDITIS

https://www.cdc.gov/mmwr/volumes/70/wr/mm7035e5.htm; https://www.cdc.gov/mmwr/volumes/70/wr/mm7027e2.htm

https://covid.cdc.gov/covid-data-tracker/#mis-national-surveillance; https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-08-30/03-COVID-Su-508.pdf

Occurs frequently in children and adults with COVID-19 infection

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Risk myocarditis: 1.5 / 1,000 COVID positive

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COVID-19 Infection

MIS-C

COVID-19 Vaccine

MYOCARDITIS

https://www.cdc.gov/mmwr/volumes/70/wr/mm7035e5.htm; https://www.cdc.gov/mmwr/volumes/70/wr/mm7027e2.htm

https://covid.cdc.gov/covid-data-tracker/#mis-national-surveillance; https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-08-30/03-COVID-Su-508.pdf

Occurs frequently in children and adults with COVID-19 infection

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Risk myocarditis: 1.5 / 1,000 COVID positive

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COVID-19 Infection

MIS-C

Multi-system Inflammatory Syndrome in Children

Rare but serious condition following COVID-19 infection

Inflammation seen in many organs

Thru October 4th, 2021

5217 cases

46 deaths

6-11 year olds account for 38% of MIS-C cases

Risk MIS-C: 0.9 / 1000 COVID positive children

COVID-19 Vaccine

MYOCARDITIS

Multi-system Inflammatory Syndrome in Children

• Rare but serious condition following COVID-19 infection
• Inflammation seen in many organs
• Thru October 4th, 2021
• 5217 cases
• 46 deaths
• 6-11 year olds account for 38% of MIS-C cases
• Risk MIS-C: 0.9 / 1000 COVID positive children

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https://www.cdc.gov/mmwr/volumes/70/wr/mm7035e5.htm; https://www.cdc.gov/mmwr/volumes/70/wr/mm7027e2.htm

https://covid.cdc.gov/covid-data-tracker/#mis-national-surveillance; https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-08-30/03-COVID-Su-508.pdf

COVID-19 VACCINE MYTHS

FALSE: causes COVID disease

FALSE: causes infertility

FALSE: changes your DNA

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/facts.html

COVID-19 VACCINE MYTHS

FALSE: not a magnet

FALSE: 150,000 deaths from COVID vaccine

FALSE: vaccine inserts microchip

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/facts.html

THANK YOU MARIN COMMUNITY

97.3% of the eligible Marin population has received at least one COVID-19 vaccine dose

Increased vaccination coverage of adults and children benefits individuals and slows spread, decreasing the burden of COVID-19 on vulnerable communities and populations

https://www.sfchronicle.com/health/article/One-Bay-Area-county-is-approaching-nearly-100-of-16474541.php; https://www.immunology.org/celebrate-vaccines/public-engagement/guide-childhood-vaccinations/how-vaccines-work

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Preparing for Pediatric COVID-19 Vaccinations in Marin County

October 13, 2021

Current status:

• 92 percent of Marin residents age 12 and over are fully vaccinated

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• 80 percent of all residents are fully vaccinated

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• Approximately 33,000 residents are not eligible for vaccination because they are under age12

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• We anticipate authorization to offer vaccination to our 20,000 5-11 years olds by the end of the month

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Goal:

• 75% of Marin County residents age 5-11 will be protected with at least one dose of within one month of authorization

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• Approximately 15 thousand out of 20 thousand residents age 5-11

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Knowns

• Unvaccinated people are at higher risk for infection

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• Risk for infection is even higher when unvaccinated people are gathered together

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• When infected, unvaccinated people are at higher risk for
• Infecting others
• Serious illness and hospitalization
• Death

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SARS- CoV-2 Variants Active in Marin County

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Data accessed 10/5/2021

• 28 cases
• 12 students, 1 staff

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• All unvaccinated

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• 5 students infected others in household

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Vaccination protects each child, as well as their classmates, friends and family

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What have we learned about the benefits of high vaccination rates in Marin?

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Marin

Source: “California COVID divide: Stark correlation between counties’ vaccination and case rates.” Bay Area News Group, Sept. 23, 2021

What Does Our Vaccination Rate Mean for Us?

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What Does Our Vaccination Rate Mean for Us?

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Policies Tied to Vaccination Status

• Quarantine: Unvaccinated close contacts must quarantine
• Testing: Unvaccinated students in higher risk activities test weekly
• Indoor events: Increasing number require vaccination to attend
• Travel: Unvaccinated travelers prevented from entering or required to quarantine
• Vaccine verification required in a growing number of settings
• Likely requirement for school attendance by next school year

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Where will we be able to get vaccinated

once its authorized?

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School Pediatric Vaccination Clinics:�Weekends

*Pending FDA & CDC Approval

^ Increased time between doses due to Thanksgiving Holiday

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School Pediatric Vaccination Clinics:�Weekdays

*Pending FDA & CDC Approval

^ Increased time between doses due to Thanksgiving Holiday

Additional Pediatric Vaccination Clinics�

• Marin Community Clinics and MCPH, COVID-19 and Flu vaccine
• 3240 Kerner Blvd, San Rafael
• Friday: 4pm-8pm (October 29, November 5, 12,19, December 3, 10, 17)
• Saturday: 11am-4pm (October 30, November 6, 13, 20, December 4, 11, 18)

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• Northgate Mall Safeway and MCPH–Adult and Pediatric COVID-19 and Flu Vaccines
• Tuesday & Wednesday: 1 – 7pm
• Thursday – Saturday: 9am – 3pm

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• Mobile Vaccination Sites
• Mondays – San Rafael Encampment (Flu)/Marinship Encampment (Flu)
• Tuesdays – Marin City Health & Wellness Center (Flu)/Coastal Health Alliance (Flu)
• Wednesdays – Goodman Lumber Supply (Mill Valley)/Dollar Tree (Novato)
• Thursdays – Grocery Outlet (San Rafael)/San Geronimo Food Bank
• Fridays – Grocery Outlet (Novato)
• Saturdays – Canal Alliance (San Rafael) (Flu)
• Sundays – Various Churches throughout Marin

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Thank you

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