corona-mutando 15: Pfizer warnt ImpfprobandINNen vor Geschlechtsverkehr & Stillen nach der Impfung.

Schwangere dürfen nicht an den Pfizer/BioNTech-Studien teilnehmen. Das heißt: Schwangere dürfen sich nicht impfen lassen!

Führende Impfstoffhersteller wie Pfizer warnen ihre ProbandINNen davor, sich nach der Impfung fortzupflanzen. (vgl. Pfizer, S. 132) Damit bestätigt der Pharmakonzern, dass der mRNA-Impfstoff negative Auswirkungen auf die menschliche Reproduktion haben kann und es wird trotzdem geimpft!

PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001
Page 1
A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND,
DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY,
IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE
CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS

Study Sponsor: BioNTech
Study Conducted By: Pfizer

Study Intervention Number: PF-07302048
Study Intervention Name: RNA-Based COVID-19 Vaccines
US IND Number: 19736
EudraCT Number: 2020-002641-42
Protocol Number: C4591001
Phase: 1/2/3
Short Title: A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals

Hier die Pfizer-Warnung im Original:

PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001
Page 132


10.4. Appendix 4: Contraceptive Guidance


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.


• In addition 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 1 of 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 of 28 days after the last dose of study intervention). The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.

PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001
Page 134


10.4.4. Contraception Methods


Contraceptive use by men or women should be consistent with local availability/regulations regarding the use of contraceptive methods for those participating in clinical trials.

  1. Implantable progestogen-only hormone contraception associated with inhibition of ovulation.
  2. Intrauterine device.
  3. Intrauterine hormone-releasing system.
  4. Bilateral tubal occlusion.
  5. Vasectomized partner:
    • Vasectomized partner is a highly effective contraceptive method provided that the partner is the sole sexual partner of the woman of childbearing potential and the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used. The spermatogenesis cycle is approximately 90 days.
  6. Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation:
    • Oral;
    • Intravaginal;
    • Transdermal;
    • Injectable.
  7. Progestogen-only hormone contraception associated with inhibition of ovulation:
    • Oral;
    • Injectable.
  8. Sexual abstinence:
    • Sexual abstinence is considered a highly effective method only if defined as
    refraining from heterosexual intercourse during the entire period of risk associated with the study intervention. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.
  9. Progestogen-only oral hormonal contraception where inhibition of ovulation is not the primary mode of action.
  10. Male or female condom with or without spermicide.
  11. Cervical cap, diaphragm, or sponge with spermicide.
  12. A combination of male condom with either cervical cap, diaphragm, or sponge with spermicide (double-barrier methods).

Autor: Hartmut Barth-Engelbart

Autor von barth-engelbart.de

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