- Approval Id
- 0b86ede5561b9405
- Drug Name
- COMIRNATY ORIGINAL/OMICRON BA.4-5 CONCENTRATE FOR DISPERSION FOR INJECTION 1.5/1.5 MICROGRAMS/DOSE
- Product Name
- COMIRNATY ORIGINAL/OMICRON BA.4-5 CONCENTRATE FOR DISPERSION FOR INJECTION 1.5/1.5 MICROGRAMS/DOSE
- Approval Number
- SIN17053P
- Approval Date
- 2024-07-25
- 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 6 months through <5 years of age</u></em></p>
<p>COMIRNATY (Bivalent) (For Age 6 Months to <5 Years) (Vials with Maroon Cap) is administered intramuscularly after dilution as a primary series of 3 doses (0.2 mL). The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose.</p>
<p>Individuals who will turn from 4 years to 5 years of age between their doses in the vaccination series should receive their age-appropriate dose at the time of the vaccination and the interval between doses is determined by the individual’s age at the start of the vaccination series.</p>
<p><em><u>Booster dose in individuals 6 months through <5 years of age</u></em></p>
<p>A booster dose of COMIRNATY (Bivalent) (For Age 6 Months to <5 Years) (Vials with Maroon Cap) should be administered intramuscularly at least 3 months after the last prior dose in individuals 6 months through <5 years of age.</p>
<p>COMIRNATY (Bivalent) (For Age 6 Months to <5 Years) (Vials with Maroon Cap) cannot be used in individuals 5 years of age and older.</p>
<p><em><u>Interchangeability</u></em></p>
<p>The interchangeability of COMIRNATY (Bivalent) with other COVID-19 vaccines to complete the primary vaccination series has not been established. Individuals who have received 1 dose of COMIRNATY or COMIRNATY (Bivalent) should receive a second and third 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 primary series of 3 doses 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 paediatric participants aged less than 6 months have not yet been established.</p>
<p><u>Method of administration</u></p>
<p>In individuals 6 to less than 12 months of age, administer COMIRNATY (Bivalent) intramuscularly in the anterolateral aspect of the thigh. In individuals 1 years of age and older, administer COMIRNATY (Bivalent) intramuscularly in the anterolateral aspect of the thigh or the deltoid muscle.</p>
<p>Do not inject the vaccine intravascularly, subcutaneously or intradermally.</p>
<p>After dilution, vials of COMIRNATY (Bivalent) (For Age 6 Months to <5 Years) (Vials with Maroon Cap) contain 10 doses of 0.2 mL of vaccine.</p>
<p>Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Irrespective of the type of syringe and needle:</p>
<ul>
<li>Each dose must contain 0.2 mL of vaccine.</li>
<li>If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the 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, dilution, 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) (For Age 6 Months to <5 Years) (Vials with Maroon Cap) is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 6 months to <5 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.
