vaccine for COVID-19 natural and safe

[David Merrill]

The grammar is very revealing, once you know how to say teratogenicity.

4.2. Scientific Rationale for Study Design

Additional surveillance for COVID-19 will be conducted as part of the study, given the potential risk of disease enhancement. If a participant experiences symptoms, as detailed in Section 8.13, a COVID-19 illness and subsequent convalescent visit will occur. As part of these visits, samples (nasal [midturbinate] swab and blood) will be taken for antigen and antibody assessment as well as recording of COVID-19–related clinical and laboratory information (including local diagnosis).

Human reproductive safety data are not available for BNT162 RNA-based COVID-19 vaccines, but there is no suspicion of human teratogenicity based on the intended mechanism of action of the compound. Therefore, the use of a highly effective method of contraception is required (see Appendix 4).

Feel the grammar? This is Pfizer and BionTech intentionally avoiding the creation of any evidence that the mRNA might cause any birth defects, including infertility.

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

10.4.3. Woman of Childbearing Potential

A woman is considered fertile following menarche and until becoming postmenopausal unless permanently sterile (see below).
If fertility is unclear (eg, amenorrhea in adolescents or athletes) and a menstrual cycle cannot be confirmed before the first dose of study intervention, additional evaluation should be considered.

Women in the following categories are not considered WOCBP:

1. Premenarchal.

2. Premenopausal female with 1 of the following:

• Documented hysterectomy;

• Documented bilateral salpingectomy;

• Documented bilateral oophorectomy.

For individuals with permanent infertility due to an alternate medical cause other than the above, (eg, mullerian agenesis, androgen insensitivity), investigator discretion should be applied to determining study entry.

Note: Documentation for any of the above categories can come from the site personnel’s review of the participant’s medical records, medical examination, or medical history interview. The method of documentation should be recorded in the participant’s medical record for the study.

3. Postmenopausal female:

• A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. In addition...

I hired Bill as my developer (Artificial Intuition) with the cure for malaria. Rumor has it that he wants to use mosquitoes for spreading his culling mRNA instead. No need. He has plenty of people to spread this synthetic prion. Rather than reprogram the mosquito's central nervous system through resonant frequency.