The World Health Organization (WHO) warns that Moderna coronavirus vaccine should not be used in pregnant women, affecting more than three million pregnant mothers in the US
So far, no vaccine trials have included pregnant women and are not expected to pass in the first trimester of 2021, which means there are no safety data, according to the WHO.
Researchers want to determine that vaccines are safe and effective in healthy, non-pregnant people before testing them on expectant mothers and their future children.
“Although pregnancy poses a higher risk of COVID-19 in women, the use of this vaccine is not currently recommended in pregnant women unless they have a high risk of exposure,” the statement said. the WHO published this Tuesday.
High-risk pregnant women include those who are front-line health workers or who have underlying conditions.
This is the same guidance that the WHO issued on the Pfizer vaccine just three weeks earlier.
But doctors in the United States have opposed excluding pregnant women from vaccine recommendations because of their high risk of serious COVID-19 disease and say patients should decide whether or not to want the vaccine.
The World Health Organization has recommended that pregnant women not receive the Moderna coronavirus vaccine due to lack of safety data and should only be immunized if they are at high risk. Pictured: A health worker administers a dose of Pfizer-BioNTech COVID-19 to Clalit Health Services in Tel Aviv on January 23
The WHO recommendation will affect more than three million pregnant women in the US, as the country continues to vaccinate about 1.25 million people every day (above)
On Tuesday, in a virtual briefing, WHO vaccination director Kate O’Brien stressed the need for clinical trials of the Modern vaccine in pregnant women.
“There’s no reason to think there might be a problem during pregnancy, we just acknowledge that the data isn’t there right now,” she said.
However, the American College of Obstetrics and Gynecology has strongly opposed it the exclusion of pregnant women from vaccination trials and guidelines.
In a statement, the organization wrote that pregnant women should choose whether or not to get vaccinated and be informed of any risks.
“Pregnant people are more likely to have certain manifestations of serious illnesses associated with COVID-19 infection such as ICU admission, mechanical ventilation and death,” the statement says.
“In addition, more than half of pregnant women also belong to another high-priority category, including front-line workers and those with underlying conditions.
“ACOG continues to urge that, for pregnant people, the decision to vaccinate should be left to each patient in consultation with their trusted physician.”
There are currently no data on how many women became pregnant during the Moderna coronavirus vaccine process.
However, during the Food and Drug Administration (FDA) advisory committee meeting on whether or not to approve the Pfizer vaccine (the only other feature approved in the U.S.), the researchers revealed that during the trial they produced 23 pregnancies on November 14th.
Of the pregnancies, 12 were from the vaccine group and 11 from the placebo group.
In the vaccine group, four were immunized before their last menstruation, four in the 30 days following their last menstruation, and four more than 30 days later.
In the placebo group, two small inoculations before their last menstrual period, six within 30 days after the last menstrual period, and two more than 30 days later.
No results are known yet, apart from a woman in the placebo group who had a miscarriage less than 20 weeks pregnant.
It is not uncommon not to include pregnant women in vaccine trials.
Many gynecologists have objected to excluding pregnant women from vaccine recommendations because patients pregnant with COVID-19 are twice as likely to be admitted to the ICU and three times more likely to need mechanical ventilation (above).
For example, expectant mothers have never been included in studies on the flu vaccine, but doctors have encouraged them to get it after years of data showing that jab behaved normally in healthy participants.
Doctors say they are concerned that pregnant women will not receive the coronavirus vaccine because millions of pregnant or breastfeeding women make up the staff.
In fact, according to the Centers for Disease Control and Prevention (CDC), 75 percent of the health workforce is female and about 330,000 health workers “could be pregnant or recently after childbirth at the time of implementation. of the vaccine “.
In addition, CDC data show that patients pregnant with COVID-19 are twice as likely to be admitted to the ICU and three times more likely to need mechanical ventilation than women not pregnant with the disease.
Recently, the Society for Maternal-Fetal Medicine asked the federal government to include pregnant and lactating women in vaccine trials.
And, in a post published in STAT News, three Johns Hopkins professors urged the FDA to allow pregnant or postpartum health workers to receive the shot.
“We do not agree with the position of the UK authorities which may make pregnant or nursing healthcare workers unable to make the vaccine impossible regardless of their circumstances,” they wrote.
“If we cannot offer vaccines to pregnant or breastfeeding health workers, it is up to health systems to offer them alternative protection strategies such as protection, reassignment or paid leave.
“Still, this may not be a viable strategy for most health centers, which cannot afford to operate without a significant portion of their workforce.”
Pregnant women have not been included in clinical trials and researchers are waiting to see if any women in the studies became pregnant as the first indicator. In the photo: a vial of the Modern COVID-19 vaccine is seen in a local clinic
In the UK, the Medicines and Health Products Regulatory Agency (MHRA) published guidelines last month to make it clear that pregnant women should not be inoculated until they have given birth.
The government said this applies to vaccines that have been or could be approved, including those manufactured by Pfizer, Moderna and AstraZeneca Plc.
Women who believe they may be pregnant are asked to delay vaccination until they are sure they are not, and people trying to have a baby should not be immunized either.
“There is currently insufficient evidence to recommend vaccinating pregnant women against COVID-19,” said Dr Mary Ross Davie of the Royal College of Midwives in the UK at the time.
“There is no evidence of harm, but there is also no current safety evidence, as pregnant women were excluded, as is normal, from all vaccination trials.”