PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
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10.4.1.Male Participant Reproductive Inclusion Criteria
Male participants are eligible to participate if they agree to the following requirements during the intervention period and for at least 28 days after the last dose of study intervention, which corresponds to the time needed to eliminate reproductive safety risk of the study intervention(s):
•Refrain from donating sperm. PLUS either:
•Be abstinent from heterosexual intercourse with a female of childbearing potential as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent. OR
•Must agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person.
•Inaddition to male condom use, a highly effective method of contraception may be considered in WOCBP partners of male participants(refer to the list of highly effective methods below in Section 10.4.4).
10.4.2.Female Participant Reproductive Inclusion Criteria
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1of the following conditions applies:
•Is not a WOCBP (see definitions below in Section 10.4.3).OR
•Is a WOCBP and using an acceptable contraceptive method as described below during the intervention period (for a minimum of28 days after the last dose of study intervention).