Moderna will begin studying its COVID vaccine in pregnant women, according to a posting on ClinicalTrials.gov. The observational study, expected to begin July 22, will enroll about 1,000 females over age 18 who will be studied over a 21-month period.
Women who received a Moderna vaccine during the 28 days prior to their last menstrual period, or at any time during pregnancy, are eligible.
The study will measure the number of participants who have infants with suspected major and minor congenital malformations, the number of participants with any pregnancy complications, the number of participants with any pregnancy outcomes and the number of participants with infant outcomes, Fox Business reported.
Currently, the Centers for Disease Control and Prevention (CDC) says pregnant women can get a COVID vaccine. But the CDC also acknowledges there is limited data available about the safety of COVID vaccines for people who are pregnant.
The CDC website states:
“No evidence exists of risk to the fetus from vaccinating pregnant people with non-replicating vaccines in general. However, the potential risks of COVID-19 vaccines to the pregnant person and the fetus are unknown, because these vaccines have not been extensively studied in pregnant people.”
According to the CDC’s website, as of June 29, data collected from the CDC and U.S. Food and Drug Administration’s (FDA) safety monitoring systems had not identified “any safety concerns for pregnant people who were vaccinated or their babies,” but the agencies stressed findings are preliminary.
Experts urge caution
Margulis told The Defender in an email:
“We have no long-term studies showing it’s safe. We made this mistake with diethylstilbestrol — a synthetic estrogen thought to be safe during pregnancy that was later found to cause aggressive (and sometimes lethal) cancer in the genitals of young teenagers whose moms had been prescribed it.”
Margulis believes it is irresponsible, and even unethical, to assert that we know the Moderna vaccine is safe for pregnancy.
“It’s imperative to use the precautionary principle when it comes to this highly experimental technology. The burden of proof must be on the intervention. We have no evidence that this is safe. But ample evidence shows that it is dangerous to expose pregnant women and unborn babies to drugs and interventions that can disrupt immunity.”
The most recent data from the Vaccine Adverse Events Reporting System (VAERS) — one of the safety monitoring systems co-managed by the FDA and CDC — has received 2,678 reports of adverse events related to COVID vaccines in pregnant women, including 994 reports of miscarriage or premature birth between Dec. 14, 2020 and July 2, 2021….
I’m confused. I thought this WAS the clinical trial. They just forgot to collect the data that they’ve been generating. And the terminology is also confusing. Is it pregnant “people” or pregnant women? Is pregnancy even a thing?
And why are they suddenly interested in actual evidence anyway. Look at the insert on almost any vaccine and it proudly proclaims that no studies have been done to determine safety in pregnant women. Yet the CDC continues to push that experiment as well, again without collecting data. So why are they bothering now? They obviously don’t care about the women or the children. Is anyone being fooled by this charade?
Why would any woman trust their health to an agency that doesn’t even believe women are essential?
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