Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

COVID-19 vaccine

Generic name
COVID-19 vaccine
Brand name
ATC Code
J07BN01

Pharmacokinetics in children

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

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Available formulations

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Dosages

Prevention of COVID-19
  • Intramuscular
    • ≥ 12 years

      • Primary vaccination series: 
        Comirnaty:         30 mcg/dose once, repeat 21 days after 1st vaccination
        Spikevax: 100 mcg/dose once, repeat 28 days after 1st vaccination
        Nuvaxovid: 5 mcg/dose once, repeat 21 days after 1st vaccination

        Severely immunocompromised patients (Comirnaty en Spikevax): a third dose of the primary vaccination series may be administered at least 28 days after the second dose.

        Booster:
        Comirnaty: 30 mcg/dose once, at least 3 months after the primary vaccination series
        Spikevax: 50 mcg/dose once, at least 3 months after the primary vaccination series

    • 5 years up to 12 years

      • Primary vaccination series
        Comirnaty: 5-12 years:         10 mcg/dose once, repeat 21 days after 1st vaccination
        Spikevax: 6-12 years: 50 mcg/dosis éénmalig, repeat 28 days after 1st vaccination

        Severely immunocompromised patients: a third dose of the primary course may be administered intramuscularly at least 28 days after the second dose.

        Booster
        Comirnaty: 5-12 years: 10 mcg/dose once, at least 6 months after the primary series.

    • 6 months up to 5 years

      • Primary vaccination series
        Comirnaty: 6 months-5 years:         3 mcg/dose once, repeat 21 and 77 days after 1st vaccination
        Spikevax: 6 months-6 years: 25 mcg/dosis éénmalig, repeat 28 days after 1st vaccination

        Severely immunocompromised patients:  Spikevax: a third dose of the primary course may be administered intramuscularly at least 28 days after the second dose.

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Comirnaty:
6mnd - 2 years: irritability (> 60%), drowsiness (> 40%), decreased appetite (> 30%), injection site sensitivity (> 20%), injection site redness and fever (> 10%)
2-5 years: injection site pain and fatigue (> 40%), injection site redness and fever (> 10%).
5-12 years: injection site pain (> 70%), fatigue (> 40%), headache (> 30%), myalgia, chills, injection site redness and swelling of injection site (> 10%).
12 -16 years: injection site pain (> 90%), fatigue and headache (> 70%), myalgia and chills (> 40%), arthralgia and pyrexia (> 20%).
≥ 16 years: injection plate pain (> 80%), fatigue (> 60%), headache (> 50%), myalgia(> 40%), chills (> 30%), arthralgia (> 20%), pyrexia and swelling of injection site (> 10%)

Spikevax: 
6 months-2 years: irritability/crying (81.5%), injection site pain (56.2%), drowsiness (51.1%), loss of appetite (45.7%), fever (21.8%), injection site swelling (18.4%), injection site erythema (17.9%) and axillary swelling/sensitivity (12.2%).
2-3 years: injection site pain (76.8%), irritability/crying (71.0%), drowsiness (49.7%), loss of appetite (42.4%), fever (26.1%), injection site erythema (17.9%), injection site swelling (15.7%) and axillary swelling/sensitivity (11.5%).
3-6 years: pain at the injection site (83.8%), fatigue (61.9%), headache (22.9%), myalgia (22.1%), fever (20.9%), chills (16.8%), nausea/vomiting (15.2%), axillary swelling/sensitivity (14.3%), arthralgia (12.8%), erythema at the injection site (9.5%) and swelling at
the injection site (8.2%).
6 -12 years: injection site pain (98.4%), fatigue (73.1%), headache (62.1%), myalgia (35.3%), chills (34.6%), nausea/vomiting (29.3%), axillary swelling/sensitivity (27.0%), fever (25.7%), injection site erythema (24.0%), injection site swelling (22.3%) and arthralgia (21.3%).
12-18 years: : injection site pain (97%), headache (78%), fatigue (75%), myalgia (54%), chills (49%), axillary swelling/sensitivity (35%), arthralgia (35%), nausea/vomiting (29%), injection site swelling (28%), injection site erythema (26%) and fever (14%). 

Nuvaxovid:
≥ 12 years: injection site sensitivity (71%), injection site pain (67%), headache (63%), myalgia (57%), fatigue (54%), malaise (43%), nausea or vomiting (23%), arthralgia (19%) and pyrexia (17%). Fever was observed more frequently in adolescents aged 12 to 17 years compared with adults, with the frequency being very common after the second dose in adolescents.

Myocarditis and pericarditis
After vaccination, myocarditis and pericarditis have been observed in very rare cases. These conditions can occur within days of vaccination. Most cases occurred within 14 days after vaccination, more often after the second dose compared with the first dose, and more often in boys and  young men.


 

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Encephalitis vaccines
J07BA02
J07BA01
Influenza vaccines
J07BB02
J07BB02
Hepatitis vaccines
J07BC20
J07BC02
J07BC01
Measles vaccines
J07BD52
Poliomyelitis vaccines
J07BF03
Rabies vaccines
J07BG01
Rota virus diarrhea vaccines
J07BH01
Varicella zoster vaccines
J07BK01
Yellow fever vaccines
J07BL01
Papillomavirus vaccines
J07BM03
J07BM02
Other viral vaccines
J07BX04

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References

  1. MODERNA BIOTECH SPAIN, S.L.,, SmPC Spikevax, (EU/1/20/1507/001), Rev 35; 22-12-2022, www.ema.europa.eu
  2. BioNTech Manufacturing GmbH, SmPC Comirnaty, (EU/1/20/1528/001), Rev 37; 25-01-2023, www.ema.europa.eu
  3. Novavax CZ, a.s., SmPC Nuvaxovid (EU/1/21/1618) Rev 6, 25-10-2022, www.ema.europa.eu

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Changes

Changes