MISSING: 50 Pregnant Women From Pfizer Clinical Trials
Missing: 50 Pregnant Women
HAVE YOU SEEN THEM?
In the first batch of Pfizer documents released, the volunteer group I am a part of was assigned to review Document 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports. Because there were a significant number of Adverse Events reported in pregnant women, I decided to pay close attention to future documents regarding vaccine effects on pregnancy.
According to the Pfizer Clinical Protocol Document, women who are pregnant or breastfeeding were to be excluded from the vaccine trials. They were not allowed to begin them if pregnant:
11.Women who are pregnant or breastfeeding.
And, if they became pregnant during the study, they were withdrawn from receiving further vaccinations:
“Stopping Rule Criteria for Each BNT162 Vaccine Candidate:”
8.2.6. Pregnancy Testing
Pregnancy tests may be urine or serum tests, but must have a sensitivity of at least
25 mIUmL. Pregnancy tests will be performed in WOCBP at the times listed in the SoA, immediately before the administration of each vaccine dose. A negative pregnancy test result will be required prior to the participant’s receiving the study intervention. Pregnancy tests may also be repeated if requested by IRBsECs or if required by local regulations. In the case of a positive confirmed pregnancy, the participant will be withdrawn from administration of study intervention but may remain in the study.
The Clinical Overview document below lists 50 women who were a part of the Clinical Trials that reported pregnancies.
As I read it, 16 of them withdrew from the study due to pregnancy. The wording is confusing, but it appears that at least the remaining 34 women “continue to be followed for pregnancy outcomes.” It could also be construed to mean all 50 are to be followed. See below:
2.5 Clinical Overview Document
Pg. 320, 321
At the time of the data cutoff date (13 March 2021), a total of 50 participants who had received BNT162b2 had reported pregnancies, including 42 participants originally randomized to the BNT162b2 group and 8 participants originally randomized to the placebo group who then received BNT162b2. In total, 12 participants (n=6 each in the randomized BNT162b2 and placebo groups) withdrew from the blinded placebo-controlled vaccination period of the study due to pregnancy, and 4 participants originally randomized to placebo who then received BNT162b2 withdrew from the open-label vaccination period due to pregnancy (Table 54). These participants continue to be followed for pregnancy outcomes. No births have been reported from individuals who have become pregnant in Study C4591001 as of the time of this submission.
According to the Clinical Protocols Document these women should be followed for a minimum of 6 months from their last visit, ostensibly the date when they were withdrawn:
4.4. End of Study Definition
A participant is considered to have completed the study if he/she has completed all phases of the study, including the last visit. Note that participants enrolled in Phase 1 in groups that do not proceed to Phase 2/3 may be followed for fewer than 24 months (but no less than 6 months after the last vaccination).
The end of the study is defined as the date of last visit of the last participant in the study.
Using Abstractor, a front-end search tool that searches all released Pfizer documents, I did a search using the terms “pregnant and pregnancy” and yet found no updated information on these women and their pregnancy outcomes.
As more information on the dangers to pregnant women from the mRNA vaccines surfaces, some of which the manufacturers had at their disposal very early on, I feel it is imperative that we hear the stories of these 50 women and their babies.