FDA-Approved or FDA-Authorized Vaccination Schedule

The FDA has approved COMIRNATY for individuals 16 years of age and older as a primary series of 2 doses given 3 weeks apart.

Select CDC Considerations for Intervals for mRNA COVID-19 Vaccine Primary Series

The CDC has provided guidance that differs from the FDA-approved primary series dosing interval above. On February 22, 2022, the CDC updated its Interim Clinical Considerations for Use of COVID-19 Vaccines  for healthcare professionals to include consideration of an extended interval, up to 8 weeks, between the first and second doses of an mRNA COVID-19 vaccine primary series schedule for people who are not moderately or severely immunocompromised. This applies to some people ages 12 years and older—especially males 12 to 39 years of age—as they may have a small but elevated risk of myocarditis (inflammation of the heart muscle) associated with mRNA COVID-19 vaccines. The CDC states that increasing the interval between the first and second dose of the vaccine may help reduce this risk, while also increasing vaccine effectiveness.

Your healthcare or vaccination provider will help you decide the timing of the second primary series dose that is right for you.

FDA-Approved or FDA-Authorized Vaccination Schedule

The FDA has approved COMIRNATY for individuals 16 years of age and older as a primary series of 2 doses given 3 weeks apart.

Select CDC Considerations for Intervals for mRNA COVID-19 Vaccine Primary Series

The CDC has provided guidance that differs from the FDA-approved primary series dosing interval above. On February 22, 2022, the CDC updated its Interim Clinical Considerations for Use of COVID-19 Vaccines  for healthcare professionals to include consideration of an extended interval, up to 8 weeks, between the first and second doses of an mRNA COVID-19 vaccine primary series schedule for people who are not moderately or severely immunocompromised. This applies to some people ages 12 years and older—especially males 12 to 39 years of age—as they may have a small but elevated risk of myocarditis (inflammation of the heart muscle) associated with mRNA COVID-19 vaccines. The CDC states that increasing the interval between the first and second dose of the vaccine may help reduce this risk, while also increasing vaccine effectiveness.

• The CDC continues to recommend a 3-week interval between the first and second dose of the vaccine for people who are moderately or severely immunocompromised, adults ages 65 years and older, and others who need rapid protection due to increased concern about community transmission or risk of severe disease.

Your healthcare or vaccination provider will help you decide the timing of the second primary series dose that is right for you.

You should contact your healthcare or vaccination provider or the location where you received your first dose to discuss the appropriate timing of your second primary series dose.

FDA-Approved or FDA-Authorized Vaccination Schedule

The FDA-approved or FDA-authorized interval between the first and second dose has not changed, and is as follows:

Select CDC Considerations for Intervals for mRNA COVID-19 Vaccine Primary Series

The CDC has provided guidance that differs from the FDA-approved or FDA-authorized primary series dosing interval above. On February 22, 2022, the CDC updated its Interim Clinical Considerations for Use of COVID-19 Vaccines  for healthcare professionals to include consideration of an extended interval, up to 8 weeks, between the first and second doses of an mRNA COVID-19 vaccine primary series schedule for people who are not moderately or severely immunocompromised. This applies to some people ages 12 years and older—especially males 12 to 39 years of age—as they may have a small but elevated risk of myocarditis (inflammation of the heart muscle) associated with mRNA COVID-19 vaccines. The CDC states that increasing the interval between the first and second dose of the vaccine may help reduce this risk, while also increasing vaccine effectiveness.

Your healthcare or vaccination provider will help you decide the timing of the second primary series dose that is right for you.

If you are immunocompromised, you may be eligible to receive a third dose of the vaccine under the emergency use authorization. Consult with your healthcare provider. Click here to learn more.

If you are pregnant or breastfeeding, discuss your options with your healthcare provider. Available data on COMIRNATY administered to pregnant women is insufficient to inform vaccine-associated risks in pregnancy.

Breastfeeding:

It is not known whether COMIRNATY is excreted in human milk. Data are not available to assess the effects of COMIRNATY on the breastfed infant or on milk production/excretion.

According to the CDC,

For more information, visit the CDC website.

Tell the vaccination provider about all of your medical conditions, including if you:

According to the FDA, "During a public health emergency, the FDA can use its Emergency Use Authorization (EUA) authority to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives."

The EUA is in effect from the time of EUA authorization for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the vaccine unless the declaration is terminated or authorization revoked sooner.

FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use.

No. The vaccine does not contain live virus that causes COVID-19.

There is a remote chance that the vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received your vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the 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 vaccine. The chance of having this occur is very low. You should seek medical attention right away if you have any of the following symptoms after receiving the vaccine:

Side effects that have been reported with the vaccine include:

If you experience a severe allergic reaction or other severe symptom, call 9‑1‑1, or go to the nearest hospital.

Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.

Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include either “COMIRNATY (COVID‑19 Vaccine, mRNA)” or “Pfizer-BioNTech COVID‑19 Vaccine EUA”, as appropriate, in the first line of box #18 of the report form.

In addition, you can report side effects to Pfizer Inc. at the contact information provided below.

Website: www.pfizersafetyreporting.com
Fax number: 1-866-635-8337
Telephone number: 1-800-438-1985

You should not get the vaccine if you:

The vaccine in the purple cap includes the following ingredients: mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.

​​​​​​​The vaccine in the gray cap includes the following ingredients: mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), tromethamine, tromethamine hydrochloride, and sucrose.

The vaccine in the orange cap includes the following ingredients: mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), tromethamine, tromethamine hydrochloride, sucrose and sodium chloride.

No, the vaccine does not contain preservative.

The vial stoppers are not made with natural rubber latex.

We are committed to ensuring that underrepresented populations participate in all our studies by sharing with our investigative sites the importance of recruiting people who fully represent the racial and ethnic diversity of their communities.

Individuals 16 years and older:
Approximately 42% of overall participants in the clinical study of the vaccine have racially and ethnically diverse backgrounds.

For more information about COVID-19 vaccination, please visit the CDC website.