“INFORMATION TO PROVIDE TO VACCINE RECIPIENTS/CAREGIVERS
As the vaccination provider, you must communicate to the recipient or their caregiver, information consistent with the ‘Vaccine Information Fact Sheet for Recipients and Caregivers’ (and provide a copy or direct the individual to the website www.cvdvaccine.com to obtain the Vaccine Information Fact Sheet for Recipients and Caregivers) prior to the individual receiving each dose of the Pfizer-BioNTech COVID-19 Vaccine, including:
- FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine, which is not an FDA-approved vaccine.
- There is an option to accept or refuse Pfizer-BioNTech COVID-19 Vaccine.
- The significant known and potential risks and benefits of the Pfizer-BioNTech COVID-19 Vaccine, and the extent to which such risks and benefits are unknown [sic]…
11.1 Pregnancy – Risk Summary: … Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
11.2 Lactation – Risk Summary: Data are not available to assess the effects of Pfizer-BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion.”