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​​​​​​​Summary of Safety Profile of COMIRNATY for Participants 12 Years and Older

The safety of COMIRNATY was evaluated in participants 12 years of age and older in 2 clinical studies that included 23,205 participants (comprised of 22,074 participants 16 years of age and older and 1,131 adolescents 12 to 15 years of age) that have received at least one dose of COMIRNATY.

The overall safety profile of COMIRNATY in adolescents 12 to 15 years of age was similar to that seen in participants 16 years of age and older. 

​​​​​​​Additionally, 306 existing Phase 3 participants 18 to 55 years of age received a booster dose (third dose) of COMIRNARY approximately 6 months after the second dose. The overall safety profile for the booster dose (third dose) was similar to that seen after 2 doses.

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Participants 16 years of age and older – after 2 doses

In Study 2, a total of 22,026 participants 16 years of age or older received at least 1 dose of COMIRNATY and a total of 22,021 participants 16 years of age or older received placebo (including 138 and 145 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively). A total of 20,519 participants 16 years of age or older received 2 doses of COMIRNATY.

At the time of the analysis of Study 2 with a data cut-off of 13 March 2021 for the placebo-controlled blinded follow-up period up to the participants’ unblinding dates, a total of 25,651 (58.2%) participants (13,031 COMIRNATY and 12,620 placebo) 16 years of age and older were followed up for ≥ 4 months after the second dose. This included a total of 15,111 (7,704 COMIRNATY and 7,407 placebo) participants 16 to 55 years of age and a total of 10,540 (5,327 COMIRNATY and 5,213 placebo) participants 56 years of age and older. 

The most frequent adverse reactions in participants 16 years of age and older that received 2 doses were injection site pain (> 80%), fatigue (> 60%), headache (> 50%), myalgia (>40%), chills (> 30%), arthralgia (> 20%), pyrexia and injection site swelling (> 10%) and were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age.

The safety profile in 545 participants 16 years of age and older receiving COMIRNATY, that were seropositive for SARS-CoV-2 at baseline, was similar to that seen in the general population.

Adolescents 12 to 15 years of age – after 2 doses

In an analysis of Study 2, based on data up to the cut-off date of 13 March 2021, 2,260 adolescents (1,131 COMIRNATY and 1,129 placebo) were 12 to 15 years of age. Of these, 1,308 adolescents (660 COMIRNATY and 648 placebo) have been followed for at least 2 months after the second dose of COMIRNATY. The safety evaluation in Study 2 is ongoing.

The most frequent adverse reactions in adolescents 12 to 15 years of age that received 2 doses were injection site pain (> 90%), fatigue and headache (> 70%), myalgia and chills (> 40%), arthralgia and pyrexia (> 20%).

Participants 18 years of age and older – after booster dose (third dose)

A subset from Study 2 Phase 2/3 participants of 306 adults 18 to 55 years of age who completed the original COMIRNARY 2-dose course, received a booster dose (third dose) of COMIRNARY approximately 6 months (range of 4.8 to 8.0 months) after receiving Dose 2.
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The most frequent adverse reactions in participants 18 to 55 years of age were injection site pain (> 80%), fatigue (> 60%), headache (> 40%), myalgia (> 30%), chills and arthralgia (> 20%). 

For more information on COMIRNATY in clinical trials, visit

 ClinicalTrials.gov

Tabulated list of adverse reactions from clinical studies and post-authorisation experience in individuals 12 years of age and older

Adverse reactions observed during clinical studies are listed below according to the following frequency categories: 

Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data).​​​​​​​​​​​​​

Table 1: Adverse reactions from COMIRNATY clinical trials and post-authorisation experience in individuals 12 years of age and older

System Organ Class

Very common
​​​​​​​ (≥ 1/10)

Common
​​​​​​​ (≥ 1/100 to 1/10)

Uncommon
​​​​​​​​(≥ 1/1,000 to 1/100)

Rare
(≥ 1/10,000 to 1/1,000)

Very Rare
(< 1/10,000)

Not known​​​​​​​
​​​​​​​(cannot be estimated from the available data)

Blood and lymphatic system disorders

 

 

Lymphadenopathya

 

 

 

Immune system disorders

 

 

Hypersensitivity reactions (e.g. rash, pruritus, urticaria,b angioedemab)

 

 

Anaphylaxis

Metabolism and nutrition disorders

 

 

Decreased appetite

 

 

 

Psychiatric disorders

 

 

Insomnia

 

 

 

 

 

Nervous system disorders

Headache

 

Lethargy

Acute peripheral facial paralysisc

 

Cardiac disorders

 

 

 

 

 

Myocarditis;d
Pericarditisd

Gastrointestinal disorders

Diarrhoead

Nausea; Vomitingd

 

 

 

 

Skin and subcutaneous tissue disorder

 

 

Hyperhidrosis; Night sweats

 

 

Erythema multiformed

Musculoskeletal and connective tissue disorders

Arthralgia; Myalgia

 

Pain in extremitye

 

 

 

General disorders and administration site conditions

Injection site pain; Fatigue; Chills; Pyrexia;f Injection site swelling

Injection site redness

Asthenia;
Malaise;
Injection site pruritus

 

 

Extensive swelling of vaccinated limb;d
Facial swellingg
  1. A higher frequency of lymphadenopathy (5.2% vs 0.4%) was observed in participants receiving a booster dose (third dose) compared to participants receiving 2 doses.
  2. The frequency category for urticaria and angioedema was Rare.
  3. Through the clinical trial safety follow-up period to 14 November 2020, acute peripheral facial paralysis (or palsy) was reported by four participants in the COVID-19 mRNA Vaccine group. Onset was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of acute peripheral facial paralysis (or palsy) were reported in the placebo group.
  4. Adverse reaction determined post‑authorisation.
  5. Refers to vaccinated arm.
  6. A higher frequency of pyrexia was observed after the second dose compare to the first dose.
  7. Facial swelling in vaccine recipients with a history of injection of dermatological fillers has been reported in the post-marketing phase.

Description of selected adverse reactions

Myocarditis
The increased risk of myocarditis after vaccination with COMIRNATY is highest in younger males.

Two large European pharmacoepidemiological studies have estimated the excess risk in younger males following the second dose of COMIRNATY. One study showed that in a period of 7 days after the second dose there were about 0.265 (95% CI 0.255 - 0.275) extra cases of myocarditis in 12-29 year old males per 10,000 compared to unexposed persons. In another study, in a period of 28 days after the second dose there were 0.57 [95% CI 0.39 – 0.75] extra cases of myocarditis in 16-24 year old males per 10,000 compared to unexposed persons.

Reporting of suspected adverse reactions

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 [COUNTRY TO INSERT URL/LINK TO LOCAL REPORTING SYSTEM WEBSITE] and include batch/Lot number if available.

Overdose

Overdose data is available from 52 study participants included in the clinical trial that due to an error in dilution received 58 micrograms of COMIRNATY. The vaccine recipients did not report an increase in reactogenicity or adverse reactions. 

In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.

For more information ​​​​​​​

[Country to insert: customer service contact information]

Marketing Authorisation
Holder: BioNTech
Manufacturing GmbH
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COMIRNATY COVID-19 mRNA Vaccine (nucleoside modified), which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.

 ​​​​​​​​​​©2021 Pfizer Inc. All rights reserved. December 2021. PP-CMR-GLB-0080​​​

SmPC Updates

Updates to General Recommendations and Undesirable Effects regarding Myocarditis and Pericarditis. Please see sections 4.4 and 4.8 of Summary of Product Characteristics for details. This update concerns all available formulations of COMIRNATY.

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