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.

The COVID-19 vaccine is used to help prevent COVID-19 caused by SARS-CoV-2.

The US Food and Drug Administration (FDA) has approved the Spikevax vaccine for active immunization to prevent COVID-19 in people 12 years of age and older.

COVID-19 vaccine does not contain coronavirus and cannot give you COVID-19. This vaccine will not treat an active COVID-19 infection.

Like any vaccine, COVID-19 vaccine may not provide protection in every person.

Becoming infected with COVID-19 is much more dangerous to your health than receiving this vaccine.

Read all vaccine information sheets provided to you. Follow the label directions or your vaccination provider's instructions.

The Spikevax COVID-19 vaccine is given in people at least 12 years old as a single injection (shot) into a muscle.

For people who have already received a dose of any COVID-19 vaccine: a single dose of Spikevax COVID-19 vaccine is given 2 months after the last dose of any COVID-19 vaccine.

You will receive a reminder card showing the date and type of each injection. Take this card with you each time you receive a COVID-19 vaccine.

Keep using infection control methods when you are in public or around others who may not have been vaccinated. This includes social distancing, hand-washing, using protective face covering, disinfecting surfaces you touch a lot, and not sharing personal items with others.

Receiving a COVID-19 vaccine will not cause you to test positive on a coronavirus test. However, once your body develops immunity to COVID-19, you could test positive on an antibody test (a test to detect immunity in your body from previous exposure to coronavirus).

It is not known how long this vaccine will protect you from infection with COVID-19. It also is not known how long immunity will last in a person who's been infected with and recovered from COVID-19. COVID-19 vaccine is still being studied and all of its risks are not yet known. Updated federal public health recommendations may be found at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html

Usual Adult Dose for COVID-19:

12 years and older:
Dark blue cap/label multidose vial (50 mcg/0.5 mL): 0.5 mL IM once, administered at least 2 months after the last dose of vaccine

Comments:
-This drug is not approved by the US FDA to prevent COVID-19. The US FDA has issued a BLA for the use of this drug to prevent COVID-19.
-For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Use: For active immunization to prevent SARS-CoV-2, including the COVID-19 Omicron (XBB.1.5) virus strain variant

Usual Pediatric Dose for COVID-19:

For investigational use only

12 years and older:
Dark blue cap/label multidose vial (50 mcg/0.5 mL): 0.5 mL IM once, administered at least 2 months after the last dose of vaccine.

Comments:
-This drug is not approved by the US FDA to prevent COVID-19. The US FDA has issued an EUA for the use of this drug to prevent COVID-19.
-For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Use: For active immunization to prevent SARS-CoV-2, including the COVID-19 Omicron (XBB.1.5) virus strain variant

You should not receive this vaccine if you've ever had a severe allergic reaction to Spikevax or Moderna COVID-19 vaccine.

If you are infected with COVID-19, are waiting for testing results, or are exposed to someone infected with COVID-19: You may not be able to receive this vaccine until you have no symptoms and/or your required quarantine period has ended. Receiving this vaccine will not make you less contagious to other people if you are infected with COVID-19 but you have no symptoms.

Ask your doctor if you are unsure about any COVID-19 treatments you received.

Tell your vaccination provider if you:

• have any allergies;

• have had inflammation in or around your heart (myocarditis or pericarditis);

• have a fever;

• have bleeding problems or taking a blood thinner (warfarin, Coumadin, Jantoven);

• have a weak immune system caused by disease or by using certain medicines;

• are pregnant, plan to become pregnant, or breastfeeding;

• have received any other COVID-19 vaccine or if you are scheduled to receive a vaccine; or

• have fainted after receiving an injection.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of this vaccine on the baby.

Tell your doctor if you are pregnant or breastfeeding.

Be sure to receive all recommended doses of COVID-19 vaccine or you may not be fully protected. Contact your vaccination provider or health department if you miss a dose.

An overdose of this vaccine is unlikely to occur.

Avoid receiving other vaccines without first seeking medical advice.