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Clinical Guideline on COVID-19
Vaccination for Adolescents
(12 – 17 years)
Contents
1. Background
2. Recommendations
3. Introduction
4. Priority Groups for COVID-19 Vaccination
5. COVID-19 vaccines for adolescents
6. Contraindications and precautions
7. Pre-Vaccination Assessment
8. Administration
9. Consent
10. Monitoring of Adverse Events Following Immunisation (AEFI)
Background
• Guidelines on COVID-19 vaccination in adolescents age 12 – 17
years
• No COVID-19 vaccine yet approved for children below 12 years
of age
• To protect children too young to be vaccinated, ALL eligible
adults should be vaccinated e.g. family members, nanny,
guardians, teachers etc
RECOMMENDATIONS
1. Adolescents WITH underlying medical conditions (comorbidities)
are prioritized to receive COVID-19 vaccine because they can get
very ill with COVID-19
2. Healthy adolescents are also recommended to receive COVID-19
vaccine because they can also be very ill with COVID-19, although
their risks are lower
RECOMMENDATIONS
3. Recommended vaccine is Comirnaty (Pfizer-BioNTech) vaccine
0.3ml (30mcg) 2 doses at least 21 days apart
4. Taking medications to PREVENT fever or pain (e.g paracetamol)
from vaccination is not advisable. Use only when having fever
or pain AFTER vaccination
Introduction
• Children and adolescents are less affected than adults
• Majority are without symptom or had mild, self-limiting symptoms
• However, some children and adolescents became very ill with COVID-19 and
a few have died.
• Many of them have underlying chronic medical conditions that predispose them to
severe illness and are more likely to develop complications arising from COVID-19
• At risk of developing a rare, but serious condition known as Multi System Inflammatory
Syndrome in Children (MIS-C)
• Recently, the proportion of children and adolescents reported to have COVID-19 has
increased
Introduction
• Children and adolescents suffer huge indirect impact from COVID-19
• Disrupted family
• Interrupted schooling and education
• Social life
• mental and development issues
Priority Groups for COVID-19 Vaccination in Adolescents (1)
• Children with underlying medical conditions are at a greater risk for severe
COVID-19 including hospitalisation, ICU admission and death.
• A wide spectrum of underlying medical conditions associated with severe
COVID-19 have been reported e.g. chronic respiratory diseases, heart
diseases, hypertension, immunosuppression, diabetes mellitus, chronic
kidney diseases, neurological conditions and obesity.
• Due to the increase risk of severe COVID-19, this category of children and
adolescents should be prioritised to receive COVID-19 vaccination as soon
as possible.
Priority Groups for COVID-19 Vaccination in Adolescents (2)
Underlying medical conditions that increased the risk for severe COVID-19
(Conditions listed here are in no order of priority)
1. Immunocompromised due to
disease or treatment*
Bone marrow or stem cell transplant recipients.
Solid organ transplant recipients.
Haematological malignancies.
Cancer patients on active chemotherapy.
Severe aplastic anaemia.
Autoimmune or autoinflammatory disorders requiring long term
immunosuppressive treatment.
Receiving systemic steroids for > 1 month at a daily dose equivalent to prednisolone
20mg or more (for patient weighing < 10kg, prednisolone dose of > 2mg/kg/day for >
14 days).
Receiving immunosuppressive or immune-modulating biological therapy such as
anti-TNF, rituximab.
2. HIV Infection HIV infection at all stages.
Priority Groups for COVID-19 Vaccination in Adolescents (3)
Underlying medical conditions that increased the risk for severe COVID-19
(Conditions listed here are in no order of priority)
3. Asplenia or dysfunction of the spleen Those who have undergone splenectomy and those with conditions that may
lead to splenic dysfunction, such as thalassemia major and coeliac syndrome.
4. Chronic heart disease and vascular
disease
Congenital heart disease, cardiomyopathy, individuals with arrhythmia, chronic
rheumatic heart disease with valve involvement , pulmonary hypertension and
right heart failure, chronic heart failure, individuals with aortic root dilatation.
5. Chronic kidney disease Kidney transplantation, ESRD on haemodialysis and CAPD, chronic kidney
disease stage 3 and 4. Glomerulonephritis e.g. lupus nephritis.
Nephro-urological problems.
6. Chronic gastrointestinal/liver disease Cirrhosis, biliary atresia.
Inflammatory bowel disease, malabsorption syndrome.
7. Chronic neurological disease Cerebral palsy, chronic neuromuscular disease, epilepsy, learning disabilities,
autism spectrum disorder, chronic demyelinating disease, hereditary and
degenerative disease of the nervous system or muscles, stroke; or neurological
disability requiring assistance in activities of daily living.
Priority Groups for COVID-19 Vaccination in Adolescents (4)
Underlying medical conditions that increased the risk for severe COVID-19
(Conditions listed here are in no order of priority)
8. Chronic respiratory disease Chronic lung disease (e.g. BPD survivors, bronchiectasis, bronchiolitis obliterans,
chronic aspiration pneumonia, cystic fibrosis and primary ciliary dyskinesia).
Chronic restrictive lung disease (e.g. neuromuscular disorders, syndromic with
hypotonia, skeletal disorders, metabolic disorders like mucopolysaccharidosis).
Chronic upper and lower airway obstruction (e.g. severe OSAS, malacic, stenosis,
asthma).
Hypoventilation syndrome (e.g CCHS).
9. Chronic endocrine disease Diabetes mellitus type 1, type 2, monogenic.
Hypopituitarism, isolated growth hormone deficiency, diabetes insipidus, adrenal
insufficiency.
10. Obesity BMI at or above the 95th percentile for adolescents of the same age and sex.
11. Genetic conditions Down syndrome.
Genetic disorders affecting the immune system e.g primary immunodeficiency
disorders.
Inherited metabolic diseases with risk of acute metabolic decompensation,
respiratory or cardiac complications, and frequent exacerbation induced by
infection.
Priority Groups for COVID-19 Vaccination in Adolescents (5)
Underlying medical conditions that increased the risk for severe COVID-19
(Conditions listed here are in no order of priority)
12. Chronic dermatological disease Chronic dermatoses requiring immunosuppressive drugs and/or biologics.
Complex vascular anomalies including complex vascular malformations and
complex vascular tumours.
Genodermatoses including ichthyoses syndromes, epidermolysis bullosa
and others that is associated with immunosuppression.
13. Severe mental illness Schizophrenia or bipolar disorder, or any mental illness that causes severe
functional impairment.
14. Adolescents in long-stay nursing and
residential care settings
Many adolescents in residential care settings will be eligible for vaccination
because they fall into one of the risk groups above (for example learning
disabilities). Given the likely high risk of exposure in these settings, where a
high proportion of the population would be considered eligible, vaccination
of the whole resident population is recommended.
Younger residents in care homes for the elderly will be at high risk of
exposure, and although they may be at lower risk of mortality than older
residents should not be excluded from vaccination programmes.
Priority Groups for COVID-19 Vaccination in Adolescents (6)
Underlying medical conditions that increased the risk for severe COVID-19
(Conditions listed here are in no order of priority)
Other risk groups
1. Household contacts of people
with immunosuppression
Those who expect to share living accommodation on most days with
individuals who are immunosuppressed (defined as above).
2. Carers Those who are the sole or primary carer of a disabled person who is at
increased risk of COVID-19 related mortality.
COVID-19 Vaccine for Adolescents
• Only Pfizer-BioNTech COVID-19 vaccine (mRNA) is approved for use in
adolescents 12 years and older in Malaysia
• Clinical trial in adolescents showed:
• Vaccine is safe and well-tolerated in adolescents: adverse events were
mild to moderate e.g. pain at injection site, fatigue, headache - quickly
resolved in 1-2 days
• No serious adverse events
• Good production of neutralising antibodies: antibody level achieved
higher than in young adults
• Vaccine efficacy was excellent (100%) ie protect recipients from
symptomatic COVID-19
N Engl J Med May 27, 2021
Contraindications
Allergy
• Pfizer-BioNTech vaccine is contraindicated in individuals who
have had an allergic reaction to a previous dose of the vaccine
or to any of its components.
Precautions (1)
Giving Other vaccines at the same time
• If possible, do not give COVID-19 vaccine simultaneously with other
vaccines. This is to avoid confounding possible adverse events. Defer the
vaccination for at least 2 weeks, if feasible.
• If it is unavoidable, e.g. the risk of the adolescent missing subsequent
appointment for vaccination is high, coadministration of routine
childhood/adolescent vaccine and COVID-19 vaccine is allowed.
Precautions (2)
Medications
• Taking medications to PREVENT fever or pain before or during
vaccination is not advisable
• E.g. paracetamol, ibuprofen
• May interfere with immune response
• Use only when having fever or pain AFTER vaccination
Pre vaccination assessment
• Pre-vaccination assessment (PVA) is an assessment conducted by the doctor to
determine the suitability of individual to receive the vaccine, when to receive
the vaccine and where he/she receive the vaccine (i.e hospitals, health clinics
or other vaccination centres).
• Not all adolescents with co-morbidities will require PVA. In general,
adolescents that require PVA include:
1. Immunocompromised adolescents e.g due to diseases or on medications
that suppress their immune system)
2. Adolescents with tendency to bleed e.g. haemophilia, ITP, or on
anticoagulants (blood thinning medications)
3. Adolescents with history of severe allergy (e.g. anaphylaxis)
Consent
• Information regarding the vaccine’s efficacy, safety and possible
adverse reactions should be clearly explained to the adolescents
and to their parents/ caregivers prior to the vaccination. Parents
or caregivers will be required to sign the informed consent form
on behalf of the adolescents.
Adverse Events Following Immunisation (AEFI)
• Very rare reports (less than 0.01%) in several countries of condition
affecting the heart after mRNA COVID-19 vaccines
• Myocarditis (inflammation of heart muscle)
• Pericarditis (inflammation of outer lining of the heart)
• Most cases were male adolescents and young adults below 30 years
• Usually after second dose of vaccine
• Usually within one week after vaccination
• Most cases appeared to be mild, responded well to medications and
rest and recovered quickly
Symptoms of myocarditis and pericarditis
• Chest pain
• Difficulty breathing, breathless
• Palpitations (feeling of having a fast-beating or pounding heart)
• Fainting
What to do if you or your child have any of
the symptoms?
• Seek medical care at your nearest health clinics or hospitals
(especially if it is within a week after COVID-19 vaccination)
• Informed that you or your child have recently received COVID-19
vaccine
• Doctors will examine and do further tests and provide appropriate
treatment
THANK YOU

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Clinical Guideline on COVID-19 Vaccination for Adolescents

  • 1. Clinical Guideline on COVID-19 Vaccination for Adolescents (12 – 17 years)
  • 2.
  • 3. Contents 1. Background 2. Recommendations 3. Introduction 4. Priority Groups for COVID-19 Vaccination 5. COVID-19 vaccines for adolescents 6. Contraindications and precautions 7. Pre-Vaccination Assessment 8. Administration 9. Consent 10. Monitoring of Adverse Events Following Immunisation (AEFI)
  • 4. Background • Guidelines on COVID-19 vaccination in adolescents age 12 – 17 years • No COVID-19 vaccine yet approved for children below 12 years of age • To protect children too young to be vaccinated, ALL eligible adults should be vaccinated e.g. family members, nanny, guardians, teachers etc
  • 5. RECOMMENDATIONS 1. Adolescents WITH underlying medical conditions (comorbidities) are prioritized to receive COVID-19 vaccine because they can get very ill with COVID-19 2. Healthy adolescents are also recommended to receive COVID-19 vaccine because they can also be very ill with COVID-19, although their risks are lower
  • 6. RECOMMENDATIONS 3. Recommended vaccine is Comirnaty (Pfizer-BioNTech) vaccine 0.3ml (30mcg) 2 doses at least 21 days apart 4. Taking medications to PREVENT fever or pain (e.g paracetamol) from vaccination is not advisable. Use only when having fever or pain AFTER vaccination
  • 7. Introduction • Children and adolescents are less affected than adults • Majority are without symptom or had mild, self-limiting symptoms • However, some children and adolescents became very ill with COVID-19 and a few have died. • Many of them have underlying chronic medical conditions that predispose them to severe illness and are more likely to develop complications arising from COVID-19 • At risk of developing a rare, but serious condition known as Multi System Inflammatory Syndrome in Children (MIS-C) • Recently, the proportion of children and adolescents reported to have COVID-19 has increased
  • 8. Introduction • Children and adolescents suffer huge indirect impact from COVID-19 • Disrupted family • Interrupted schooling and education • Social life • mental and development issues
  • 9. Priority Groups for COVID-19 Vaccination in Adolescents (1) • Children with underlying medical conditions are at a greater risk for severe COVID-19 including hospitalisation, ICU admission and death. • A wide spectrum of underlying medical conditions associated with severe COVID-19 have been reported e.g. chronic respiratory diseases, heart diseases, hypertension, immunosuppression, diabetes mellitus, chronic kidney diseases, neurological conditions and obesity. • Due to the increase risk of severe COVID-19, this category of children and adolescents should be prioritised to receive COVID-19 vaccination as soon as possible.
  • 10. Priority Groups for COVID-19 Vaccination in Adolescents (2) Underlying medical conditions that increased the risk for severe COVID-19 (Conditions listed here are in no order of priority) 1. Immunocompromised due to disease or treatment* Bone marrow or stem cell transplant recipients. Solid organ transplant recipients. Haematological malignancies. Cancer patients on active chemotherapy. Severe aplastic anaemia. Autoimmune or autoinflammatory disorders requiring long term immunosuppressive treatment. Receiving systemic steroids for > 1 month at a daily dose equivalent to prednisolone 20mg or more (for patient weighing < 10kg, prednisolone dose of > 2mg/kg/day for > 14 days). Receiving immunosuppressive or immune-modulating biological therapy such as anti-TNF, rituximab. 2. HIV Infection HIV infection at all stages.
  • 11. Priority Groups for COVID-19 Vaccination in Adolescents (3) Underlying medical conditions that increased the risk for severe COVID-19 (Conditions listed here are in no order of priority) 3. Asplenia or dysfunction of the spleen Those who have undergone splenectomy and those with conditions that may lead to splenic dysfunction, such as thalassemia major and coeliac syndrome. 4. Chronic heart disease and vascular disease Congenital heart disease, cardiomyopathy, individuals with arrhythmia, chronic rheumatic heart disease with valve involvement , pulmonary hypertension and right heart failure, chronic heart failure, individuals with aortic root dilatation. 5. Chronic kidney disease Kidney transplantation, ESRD on haemodialysis and CAPD, chronic kidney disease stage 3 and 4. Glomerulonephritis e.g. lupus nephritis. Nephro-urological problems. 6. Chronic gastrointestinal/liver disease Cirrhosis, biliary atresia. Inflammatory bowel disease, malabsorption syndrome. 7. Chronic neurological disease Cerebral palsy, chronic neuromuscular disease, epilepsy, learning disabilities, autism spectrum disorder, chronic demyelinating disease, hereditary and degenerative disease of the nervous system or muscles, stroke; or neurological disability requiring assistance in activities of daily living.
  • 12. Priority Groups for COVID-19 Vaccination in Adolescents (4) Underlying medical conditions that increased the risk for severe COVID-19 (Conditions listed here are in no order of priority) 8. Chronic respiratory disease Chronic lung disease (e.g. BPD survivors, bronchiectasis, bronchiolitis obliterans, chronic aspiration pneumonia, cystic fibrosis and primary ciliary dyskinesia). Chronic restrictive lung disease (e.g. neuromuscular disorders, syndromic with hypotonia, skeletal disorders, metabolic disorders like mucopolysaccharidosis). Chronic upper and lower airway obstruction (e.g. severe OSAS, malacic, stenosis, asthma). Hypoventilation syndrome (e.g CCHS). 9. Chronic endocrine disease Diabetes mellitus type 1, type 2, monogenic. Hypopituitarism, isolated growth hormone deficiency, diabetes insipidus, adrenal insufficiency. 10. Obesity BMI at or above the 95th percentile for adolescents of the same age and sex. 11. Genetic conditions Down syndrome. Genetic disorders affecting the immune system e.g primary immunodeficiency disorders. Inherited metabolic diseases with risk of acute metabolic decompensation, respiratory or cardiac complications, and frequent exacerbation induced by infection.
  • 13. Priority Groups for COVID-19 Vaccination in Adolescents (5) Underlying medical conditions that increased the risk for severe COVID-19 (Conditions listed here are in no order of priority) 12. Chronic dermatological disease Chronic dermatoses requiring immunosuppressive drugs and/or biologics. Complex vascular anomalies including complex vascular malformations and complex vascular tumours. Genodermatoses including ichthyoses syndromes, epidermolysis bullosa and others that is associated with immunosuppression. 13. Severe mental illness Schizophrenia or bipolar disorder, or any mental illness that causes severe functional impairment. 14. Adolescents in long-stay nursing and residential care settings Many adolescents in residential care settings will be eligible for vaccination because they fall into one of the risk groups above (for example learning disabilities). Given the likely high risk of exposure in these settings, where a high proportion of the population would be considered eligible, vaccination of the whole resident population is recommended. Younger residents in care homes for the elderly will be at high risk of exposure, and although they may be at lower risk of mortality than older residents should not be excluded from vaccination programmes.
  • 14. Priority Groups for COVID-19 Vaccination in Adolescents (6) Underlying medical conditions that increased the risk for severe COVID-19 (Conditions listed here are in no order of priority) Other risk groups 1. Household contacts of people with immunosuppression Those who expect to share living accommodation on most days with individuals who are immunosuppressed (defined as above). 2. Carers Those who are the sole or primary carer of a disabled person who is at increased risk of COVID-19 related mortality.
  • 15. COVID-19 Vaccine for Adolescents • Only Pfizer-BioNTech COVID-19 vaccine (mRNA) is approved for use in adolescents 12 years and older in Malaysia • Clinical trial in adolescents showed: • Vaccine is safe and well-tolerated in adolescents: adverse events were mild to moderate e.g. pain at injection site, fatigue, headache - quickly resolved in 1-2 days • No serious adverse events • Good production of neutralising antibodies: antibody level achieved higher than in young adults • Vaccine efficacy was excellent (100%) ie protect recipients from symptomatic COVID-19 N Engl J Med May 27, 2021
  • 16. Contraindications Allergy • Pfizer-BioNTech vaccine is contraindicated in individuals who have had an allergic reaction to a previous dose of the vaccine or to any of its components.
  • 17. Precautions (1) Giving Other vaccines at the same time • If possible, do not give COVID-19 vaccine simultaneously with other vaccines. This is to avoid confounding possible adverse events. Defer the vaccination for at least 2 weeks, if feasible. • If it is unavoidable, e.g. the risk of the adolescent missing subsequent appointment for vaccination is high, coadministration of routine childhood/adolescent vaccine and COVID-19 vaccine is allowed.
  • 18. Precautions (2) Medications • Taking medications to PREVENT fever or pain before or during vaccination is not advisable • E.g. paracetamol, ibuprofen • May interfere with immune response • Use only when having fever or pain AFTER vaccination
  • 19. Pre vaccination assessment • Pre-vaccination assessment (PVA) is an assessment conducted by the doctor to determine the suitability of individual to receive the vaccine, when to receive the vaccine and where he/she receive the vaccine (i.e hospitals, health clinics or other vaccination centres). • Not all adolescents with co-morbidities will require PVA. In general, adolescents that require PVA include: 1. Immunocompromised adolescents e.g due to diseases or on medications that suppress their immune system) 2. Adolescents with tendency to bleed e.g. haemophilia, ITP, or on anticoagulants (blood thinning medications) 3. Adolescents with history of severe allergy (e.g. anaphylaxis)
  • 20. Consent • Information regarding the vaccine’s efficacy, safety and possible adverse reactions should be clearly explained to the adolescents and to their parents/ caregivers prior to the vaccination. Parents or caregivers will be required to sign the informed consent form on behalf of the adolescents.
  • 21. Adverse Events Following Immunisation (AEFI) • Very rare reports (less than 0.01%) in several countries of condition affecting the heart after mRNA COVID-19 vaccines • Myocarditis (inflammation of heart muscle) • Pericarditis (inflammation of outer lining of the heart) • Most cases were male adolescents and young adults below 30 years • Usually after second dose of vaccine • Usually within one week after vaccination • Most cases appeared to be mild, responded well to medications and rest and recovered quickly
  • 22. Symptoms of myocarditis and pericarditis • Chest pain • Difficulty breathing, breathless • Palpitations (feeling of having a fast-beating or pounding heart) • Fainting
  • 23. What to do if you or your child have any of the symptoms? • Seek medical care at your nearest health clinics or hospitals (especially if it is within a week after COVID-19 vaccination) • Informed that you or your child have recently received COVID-19 vaccine • Doctors will examine and do further tests and provide appropriate treatment
  • 24.