@bubu12
 

REG 174 INFORMATION FOR UK HEALTHCARE PROFESSIONALS

NAME OF THE MEDICINAL PRODUCT : COVID-19 mRNA Vaccine BNT162b2 concentrate for solution for injection

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of COVID-19 mRNA Vaccine BNT162b2.

Animal reproductive toxicity studies have not been completed. COVID-19 mRNA Vaccine BNT162b2 is not recommended during pregnancy.

For women of childbearing age, pregnancy should be excluded before vaccination. In addition, women of childbearing age should be advised to avoid pregnancy for at least 2 months after their second dose.

Breast-feeding

It is unknown whether COVID-19 mRNA Vaccine BNT162b2 is excreted in human milk. A risk to the newborns/infants cannot be excluded. COVID-19 mRNA Vaccine BNT162b2 should not be used

during breast-feeding.

Fertility

It is unknown whether COVID-19 mRNA Vaccine BNT162b2 has an impact on fertility.

No data on the COVID-19 mRNA Vaccine BNT162b2 are available on vaccine placental transfer or excretion in milk.