Important update: Healthcare facilities
CDC has updated select ways to operate healthcare systems effectively in response to COVID-19 vaccination. Learn more
UPDATE
Given new evidence on the B.1.617.2 (Delta) variant, CDC has updated the guidance for fully vaccinated people. CDC recommends universal indoor masking for all teachers, staff, students, and visitors to K-12 schools, regardless of vaccination status. Children should return to full-time in-person learning in the fall with layered prevention strategies in place.
UPDATE
The White House announced that vaccines will be required for international travelers coming into the United States, with an effective date of November 8, 2021. For purposes of entry into the United States, vaccines accepted will include FDA approved or authorized and WHO Emergency Use Listing vaccines. More information is available here.
UPDATE
Travel requirements to enter the United States are changing, starting November 8, 2021. More information is available here.

Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY): Overview and Safety

Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY): Overview and Safety
Recommended for People 6 Months and Older

Primary Series: 5 Years and Older: 2 doses of Pfizer-BioNTech in the primary series, given 3–8 weeks apart. People who are moderately or severely immunocompromised (have a weakened immune system) should get a 3rd dose at least 4 weeks after their 2nd dose in the primary series.

6 months through 4 years: 3 doses of Pfizer-BioNTech in the primary series. The first and second doses are separated by three to eight weeks and the second and third doses are separated by at least eight weeks. For people who are moderately or severely immunocompromised (have a weakened immune system), the first and second doses are separated by three weeks, and the second and third doses are separated by at least eight weeks.

Boosters: 5 years and older: People who received a Pfizer-BioNTech primary series should get a booster. Only some people can get a 2nd booster dose.

6 months through 4 years: Currently a booster dose is not authorized for children in this age group.

Use CDC’s COVID-19 booster tool to learn if and when you can get boosters to stay up to date with your COVID-19 vaccines.


Learn about the recommended timing between Pfizer-BioNTech COVID-19 vaccines and boosters for:

Ages 18 and OlderAges 12–17Ages 11 and UnderImmunocompromised

General Information

Manufacturer: Pfizer, Inc., and BioNTech

Type of Vaccine: mRNA

How Given: Shot in the muscle of the upper arm

Number of Shots: 2 doses in the primary series, given 3–8 weeks apart.

People ages 6 months – 4 years who are moderately or severely immunocompromised should get a third dose at least 8 weeks after their second dose. For those five years and older who are moderately or severely immunocompromised the third dose should be at least 4 weeks after the second dose.

Booster Shots:  At this time, only those 5 years of age and older should get a booster.

Does NOT Contain: Eggs, preservatives, latex, metals
View full list of ingredients

Name: BNT162b2

Brand name: COMIRNATY

Pfizer-BioNTech (COMIRNATY) Name Change

After FDA approval, the FDA-authorized Pfizer-BioNTech COVID-19 vaccine for individuals ages 16 years and older was marketed as COMIRNATY. No change was made to the vaccine’s formula with the name change.

The Pfizer-BioNTech vaccine label remains for individuals ages 6 months –15 years since the vaccine is authorized but not yet approved for these age groups.

Safety Data Summary

  • COVID-19 vaccines have undergone—and will continue to undergo—the most intensive safety monitoring in U.S. history. Evidence from the hundreds of millions of COVID-19 vaccines already administered in the United States, and the billions of vaccines administered globally, demonstrates that they are safe and effective.
  • Side effects that happen within 7 days of getting vaccinated are common but are mostly mild. Some people have side effects that affect their ability to do daily activities.
  • Side effects throughout the body (such as fever, chills, tiredness, and headache) are more common after the second dose of the vaccine.
  • Severe allergic reactions to vaccines are rare but can happen.
  • There is a rare risk of myocarditis and pericarditis associated with mRNA COVID-19 vaccination, mostly among males ages 12 through 39 years. The rare risk may be further reduced with a longer interval between the first and second dose. Learn more about the timing for your second dose.

Learn more about vaccine safety monitoring after a vaccine is authorized or approved for use.

How Well the Vaccine Works

  • Vaccines reduce the risk of COVID-19, including the risk of severe illness and death among people who are fully vaccinated.
  • COVID-19 vaccines are effective, but studies have shown vaccine protection declines over time—especially with the Omicron variant. Learn more about getting a booster shot to enhance or restore protection against COVID-19.
  • All FDA-approved or authorized COVID-19 vaccines provide substantial protection against COVID-19 hospitalization and death.
  • CDC will continue to provide updates as we learn more.

Learn about demographic information for people ages 16 years and older who participated in the trials.

Pfizer-BioNTech COVID-19 Vaccine Ingredients

All COVID-19 vaccine ingredients are safe. Nearly all of the ingredients in COVID-19 vaccines are ingredients found in many foods – fats, sugars, and salts. The Pfizer-BioNTech COVID-19 vaccine also contains a harmless piece of messenger RNA (mRNA). The COVID-19 mRNA teaches cells in the body how to create an immune response to the virus that causes COVID-19. This response helps protect you from getting sick with COVID-19 in the future. After the body produces an immune response, it discards all of the vaccine ingredients, just as it would discard any substance that cells no longer need. This process is a part of normal body functioning.

All COVID-19 vaccines are manufactured with as few ingredients as possible and with very small amounts of each ingredient. Each ingredient in the vaccine serves a specific purpose as seen in the table below.

To learn about Pfizer-BioNTech COVID-19 vaccine dosing for different age groups, please visit the Pfizer-BioNTech clinical information page.

Ingredients in children’s Pfizer-BioNTech COVID-19 vaccine

The Pfizer-BioNTech COVID-19 vaccines for people ages 6 months  through 11 years old and the updated formulation of the Pfizer-BioNTech COVID-19 vaccine for people ages 12 years and older contain the following ingredients. While the ingredients are the same for all ages, people ages 12 years and older receive a higher dosage than children ages 6 months through 11 years old.

Type of Ingredient

Type of Ingredient

Type of Ingredient

Ingredient

Ingredient

Ingredient

Purpose

Purpose

Purpose

Messenger ribonucleic acid (mRNA)

Type of Ingredient

Messenger ribonucleic acid (mRNA)

  • Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2
Ingredient
  • Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2

Provides instructions the body uses to build a harmless piece of a protein from the virus that causes COVID-19. This protein causes an immune response that helps protect the body from getting sick with COVID-19 in the future.

Purpose

Provides instructions the body uses to build a harmless piece of a protein from the virus that causes COVID-19. This protein causes an immune response that helps protect the body from getting sick with COVID-19 in the future.

Lipids (fats)

Type of Ingredient

Lipids (fats)

  • 2[(polyethylene glycol (PEG))-2000]-N,N-ditetradecylacetamide
  • 1,2-distearoyl-sn-glycero-3-phosphocholine
  • Cholesterol (plant derived)
  • ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)
Ingredient
  • 2[(polyethylene glycol (PEG))-2000]-N,N-ditetradecylacetamide
  • 1,2-distearoyl-sn-glycero-3-phosphocholine
  • Cholesterol (plant derived)
  • ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)

Work together to help the mRNA enter cells.

Purpose

Work together to help the mRNA enter cells.

Salts and sugar

Type of Ingredient

Salts and sugar

  • Dibasic sodium phosphate dihydrate
  • Monobasic potassium phosphate
  • Potassium chloride (common food salt)
  • Sodium chloride (basic table salt)
  • Sucrose (basic table sugar)
Ingredient
  • Dibasic sodium phosphate dihydrate
  • Monobasic potassium phosphate
  • Potassium chloride (common food salt)
  • Sodium chloride (basic table salt)
  • Sucrose (basic table sugar)

Work together to help keep the vaccine molecules stable while the vaccine is manufactured, frozen, shipped, and stored until it is ready to be given to a vaccine recipient.

Purpose

Work together to help keep the vaccine molecules stable while the vaccine is manufactured, frozen, shipped, and stored until it is ready to be given to a vaccine recipient.

Messenger ribonucleic acid (mRNA):
Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2

Purpose
Provides instructions the body uses to build a harmless piece of a protein from the virus that causes COVID-19. This protein causes an immune response that helps protect the body from getting sick with COVID-19 in the future.


Lipids (fats):

  • 2[(polyethylene glycol (PEG))-2000]-N,N-ditetradecylacetamide
  • 1,2-distearoyl-sn-glycero-3-phosphocholine
  • Cholesterol (plant derived)
  • (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)

Purpose
Work together to help the mRNA enter cells.


Salts and sugar:

  • Dibasic sodium phosphate dihydrate
  • Monobasic potassium phosphate
  • Potassium chloride (common food salt)
  • Sodium chloride (basic table salt)
  • Sucrose (basic table sugar)

Purpose
Work together to help keep the vaccine molecules stable while the vaccine is manufactured, frozen, shipped, and stored until it is ready to be given to a vaccine recipient.

Ingredients in children’s Pfizer-BioNTech COVID-19 vaccine and the updated formulation for people ages 12 years and older

The Pfizer-BioNTech COVID-19 vaccine for people ages 5 through 11 years old and the updated formulation of the Pfizer-BioNTech COVID-19 vaccine for people ages 12 years and older contain the following ingredients. While the ingredients are the same for all ages, people ages 12 years and older receive a higher dosage than children ages 5 through 11 years old.

Type of Ingredient

Type of Ingredient

Type of Ingredient

Ingredient

Ingredient

Ingredient

Purpose

Purpose

Purpose

Messenger ribonucleic acid (mRNA)

Type of Ingredient

Messenger ribonucleic acid (mRNA)

  • Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2
Ingredient
  • Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2

Provides instructions the body uses to build a harmless piece of a protein from the virus that causes COVID-19. This protein causes an immune response that helps protect the body from getting sick with COVID-19 in the future.

Purpose

Provides instructions the body uses to build a harmless piece of a protein from the virus that causes COVID-19. This protein causes an immune response that helps protect the body from getting sick with COVID-19 in the future.

Lipids (fats)

Type of Ingredient

Lipids (fats)

  • 2[(polyethylene glycol (PEG))-2000]-N,N-ditetradecylacetamide
  • 1,2-distearoyl-sn-glycero-3-phosphocholine
  • Cholesterol (plant derived)
  • ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)
Ingredient
  • 2[(polyethylene glycol (PEG))-2000]-N,N-ditetradecylacetamide
  • 1,2-distearoyl-sn-glycero-3-phosphocholine
  • Cholesterol (plant derived)
  • ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)

Work together to help the mRNA enter cells.

Purpose

Work together to help the mRNA enter cells.

Sugar and acid stabilizers

Type of Ingredient

Sugar and acid stabilizers

  • Sucrose (table sugar)
  • Tromethamine
  • Tromethamine hydrochloride
Ingredient
  • Sucrose (table sugar)
  • Tromethamine
  • Tromethamine hydrochloride

Work together to help keep the vaccine molecules stable while the vaccine is manufactured, frozen, shipped, and stored until it is ready to be given to a vaccine recipient.

Purpose

Work together to help keep the vaccine molecules stable while the vaccine is manufactured, frozen, shipped, and stored until it is ready to be given to a vaccine recipient.

Messenger ribonucleic acid (mRNA):
Nucleoside-modified mRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2

Purpose
Provides instructions the body uses to build a harmless piece of a protein from the virus that causes COVID-19. This protein causes an immune response that helps protect the body from getting sick with COVID-19 in the future.


Lipids (fats):

  • 2[(polyethylene glycol (PEG))-2000]-N,N-ditetradecylacetamide
  • 1,2-distearoyl-sn-glycero-3-phosphocholine
  • Cholesterol (plant derived)
  • ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)

Purpose
Work together to help the mRNA enter cells.


Sugar and acid stabilizers:

  • Sucrose (table sugar)
  • Tromethamine
  • Tromethamine hydrochloride

Purpose
Work together to help keep the vaccine molecules stable while the vaccine is manufactured, frozen, shipped, and stored until it is ready to be given to a vaccine recipient.

Ingredients that are NOT used in COVID-19 vaccines

The above table lists ALL ingredients in the Pfizer-BioNTech COVID-19 vaccine. There are NO ingredients in this vaccine beyond what is listed in the table. The Pfizer-BioNTech COVID-19 vaccine has:

  • No preservatives like thimerosal or mercury or any other preservatives.
  • No antibiotics like sulfonamide or any other antibiotics.
  • No medicines or therapeutics like ivermectin or any other medications.
  • No tissues like aborted fetal cells, gelatin, or any materials from any animal.
  • No food proteins like eggs or egg products, gluten, peanuts, tree nuts, nut products, or any nut byproducts (COVID-19 vaccines are not manufactured in facilities that produce food products).
  • No metals like iron, nickel, cobalt, titanium, rare earth alloys, or any manufactured products like microelectronics, electrodes, carbon nanotubes or other nanostructures, or nanowire semiconductors.
  • No latex. The vial stoppers used to hold the vaccine also do not contain latex.