Generic name: COVID-19 Vaccine, mRNA
Dosage form: suspension for injection, for intramuscular use
Drug class: Viral vaccines
What is Spikevax?
Spikevax (COVID-19 Vaccine, mRNA) is a vaccine which may help your body develop immunity to SARS-CoV-2, the virus that causes COVID-19. Spikevax is a FDA approved vaccine and also has Emergency Use Authorisation (EUA) to be used in specific groups to help prevent severe disease and death from COVID-19.
Vaccination with Spikevax may not protect all people who receive the vaccine.
Spikevax COVID-19 vaccine (monovalent) is FDA approved for:
- A two-dose primary series for the prevention of COVID-19 in individuals 18 years of age and older, given one month apart.
Spikevax COVID-19 vaccine (monovalent) has emergency use authorisation for:
- A two-dose primary series to individuals 12 years through 17 years of age.
- A third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise, given at least 4 weeks after second dose.
What is COVID-19?
COVID-19 is a serious disease caused by a coronavirus called SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). COVID-19 is spread from person to person through the air.
COVID-19 can affect your lungs or other organs. Symptoms may be mild or serious and include fever, chills, cough, sore throat, shortness of breath, tiredness, body aches, headache, loss of taste or smell, runny or stuffy nose, nausea, vomiting, or diarrhea.
What is the difference between Spikevax and Moderna COVID-19 Vaccines?
The original Moderna COVID-19 Vaccine (monovalent) contains the same vaccine as Spikevax. They contain one messenger RNA (mRNA) component of the original strain of SARS-CoV-2. The EUA approved original vaccine has the name Moderna COVID-19 Vaccine and when it is used as a FDA approved medicine it has the brand name Spikevax.
Moderna COVID-19 Vaccine (monovalent)
Moderna COVID-19 Vaccine (monovalent) has emergency use authorization to prevent COVID-19 as a:
- Two-dose primary series for individuals 6 months of age and older.
- Third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise.
Moderna COVID-19 Vaccine, Bivalent
Moderna COVID-19 Vaccine, Bivalent contains two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2. Sometimes the bivalent vaccine is also called Moderna bivalent Original/Omicron vaccine or an “updated booster”.
Moderna COVID-19 Vaccine, Bivalent has emergency use authorization for use in individuals 18 years of age and older as a single booster dose when given at least 2 months after either:
- Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or
- Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.
Who should not receive Spikevax?
You should not receive Spikevax if you:
- had a severe allergic reaction after receiving a previous dose of Spikevax (also called Moderna COVID-19 Vaccine)
- had a severe allergic reaction to any ingredient of this vaccine (see below 'What are the ingredients in Spikevax?')
What should I tell my healthcare provider?
Tell your healthcare provider about all of your medical conditions, including if you:
- have any allergies
- had a severe allergic reaction after receiving a previous dose of any COVID-19 vaccine
- have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
- have a fever
- have a bleeding disorder or are on a blood thinner
- are immunocompromised or are on a medicine that affects your immune system
- are pregnant or plan to become pregnant
- are breastfeeding
- have received any other COVID-19 vaccine
- have ever fainted in association with an injection
How is Spikevax given?
Spikevax is given as an injection into the muscle. The Spikevax vaccination series is 2 doses given 1 month apart. If you receive one dose of Spikevax, you should receive a second dose of Spikevax 1 month later to complete the vaccination series.
Dosing information
Spikevax is administered as an intramuscular injection that is given as a series of two doses (0.5 mL each) one month apart.
What other drugs will affect Spikevax?
Tell your healthcare provider if you take:
- a blood thinner
- a medicine that affects your immune system
Also tell your healthcare provider if you have received any other COVID-19 vaccine.
What are the risks of Spikevax?
Severe allergic reactions have occurred in some people who have received Spikevax (also called Moderna COVID-19 Vaccine). There is a very small chance that Spikevax could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of Spikevax. For this reason, your healthcare provider may ask you to stay for a short time at the place where you received your vaccine.
Signs of a severe allergic reaction can include:
- Difficulty breathing
- Swelling of your face and throat
- A fast heartbeat
- A rash all over your body
- Dizziness and weakness
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received Spikevax (also called Moderna COVID-19 Vaccine), more commonly in males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days following receipt of the second dose of Spikevax. The chance of this happening is very low. 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
Spikevax side effects
Side effects that have been reported in clinical trials with Spikevax include:
- Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness
- General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, and fever
In trial participants 18 through 64 years, the most commonly reported (≥10%) adverse reactions were pain at injection site (93.3%), fatigue (71.9%), headache (68.7%), myalgia (64.8%), chills (49.7%), arthralgia (48.6%), nausea/vomiting (25.7%), axillary swelling/tenderness (22.2%), fever (17.3%), swelling at the injection site (15.4%), and erythema at the injection site (10.5%).
In trial participants 65 years of age and older, the most commonly reported (≥10%) adverse reactions were pain at injection site (88.3%), fatigue (64.8%), headache (53.3%), myalgia (51.8%), arthralgia (40.2%), chills (32.7%), nausea/vomiting (15.0%), swelling at the injection site (13.0%), and axillary swelling/tenderness (12.7%).
Side effects that have been reported during post-authorization use of the vaccine include:
- Severe allergic reactions
- Myocarditis (inflammation of the heart muscle)
- Pericarditis (inflammation of the lining outside the heart)
- Fainting in association with injection of the vaccine
These may not be all of the possible side effects of Spikevax. Ask your healthcare provider about any side effects that concern you. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or https://vaers.hhs.gov.
Pregnancy or breastfeeding
If you are pregnant or breastfeeding, discuss your options with your healthcare provider.
A pregnancy exposure registry is available. You are encouraged to contact the registry as soon as you become aware of your pregnancy by calling 1-866-MODERNA (1 866-663-3762), or ask your healthcare provider to contact the registry for you.
Can I receive Spikevax or the Moderna COVID19 Vaccine at the same time as other vaccines?
Data has not yet been submitted to FDA on administration of Spikevax or the Moderna COVID-19 Vaccine at the same time as other vaccines. If you are considering receiving Spikevax or the Moderna COVID-19 Vaccine with other vaccines, discuss your options with your healthcare provider.
What if I am immunocompromised?
If you are immunocompromised, you may receive a third primary series dose of the vaccine. The third dose may still not provide full immunity to COVID-19 in people who are immunocompromised, and you should continue to maintain physical precautions to help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate.
What are the ingredients in Spikevax?
Spikevax contains the following ingredients: messenger ribonucleic acid (mRNA), lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2- distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate trihydrate, and sucrose.
Spikevax does not contain SARS-CoV-2, the virus that causes COVID-19. Spikevax cannot give you COVID-19.
Spikevax does not contain preservatives.
What else do I need to know?
Keep your vaccination card. When you receive your first dose, you will get a vaccination card to show you when to return for your second dose of Spikevax (also called the Moderna COVID19 Vaccine). Remember to bring your card when you return.
If you would like more information, talk to your healthcare provider or visit www.Spikevax.com or call 1-866-MODERNA (1-866-663-3762).
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