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Sars-cov-2 mrna (tozinameran) vaccine Pregnancy and Breastfeeding Warnings

Sars-cov-2 mrna (tozinameran) vaccine is also known as: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine

Sars-cov-2 mrna (tozinameran) vaccine Pregnancy Warnings

Animal studies have failed to reveal evidence of fetal harm. Animal studies of a dose equivalent to a single human dose given on 4 occasions (twice prior to mating and twice during gestation) showed no evidence of developmental harm to the fetus. There are no controlled data in human pregnancy.

There is a pregnancy exposure registry monitoring pregnancy outcomes in patients exposed to this drug during pregnancy; patients vaccinated with this drug during pregnancy are encouraged to enroll in the registry at https://mothertobaby.org/ongoing-study/covid19-vaccines/

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not formally assigned to a pregnancy category

Risk summary: Insufficient data available on use of this drug in pregnancy to inform a drug related risk.

Comment:
-A pregnancy exposure registry is available.

See references

Sars-cov-2 mrna (tozinameran) vaccine Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references

References for pregnancy information

  1. "Product Information. Pfizer-BioNTech COVID-19 Vaccine PF (SARS-CoV-2 (COVID-19) mRNA BNT-162b2 vaccine)." Pfizer Inc., Madison, NJ.
  2. "Product Information. Pfizer-BioNTech COVID-19 Vaccine PF (SARS-CoV-2 mRNA (tozinameran) vaccine)." Pfizer Inc. (2022):

References for breastfeeding information

  1. "Product Information. Pfizer-BioNTech COVID-19 Vaccine PF (SARS-CoV-2 (COVID-19) mRNA BNT-162b2 vaccine)." Pfizer Inc., Madison, NJ.
  2. "Product Information. Pfizer-BioNTech COVID-19 Vaccine PF (SARS-CoV-2 mRNA (tozinameran) vaccine)." Pfizer Inc. (2022):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.