Pfizer-BioNTech Covid-19 Vaccine | Pfizer Medical Information

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European Medicines Agency has issued a Conditional Marketing Authorisation to permit use of COMIRNATY, COVID-19 mRNA vaccine from Pfizer/BioNTech, for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 12 years of age and older.

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

COMIRNATY Quick Search

Pharmacovigilance website

You can report an adverse related to the Pfizer-BioNTech COVID-19 Vaccine, either on the gouvernmental website https://signalement.social-sante.gouv.fr, or on the Safety Pfizer website at www.pfizersafetyreporting.com.
A NSM information on COVID-19 vaccines

Information from the National health and medications agency (ANSM) regarding COVID-19 vaccines are available at: www.ansm.sante.fr/Dossiers/COVID-19-Vaccins
Guidance and instructions for healthcare professionals on how to use the Comirnaty vaccine

Access safety data sheets, instructions on how to use the vaccine, le dry ice or the thermo-shipper, guidance for shipping, handling, storage or administration, on the website  www.comirnatyglobal.com.
HAS Recommendations

In the context of Covid-19 pandemic, you can access the work and recommendations of the Haute Autorité de Santé (HAS)
Conditional marketing authorization from the EC following EMA recommendation

Following the EMA recommendation, the European Commission (EC) has granted a conditional marketing authorization for the Comirnaty vaccine for active immunization to prevent COVID-19 in individuals 12 years of age and older. You can access the EMA’s human medicines committee (CHMP) opinion on the following link: https://www.ema.europa.eu/en/news/ema-recommends-first-covid-19-vaccine-authorisation-eu
Resources

Due to the recent approval of the vaccine by the EMA and European Commission, the Summary of Product Characteristics for COMIRNATY available here, will be available soon on the French Public database of medications.

Summary of Product Characteristics

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Summary of Product Characteristics

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4.1 Therapeutic indications

Comirnaty is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older.

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

4.2 Posology and method of administration

Posology

Individuals 12 years of age and older
Comirnaty is administered intramuscularly after dilution as a course of 2 doses (0.3 mL each). It is recommended to administer the second dose 3 weeks after the first dose (see sections 4.4 and 5.1).

There are no data available on the interchangeability of Comirnaty with other COVID-19 vaccines to complete the vaccination course. Individuals who have received 1 dose of Comirnaty should receive a second dose of Comirnaty to complete the vaccination course.

Paediatric population
The safety and efficacy of Comirnaty in paediatric participants aged less than 12 years have not yet been established. Limited data are available.

Elderly population
No dosage adjustment is required in elderly individuals ≥ 65 years of age.

Method of administration

Comirnaty should be administered intramuscularly after dilution (see section 6.6).

After dilution, vials of Comirnaty contain six doses of 0.3 mL of vaccine. In order to extract six doses from a single vial, low dead-volume syringes and/or needles should be used. 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 a sixth dose from a single vial. Irrespective of the type of syringe and needle:

Each dose must contain 0.3 mL of vaccine.
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
Do not pool excess vaccine from multiple vials.

The preferred site is the deltoid muscle of the upper arm.

Do not inject the vaccine intravascularly, subcutaneously or intradermally.

The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.

For precautions to be taken before administering the vaccine, see section 4.4.

For instructions regarding thawing, handling and disposal of the vaccine, see section 6.6.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number
of the administered product should be clearly recorded.

General recommendations

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. A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Comirnaty.

Myocarditis and pericarditis

Very rare cases of myocarditis and pericarditis have been observed following vaccination with Comirnaty. These cases have primarily occurred within 14 days following vaccination, more often after the second vaccination, and more often in younger men. Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general.

Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees 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 this condition.

Anxiety-related reactions

Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions (e.g. dizziness, palpitations, increases in heart rate, alterations in blood pressure, tingling sensations and sweating) may occur in association with the vaccination process itself. Stress-related reactions are temporary and resolve on their own. Individuals should be advised to bring symptoms to the attention of the vaccination provider for evaluation. It is important that precautions are in place to avoid injury from fainting.

Concurrent illness

Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.

Thrombocytopenia and coagulation disorders

As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.

Immunocompromised individuals

The efficacy, safety and immunogenicity of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of Comirnaty may be lower in immunosuppressed individuals.

Duration of protection

The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials.

Limitations of vaccine effectiveness

As with any vaccine, vaccination with Comirnaty may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their second dose of vaccine.

Excipients

This vaccine contains less than 1 mmol potassium (39 mg) per dose, that is to say essentially ‘potassium free’.

This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free’.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

Concomitant administration of Comirnaty with other vaccines has not been studied.

4.6 Fertility, pregnancy and lactation

Pregnancy

There is limited experience with use of Comirnaty in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see section 5.3). Administration of Comirnaty in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.

Breast-feeding

It is unknown whether Comirnaty is excreted in human milk.

Fertility

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3)

4.7 Effects on ability to drive and use machines

Comirnaty has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines.

4.8 Undesirable effects

Summary of safety profile

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.

Participants 16 years of age and older
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 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
In an analysis of Study 2, based on data up to the cutoff 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 were injection site pain (> 90%), fatigue and headache (> 70%), myalgia and chills (> 40%), arthralgia and pyrexia (> 20%).

Tabulated list of adverse reactions from clinical studies and postauthorisation 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)	Not known (cannot be estimated from the available data)
Blood and lymphatic system disorders			Lymphadenopathy
Immune system disorders			Hypersensitivity reactions (e.g. rash, pruritus, urticaria,^a angioedema^a )		Anaphylaxis
Metabolism and nutrition disorders			Decreased appetite
Psychiatric disorders			Insomnia
Nervous system disorders	Headache		Lethargy	Acute peripheral facial paralysis^b
Cardiac disorders					Myocarditis;^c Pericarditis^c
Gastrointestinal disorders	Diarrhoea^c	Nausea; Vomiting^c
Skin and subcutaneous tissue disorder			Hyperhidrosis; Night sweats
Musculoskeletal and connective tissue disorders	Arthralgia; Myalgia		Pain in extremity^d
General disorders and administration site conditions	Injection site pain; Fatigue; Chills; Pyrexia^e; Injection site swelling	Injection site redness	Asthenia; Malaise; injection site pruritus		Extensive swelling of vaccinated limb;^c Facial swelling^f
a. The frequency category for urticaria and angioedema was Rare. b. 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. c. Adverse reaction determined post authorisation. d. Refers to vaccinated arm. e. A higher frequency of pyrexia was observed after the second dose f. Facial swelling in vaccine recipients with a history of injection of dermatological fillers has been reported in the post-marketing phase.

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 the national reporting system listed in www.signalement-sante.gouv.fr and include batch/Lot number if available.

4.9 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.

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Pharmacological Properties

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5.1 Pharmacodynamic properties

Pharmacotherapeutic group: vaccines, other viral vaccines, ATC code: J07BX03

Mechanism of action

The nucleoside-modified messenger RNA in Comirnaty is formulated in lipid nanoparticles, which enable delivery of the non replicating RNA into host cells to direct transient expression of the SARS‑CoV-2 S antigen. The mRNA codes for membrane-anchored, full-length S with two point mutations within the central helix. Mutation of these two amino acids to proline locks S in an antigenically preferred prefusion conformation. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19.

Efficacy

Study 2 is a multicentre, multinational, Phase 1/2/3 randomised, placebo-controlled, observer-blind dose-finding, vaccine candidate selection and efficacy study in participants 12 years of age and older. Randomisation was stratified by age: 12 to 15 years of age, 16 to 55 years of age, or 56 years of age and older, with a minimum of 40% of participants in the ≥ 56-year stratum. The study excluded participants who were immunocompromised and those who had previous clinical or microbiological diagnosis of COVID-19. Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment, were included as were participants with known stable infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV).

Efficacy in participants 16 years of age and older
In the Phase 2/3 portion of Study 2, based on data accrued through 14 November 2020, approximately 44,000 participants were randomised equally and were to receive 2 doses of COVID-19 mRNA Vaccine or placebo. The efficacy analyses included participants that received their second vaccination within 19 to 42 days after their first vaccination. The majority (93.1%) of vaccine recipients received the second dose 19 days to 23 days after Dose 1. Participants are planned to be followed for up to 24 months after Dose 2, for assessments of safety and efficacy against COVID-19. In the clinical study, participants were required to observe a minimum interval of 14 days before and after administration of an influenza vaccine in order to receive either placebo or COVID-19 mRNA Vaccine. In the clinical study, participants were required to observe a minimum interval of 60 days before or after receipt of blood/plasma products or immunoglobulins within through conclusion of the study in order to receive either placebo or COVID‑19 mRNA Vaccine.

The population for the analysis of the primary efficacy endpoint included, 36,621 participants 12 years of age and older (18,242 in the COVID-19 mRNA Vaccine group and 18,379 in the placebo group) who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. In addition, 134 participants were between the ages of 16 to 17 years of age (66 in the COVID-19 mRNA Vaccine group and 68 in the placebo group) and 1,616 participants 75 years of age and older (804 in the COVID-19 mRNA Vaccine group and 812 in the placebo group).

At the time of the primary efficacy analysis, participants had been followed for symptomatic COVID‑19 for in total 2,214 person‑years for the COVID-19 mRNA Vaccine and in total 2,222 person‑years in the placebo group.

There were no meaningful clinical differences in overall vaccine efficacy in participants who were at risk of severe COVID-19 including those with 1 or more comorbidities that increase the risk of severe COVID-19 (e.g. asthma, body mass index (BMI) ≥ 30 kg/m², chronic pulmonary disease, diabetes mellitus, hypertension).

The vaccine efficacy information is presented in Table 2.

Table 2: Vaccine efficacy – First COVID-19 occurrence from 7 days after Dose 2, by age subgroup – participants without evidence of infection prior to 7 days after Dose 2 – evaluable efficacy (7 days) population
First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS‑CoV-2 infection*
Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT‑PCR) and at least 1 symptom consistent with COVID-19 [Case definition: (at least 1 of) fever, new or increased cough, new or increased shortness of breath, chills, new or increased muscle pain, new loss of taste or smell, sore throat, diarrhoea or vomiting.] Participants who had no serological or virological evidence (prior to 7 days after receipt of the last dose) of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2 not detected by nucleic acid amplification tests (NAAT) [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit prior to 7 days after Dose 2 were included in the analysis. a N = Number of participants in the specified group. b n1 = Number of participants meeting the endpoint definition. c Total surveillance time in 1,000 person-years for the given endpoint across all participants within each group at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period. d n2 = Number of participants at risk for the endpoint. e Two-sided confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted to the surveillance time. CI not adjusted for multiplicity.
Subgroup	COVID‑19 mRNA Vaccine N^a = 18,198 Cases n1^b Surveillance time^c (n2^d)	Placebo N^a = 18,325 Cases n1^b Surveillance time^c (n2^d)	Vaccine efficacy % (95% CI)^e
All participants	8 2.214 (17,411)	162 2.222 (17,511)	95.0 (90.0, 97.9)
16 to 64 years	7 1.706 (13,549)	143 1.710 (13,618)	95.1 (89.6, 98.1)
65 years and older	1 0.508 (3848)	19 0.511 (3880)	94.7 (66.7, 99.9)
65 to 74 years	1 0.406 (3074)	14 0.406 (3095)	92.9 (53.1, 99.8)
75 years and older	0 0.102 (774)	5 0.106 (785)	100.0 (-13.1, 100.0)

Efficacy of COVID-19 mRNA Vaccine in preventing first COVID-19 occurrence from 7 days after Dose 2 compared to placebo was 94.6% (95% confidence interval of 89.6% to 97.6%) in participants 16 years of age and older with or without evidence of prior infection with SARS-CoV-2.

Additionally, subgroup analyses of the primary efficacy endpoint showed similar efficacy point estimates across genders, ethnic groups, and participants with medical comorbidities associated with high risk of severe COVID-19.

Updated efficacy analyses were performed with additional confirmed COVID-19 cases accrued during blinded placebo-controlled follow-up, representing up to 6 months after Dose 2 in the efficacy population.

The updated vaccine efficacy information is presented in Table 3.

Table 3: Vaccine efficacy – First COVID-19 occurrence from 7 days after Dose 2, by age subgroup – participants without evidence of prior SARS-CoV-2 infection* prior to 7 days after Dose 2 – evaluable efficacy (7 days) population during the placebo‑controlled follow-up period
Subgroup	COVID‑19 mRNA Vaccine N^a=20,998 Cases n1^b Surveillance time^c (n2^d)	Placebo N^a=21,096 Cases n1^b Surveillance time^c (n2^d)	Vaccine efficacy % (95% CI^e)
Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT‑PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhoea; vomiting). * Participants who had no evidence of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit prior to 7 days after Dose 2 were included in the analysis. a N = Number of participants in the specified group. b n1 = Number of participants meeting the endpoint definition. c Total surveillance time in 1,000 person-years for the given endpoint across all participants within each group at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period. d n2 = Number of participants at risk for the endpoint. e Two-sided 95% confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted to the surveillance time. f Included confirmed cases in participants 12 to 15 years of age: 0 in the COVID‑19 mRNA Vaccine group; 16 in the placebo group.
All participants^f	77 6.247 (20,712)	850 6.003 (20,713)	91.3 (89.0, 93.2)
16 to 64 years	70 4.859 (15,519)	710 4.654 (15,515)	90.6 (87.9, 92.7)
65 years and older	7 1.233 (4192)	124 1.202 (4226)	94.5 (88.3, 97.8)
65 to 74 years	6 0.994 (3350)	98 0.966 (3379)	94.1 (86.6, 97.9)
75 years and older	1 0.239 (842)	26 0.237 (847)	96.2 (76.9, 99.9)

In the updated efficacy analysis, efficacy of COVID-19 mRNA Vaccine in preventing first COVID-19 occurrence from 7 days after Dose 2 compared to placebo was 91.1% (95% CI of 88.8% to 93.0%) in participants in the evaluable efficacy population with or without evidence of prior infection with SARS-CoV-2.

Additionally, the updated efficacy analyses by subgroup showed similar efficacy point estimates across sexes, ethnic groups, geography and participants with medical comorbidities and obesity associated with high risk of severe COVID-19.

Efficacy against severe COVID‑19
Updated efficacy analyses of secondary efficacy endpoints supported benefit of the COVID-19 mRNA Vaccine in preventing severe COVID‑19.

As of 13 March 2021, vaccine efficacy against severe COVID-19 is presented only for participants with or without prior SARS-CoV-2 infection (Table 4) as the COVID-19 case counts in participants without prior SARS-CoV-2 infection were the same as those in participants with or without prior SARS-CoV-2 infection in both the COVID‑19 mRNA Vaccine and placebo groups.

Table 4: Vaccine efficacy – First severe COVID-19 occurrence in participants with or without prior SARS-CoV-2 infection based on the Food and Drug Administration (FDA)* after Dose 1 or from 7 days after Dose 2 in the placebo-controlled follow-up
	COVID‑19 mRNA Vaccine Cases n1^a Surveillance time (n2^b)	Placebo Cases n1^a Surveillance time (n2^b)	Vaccine efficacy % (95% CI^c)
Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhoea; vomiting). * Severe illness from COVID‑19 as defined by FDA is confirmed COVID‑19 and presence of at least 1 of the following: Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 beats per minute, saturation of oxygen ≤ 93% on room air at sea level, or ratio of arterial oxygen partial pressure to fractional inspired oxygen < 300 mm Hg); Respiratory failure [defined as needing high‑flow oxygen, noninvasive ventilation, mechanical ventilation or extracorporeal membrane oxygenation (ECMO)]; Evidence of shock (systolic blood pressure < 90 mm Hg, diastolic blood pressure < 60 mm Hg, or requiring vasopressors); Significant acute renal, hepatic, or neurologic dysfunction; Admission to an Intensive Care Unit; Death. a n1 = Number of participants meeting the endpoint definition. b n2 = Number of participants at risk for the endpoint. c Two-side confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted to the surveillance time. d Efficacy assessed based on the Dose 1 all available efficacy (modified intention-to-treat) population that included all randomised participants who received at least 1 dose of study intervention. e Total surveillance time in 1,000 person-years for the given endpoint across all participants within each group at risk for the endpoint. Time period for COVID-19 case accrual is from Dose 1 to the end of the surveillance period. f Efficacy assessed based on the evaluable efficacy (7 Days) population that included all eligible randomised participants who receive all dose(s) of study intervention as randomised within the predefined window, have no other important protocol deviations as determined by the clinician. g Total surveillance time in 1,000 person-years for the given endpoint across all participants within each group at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
After Dose 1^d	1 8.439^e (22,505)	30 8.288^e (22,435)	96.7 (80.3, 99.9)
7 days after Dose 2^f	1 6.522^g (21,649)	21 6.404^g (21,730)	95.3 (70.9, 99.9)

Efficacy and immunogenicity in adolescents 12 to 15 years of age

In an analysis of Study 2 in adolescents 12 to 15 years of age without evidence of prior infection, there were no cases in 1005 participants who received the vaccine and 16 cases out of 978 who received placebo. The point estimate for efficacy is 100% (95% confidence interval 75.3, 100.0). In participants with or without evidence of prior infection there were 0 cases in the 1119 who received vaccine and 18 cases in 1110 participants who received placebo. This also indicates the point estimate for efficacy is 100% (95% confidence interval 78.1, 100.0).

In Study 2, an analysis of SARS-CoV-2 neutralising titres 1 month after Dose 2 was conducted in a randomly selected subset of participants who had no serological or virological evidence of past SARSCoV-2 infection up to 1 month after Dose 2, comparing the response in adolescents 12 to 15 years of age (n = 190) to participants 16 to 25 years of age (n = 170).

The ratio of the geometric mean titres (GMT) in the 12 to 15 years of age group to the 16 to 25 years of age group was 1.76, with a 2sided 95% CI of 1.47 to 2.10. Therefore, the 1.5fold noninferiority criterion was met as the lower bound of the 2sided 95% CI for the geometric mean ratio [GMR] was > 0.67.

Paediatric population

The European Medicines Agency has deferred the obligation to submit the results of studies with Comirnaty in the paediatric population in prevention of COVID-19 (see section 4.2 for information on paediatric use).

This medicinal product has been authorised under a so-called ‘conditional approval’ scheme. This means that further evidence on this medicinal product is awaited. The European Medicines Agency will review new information on this medicinal product at least every year and this SmPC will be updated as necessary.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeat dose toxicity and reproductive and developmental toxicity.

General toxicity
Rats intramuscularly administered Comirnaty (receiving 3 full human doses once weekly, generating relatively higher levels in rats due to body weight differences) demonstrated some injection site oedema and erythema and increases in white blood cells (including basophils and eosinophils) consistent with an inflammatory response as well as vacuolation of portal hepatocytes without evidence of liver injury. All effects were reversible.

Genotoxicity/Carcinogenicity
Neither genotoxicity nor carcinogenicity studies were performed. The components of the vaccine (lipids and mRNA) are not expected to have genotoxic potential.

Reproductive toxicity
Reproductive and developmental toxicity were investigated in rats in a combined fertility and developmental toxicity study where female rats were intramuscularly administered Comirnaty prior to mating and during gestation (receiving 4 full human doses that generate relatively higher levels in rat due to body weight differences, spanning between pre-mating day 21 and gestational day 20). SARS‑CoV-2 neutralizing antibody responses were present in maternal animals from prior to mating to the end of the study on postnatal day 21 as well as in foetuses and offspring. There were no vaccine‑related effects on female fertility, pregnancy, or embryo-foetal or offspring development. No Comirnaty data are available on vaccine placental transfer or excretion in milk.

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Pharmaceutical Particulars

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6.1 List of excipients

((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315)
2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159)
1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC)
Cholesterol
Potassium chloride
Potassium dihydrogen phosphate
Sodium chloride
Disodium phosphate dihydrate
Sucrose
Water for injections

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3 Shelf life

Unopened vial

Frozen vial
9 months at -90 °C to -60 °C
Within the 9 - month shelf life unopened vials may be stored and transported at -25 °C to -15 °C for a single period of up to 2 weeks and can be returned to -90 °C to -60 °C.

Thawed vial
1 month at 2 °C to 8 °C
Within the 1 month shelf-life at 2 °C to 8 °C, up to 12 hours may be used for transportation.
Prior to use, the unopened vaccine can be stored for up to 2 hours at temperatures up to 30 °C.

Once thawed, the vaccine should not be re-frozen.

Handling of temperature excursions once removed from the freezer
Stability data indicate that the unopened vial is stable for up to:

24 hours when stored at temperatures from -3 °C to 2 °C
a total of 4 hours when stored at temperatures from 8 °C to 30 °C; this includes the 2 hours at up to 30 °C detailed above

This information is intended to guide healthcare professionals only in case of temporary temperature excursion.

Transfers of frozen vials stored at ultra-low temperature(< -60 °C)

Closed-lid vial trays containing 195 vials removed from ultra-low temperature frozen storage (< -60 °C) may be at temperatures up to 25 °C for up to 5 minutes.
Open-lid vial trays, or vial trays containing less than 195 vials, removed from ultra-low temperature frozen storage (< -60 °C) may be at temperatures up to 25 °C for up to 3 minutes.
After vial trays are returned to frozen storage following temperature exposure up to 25 °C, they must remain in frozen storage for at least 2 hours before they can be removed again.

Transfers of frozen vials stored at -25 °C to -15 °C

Closed-lid vial trays containing 195 vials removed from frozen storage (-25 °C to -15 °C) may be at temperatures up to 25 °C for up to 3 minutes.
Open-lid vial trays, or vial trays containing less than 195 vials, removed from frozen storage (-25 °C to -15 °C) may be at temperatures up to 25 °C for up to 1 minute.

Once a vial is removed from the vial tray, it should be thawed for use.

Diluted medicinal product

Chemical and physical in-use stability, including during transportation, has been demonstrated for 6 hours at 2 ºC to 30 ºC after dilution in sodium chloride 9 mg/mL (0.9%) solution for injection. 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.

6.4 Special precautions for storage

Store in a freezer at -90 °C to -60 °C.
Store in the original package in order to protect from light.
During storage, minimise exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
Thawed vials can be handled in room light conditions.

For storage conditions after thawing and dilution of the medicinal product, see section 6.3.

6.5 Nature and contents of container

2 mL clear multidose vial (type I glass) with a stopper (synthetic bromobutyl rubber) and a flip-off plastic cap with aluminium seal. Each vial contains 6 doses, see section 6.6.

Pack size: 195 vials

6.6 Special precautions for disposal and other handling

Handling instructions

Comirnaty should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared dispersion.

THAWING PRIOR TO DILUTION
	The multidose vial is stored frozen and must be thawed prior to dilution. Frozen vials should be transferred to an environment of 2 °C to 8 °C to thaw; a 195 vial pack may take 3 hours to thaw. Alternatively, frozen vials may also be thawed for 30 minutes at temperatures up to 30 °C for immediate use. The unopened vial can be stored for up to 1 month at 2 °C to 8 °C. Within the 1 month shelf-life at 2 °C to 8 °C, up to 12 hours may be used for transportation. Allow the thawed vial to come to room temperature and gently invert it 10 times prior to dilution. Do not shake. Prior to dilution, the thawed dispersion may contain white to off-white opaque amorphous particles.
DILUTION
	The thawed vaccine must be diluted in its original vial with 1.8 mL sodium chloride 9 mg/mL (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques.
	Equalise vial pressure before removing the needle from the vial stopper by withdrawing 1.8 mL air into the empty diluent syringe.
	Gently invert the diluted dispersion 10 times. Do not shake. The diluted vaccine should present as an off-white dispersion with no particulates visible. Do not use the diluted vaccine if particulates or discolouration are present.
	The diluted vials should be marked with the appropriate date and time. After dilution store at 2 ºC to 30 ºC and use within 6 hours, including any transportation time. Do not freeze or shake the diluted dispersion. If refrigerated, allow the diluted dispersion to come to room temperature prior to use.
PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF COMIRNATY
	After dilution, the vial contains 2.25 mL from which 6 doses of 0.3 mL can be extracted. Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab. Withdraw 0.3 mL of Comirnaty. Low dead-volume syringes and/or needles should be used in order to extract 6 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 a sixth dose from a single vial. Each dose must contain 0.3 mL of vaccine. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume. Discard any unused vaccine within 6 hours after dilution.

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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COMIRNATY (COVID-19 mRNA vaccine)

COMIRNATY Quick Search

Summary of Product Characteristics

Name of the Medicinal Product

Qualitative and Quantitative Composition

Pharmaceutical Form

Clinical Particulars

4.1 Therapeutic indications

4.2 Posology and method of administration

4.3 Contraindications

4.4 Special warnings and precautions for use

4.5 Interaction with other medicinal products and other forms of interaction

4.6 Fertility, pregnancy and lactation

4.7 Effects on ability to drive and use machines

4.8 Undesirable effects

4.9 Overdose

Pharmacological Properties

5.1 Pharmacodynamic properties

5.2 Pharmacokinetic properties

5.3 Preclinical safety data

Pharmaceutical Particulars

6.1 List of excipients

6.2 Incompatibilities

6.3 Shelf life

6.4 Special precautions for storage

6.5 Nature and contents of container

6.6 Special precautions for disposal and other handling

Marketing Authorisation Holder

Marketing Authorisation Number(s)

Date of First Authorisation/Renewal of the Authorisation

Date of Revision of the Text