The Moderna laboratory will begin testing its experimental COVID-19 vaccine in pregnant women to study pregnancy outcomes after exposure, ClinicalTrials.gov reports.
The trial aims to recruit about 1,000 women over the age of 18 who will be studied over a 21-month period, from whom primary data will be collected after inoculation with the vaccine.
According to the data, women exposed to the Modern COVID-19 vaccine during the 28 days before their last menstrual period or at any time during pregnancy will be eligible.
The study in participating women will measure:
The number of pregnant women who have babies with suspected major and minor congenital malformations, studied up to one year of age of the child, citing some serious, medically, and socially significant, requiring surgical intervention or life-threatening, such as cleft lip, spina bifida, etc.
The number of women with pregnancy complications. This will be measured from the end of the first trimester (approximately 14 weeks) to the middle of the third trimester (approximately 34 weeks). Complications could include pre-eclampsia, eclampsia, pregnancy-induced hypertension, prenatal hemorrhage, preterm delivery, gestational diabetes, dysfunctional labor, premature rupture of membranes, placenta praevia, postpartum hemorrhage, small-for-gestational-age (SGA) fetus and intrauterine growth restriction (IUGR), and non-certain fetal status.
The number of women with any pregnancy outcome, which may include miscarriage, stillbirth, elective or therapeutic termination of pregnancy, preterm birth, ectopic pregnancy, maternal death, and diagnosis of COVID-19.
The number of participating women with adverse infant outcomes may include congenital malformations, gestational age size, low birth weight, developmental delay, infant hospitalization, neonatal death, encephalopathy, respiratory distress, neonatal/infant infection, and infant death.
The U.S. Center for Disease Control and Prevention (CDC) states that pregnant women can receive the vaccine. Still, no trials specifically studying this population were conducted when the FDA granted emergency use authorization for either vaccine in December 2020, Fox Business reported.
Moreover, the CDC itself acknowledges on its website that there is insufficient data to assess safety:
“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,” the CDC says.
As reported by Childrens Health Defense, in January the World Health Organization said pregnant women should not receive a COVID vaccine, but a week later, it reversed its position and recommended everyone get the shot, including pregnant women.
Post-authorisation monitoring and research are the main ways the CDC obtains data on vaccine safety during pregnancy, according to March 1 specifications by the CDC’s Vaccine Safety Panel.
The CDC website further indicates that 133,466 pregnant women have already received a COVID vaccine as of 12 July, so all of this reveals that the vaccine is being given to pregnant women before studies have determined whether it is safe for that population.
It is not the monitoring, which the vaccine safety panel specified is necessary to establish vaccine safety, that led the CDC to recommend in April that pregnant women be inoculated against COVID, but was based on a retrospective study published in the New England Journal of Medicine, Childrens Health Defense said.
And according to the study authors, in data collected over the course of two months, they found no increased risks during pregnancy, birth complications or identifiable risks to the fetus among those who received the vaccine.
But Dr Brian Hooker, scientific director of Children’s Health Defense and a professor of biology at Simpson University, said the results were highly skewed.
“The majority of the denominator received their vaccine in the third trimester where pregnancy loss would be much less,” and that “and there are no data on the outcomes of the other women who received their vaccine in the first trimester (i.e., whether they carried to term).”
Adding that, due to the very limited duration of the study, “there is also no data regarding any incidence of clotting disorders reported or any type of blood malady that may occur (e.g., spotting or bleeding during pregnancy),” he said, “in order to adequately assess these outcomes, pregnancies need to be followed to term.”