BioNTech Results Presentation Deck slide image

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 . 4 ● ● ● ● 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 o O BIONTECH
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