BioNTech Results Presentation Deck
Safety Information
AUTHORIZED USE IN THE U.S.
COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) in individuals 12 yrs of age and older. It is also authorized under EUA to provide a 3-dose primary series to individuals 6 months through 4 yrs of age, 2-dose primary series to
individuals 5 yrs of age and older, a third primary series dose to individuals 5 yrs of age and older who have been determined to have certain kinds of immunocompromise, a single booster dose to individuals 5
through 11 yrs of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATYⓇ, a third primary series dose to individuals 12 years of age and older with certain
kinds of immunocompromise, a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®, a first booster dose to
individuals 18 yrs of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine, a second booster dose to individuals 50 yrs of age and older who have received a first
booster dose of any authorized COVID-19 vaccine; and a second booster dose to individuals 12 yrs of age and older who have been determined to have certain kinds of immunocompromise and who have received
a first booster dose of any authorized COVID-19 vaccine.
The booster schedule is based on the labeling information of the vaccine used for the primary series.
IMPORTANT SAFETY INFORMATION
Individuals should not get the vaccine if they:
had a severe allergic reaction after a previous dose of this vaccine
• had a severe allergic reaction to any ingredient of this vaccine
Individuals should tell the vaccination provider about all of their medical conditions, including if they:
have any allergies
have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
• have a fever
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have a bleeding disorder or are on a blood thinner
are immunocompromised or are on a medicine that affects the immune system
are pregnant, plan to become pregnant, or are breastfeeding
have received another COVID-19 vaccine
have ever fainted in association with an injection
The vaccine may not protect everyone. Side effects reported with the vaccine include:
• There is a remote chance that the vaccine could cause a severe allergic reaction
o A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, vaccination providers may ask individuals to stay at the place where they
received the vaccine for monitoring after vaccination
Signs of a severe allergic reaction can include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness
If an individual experiences a severe allergic reaction, they should call 9-1-1 or go to the nearest hospital
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