COMIRNATY LP.8.1 3 micrograms/dose concentrate for dispersion for injection 3-dose vial (dilute before use)

Full name: COMIRNATY LP.8.1 3 micrograms/dose concentrate for dispersion for injection 3-dose vial COVID-19 mRNA Vaccine¹

Indication: indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years¹

The use of this vaccine should be in accordance with official recommendations.¹

How does the Pfizer/BioNTech Vaccine COMIRNATY LP.8.1 differ from Pfizer/BioNTech's pre-existing COMIRNATY Vaccines?
COMIRNATY LP.8.1 3 micrograms/dose concentrate for dispersion (dilute before use) is a monovalent vaccine adapted to target the LP.8.1 COVID-19 variant.

Posology:
The dose of COMIRNATY LP.8.1 is 0.3mL given intramuscularly.

There should be an interval of at least 3 months between administration of COMIRNATY LP.8.1 and the last prior dose of a COVID-19 vaccine.

Please refer to 4.2 of the Summary of Product Characteristics for more information.

Administration: In infants from 6 to 12 months of age, the recommended injection site is the anterolateral aspect of the thigh. In individuals 1 to 4 years of age, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle. Dilute before use.

Pack size: 10 x 3 dose vials¹

Dilution status: Dilute with 1.1mL of sodium chloride 9mg/mL (0.9%) solution for injection.¹

Posology:

Please refer to 4.2 of the Summary of Product Characteristics for more information.

Administration:administered intramuscularly after dilution. In infants from 6 to less than 12 months of age, the recommended injection site is the anterolateral aspect of the thigh. In individuals 1 year of age and older, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle.¹

Refrigerated storage (2°C to 8°C) once thawed: 10 weeks storage and transportation within the 18-month shelf life. Once thawed the vaccine should not be re-frozen.¹

Vial: 3 dose vial¹

Dose: 3 micrograms (0.3mL)¹

Room temperature stability before use: the unopened vials can be stored for up to 12 hours at temperatures between 8^oC and 30^oC.¹

Stability of opened vials: Chemical and physical in-use stability has been demonstrated for 12 hours at 2^oC to 30^oC, after dilution with sodium chloride 9 mg/mL (0.9%) solution for injection, which includes up to 6 hours transportation time. From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user. Discard any unused vaccine within 12 hours after dilution.¹

Click here for Summary of Product Characteristics

Verification, handling & preparation of COMIRNATY LP.8.1 3 micrograms/dose concentrate (dilute before use)

Undesirable Effects:
The safety of COMIRNATY LP.8.1 is inferred from safety data of the prior COMIRNATY vaccines, given as first, second or subsequent doses.

The most common adverse reactions (classified as very common >1/10 ) from COMIRNATY and COMIRNATY Original/Omicron BA.4-5 clinical trials and COMIRNATY post-authorisation experience in individuals 6 months of age and older were:

Irritability^ⱡ
Diarrhoea
Headache
Drowsiness^ⱡ
Arthralgia/Myalgia
Injection site pain/tendernessⱡ/swelling
Pyrexia*
Chills
Fatigue

Vomiting (only in immunocompromised patients from 2 to 18 years old)
Decreased appetite (only in participants from 6 to 23 months)
Injection site redness occurred at a higher frequency (very common) in participants 6 months to 11 years of age and in immunocompromised participants 2 years of age and older.

^ⱡIrritability, injection site tenderness, and drowsiness pertain to participants 6 to 23 months of age

* a higher frequency of pyrexia was observed after a second dose compared to a first dose

Hypersensitivity and anaphylaxis:

Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.

Close observation for at least 15 minutes is recommended following vaccination. No further dose of the vaccine should be given to those who have experienced anaphylaxis after a prior dose of COMIRNATY.

Myocarditis and pericarditis:

There is an increased risk of myocarditis and pericarditis following vaccination with COMIRNATY. These conditions can develop within a few days after vaccination and have primarily occured within 14 days. They have been observed more often after the second vaccination and more often in younger males. Available data indicate that most cases recover. Some cases required intensive care support and fatal cases have been observed.

Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees (including parents or caregivers) should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination.

Healthcare professionals should consult guidance and/or specialists to diagnose and treat the conditions.

Before administering the vaccine, refer to the Summary of Product Characteristics for further details.

Adverse Event Reporting

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via a Yellow card. Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store and include the batch/Lot number if available.

Alternatively, adverse events of concern in association with COMIRNATY can be reported to Pfizer Medical Information on 01304 616161 or via www.pfizersafetyreporting.com.

Please do not report the same adverse event(s) to both systems as all reports will be shared between Pfizer and MHRA (in an anonymised form) and dual reporting will create unnecessary duplicates.

References:

Comirnaty LP.8.1 3 micrograms/dose concentrate for dispersion for injection 3-dose vial children 6 months - 4 years COVID-19 mRNA Vaccine Summary of Product Characteristics. Available at https://www.medicines.org.uk/emc/product/101152 (accessed: August 2025)

PP-CMR-GBR-0901. August 2025

*Healthcare Professionals ** Other Relevant Decision Makers

The product information provided in this site is intended only for Healthcare Professionals and Other Relevant Decision Makers resident in United Kingdom.

This website is brought to you by Pfizer Limited, a company registered in England and Wales under No. 526209 with its registered office at Ramsgate Road, Sandwich, Kent CT13 9NJ, VAT registration number GB201048427.

The products discussed may have different product labelling in other countries.

COMIRNATY LP.8.1 3 micrograms/dose concentrate for dispersion for injection 3-dose vial (dilute before use)

Verification, handling & preparation of COMIRNATY LP.8.1 3 micrograms/dose concentrate (dilute before use)

Adverse Event Reporting

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