Ministry of Health Malaysia

Clinical Guideline on COVID-19

Vaccination for Children (5 – 11 years)
Dr Nik Khairulddin Nik Yusoff
Consultant Paediatrician –Infectious Disease
Hospital Raja Perempuan Zainab II
31 January 2022
 Guideline • Dr Sabeera Begum Kadeer
Ibrahim
Committee • Dato’ Dr Rus Anida Awang
Members • Dr Jeyaseelan Nachiappan
• Dr Fong Siew Moy
• Dr Nik Khairulddin Nik Yusoff
• Dr Thiyagar Nadarajaw
• Dr Selva Kumar a/l
Sivapunniam
• Dr See Kwee Ching
• Dr Nazzlin Dizana Din
• Dr Amelia Alias
• Dr David Ng Chun Ern
• Dr Wong Seu Wei
• Dr Rozita Zakaria
• Dr Suraya Amir Husin
• Dr Jafanita Jamaludin
• Dr Sangeeta a/p
Subramaniam
• Bibi Faridha Mohd Salleh
• Perkhidmatan Farmasi KKM
Contents

1. Background
2. Recommendations
3. Introduction
4. Priority Groups for COVID-19 Vaccination
5. COVID-19 vaccines for children
6. Contraindications and precautions
7. Pre-Vaccination Assessment
8. Administration
9. Consent
10. Monitoring of Adverse Events Following Immunisation (AEFI)
RECOMMENDATIONS

• COVID-19 vaccination is recommended for all children aged 5-11 years.

• Children aged 5-11 years with underlying medical conditions are at an

increased risk for severe illness and should be prioritised to receive COVID-
19 vaccination.

• The Committee recommends Comirnaty® (Pfizer-BioNTech) vaccine

paediatric formulation for COVID-19 vaccination of children 5-11 years.
Two doses of the vaccine (10mcg per dose) should be given 8 weeks apart.
Priority Groups for COVID-19 Vaccination in Children (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 increased risk of severe COVID-19, this category of children

should be prioritised to receive COVID-19 vaccination.
Tsankov BK, et al. Int J Infect Dis. 2021 Feb; 103: 246–256.
Kompaniyets L, et al. JAMA Netw Open. 2021;4(6):e2111182.
Shi Q, et al. EClin Med. 2021;41. doi:10.1016/j.eclinm.2021.101155.
Priority Groups for COVID-19 Vaccination in Children (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 Bone marrow or stem cell transplant recipients.
disease or treatment* 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 Children (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 Congenital heart disease, cardiomyopathy, individuals with arrhythmia, chronic
disease 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 Children(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 children 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 Children (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.
14. Children in long-stay nursing and Many children in residential care settings will be eligible for vaccination
residential care settings 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.
Other risk groups
1. Household contacts of people with Those who expect to share living accommodation on most days with
immunosuppression individuals who are immunosuppressed (defined as above).
 COVID-19 Vaccine for Children

• Only Pfizer-BioNTech COVID-19 vaccine (mRNA) is approved for use in

children 5-11 years in Malaysia

• Clinical trial in children (n= 2268) showed:

• Vaccine is safe and well-tolerated:
• adverse events were mild to moderate e.g. pain at injection site, fatigue, headache - quickly resolved
• No serious adverse events / no myocarditis
• Immunogenic: good production of neutralising antibodies. Antibody level achieved non-
inferior to young adults (GMR 1.04, 95% CI: 0.93-1.18)
• Vaccine efficacy was excellent (90.7%) ie protect recipients from symptomatic COVID-19

• Emerging real-world data (> 8 million doses) supporting safety of the vaccine
Walter EB. N Engl J Med 2022; 386:35-46
Su JR. COVID-19 vaccine safety updates: ACIP Meeting. January 5, 2022.
 Adverse events within 7 days
of COVID-19 vaccination

Local
• Pain at injection site 71 – 74%
• Redness 15 – 19%%
• Swelling 10-15%

Systemic
• Fatigue 34 – 39%
• Headache 22 – 28%
• Muscle pain 9 – 12%
• Chills 5 – 10%

Walter EB. N Engl J Med 2022; 386:35-46

Myocarditis and pericarditis following mRNA
COVID-19 vaccination

• Very rare reports of acute myocarditis/pericarditis following mRNA vaccines

• Predominantly in young individuals, male, after 2nd dose
• Usually within one week after vaccination
• Symptoms – SOB, chest pain, palpitation, fainting
• Most cases appeared to be mild, responded well to medications and rest and
recovered quickly
• Mechanism still uncertain

• Incidence in children 5-11 years unknown but expected to be very low

• AEFI surveillance (VAERS) in USA: risk substantially lower than for adolescents 12-
17 years
Su JR. COVID-19 vaccine safety updates: ACIP Meeting. January 5, 2022.
Su JR. COVID-19 vaccine safety updates: ACIP Meeting. January 5, 2022.
Contraindications

• Pfizer-BioNTech COVID-19 vaccine is contraindicated in

individuals:
• who have had severe allergic reactions after a previous dose
of the vaccine or to any of the vaccine ingredients.

• who develop allergic reaction of any severity within 72 hours

after a previous dose or any known allergy to any of the
vaccine ingredient.
Precautions

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 child missing subsequent

appointment for vaccination is high, coadministration of routine childhood
vaccine and COVID-19 vaccine is allowed.
Precautions

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
Precautions

Children with Multisystem Inflammatory Syndrome in Children (MIS-C)

• Children with a prior history of MIS-C may receive COVID-19 vaccine.
However, it should be deferred until clinical recovery has been achieved or
until it has been more than 90 days since diagnosis, whichever is longer

Children with SARS-CoV-2 infection

• Children with previous history of SARS-CoV-2 infection can receive COVID-
19 vaccination. The vaccine can be given after the child has recovered from
his/her illness and has met criteria to discontinue isolation
 Multisystem Inflammatory
Syndrome in Children (MIS-C)

• Severe hyperinflammatory
syndrome occurring 2–6 weeks after
acute SARS-CoV-2 infection among
persons <21 years old
• 1 in 3000 cases 1
• 60-70% admitted to ICU
• 1-2% mortality 2

1. Payne AB et al. JAMA Network Open. 2021;4(6):e2116420; 2. Kaushik A. Pediatr Infect Dis J 2020;39(11):e340
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 children with co-morbidities will require PVA. In general, children that require PVA
include:
• Immunocompromised children e.g due to diseases or on medications that suppress
their immune system)
• Children with tendency to bleed e.g. haemophilia, ITP, or on anticoagulants (blood
thinning medications)
• Children with history of severe allergy (e.g. anaphylaxis)
Vaccine Formulation

• The paediatric formulation of Comirnaty® (Pfizer-BioNTech) COVID-19

vaccine DIFFERS from adolescents/adult formulation.
• Supplied in a 10-dose vial (orange cap)
• Requires dilution with 1.3ml of normal saline
• Each dose administered is 0.2ml containing 10mcg of mRNA vaccine

• Given by IM injection into the deltoid muscle, or anterolateral thigh

Dosing Schedule

• The Committee recommends the vaccine to be given 2 doses, 8 weeks apart.

Rationale:
• Emerging data in adults suggesting longer interval may results in:
• stronger immune response
• higher vaccine effectiveness
• potentially longer duration of protection
• reduced risk of myocarditis/pericarditis following a second dose of the
vaccine
• Extended dosing intervals have not yet been directly studied in children.
Tauzin A, et al. Cell Host & Microbe 2022;30:97-109.
Payne R, et al. Cell 2021;184:5699-714.e11.
Buchan SA, medRxiv 2021. Doi: 10.1101/2021.12.02.21267156.
Immunogenicity of
standard and extended
dosing intervals of
BNT162b2 mRNA
vaccine

• 589 UK HCW
• BNT162b2 vaccine with an extended
interval between doses is highly
protective
• Antibody levels were higher after the
extended regimen compared with the
short regimen
• The extended regimen enriches for
virus-specific CD4+ T cells expressing IL-2
• Antibody levels wane after each dose,
but B and T cell pools are maintained

Payne R, et al. Cell 2021;184:5699-714.e11.

Comparison of Serological Outcomes in Paramedics Who Received Short (≤28
Days) vs Medium (42-49 Days) mRNA Vaccine Dosing Intervals

Grunau B, et al. JAMA December 3, 2021. doi:10.1001/jama.2021.21921

Reporting rate of myocarditis among people
completed 2 doses in Ontario, Canada

Buchan SA, medRxiv 2021. Doi: 10.1101/2021.12.02.21267156.

Other considerations

• Children should receive the age-appropriate vaccine formulation and dose

regardless of their size or body weight

• The dosage recommendation is according to birth date

• Children who turn 12 after their first dose may be given
adolescent/adult Comirnaty® (Pfizer-BioNTech) vaccine formulation and
dose (30mcg) to complete their primary vaccine course.
• If the second dose of 10mcg is inadvertently given, the dose should still
be considered valid and the series complete
Monitoring of AEFI

• All AEFI should be reported to NPRA

• If suspecting acute myocarditis/pericarditis following receipt of

COVID-19 vaccine, use algorithm on diagnosis and management
of children with myocarditis/pericarditis following COVID-19
vaccination
 Symptoms of myocarditis and pericarditis

• Chest pain

• Difficulty breathing, breathless

• Palpitations (feeling of having a fast-beating or pounding heart)

• Fainting
 Advice for parents/children

• Refrain from doing rigorous exercise for one week after receiving
the vaccine

• If you/ your child develop 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
Annex 3
THANK YOU