Pediatric Vaccines

Vaccine Development Schedule

1) lab, 2) animal trials, 3) human clinical trials

Phase 1 clinical trial

20-100 healthy volunteers, overall focus is safety

Phase 2 Clinical Trials

Several 100s of volunteers, focus on dosage to immune response impact and short-term side effects

Phase 3 Clinical Trials

100s to 1000s of participants, control groups used. focus on safety, effectiveness and common side effects

Vaccine manufacturing tracking

Produced in lots, each of which must be approved by FDA
Manufacturing facilities checked for quality and safety

Vaccine Monitoring

even after licensed, vaccines are closely monitored
Large clinical trials may not reveal rare side effects
Clinical trials not always inclusive

Vaccine Adverse Event Reporting System (VAERS)

system open to any clinician to report adverse events after vaccination (may or may) not be related
Report: lot #, exp. date, and what happened

Clinical Immunization Safety Assessment

managed by CDC, establishes if side effects are correlational or causal

Advisory Committee on Immunization Practices (ACIP)

makes vaccine recommendations as public health advice, meets 3x/year, open to public & public comment
Vaccine schedule approved by AAP and AAFP. Does not align with CDC currently

Vaccine recommendations based on…

age, prior vaccines, health conditions, lifestyle, occupation, travel, pregnancy, etc.

Vaccinations at Birth

HepB and RSV*

RSV vaccination at birth

1 dose to high risk infants born Oct-March, 1 dose before RSV season if born April-Sept if mom unvaccinated

HepB vaccination at birth

1 dose within 24 hours if stable and >2,000 grams

RSV vaccination

Nirsevimab, monoclonal antibody, recommended for all infants <8 months

RSV vaccination for mother

can be given 14 days prior to delivery, then no need to vaccinate infant

RSV

Respiratory virus can cause lower airway infection (bronchiolitis) and pneumonia, dangerous to older adults and those with chronic conditions

HepB vaccine

Recombinant, administered within 24hrs of birth, 1-2 mos, and 6-18 mos.

HepB

infection to liver, potentially leading to cirrhosis. Children with HepB can convert into a carrier state

HepB common cases in childhood

mom was HepB negative. Unvaccinated infant was exposed to infected family member

1 month visit

HepB vaccine (booster or first injection)

2 month visit

DTap, HiB, PVC-15, PVC-20, IPV, Rotavirus

Warnings for 2 month visit to parents

Shot heavy visit, some are combination shots. Bring someone comfortable holding child during this process

DTaP vaccine

strong component for Diptheria, Tetanus, and Pertussis
Inactivated vaccine
5-dose series

HiB vaccine

Haemophilus Influenzae Type B
Conjugate vaccine
4 dose or 3 dose series (depends on brand)

Hib infection

Haemophilus Influenzae Type B commonly causes epiglottitis and meningitis. Inflamed throat can block airway completely

IPV vaccine

inactivated polio vaccine
4-dose series

Polio

virus infecting the brainstem and spinal cord
leads to permanent limb dysfunction
recent case in 2022

PCV15 and PCV20 vaccine

pneumococcus
4-dose series

Pneumococcus

significant disease in <5 y/o, children have smaller airways which are easier to compromise
Meningitis, blood infections, ear infections, etc.

Rotavirus (RV) Vaccine

live, oral vaccine
2 or 3 dose series (depending on brand)

Rotavirus

viral gastroenteritis

Timing of rotavirus vaccination

Do not start on or after wk 15, 0 days old. Max age for final dose is 8 months
2 doses, equal efficacy

4 month visit

DTaP, Hib, PCV15, PCV20, IPV, Rotavirus, HepB (often as a combination)
Nothing new (just boosters)

6 month visit

DTaP, IPV, PCV15, PCV20, Rotavirus, Influenza (inactivated only), HepB, COVID-19

Combination 6 month vaccines

HepB, IPV, and DTaP

#1 complication of influenza

pneumonia

Influenza Vaccine if <2 y/o

Inactivated vaccine only

Influenza vaccine recommendation

can be vaccinated annually starting at 6 mos. Can still receive if egg allergy

Influenza vaccine if 6mos - 8y/o

if first time or only one previous dose in lifetime, requires 2 doses at least 28 days apart

Influenza vaccine if >9 y.o

1 dose annually

Trivalent Influenza Vaccine

2 influenza A, 1 influenza B

Quadrivalent Influenza vaccine

2 influenza A, 2 influenza B
Most common

Concern for Intranasal live attenuated influenza vaccine (LAIV)

cannot have immunocompromised individuals around the child, contraindicated if asthma or wheezing (2-4 y/o, occurred in past 12 months), precaution if >5 y/o with asthma

COVID Vaccine

guidance continues to involve, decided upon with shared decision making. 2-dose if 6 mos - 4y/o, 1 dose if 5-18 y/o

9 month visit

no vaccines! Ok to catch-up on missed vaccines at visit

12 month visit

HiB, PVC15, PCV20, MMR, Varicella, HepA

MMR & Varicella co-formulated

can give as one shot but can lower seizure threshold if combined

MMR Vaccine

live virus vaccine
May start at 6 months if traveling internationally
2 to 3 dose series (if given at 6 mo)

2025 Measles outbreak

14 separate outbreaks, mainly affecting unvaccinated individuals and young children d/t lower immune system

Varicella Vaccine

Live virus vaccine
2 dose series
Goal is to prevent complications of virus - pneumonia, meningitis, shingles

HepA Vaccine

inactivated vaccine
2-dose series

HepA

self-limited viral inflammation of liver, acquired by contaminated food and water

15 month visit

DTap

18 month visit

HepA #2

2 year & 3 year visits

annual flu and covid vaccine
reassess need for any missed vaccines, identify new risk factors

4-6 year visits

Kindergarden shots
DTaP, IPV, MMR, Varicella, Covid, Flu

11-12 year visit

Tdap, HPV, Meningococcal, COVID, Flu

Tdap

tetanus, diptheria, pertussis
Given at 11-12 y/o
Given to a pregnant adolescent during each pregnancy
Given every 10 years as an adult

HPV effectiveness

most effective if given before activity begins, more robust immune system when young

HPV vaccine

inactivated subunit
Gardasil 9
2-dose is started before 15 y/o
3-dose if started after 15 y/o

HPV

human papilloma virus
can lead to cervical, vaginal, penile, anal, and oropharyngeal cancers

HPV vaccine biggest side effect

vasovagal syncope

Meningococcal vaccine

2 dose series starting 11-12 y/o and at 16 y/o (NOT A DAY EARLIER)
Given before high school and college

Meningococcus - Bacterial Meningitis

very serious, very quickly. Often results in long-term disability or death

16-18 year visit

Meningococcal boosted, COVID, Flu

Local reactions to vaccinations

most common reaction, often in inactivated vaccines
pain, swelling, redness at injection site

knot under subQ fat side effect

IM injection done improperly, not all vaccine went into the muscle

Systemic Reactions to vaccines

fever w/febrile seizure, general unwell feeling, headache
may be d/t vaccine or concurrent viral infection

Live vaccine systemic reaction

mild fever and rash, can occur 7-21 days after vaccination

Anaphylactic Reaction to vaccine

will not know of until shot is given
antigen or vaccine preservative can look like an allergic trigger

Contraindication

a patient condition that greatly increases the risk of severe adverse reaction, will not treat with that specific treatment

Precaution

a patient condition that might increase the risk or severity of an adverse reaction, will give anticipatory guidance

Vaccine Hesitancy

A state of indecision or uncertainty about a vaccination before a decision is made, tends to increase as new information and policies come into public knowledge
top 10 threat to global health

Reasons for vaccine hesitancy

complacency, declining trust in experts, preference of alternative health, politics, historical ethical violations by medical professionals

Evidence based recommendations to help with vaccine hesitancy

build trust and relationship with family, make a definitive statement, discuss specific concerns, counter misinformation by knowing stats

Dismissal

last resort, must sign refusal to vaccinate form.
Consider if dismissal will cause more harm to the patient
must help with transition of care