The World Health Organization (WHO) warns that Moderna’s coronavirus vaccine should not be used in pregnant women – this affects more than three million expectant mothers in the US.
So far no vaccine studies have been conducted on pregnant women – and that is not expected to happen until after the first quarter of 2021 – meaning there is no safety data, WHO says.
Researchers want to determine that the vaccines are safe and effective in healthy, non-pregnant people before testing them on mothers-to-be and their future children.
Although pregnancy puts women at higher risk of severe COVID-19, the use of this vaccine in pregnant women is not currently recommended unless they are at risk of high exposure, the WHO statement released Tuesday.
High-risk pregnant women include those who are primary care health professionals or who have underlying conditions.
This is the same guideline that the WHO issued on the Pfizer vaccine just three weeks earlier.
But doctors in the US oppose excluding pregnant women from vaccine recommendations because of their high risk of serious illness from COVID-19 and say patients should decide for themselves whether they want the injection or not.
The World Health Organization has recommended pregnant women not to receive Moderna’s coronavirus vaccine due to a lack of safety data and only be immunized if they are at high risk. Pictured: A health professional administers a dose of Pfizer-BioNTech COVID-19 at Clalit Health Services, in Tel Aviv, Jan. 23
WHO recommendation affects more than three million pregnant women in the US as the country continues to vaccinate about 1.25 million people every day (above)
In a virtual briefing on Tuesday, Kate O’Brien, WHO’s director of immunization, stressed that clinical trials of the Moderna vaccine are needed in pregnant women.
“There is no reason to think there could be a problem in pregnancy, we just recognize that the data is not there right now,” she said.
However, the American College of Obstetrics and Gynecology is vehemently against it the exclusion of pregnant women from vaccination trials and counseling.
In a statement, the organization wrote that pregnant women should choose whether or not they want to be vaccinated and be informed of any risks.
“Pregnant individuals are more likely to have certain manifestations of serious illness related to COVID-19 infection, such as IC admission, mechanical ventilation, and death,” the statement read.
Furthermore, more than half of pregnant individuals also fall into another high-priority category, including front-line workers and those with underlying conditions.
“ACOG continues to insist that for pregnant individuals, the decision to vaccinate should be left to each patient in consultation with their trusted physician.”
There is currently no data on how many women became pregnant during the trial with Moderna’s coroan virus vaccine.
However, at the Food and Drug Administration (FDA) advisory committee meeting on whether or not to approve Pfizer’s vaccine – the only other shot approved in the US – researchers revealed that 23 pregnancies occurred in the process as of November 14.
Of the pregnancies, 12 belonged to the vaccine group and 11 to the placebo group.
In the vaccine group, four were immunized before their last menses, four within 30 days of their last menses, and four more than 30 days after.
In the placebo group, two contractions were vaccinated prior to their last period, six within 30 days of their last period and two more than 30 days after.
No outcomes are yet known, except for a woman in the placebo group who miscarried after a pregnancy of less than 20 weeks.
It is not uncommon not to include pregnant women in vaccine studies.
Many gynecologists oppose excluding pregnant women from vaccine recommendations because pregnant COVID-19 patients are twice as likely to be admitted to ICUs and three times more likely to be on mechanical ventilation (above)
For example, expectant mothers were never included in studies of flu shots, but were encouraged by doctors to get it after years of data showing that the shot was behaving normally in healthy participants.
Doctors say they are concerned about pregnant women not getting the coronavirus vaccine because millions of pregnant or breastfeeding women make up the workforce.
In fact, according to the Centers for Disease Control and Prevention (CDC), 75 percent of health care workers are women, and about 330,000 health workers “could be pregnant or recently postpartum at the time the vaccine is implemented.”
In addition, data from the CDC shows that pregnant COVID-19 patients are twice as likely to be admitted to ICUs and three times more likely to be on mechanical ventilation than non-pregnant women with the disease.
Recently, the Society for Maternal-Fetal Medicine called on the federal government to involve pregnant and lactating women in vaccine studies.
And, in an opinion piece in STAT News, three Johns Hopkins professors urged the FDA to give pregnant or postpartum health workers permission to receive the shot.
“We disagree with the position of the UK authorities that it may make it impossible for pregnant or nursing health workers to receive the vaccine regardless of their circumstances,” they wrote.
‘If we cannot offer vaccines to pregnant or nursing primary health care workers, it is up to health systems to offer them alternative protection strategies such as foreclosure, relocation or paid time off.
“Still, this may not be a viable strategy for most healthcare facilities, which cannot afford to work without a significant portion of their workforce.”
Expectant women are not included in clinical studies, and researchers are waiting to see if women in studies became pregnant as an early indicator. Pictured: A vial of the Moderna COVID-19 vaccine is seen at a local clinic
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) last month issued guidelines making it clear that pregnant women should not be vaccinated until after delivery.
The government said this applies to vaccines that have been or could be approved, including those made by Pfizer, Moderna and AstraZeneca Plc.
Women who think they may be pregnant are urged to delay vaccination until they are sure they are not, and those trying to have a baby should not be immunized either.
“Currently, there is not enough evidence to recommend vaccinating pregnant women against COVID-19,” said Dr. Mary Ross Davie of the British Royal College of Midwives at the time.
“There is no evidence of harm, but there is also no current evidence of safety, as pregnant women were, as usual, excluded from all vaccination studies.”