- Approval Id
- 6087bd0579f96411
- Drug Name
- COMIRNATY ORIGINAL/OMICRON BA.4-5 DISPERSION FOR INJECTION 5/5 MICROGRAMS/DOSE (SINGLE-DOSE VIAL)
- Product Name
- COMIRNATY ORIGINAL/OMICRON BA.4-5 DISPERSION FOR INJECTION 5/5 MICROGRAMS/DOSE (SINGLE-DOSE VIAL)
- Approval Number
- SIN17058P
- Approval Date
- 2024-08-01
- Registrant
- PFIZER PRIVATE LIMITED
- Licence Holder
- BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p><em><u>Individuals 5 through <12 years of age</u></em></p>
<p>COMIRNATY (Bivalent) (Do Not Dilute) (For Age 5 Years to <12 Years) (Vials with Blue Cap) is administered intramuscularly as a primary series of 2 doses (0.3 mL) at greater than or equal to 21 days (preferably 3 weeks) apart.</p>
<p>If the primary series starts with COMIRNATY (For Age 5 Years to <12 Years) (Vials with Orange Cap), the series may be completed with COMIRNATY (Bivalent) (Do Not Dilute) (For Age 5 Years to <12 Years) (Vials with Blue Cap).</p>
<p><u><em>Booster dose in individuals 5 through <12 years of age</em></u></p>
<p>A booster dose of COMIRNATY (Bivalent) (Do Not Dilute) (For Age 5 Years to <12 Years) (Vials with Blue Cap) should be administered intramuscularly at least 3 months after the last prior dose in individuals 5 years through <12 years of age.</p>
<p>COMIRNATY (Bivalent) (Do Not Dilute) (For Age 5 Years to <12 Years) (Vials with Blue Cap) should be used only for children 5 to <12 years of age.</p>
<p><em><u>Interchangeability</u></em></p>
<p>The interchangeability of COMIRNATY (Bivalent) with other COVID-19 vaccines to complete the primary or booster vaccination series has not been established. Individuals who have received 1 dose of COMIRNATY or COMIRNATY (Bivalent) should receive a second dose of COMIRNATY or COMIRNATY (Bivalent) to complete the primary vaccination series.</p>
<p>Individuals may not be protected until at least 7 days after their second dose of the vaccine.</p>
<p>For further information on efficacy, see section 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p><em>Paediatric population</em><br>
The safety and efficacy of COMIRNATY (Bivalent) in children aged less than 6 months has not yet been established.</p>
<p><u>Method of administration</u></p>
<p>COMIRNATY (Bivalent) should be administered intramuscularly (see section 6.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). The preferred site is the deltoid muscle of the upper arm.</p>
<p>Do not inject the vaccine intravascularly, subcutaneously or intradermally.</p>
<p>Single dose vials of COMIRNATY (Bivalent) (Do Not Dilute) (For Age 5 Years to <12 Years) (Vials with Blue Cap) contain 1 dose of 0.3 mL of vaccine.</p>
<ul>
<li>Withdraw a single 0.3 mL dose of COMIRNATY (Bivalent)</li>
<li>Discard vial and any excess volume.</li>
<li>Do not pool excess vaccine from multiple vials.</li>
</ul>
<p>The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.</p>
<p>For precautions to be taken before administering the vaccine, see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p>For instructions regarding thawing, handling, dose preparation of vaccine before administration, and disposal of the vaccine, see section 6.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- INTRAMUSCULAR
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>COMIRNATY (Bivalent) (Do Not Dilute) (For Age 5 Years to <12 Years) (Vials with Blue Cap) is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 5 to <12 years of age.</p>
<p>The use of this vaccine should be in accordance with official recommendations.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Atc Code
- J07BN01
- Pharma Manufacturer Name
- BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD.
