COVID-19 Vaccine Moderna

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Product information (corrected1) is available in English and translations to all EU 
languages will be made available soon 

 
Includes: 

 
 

Package leaflet (for patients) 
 

Summary of product characteristics (for healthcare professionals) 
 

Manufacturers and conditions of the marketing authorisation 
 

Labelling 
 
 
 
 
 
 
  

 
1  The correction concerns updated pictogram instructions with respect to the discard date/time to be noted on 
the vial and clarifications on the frozen storage conditions; this version is pending EC decision following a 
corrigendum procedure 



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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
COVID-19 Vaccine Moderna dispersion for injection 
COVID-19 mRNA Vaccine (nucleoside modified) 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
This is a multidose vial which contains 10 doses of 0.5 mL. 
 
One dose (0.5 mL) contains 100 micrograms of messenger RNA (mRNA) (embedded in SM-102 lipid 
nanoparticles).  
 
Single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription 
from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Dispersion for injection 
White to off white dispersion (pH: 7.0 – 8.0). 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
COVID-19 Vaccine Moderna is indicated for active immunisation to prevent COVID-19 caused by 
SARS-CoV-2 in individuals 18 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 18 years of age and older 
COVID-19 Vaccine Moderna is administered as a course of 2 doses (0.5 mL each). It is recommended 
to administer the second dose 28 days after the first dose (see sections 4.4 and 5.1).  
 
There are no data available on the interchangeability of COVID-19 Vaccine Moderna with other 
COVID-19 vaccines to complete the vaccination course. Individuals who have received the first dose 
of COVID-19 Vaccine Moderna should receive the second dose of COVID-19 Vaccine Moderna to 
complete the vaccination course.  
 
Paediatric population 
The safety and efficacy of COVID-19 Vaccine Moderna in children and adolescents less than 18 years 
of age have not yet been established. No data are available.  
 



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Elderly population 
No dosage adjustment is required in elderly individuals ≥65 years of age. 
 
Method of administration  
 
The vaccine should be administered intramuscularly. The preferred site is the deltoid muscle of the 
upper arm.  
 
Do not administer this 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. 
 
Hypersensitivity and anaphylaxis 
 
Anaphylaxis has been reported. Appropriate medical treatment and supervision should always be 
readily available in case of an anaphylactic reaction following administration of the vaccine.  
 
Close observation for at least 15 minutes is recommended following vaccination. The second dose of 
the vaccine should not be given to those who have experienced anaphylaxis to the first dose of 
COVID-19 Vaccine Moderna. 
 
Anxiety-related reactions 
 
Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related 
reactions may occur in association with vaccination as a psychogenic response to the needle injection. 
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 
 



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The efficacy, safety and immunogenicity of the vaccine has not been assessed in immunocompromised 
individuals, including those receiving immunosuppressant therapy. The efficacy of COVID-19 
Vaccine Moderna 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 
 
Individuals may not be fully protected until 14 days after their second dose. As with all vaccines, 
vaccination with COVID-19 Vaccine Moderna may not protect all vaccine recipients.  
 
Excipients with known effect 
 
Sodium  
This vaccine contains less than 1 mmol sodium (23 mg) per 0.5 mL 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 COVID-19 Vaccine Moderna with other vaccines has not been studied.  
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There is limited experience with use of COVID-19 Vaccine Moderna 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 COVID-19 
Vaccine Moderna 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 COVID-19 Vaccine Moderna 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 
 
COVID-19 Vaccine Moderna 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 the safety profile 
 
The safety of COVID-19 Vaccine Moderna was evaluated in an ongoing Phase 3 randomised, 
placebo-controlled, observer-blind clinical trial conducted in the United States involving 30,351 
participants 18 years of age and older who received at least one dose of COVID-19 Vaccine Moderna 



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(n=15,185) or placebo (n=15,166) (NCT04470427). At the time of vaccination, the mean age of the 
population was 52 years (range 18-95); 22,831 (75.2%) of participants were 18 to 64 years of age and 
7,520 (24.8%) of participants were 65 years of age and older. 
 
The most frequently reported adverse reactions were pain at the injection site (92%), fatigue (70%), 
headache (64.7%), myalgia (61.5%), arthralgia (46.4%), chills (45.4%), nausea/vomiting (23%), 
axillary swelling/tenderness (19.8%), fever (15.5%), injection site swelling (14.7%) and redness 
(10%). Adverse reactions 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.  
  
Overall, there was a higher incidence of some adverse reactions in younger age groups: the incidence 
of axillary swelling/tenderness, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting 
and fever was higher in adults aged 18 to < 65 years than in those aged 65 years and above. 
Local and systemic adverse reactions were more frequently reported after Dose 2 than after Dose 1. 
 
Tabulated list of adverse reactions  
  
The safety profile presented below is based on data generated in a placebo- controlled clinical 
study on 30,351 adults ≥ 18 years of age. 
  
Adverse reactions reported are listed according to the following frequency convention:  
  
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) 
  
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.  
  
MedDRA System Organ Class  Frequency  Adverse reactions  

Blood and lymphatic system 
disorders  

Very common  Lymphadenopathy*  

Immune system disorders Not known  Anaphylaxis  
Hypersensitivity 

Nervous system disorders  Very common  Headache 
Rare Acute peripheral facial 

paralysis** 
Gastrointestinal disorders  Very common  Nausea/vomiting 
Skin and subcutaneous tissue 
disorders  

Common   Rash 

Musculoskeletal and connective 
tissue disorders  

Very common  Myalgia 
Arthralgia 

General disorders 
and administration site conditions  

Very common  Injection site pain 
Fatigue 
Chills 
Pyrexia 
Injection site swelling  

Common  Injection site erythema, 
Injection site urticaria, 
Injection site rash 

Uncommon Injection site pruritus 
Rare Facial swelling*** 

*Lymphadenopathy was captured as axillary lymphadenopathy on the same side as the injection site.  



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**Throughout the safety follow-up period, acute peripheral facial paralysis (or palsy) was reported by three participants in the 
COVID-19 Vaccine Moderna group and one participant in the placebo group. Onset in the vaccine group 
participants was 22 days, 28 days, and 32 days after Dose 2.  
***There were two serious adverse events of facial swelling in vaccine recipients with a history of injection of 
dermatological fillers. The onset of swelling was reported 1 and 2 days, respectively, after vaccination  
 
The reactogenicity and safety profile in 343 subjects receiving COVID-19 Vaccine Moderna, that 
were seropositive for SARS-CoV-2 at baseline, was comparable to that in subjects seronegative for 
SARS-CoV-2 at baseline.  
 
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 Appendix V and include batch/Lot number if available. 
 
4.9 Overdose 
 
No case of overdose has been reported. 
In the event of overdose, monitoring of vital functions and possible symptomatic treatment is 
recommended. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Vaccine, other viral vaccines, ATC code: J07BX03 
 
Mechanism of action 
COVID-19 Vaccine Moderna contains mRNA encapsulated in lipid nanoparticles. The mRNA 
encodes for the full-length SARS-CoV-2 spike protein modified with 2 proline substitutions within the 
heptad repeat 1 domain (S-2P) to stabilise the spike protein into a prefusion conformation. After 
intramuscular injection, cells at the injection site and the draining lymph nodes take up the lipid 
nanoparticle, effectively delivering the mRNA sequence into cells for translation into viral protein. 
The delivered mRNA does not enter the cellular nucleus or interact with the genome, is non-
replicating, and is expressed transiently mainly by dendritic cells and subcapsular sinus macrophages. 
The expressed, membrane-bound spike protein of SARS-CoV-2 is then recognised by immune cells as 
a foreign antigen. This elicits both T-cell and B-cell responses to generate neutralising antibodies, 
which may contribute to protection against COVID-19. 
 
Clinical efficacy 
The randomised, placebo-controlled, observer-blind Phase 3 clinical study (NCT04470427) excluded 
individuals who were immunocompromised or had received immunosuppressants within 6 months, as 
well as participants who were pregnant, or with a known history of SARS-CoV-2 infection. 
Participants with stable HIV disease were not excluded. Influenza vaccines could be administered 14 
days before or 14 days after any dose of COVID-19 Vaccine Moderna. Participants were also required 
to observe a minimum interval of 3 months after receipt of blood/plasma products or immunoglobulins 
prior to the study in order to receive either placebo or COVID-19 Vaccine Moderna. 
 
A total of 30,351 subjects were followed for a median of 92 days (range: 1-122) for the development 
of COVID-19 disease.  
 
The primary efficacy analysis population (referred to as the Per Protocol Set or PPS), included 
28,207 subjects who received either COVID-19 Vaccine Moderna (n=14,134) or placebo (n=14,073) 
and had a negative baseline SARS-CoV-2 status. The PPS study population included 47.4% female, 
52.6% male, 79.5% White, 9.7% African American, 4.6% Asian, and 6.2% other. 19.7% of 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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participants identified as Hispanic or Latino. The median age of subjects was 53 years (range 18-94). 
A dosing window of –7 to +14 days for administration of the second dose (scheduled at day 29) was 
allowed for inclusion in the PPS.  98% of vaccine recipients received the second dose 25 days to 35 
days after dose 1 (corresponding to -3 to +7 days around the interval of 28 days). 
 
COVID-19 cases were confirmed by Reverse Transcriptase Polymerase Chain Reaction (RT PCR) and 
by a Clinical Adjudication Committee. Vaccine efficacy overall and by key age groups are presented 
in Table 2. 
 
Table 2: Vaccine Efficacy Analysis: confirmed COVID-19# regardless of severity starting 14 days 
after the 2nd dose – Per-Protocol Set  
 

Age Group 
(Years) 

COVID-19 Vaccine Moderna Placebo  

Subjects 
N 

COVID-
19 Cases 

n 

Incidence Rate 
of COVID-19 per 

1,000 Person-
Years 

Subjects 
N 

COVID-19 
Cases 

n 

Incidence Rate 
of COVID-19 

per 1,000 
Person-Years 

% Vaccine 
Efficacy (95% 

CI)* 

Overall 
(≥18) 

14,134 11 3.328 14,073 185 56.510 94.1 
(89.3, 96.8)** 

18 to <65 10,551 7 2.875 10,521 156 64.625 95.6 
(90.6, 97.9) 

≥65 3,583 4 4.595 3,552 29 33.728 86.4 
(61.4, 95.2) 

≥65 to <75 2,953 4 5.586 2,864 22 31.744 82.4% 
(48.9, 93.9) 

≥75 630 0 0 688 7 41.968 100% 
(NE, 100)  

#COVID-19: symptomatic COVID-19 requiring positive RT-PCR result and at least 2 systemic symptoms or 1 
respiratory symptom. Cases starting 14 days after the 2nd dose.  
*Vaccine efficacy and 95% confidence interval (CI) from the stratified Cox proportional hazard model 
** CI not adjusted for multiplicity. Multiplicity adjusted statistical analyses were carried out in an interim 
analysis based on less COVID-19 cases, not reported here. 
 
Among all subjects in the PPS, no cases of severe COVID-19 were reported in the vaccine group 
compared with 30 of 185 (16%) cases reported in the placebo group. Of the 30 participants with severe 
disease, 9 were hospitalised, 2 of which were admitted to an intensive care unit. The majority of the 
remaining severe cases fulfilled only the oxygen saturation (SpO2) criterion for severe disease (≤ 93% 
on room air).  
 
The vaccine efficacy of COVID-19 Vaccine Moderna to prevent COVID-19, regardless of prior 
SARS-CoV-2 infection (determined by baseline serology and nasopharyngeal swab sample testing) 
from 14 days after Dose 2 was 93.6% (95% confidence interval 88.5, 96.4%).  
 
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. 
 
Elderly population  
COVID-19 Vaccine Moderna was assessed in individuals 18 years of age and older, including 3,768 
subjects 65 years of age and older. The efficacy of COVID-19 Vaccine Moderna was consistent 
between elderly (≥65 years) and younger adult subjects (18-64 years).  
 



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Paediatric population 
The European Medicines Agency has deferred the obligation to submit the results of studies with the 
COVID-19 Vaccine Moderna in one or more subsets of the paediatric population in prevention of 
COVID-19 (see section 4.2 for information on paediatric use). 
 
Conditional Approval 
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: 
General toxicity studies were conducted in rats (intramuscularly receiving up to 4 doses exceeding the 
human dose once every 2 weeks). Transient and reversible injection site oedema and erythema and 
transient and reversible changes in laboratory tests (including increases in eosinophils, activated 
partial thromboplastin time, and fibrinogen) were observed. Results suggests the toxicity potential to 
humans is low. 
 
Genotoxicity/Carcinogenicity: 
In vitro and in vivo genotoxicity studies were conducted with the novel lipid component SM-102 of 
the vaccine. Results suggests the genotoxicity potential to humans is very low. Carcinogenicity studies 
were not performed. 
 
Reproductive Toxicity: 
In a developmental toxicity study, 0.2 mL of a vaccine formulation containing the same quantity of 
mRNA (100 micrograms) and other ingredients included in a single human dose of COVID-19 
Vaccine Moderna was administered to female rats by the intramuscular route on four occasions: 28 
and 14 days prior to mating, and on gestation days 1 and 13. SARS-CoV-2 antibody responses were 
present in maternal animals from prior to mating to the end of the study on lactation day 21 as well as 
in foetuses and offspring. There were no vaccine-related adverse effects on female fertility, pregnancy, 
embryo foetal or offspring development or postnatal development. No data are available of mRNA-
1273 vaccine placental transfer or excretion in milk. 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Lipid SM-102  
Cholesterol  
1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC) 
1,2-Dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 (PEG2000 DMG) 
Tromethamol 
Tromethamol hydrochloride 
Acetic acid  
Sodium acetate trihydrate  
Sucrose  
Water for injections 
 
6.2 Incompatibilities 



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This medicinal product must not be mixed with other medicinal products or diluted.  
 
6.3 Shelf life 
 
Unopened vial:  
7 months at -25ºC to -15ºC. 
 
The unopened vaccine may be stored refrigerated at 2°C to 8°C, protected from light, for maximum 30 
days. 
 
Once thawed the vaccine should not be re-frozen. 
 
The unopened vaccine may be stored at 8°C to 25°C up to 12 hours after removal from refrigerated 
conditions.  
 
Punctured Vial:  
Chemical and physical in-use stability has been demonstrated for 6 hours at 2°C to 25ºC after initial 
puncture. From a microbiological point of view, the product should be used immediately. If the 
vaccine is not used immediately, in-use storage times and conditions are the responsibility of the user 
 
6.4 Special precautions for storage 
 
Store frozen between -25ºC to -15ºC. 
Store in the original carton to protect from light. 
Do not store on dry ice or below -40ºC. 
For storage conditions after thawing and first opening see section 6.3. 
 
 
6.5 Nature and contents of container  
 
5 ml dispersion in a vial (type 1 or type 1 equivalent glass) with a stopper (chlorobutyl rubber) and a 
flip-off plastic cap with seal (aluminium seal).  
 
Each vial contains 10 doses of 0.5mL.  
 
Pack size: 10 multidose vials 
 
6.6 Special precautions for disposal and other handling 
 
The vaccine should be prepared and administered by a trained healthcare professional using aseptic 
techniques to ensure sterility of the dispersion. 
 
The vaccine comes ready to use once thawed. 
 
Do not shake or dilute. Swirl the vial gently after thawing and before each withdrawal. 
 
COVID-19 Vaccine Moderna vials are multidose.  
 
Ten (10) doses (of 0.5mL each) can be withdrawn from each vial. 
 
An additional overfill is included in each vial to ensure that 10 doses of 0.5 mL can be delivered. 
 
 



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7. MARKETING AUTHORISATION HOLDER 
 
MODERNA BIOTECH SPAIN, S.L. 
Calle Monte Esquinza 30 
28010 Madrid 
Spain 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1507/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: {DD month YYYY} 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
 
  

http://www.ema.europa.eu/


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ANNEX II 
 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE 
SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR 
BATCH RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 
E. SPECIFIC OBLIGATION TO COMPLETE POST-

AUTHORISATION MEASURES FOR THE CONDITIONAL 
MARKETING AUTHORISATION 



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A.  MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturer of the biological active substance 
 
LONZA AG 
Lonzastrasse 2 
Visp 3930 
Switzerland 
 
Name and address of the manufacturer responsible for batch release 
 
Rovi Pharma Industrial Services, S.A.  
Paseo de Europa, 50 
28703. San Sebastián de los Reyes 
Madrid, Spain 
 
In view of the declared Public Health Emergency of International Concern and in order to ensure early 
supply this medicinal product is subject to a time-limited exemption allowing reliance on batch control 
testing conducted in the registered site(s) that are located in a third country. This exemption ceases to 
be valid on 31 January 2021. Implementation of EU based batch control arrangements, including the 
necessary variations to the terms of the marketing authorisation, has to be completed by 31 January 
2021 at the latest, in line with the agreed plan for this transfer of testing. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to medical prescription. 
 
Official batch release 
 
In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken 
by a state laboratory or a laboratory designated for that purpose. 
 
 
C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of 
Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC 
and any subsequent updates published on the European medicines web-portal. 
 
The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 
6 months following authorisation.  
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
Risk management plan (RMP) 

 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance 
activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the 
marketing authorisation and any agreed subsequent updates of the RMP. 
 



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An updated RMP should be submitted: 
• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 
 
E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES 

FOR THE CONDITIONAL MARKETING AUTHORISATION 
 
This being a conditional marketing authorisation and pursuant to Article 14-a of Regulation (EC) No 
726/2004, the MAH shall complete, within the stated timeframe, the following measures: 
 

Description Due date 
In order to complete the characterisation of the active substance and 
finished product manufacturing processes, the MAH should provide 
additional data. 
 

January 2021 

In order to confirm the consistency of the active substance and finished 
product manufacturing process (Initial and final scales), the MAH should 
provide additional comparability and validation data. 

April 2021 

Interim reports will 
be provided monthly 
prior to this date. 
 

In order to ensure consistent product quality, the MAH should provide 
additional information on stability of the active substance and finished 
product and review the active substance and finished product 
specifications following further manufacturing experience.  
 

June 2021 

In order to confirm the efficacy and safety of COVID-19 Vaccine 
Moderna, the MAH should submit the final Clinical Study Report for the 
randomised, placebo-controlled, observer-blind study mRNA-1273-P301. 
 

December 2022 

  



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ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



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A. LABELLING 
  



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON 
 
 
1.  NAME OF THE MEDICINAL PRODUCT 
 
COVID-19 Vaccine Moderna dispersion for injection 
COVID-19 mRNA Vaccine (nucleoside modified) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each multidose vial contains 10 doses (0.5 mL each). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: Lipid SM-102, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), 1,2-
Dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 (PEG2000 DMG), tromethamol, 
tromethamol hydrochloride, acetic acid, sodium acetate trihydrate, sucrose, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Dispersion for injection 
10 multidose vials  
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Intramuscular use. 
Read the package leaflet before use. 
 

  
Scan here for package leaflet or visit www.modernacovid19global.com. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 

http://www.modernacovid19global.com/


19 

 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store frozen at -25°C to -15°C. 
Read the package leaflet for the shelf life after first opening and for additional storage information. 
Keep the vial in the outer carton to protect from light 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Dispose of in accordance with local requirement. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
MODERNA BIOTECH SPAIN, S.L.  
Calle Monte Esquinza, 30 
28010 Madrid  
Spain  
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/20/1507/001  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC  
SN  
NN   



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL LABEL  
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
COVID-19 Vaccine Moderna dispersion for injection 
COVID-19 mRNA Vaccine (nucleoside modified) 
IM 
 
 
2. METHOD OF ADMINISTRATION 
 
Intramuscular use 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
Multidose vial 
(10 doses of 0.5 mL) 
 
 
6. OTHER 
 

  
Scan here for package leaflet or visit www.modernacovid19global.com. 
Discard date/time: 
  

http://www.modernacovid19global.com/


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ANNEX III 
 

PACKAGE LEAFLET 
  



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Package leaflet: Information for the user 
 

COVID-19 Vaccine Moderna dispersion for injection 
COVID-19 mRNA Vaccine (nucleoside modified) 

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 

 
Read all of this leaflet carefully before you receive this vaccine because it contains important 
information for you. 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What COVID-19 Vaccine Moderna is and what it is used for  
2. What you need to know before you are given COVID-19 Vaccine Moderna  
3. How COVID-19 Vaccine Moderna is given 
4. Possible side effects  
5. How to store COVID-19 Vaccine Moderna 
6. Contents of the pack and other information 
 
 
1. What COVID-19 Vaccine Moderna is and what it is used for 
 
COVID-19 Vaccine Moderna is a vaccine used to prevent COVID-19 caused by SARS-CoV-2 . It is 
given to adults aged 18 years and older. The active substance in COVID-19 Vaccine Moderna is 
mRNA encoding the SARS-CoV-2 Spike protein. The mRNA is embedded in SM-102 lipid 
nanoparticles. 
 
As COVID-19 Vaccine Moderna does not contain the virus, it cannot give you COVID-19. 
 
How the vaccine works  
COVID-19 Vaccine Moderna stimulates the body’s natural defences (immune system). The vaccine 
works by causing the body to produce protection (antibodies) against the virus that causes COVID-19. 
COVID-19 Vaccine Moderna uses a substance called messenger ribonucleic acid (mRNA) to carry 
instructions that cells in the body can use to make the spike protein that is also on the virus. The cells 
then make antibodies against the spike protein to help fight off the virus. This will help to protect you 
against COVID-19.  
 
 
2. What you need to know before you are given COVID-19 Vaccine Moderna 
 
The vaccine must not be given if  
- you are allergic to the active substance or any of the other ingredients of this vaccine (listed in 

section 6). 
 
Warnings and precautions  
Talk to your doctor, pharmacist or nurse before you are given COVID-19 Vaccine Moderna if:  
- you have previously had a severe, life-threatening allergic reaction after any other vaccine 

injection or after you were given COVID-19 Vaccine Moderna in the past.  
- you have a very weak or compromised immune system 
- you have ever fainted following any needle injection. 
- you have a bleeding disorder  

 



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- you have a high fever or severe infection; however, you can have your vaccination if you have a 
mild fever or upper airway infection like a cold 

- you have any serious illness  
- if you have anxiety related to injections 

 
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or 
nurse before you are given COVID-19 Vaccine Moderna. 
 
As with any vaccine, the 2-dose vaccination course of COVID-19 Vaccine Moderna may not fully 
protect all those who receive it and it is not known how long you will be protected’ 
 
Children and adolescents 
COVID-19 Vaccine Moderna is not recommended for children aged under 18 years. 
 
Other medicines and COVID-19 Vaccine Moderna 
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other 
medicines. COVID-19 Vaccine Moderna may affect the way other medicines work, and other 
medicines may affect how COVID-19 Vaccine Moderna works. 
 
Pregnancy and breast-feeding  
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, tell 
your doctor, pharmacist or nurse before being vaccinated.  
 
Driving and using machines 
Do not drive or use machines if you are feeling unwell after vaccination. Wait until any effects of the 
vaccine have worn off before you drive or use machines.  
 
COVID-19 Vaccine Moderna contains sodium 
COVID-19 Vaccine Moderna contains less than 1 mmol (23 mg) sodium per dose and, that is to say, 
essentially ‘sodium-free’. 
 
 
3. How you will be given COVID-19 Vaccine Moderna 
 
COVID-19 Vaccine Moderna will be given to you as two 0.5 mL injections. It is recommended to 
administer the second dose of the same vaccine 28 days after the first dose to complete the vaccination 
course. 
 
Your doctor, pharmacist or nurse will inject the vaccine into a muscle (intramuscular injection) in your 
upper arm. 
 
During and after each injection of the vaccine, your doctor, pharmacist or nurse will watch over you 
for around 15 minutes to monitor for signs of an allergic reaction. 
 
If you miss an appointment for your 2nd dose of COVID-19 Vaccine Moderna 
- If you miss an appointment, arrange another visit as soon as possible with you doctor, nurse, or 

pharmacist. 
- If you miss a scheduled injection, you may not be fully protected against COVID-19. 
 
If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this vaccine can cause side effects, although not everybody gets them. 
 



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Get urgent medical attention if you get any of the following signs and symptoms of an allergic 
reaction:  

- feeling faint or light-headed; 
- changes in your heartbeat; 
- shortness of breath; 
- wheezing; 
- swelling of your lips, face, or throat; 
- hives or rash; 
- nausea or vomiting; 
- stomach pain. 

 
Talk to your doctor or nurse if you develop any other side effects. These can include: 
 
Very common (may affect more than 1 in 10 people):  

- swelling in the underarm 
- headache  
- nausea 
- vomiting 
- muscle ache, joint aches, and stiffness  
- pain or swelling at the injection site 
- feeling very tired 
- chills  
- fever  

 
Common (may affect up to 1 in 10 people): 

- rash 
- rash, redness, or hives at the injection site  

 
Uncommon (may affect up to 1 in 100 people): 

- itchiness at the injection site 
 
Rare (may affect up to 1 in 1000 people)  

- temporary one-sided facial drooping (Bell’s palsy) 
- swelling of the face (Swelling of the face may occur in patients who have had facial cosmetic 

injections.) 
  
Frequency unknown  

- severe allergic reactions (Anaphylaxis)  
- hypersensitivity 

 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this vaccine. 
 
 
5. How to store COVID-19 Vaccine Moderna 
 
Keep this vaccine out of the sight and reach of children. 
 
Do not use this vaccine after the expiry date which is stated on the label after EXP. The expiry date 
refers to the last day of that month. 
 
Information about storage, expiry, and use and handling are described in the section intended for 
healthcare professionals at the end of the package leaflet. 



25 

 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What COVID-19 Vaccine Moderna contains  
 
- This is a multidose vial which contains 10 doses of 0.5 mL. 
- One dose (0.5 mL) contains 100 micrograms of messenger RNA (mRNA) (embedded in SM-102 

lipid nanoparticles).  
- Single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro 

transcription from the corresponding DNA templates, encoding the viral spike (S) protein of 
SARS-CoV-2. 

- The other ingredients are lipid SM-102, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine 
(DSPC), 1,2-Dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 (PEG2000 DMG), 
trometamol, trometamol hydrochloride, acetic acid, sodium acetate trihydrate, sucrose, water for 
injections. 

 
What COVID-19 Vaccine Moderna looks like and contents of the pack 
COVID-19 Vaccine Moderna is a white to off white dispersion supplied in a glass vial with a rubber 
stopper and aluminium seal.  
 
Pack size: 10 multidose vials 
 
Marketing Authorisation Holder: 
MODERNA BIOTECH SPAIN, S.L.  
Calle Monte Esquinza 30 
28010 Madrid  
Spain 
 
Manufacturer: 
Rovi Pharma Industrial Services, S.A.  
Paseo de Europa, 50 
28703. San Sebastián de los Reyes 
Madrid, Spain 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
België/Belgique/Belgien 
Tél/Tel: +3280038405 
 

Lietuva 
Tel: +37080023365 
 

България 
Teл.: +3598002100471 
 

Luxembourg/Luxemburg 
Tél/Tel: +35280026532 

Česká republika 
Tel: +800050719 
 

Magyarország 
Tel.: +3680088442 

Danmark 
Tlf: +4580830153 
 

Malta 
Tel: +35680062397 

Deutschland 
Tel: 08001009632 
 

Nederland 
Tel: 8004090001 

Eesti 
Tel+3728000032166 

Norge 
Tlf: 80031401 



26 

 
Ελλάδα 
Τηλ: +308003212876 
 

Österreich 
Tel: +43800232927 

España 
Tel: 900031015 
 

Polska 
Tel.: +488003211487 
 

France 
Tél: 0805543016 

Portugal 
Tel: 800210256 
 

Hrvatska 
Tel: 8009614 
 
Ireland 
Tel: +3531800851200 
 

România 
Tel: +40800630047 
 
Slovenija 
Tel: +38680488802 
 

Ísland 
Sími: 8004382 

Slovenská republika 
Tel: +421800105207 
 

Italia 
Tel: +39800141758 
 

Suomi/Finland 
Puh/Tel: +358800413854 

Κύπρος 
Τηλ: +35780077065 
 

Sverige 
Tel: +4620127022 
 

Latvija 
Tel: +37180005882 
 

United Kingdom (Northern Ireland) 
Tel: 08000857562 
 

  
 
 
This leaflet was last revised in {MM/YYYY}. 
 
This vaccine has been given ‘conditional approval’. This means that there is more evidence to come 
about this vaccine. 
The European Medicines Agency will review new information on this vaccine at least every year and 
this leaflet will be updated as necessary. 
 
 
Scan the code with a mobile device to get the package leaflet in different languages.  
  

  
  
Or visit the URL https://www.ModernaCovid19Global.com  
 
Detailed information on this vaccine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.  
 
This leaflet is available in all EU/EEA languages on the European Medicines Agency website. 
 
------------------------------------------------------------------------------------------------------------------------ 

https://www.modernacovid19global.com/


27 

 
The following information is intended for healthcare professionals only: 
 
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.  
 
COVID-19 Vaccine Moderna should be administered by a trained healthcare professional.  
 
The vaccine comes ready to use once thawed. 
 
Do not shake or dilute. 
 
COVID-19 Vaccine Moderna vials are multidose. Ten (10) doses can be withdrawn from each 
multidose vial. 
 
An additional overfill is included in each vial to ensure that 10 doses of 0.5 mL can be delivered. 
 
COVID-19 Vaccine Moderna should be administered as two 0.5 mL doses. It is recommended to 
administer the second dose 28 days after the first dose. 
 
As with all injectable vaccines, appropriate medical treatment and supervision must always be 
readily available in the event of an anaphylactic reaction following the administration of 
COVID-19 Vaccine Moderna. Individuals should be observed by a healthcare professional for at least 
15 minutes after vaccination. 
 
There are no data to assess the concomitant administration of COVID-19 Vaccine Moderna with other 
vaccines. COVID-19 Vaccine Moderna must not be mixed with other vaccines or medicinal products 
in the same syringe. 
The vaccine must be administered intramuscularly. The preferred site is the deltoid muscle of the 
upper arm. Do not administer this vaccine intravascularly, subcutaneously or intradermally. 
 
Information about storage and handling 
 

 

 
 



28 

 
 

 
  



29 

 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annex IV 

Conclusions on the granting of the conditional marketing authorisation presented by the 
European Medicines Agency 

 

 



30 

Conclusions presented by the European Medicines Agency on: 

• Conditional marketing authorisation 

The CHMP having considered the application is of the opinion that the risk-benefit balance is 
favourable to recommend the granting of the conditional marketing authorisation as further 
explained in the European Public Assessment Report. 

 


	ANNEX I
	SUMMARY OF PRODUCT CHARACTERISTICS
	For the full list of excipients, see section 6.1.
	4.1 Therapeutic indications
	4.2 Posology and method of administration
	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
	5.1  Pharmacodynamic properties
	5.2 Pharmacokinetic properties
	5.3 Preclinical safety data
	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
	ANNEX II
	ANNEX III
	A. LABELLING
	1.  NAME OF THE MEDICINAL PRODUCT
	2. STATEMENT OF ACTIVE SUBSTANCE(S)
	3. LIST OF EXCIPIENTS
	4. PHARMACEUTICAL FORM AND CONTENTS
	5. METHOD AND ROUTE(S) OF ADMINISTRATION
	6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
	7. OTHER SPECIAL WARNING(S), IF NECESSARY
	8. EXPIRY DATE
	9. SPECIAL STORAGE CONDITIONS
	10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
	11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
	12. MARKETING AUTHORISATION NUMBER(S)
	EU/1/20/1507/001
	13. BATCH NUMBER
	14. GENERAL CLASSIFICATION FOR SUPPLY
	15. INSTRUCTIONS ON USE
	1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
	2. METHOD OF ADMINISTRATION
	3. EXPIRY DATE
	4. BATCH NUMBER
	5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
	6. OTHER
	ANNEX III
	PACKAGE LEAFLET
	Package leaflet: Information for the user
	COVID-19 Vaccine Moderna dispersion for injection
	- temporary one-sided facial drooping (Bell’s palsy)