INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS
- FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine,
- which is not an FDA-approved vaccine.
- The recipient or their caregiver has the option to accept or refuse Pfizer-BioNTech COVID-19 Vaccine.
- The significant known and potential risks and benefits of Pfizer-BioNTech COVID-19 Vaccine, and
- the extent to which such risks and benefits are unknown.
There is no approved alternative vaccine to prevent COVID-19. There may be clinical trials or availability under EUA of other COVID-19 vaccines.
FDA has issued an EUA for the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization against COVID-19 in individuals 16 years of age and older.
EUA = Emergency Use Authorisation.
Manufacturer says not to give to children under 16 years.
Vaccination Schedule for Individuals 16 Years of Age and Older
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
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