spikevax SIN16835P COVID-19 mRNA Vaccine Instructions

: June 13, 2024
: spikevax

Table of Contents

spikevax SIN16835P COVID-19 mRNA Vaccine
Product Information
Product Usage Instructions
What Spikevax is and what it is used for
What you need to know before you are given Spikevax
How you will be given Spikevax
Possible side effects
How to store Spikevax
Contents of the pack and other information
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

spikevax SIN16835P COVID-19 mRNA Vaccine

Product Information

Product Name: Spikevax
Generic Name: COVID-19 mRNA Vaccine (nucleoside modified)
Strength: 0.1 mg/mL
Formulation: Dispersion for injection
Active Substance: mRNA encoding the SARSCoV-2 Spike protein
Delivery System: SM-102 lipid nanoparticles
Indication: Prevention of COVID-19 disease caused by SARS-CoV-2
Age Range: Individuals aged 6 months and older

Product Usage Instructions

Please read the following instructions carefully before receiving the Spikevax vaccine:

Precautions:

Do not use the vaccine if you are allergic to the active substance or any of the other ingredients listed in section 6 of the leaflet.
Talk to your doctor, pharmacist, or nurse before receiving Spikevax if:
- You have previously had a severe, life-threatening allergic reaction after any other vaccine injection or after receiving Spikevax in the past.
- Do you have any allergies?
- You have a weak or compromised immune system.
- You have ever fainted following any needle injection?
- You have a bleeding disorder.
- You have a fever.
- You are pregnant or planning to be pregnant.
- You are breastfeeding.
- Do you have any serious illness?
- You have received another COVID-19 vaccine.
- You have anxiety related to injections.

Side Effects:
There is a low chance of developing myocarditis or pericarditis after vaccination with Spikevax. Symptoms may include chest pain, shortness of breath, or abnormal heartbeat. Seek medical attention immediately if you experience any of these symptoms.

Vaccination Course:
Spikevax is administered in a 2-dose vaccination course. It is important to note that the vaccine may not fully protect all individuals, and the duration of protection is unknown.

Children:
Spikevax is not recommended for children under 6 months old.

Interactions with Other Medicines:
Inform your doctor or pharmacist about any other medicines you are taking, have recently taken, or might take. Spikevax may interact with other medicines, and vice versa.

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 Spikevax is and what it is used for
2. What you need to know before you are given Spikevax
3. How Spikevax is given
4. Possible side effects
5. How to store Spikevax
6. Contents of the pack and other information

What Spikevax is and what it is used for

Spikevax is a vaccine used to prevent COVID-19 disease caused by SARS-CoV-2. It is given to individuals aged 6 months and older. The active substance in Spikevax is mRNA encoding the SARS-CoV-2 Spike protein. The mRNA is embedded in SM-102 lipid nanoparticles.

As Spikevax does not contain the virus, it cannot give you COVID-19.

How the vaccine works
Spikevax stimulates the body’s natural defenses (immune system). The vaccine works by causing the body to produce protection (antibodies) against the virus that causes COVID-19. Spikevax 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.

What you need to know before you are given Spikevax

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 Spikevax if:

you have previously had a severe, life-threatening allergic reaction after any other vaccine injection or after you were given Spikevax in the past.
you have any allergies
you have a very weak or compromised immune system
you have ever fainted following any needle injection?
you have a bleeding disorder
you have a fever
you are pregnant or plan to be pregnant
you are breastfeeding
Do you have any serious illness
you have received another COVID-19 vaccine
if you have anxiety related to injections

There is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) after vaccination with Spikevax (see section 4).
These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. They have been observed more often after the second vaccination, and more often in younger males.

The chance of having this occur is very low. You should avoid strenuous physical activity for two weeks after vaccination. You should seek medical attention right away if you have any of the following symptoms after receiving Spikevax:

Chest pain
Shortness of breath
Feelings of having a fast-beating, fluttering, or pounding heart

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Spikevax. As with any vaccine, the primary 2-dose vaccination course of Spikevax may not fully protect all those who receive it and it is not known how long you will be protected.

Children
Spikevax is not recommended for children aged under 6 months old.

Other medicines and Spikevax
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Spikevax may affect the way other medicines work, and other medicines may affect how Spikevax works.

Immunocompromised individuals
If you are immunocompromised, you may receive a third dose of Spikevax. The efficacy of Spikevax even after a third dose may be lower in people who are immunocompromised. In these cases, you should continue to maintain physical precautions to help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate. Discuss appropriate individual recommendations with your doctor.

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.

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

How you will be given Spikevax

Vaccination	0.10 mg/mL concentration

Primary series

It is recommended to get the second dose of the same vaccine 28 days after the first dose to complete the vaccination course.

| Children 6 months through 5 years of age

two 0.25 mL injections

Booster dose| Individuals 12 years of age and older

0.5 mL

If you are immunocompromised, you may receive a third dose of Spikevax.

If you miss an appointment for your primary 2nd dose of Spikevax

If you miss an appointment, arrange another visit as soon as possible with your doctor, nurse, or pharmacist.
If you miss a scheduled injection, you may not be fully protected against COVID-19.

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 30 minutes to monitor for signs of an allergic reaction.

If you have any further questions on the use of this vaccine, ask your doctor, pharmacist, or nurse.

Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.

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
decreased appetite (observed in 6 month to 5 year olds)
irritability/crying (observed in 6 month to 5 year olds)
headache
sleepiness (observed in 6 month to 5 year olds)
nausea
vomiting
muscle aches, joint aches, and stiffness
pain or swelling at the injection site

SIN16835P

redness at the injection site (some of which may occur approximately 9 to 11 days after the injection)
feeling very tired
chills
fever

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

rash
rash or hives at the injection site (some of which may occur approximately 9 to 11 days after the injection)

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

itchiness at the injection site
dizziness
stomach pain

Rare (may affect up to 1 in 1,000 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.)
decreased sense of touch or sensation
unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)
raised, itchy rash (urticaria) (some of which may occur approximately 7 to 13 days after the injection)

Very rare (may affect up to 1 in 10,000 people)

inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis) which can result in breathlessness, palpitations or chest pain

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.

How to store Spikevax

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, use, and handling are described in the section intended for healthcare professionals at the end of the package leaflet.
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.

Contents of the pack and other information

What Spikevax contains

Concentration	Presentation	Dose(s)	Composition

0.10 mg/mL
| Multidose vial| 5 doses

of 0.5 mL each

| One dose (0.5 mL) contains

50 micrograms of elastomer, a COVID-19 mRNA Vaccine (embedded in SM-102 lipid nanoparticles).

---|---|---|---
10 doses

of 0.25 mL each

| One dose (0.25 mL) contains 25 micrograms of elastomer, a

COVID-19 mRNA Vaccine (embedded in lipid nanoparticles).

Pre-filled syringe| 1 dose of 0.5 mL

Do not use the pre-filled syringe to deliver a partial 0.25 mL volume.

| One dose (0.5 mL) contains

50 micrograms of elastomer, a COVID-19 mRNA Vaccine (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 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 Spikevax looks like and the contents of the pack

Multidose vial
Spikevax is a white to off-white dispersion supplied in a glass vial with a rubber stopper and aluminum seal.

Pack size: 10 multidose vials

Pre-filled syringe
Spikevax is a white to off-white dispersion supplied in a pre-filled syringe.

Pack size: 10 pre-filled syringes
Note: Not all presentations may be available locally.

Product owner:
MODERNA BIOTECH SPAIN, S.L. Calle del Príncipe de Vergara 132 Plt 12 Madrid 28002 Spain

Manufacturer:

For multidose vial:
Rovi Pharma Industrial Services, S.A. Paseo de Europa, 50 28703. San Sebastián de los Reyes Madrid, Spain

For pre-filled syringes:
Rovi Pharma Industrial Services, S.A. Calle Julián Camarillo n°35 28037 Madrid Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

This leaflet was last revised in 07/2023.
Scan the code with a mobile device to get the package leaflet.

Or visit the URL https://www.ModernaCovid19Global.com.

The following information is intended for healthcare professionals only:

Spikevax 0.1 mg/mL is supplied in the following presentations:

Multidose vial (blue cap): For administration as a primary series to individuals 6 months through 5 years, and as a booster dose in individuals 12 years and older
Pre-filled syringe: For administration as a booster dose in individuals 12 years and older

Only the multidose vial (blue cap) may be used for vaccine administration to children 6 months through 5 years.

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.

Storage and preparation for administration
Spikevax should be administered by a trained healthcare professional. The vaccine comes ready to use once thawed.

Do not shake or dilute.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Spikevax is a white to off-white dispersion. It may contain white or translucent product-related particulates. Do not administer if the vaccine is discolored or contains other particulate matter.

Multidose vials

Spikevax vials are multidose.
Pierce the stopper preferably at a different site each time.

Pre-filled syringe

Spikevax is supplied in a single-dose, pre-filled syringe (without needle) containing 0.5 mL (50 micrograms) mRNA and must be thawed prior to administration.
During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.

Storage Condition	Storage Temperature	Storage Duration
Frozen	-50°C to -15°C	Until expiry

Refrigerated

2°C to 8°C

| Up to 30 days until expiry. Do not refreeze.

Ambient

8°C to 25°C

| Up to 24 hours. Do not refreeze.

The vaccine comes ready to use once thawed. Thaw each syringe before use following the instructions below.

Thaw in refrigerator	Thaw at room temperature

Thaw between 2°C to 8°C for

2 hours. Let each syringe stand at room temperature (15°C to 25°C)

for 15 minutes before administering.

| Alternatively, thaw between 15°C to 25°C for 1 hour.

After thawing, do not refreeze.
Thawed vials and pre-filled syringes can be handled in room-light conditions.

Dosing and schedule

Vaccination	0.10 mg/mL concentration