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Moderna will begin studying the COVID vaccine in pregnant women, according to a post on ClinicalTrials.gov. The observational study, expected to begin July 22, will enroll about 1,000 women over the age of 18 to be studied over a 21-month period.
Women who received a Moderna vaccine within 28 days before their last menstrual period, or at any time during pregnancy, is appropriate.
The study measured the number of participants with infants with suspected major and minor childhood behaviors, the number of participants with any pregnancy complications, the number of participants with any consequences of pregnancy and the number of participants with infantile outcomes, Reported by Fox Business.
Today, the Centers for Disease Control and Prevention (CDC) states pregnant women can have a COVID vaccine But the CDC also recognizes that there is limited data available about the safety of COVID vaccines for pregnant people.
The CDC said on the website:
“There is no evidence that there is a risk to the fetus from vaccinating pregnant women with fewer vaccines in general. However, the potential risks of the COVID-19 vaccine to pregnancy and fetus are unknown, as the vaccines have not been studied in pregnant women. “
Agreed to CDC website, through June 29, data collected from the CDC and the U.S. Food and Drug Administration’s (FDA) safety monitoring systems did not recognize “any safety concerns for vaccinated pregnant women or their infants,” but the agencies emphasized that the findings were preliminary.
Experts urge caution
Margulis said The Protector in an email:
“We don’t have long-term studies showing it’s safe. We made it wrong diethylstilbestrol -a synthetic estrogen thought to be safe during pregnancy that was later found to cause aggressive (and sometimes fatal) genital cancer in young adolescents prescribed by its mothers. “
Margulis believes it is irresponsible, and even inappropriate, to state that we know the Moderna vaccine is safe for pregnancy.
“It is necessary to use principle of precaution advent of more experimental technology. The burden of proof must be borne by the intervention. We have no evidence that it is safe. but sufficient evidence shows a risk of exposing pregnant and unborn children to drugs and interventions that can destroy resistance. ”
the latest data from the Vaccine Adverse Events Reporting System (VAERS) – one of the safety monitoring systems regulated by the FDA and CDC – received 2,678 reports of adverse events related to the COVID vaccine in pregnant women, including 994 reports of getting pregnant or not at the time of birth between December 14, 2020 and July 2, 2021.
There is a lack of data examining the safety of COVID vaccines in pregnant women
Since it was granted by the FDA in December 2020 Emergency Use Permit (EUA) for COVID vaccines, the CDC has recommended pregnant women can be the vaccine is offered – despite the fact that pregnant women excluded from initial approval clinical trials, and despite limited data on the safety and efficacy of COVID vaccines during pregnancy.
In January, the World Health Organization said women were pregnant cannot receive a COVID vaccine. A week later, the agency changes its instruction and advised everyone to take, including pregnant women.
According to a March 1 safety updates through the CDC’s vaccine safety panel on COVID vaccine and pregnancy, safety monitoring after approval and research is the primary way the CDC obtains COVID vaccination safety data during pregnancy.
That is, the vaccine is given to pregnant women before studies have determined whether the vaccine is safe for that population. the CDC website said 133,466 pregnant women had received a COVID vaccine as of July 12.
“It’s like bass-ackwards to release the vaccine to pregnant women before doing a clinical trial or proper animal study,” said Lyn Redwood, RN, MSN and president emerita of Protecting the Health of Children.
“Will the vaccine lipid nanoparticle penetrate the placenta? If so, what is the impact on children in relation to illness or death? These are the questions we need to ask. Pregnancy used to be a time where we protected the mother and baby from any potential harm, especially in the first trimester. ”
The proposed study, “Preliminary Findings of mRNA Covid-19 Safe Vaccine in Pregnant People, ”Relied on multiple vaccine surveillance systems from December 2020 to February to assess safety in Pfizer-BioNTech and Moderna vaccines to more than 35,000 pregnant women who choose to be vaccinated after vaccines are approved for emergency use.
A Utah teenager remains hospitalized with three blood clots in and in his brain developed after he received the first dose of Pfizer’s COVID vaccine. #TheDefender
– Robert F. Kennedy Jr. (@RobertKennedyJr) May 11, 2021
The study authors said they found no increased risk during pregnancy, or birth complications or known fetal risks among vaccine recipients.
Shortly afterwards, the The CDC was reformed its official recommendations that pregnant women receive a COVID vaccine are in line with study data collected over two months.
Brian Hooker, Ph.D., PE, chief scientific officer at Children’s Health and professor of biology at Simpson University, said the consequences of miscarriage were overwhelming.
Hooker told The Defender:
“Most of the denominator received their vaccine in the third trimester where pregnancy losses may be less. Most pregnancy losses are in the first trimester and there is no data on the outcomes of other women who received their vaccine in first trimester (i.e., whether it is carried over to term), or data on the temporal relationship between receiving the vaccine and getting pregnant where suspected.
“There are also no data on any incidence of clotting disorders reported or any other blood disorders that may occur (e.g., spotting or bleeding during pregnancy), and treatment with neonatal outcomes is very limited. (no APGAR score, etc.) due to the very limited duration of the study.
“This is the typical ‘not seen here’ propaganda of the CDC and its irrelevant role about the consequences of pregnancy. In order to properly assess its consequences, pregnancies must be followed to the end.”