The vaccine maker is launching a clinical trial to assess safety of its vaccine in pregnant women, despite 133,000 pregnant women having already received a COVID vaccine prior to trials.
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 evidenceshows 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.
Data assessing safety of COVID vaccines in pregnant women is lacking
Since the FDA in December 2020 granted Emergency Use Authorization (EUA) for COVID vaccines, the CDC has recommended pregnant women be offered the vaccine — despite the fact that pregnant women were excluded from preauthorization clinical trials, and despite the limited data on safety and efficacy of COVID vaccines during pregnancy.
In January, the World Health Organization said pregnant women should not receive a COVID vaccine. A week later, the agency changed its guidance and advised everyone to take the shot, including pregnant women.
According to a March 1 safety update by the CDC’s vaccine safety panel on the COVID vaccine and pregnancy, post-authorization safety monitoring and research are the primary ways the CDC obtains safety data on COVID vaccination during pregnancy.
In other words, the vaccine is given to pregnant women before studies determine whether the vaccine is safe for that population. The CDC’s websitestates that 133,466 pregnant women have already received a COVID vaccine as of July 12.
“It seems bass-ackwards to release the vaccine to pregnant women before doing a clinical trial or proper animal studies,” said Lyn Redwood, RN, MSN and president emerita of Children’s Health Defense.
“Does the vaccine lipid nanoparticle cross through the placenta? If so, what is the effect on the offspring with regard to morbidity or mortality? These are questions we need to be asking. Pregnancy used to be a time where we were to protect the mother and baby from any potential harms, especially during the first trimester.”
The retrospective study, “Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons,” relied on multiple vaccine surveillance systems from December 2020 to February to assess the safety of the Pfizer-BioNTech and Moderna vaccines in more than 35,000 pregnant women who had chosen to get vaccinated after the vaccines were approved for emergency use.