The CDC reported on Aug. 11 in a press release that the COVID-19 vaccine is "safe for pregnant people" based on a self-reported study using "v-safe, a voluntary smartphone-based surveillance system." The women followed in the study were between 6 and 20 weeks gestation. Per the study, the "cumulative risk of spontaneous abortion (SAB) from 6–19 weeks’ gestation was 14.1%."
The Moderna and Pfizer mRNA jabs were used in this research. Oddly, the CDC based its announcement on a study sponsored by the CDC itself that has not been peer-reviewed. It also expressly states that the preprint of the study "should not be interpreted as an endorsement of its validity...or for guiding clinical practice."
Research Square/SAB Study
The study excludes those whose fetuses "are at less than 6 weeks gestation."
Study of vaccinated women and spontaneous abortions
The participants were mainly non-Hispanic, white healthcare workers (75%), per Table 1 in the study:
Research Square/Table 1/Participants
2456 of the 5,086 participants met the criteria for inclusion in the study. Per the paper,
The cohort does not include a comparison group of unvaccinated pregnant people. Additionally, the cohort is relatively homogenous with respect to racial and ethnic groups and occupation, with 78% of participants non-Hispanic White and 89% healthcare personnel.
Yet, the study concludes that the risk of a spontaneous abortion (miscarriage) from the vaccine is "within the expected range."
[d]espite the limitations noted above and the inherent challenges of registry data without a comparison group, these data suggest that the cumulative risk of an SAB from 6–19 weeks’ gestation after receiving an mRNA COVID-19 vaccine is within the expected range based on previous SAB studies...Our data as of July 19, 2021, are reassuring and do not suggest an increased risk of SAB following receipt of an mRNA COVID-19 vaccine in the preconception period or during pregnancy.
Writer, Naomi Wolf, appeared on Bannon's War Room on Aug. 4 (episode 1,234, part 5) on the website, highlighted what she believes to be significant issues in the research due to the study's design. The method of data collection, demographics of participants, and its failure to follow women for the duration of pregnancy and after delivery were issues that Wolf emphasized as flawed.
Normally, the recommendation and use of a vaccine for pregnant women undergo years of peer-reviewed clinical trials before the CDC and FDA post statements affirming their safety. Wolf explains that many doctors point to the CDC as trusted sources for recommendations on the COVID-19 vaccines when the studies they are quoting as "safe and effective" do not measure up to expected historical research standards—especially for at-risk populations like children and pregnant women:
...the CDC, first of all, it's their own study. Second of all... it's overwhelmingly white women. It's health care professionals, right, who work for the bosses who work for the people who are producing the vaccine...It's not a random sample. It's not communities of color. It's the people who get health care, who get good nutrition. It rules out all kinds of risk factors... that a real random sample would have.
And then they left out cohorts that are the first six weeks of pregnancy— when you're most likely to have a miscarriage and then they concluded that it's safe and effective because the rest of the time that they checked, there wasn't an unusual amount of miscarriage. They didn't check for any other outcome except miscarriage and small birth weight. So, they didn't check for preeclampsia. They didn't check for gestational giant diabetes. They didn't check— for you know, are the kids born with abnormal limbs? Are they born with normal reflexes? Normal cognitive development? There's no checking for that!
AND on the basis of this impaired, self-selected phone check-in— It's an app called v-safe. that people are voluntarily saying "yes I'm fine" or "no I had a miscarriage." How likely are you to do that to a random platform that's checking in on you?... because of this self-reporting by a bunch of... women who are not representative of women and babies economically or racially or ethnically or in terms of their disabilities or their age! Not checking for the whole range of things that go wrong in pregnancy— horribly wrong on the basis of that— they are announcing that it's safe and effective for pregnant women.
AND this study took three months, right? Pregnancies are nine months— so they haven't even followed pregnancies all the way to the end to check that the babies are okay at three months, at six months— the way normal medicine works with obstetrics and gynecology.
With regard to follow-up, the study states that "[e]nrolled participants receive a telephone follow-up each trimester, during the postpartum period, and three months following live births." The follow-up phone calls are surveys, but no details are given on the quality of the questions asked.
The CDC press release recommends that "all people 12 years of age and older get vaccinated against COVID-19" and
"encourages all pregnant people or people who are thinking about becoming pregnant and those breastfeeding to get vaccinated to protect themselves from COVID-19," said CDC Director Dr. Rochelle Walensky. “The vaccines are safe and effective, and it has never been more urgent to increase vaccinations as we face the highly transmissible Delta variant and see severe outcomes from COVID-19 among unvaccinated pregnant people.”
One of the comments in response to the above study cites another CDC study that contradicts some of the research findings being discussed here. "A total of 96 of 104 spontaneous abortions (92.3%) occurred before 13 weeks of gestation." The same person commenting actually called and emailed the CDC about the studies to which they replied,
“There are currently limited available data on the safety of COVID-19 vaccines in pregnant people. Based on current knowledge, experts believe that mRNA vaccines and viral vector vaccines are unlikely to pose a risk for people who are pregnant."
The CDC allegedly admits that they are basing their recommendation for a vaccine on limited data.
Several other people commented as having reported miscarriages to v-safe several times and never received a callback.
Comment Section/CDC Research Square Study
Research Square/comments/Study of SAB with Vaccine
