The World Health Organization (WHO) warns that Moderna coronavirus vaccine should not be used in pregnant women – affecting more than three million expectant mothers in the US
No vaccine study has so far included pregnant women – and it is not expected to do so until after the first quarter of 2021 – which means there are no safety data, says the WHO.
Researchers want to determine if vaccines are safe and effective in healthy, non-pregnant people before testing them on expectant mothers and their future children.
“While pregnancy puts women at a higher risk of severe COVID-19, the use of this vaccine in pregnant women is not currently recommended unless they are at high risk of exposure,” the WHO statement said. published on Tuesday.
High-risk pregnant women include people who are front-line health workers or have basic 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 pregnant women being excluded from vaccination recommendations because of the high risk of severe COVID-19 disease, and say patients should decide for themselves whether or not they want the shot.
The World Health Organization has recommended that pregnant women not receive the Moderna coronavirus vaccine due to a lack of safety data and be immunized only if they are at high risk. Pictured: A healthcare worker administers a dose of Pfizer-BioNTech COVID-19 to Clalit Health Services in Tel Aviv, January 23
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)
In a virtual briefing on Tuesday, WHO’s director of immunization, Kate O’Brien, stressed the need for clinical trials with the Moderna vaccine in pregnant women.
“There is no reason to believe that there could be a problem during pregnancy, we just acknowledge that the data does not exist at this time,” she said.
However, the American College of Obstetrics and Gynecology strongly opposed it exclusion of pregnant women from vaccination and guidance studies.
In a statement, the organization wrote that pregnant women should choose whether or not to be vaccinated and be informed of any risks.
“Pregnant people are more likely to have certain manifestations of severe diseases associated with COVID-19 infection, such as admission to intensive care, mechanical ventilation and death,” the statement said.
“In addition, more than half of pregnant people also fall into another high-priority category, including front-line workers and those with basic conditions.
ACOG continues to urge that for pregnant women, the decision to vaccinate should be left to the discretion of each patient in consultation with their trusted physician.
There are currently no data on the number of women who became pregnant during the study of the Moderna coronavirus vaccine.
However, during a meeting of the Food and Drug Administration (FDA) advisory committee on whether or not to recommend Pfizer – the only other vaccine approved in the United States – the researchers revealed that 23 pregnancies occurred during the trial. November 14.
Of the pregnancies, 12 were in the vaccine group and 11 were in the placebo group.
In the vaccine group, four were immunized before their last period, four within 30 days of their last period, and four more than 30 days later.
In the placebo group, two were inoculated before their last period, six within 30 days of their last period and two more than 30 days later.
No results are known yet, except for a woman in the placebo group who had a miscarriage less than 20 weeks pregnant.
It is not uncommon for pregnant women not to be included in vaccine studies.
Many gynecologists have objected to pregnant women being excluded from vaccination recommendations because patients pregnant with COVID-19 are twice as likely to be admitted to the ICU and three times more likely to need ventilation. mechanical (above)
For example, expectant mothers were never included in influenza vaccine studies, but were encouraged by doctors to receive it after years of data showing that jaundice behaved normally in healthy participants.
Doctors say they are worried that pregnant women will not receive the coronavirus vaccine because millions of pregnant or breastfeeding women are in the workforce.
In fact, according to the Centers for Disease Control and Prevention (CDC), 75% of the health workforce is female and about 330,000 health workers could be pregnant or recently postpartum at the time the vaccine is implemented.
Moreover, data from the CDC 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 who are not pregnant with the disease.
Recently, the Society for Maternal-Fetal Medicine asked the federal government to include pregnant and lactating women in vaccine studies.
And, in an article published in STAT News, three professors at Johns Hopkins asked the FDA to allow pregnant or postpartum health workers to be allowed to receive the shot.
“We do not agree with the position of the British authorities which could make it impossible for pregnant or breastfeeding workers to receive the vaccine regardless of their circumstances,” they wrote.
“If we are not able to provide vaccines to pregnant or breastfeeding health workers, it is up to health care systems to offer them alternative protection strategies, such as protection, reassignment or paid leave.
However, this may not be a viable strategy for most healthcare facilities, which cannot afford to operate without a significant share of the workforce.
Pregnant women have not been included in clinical trials, and researchers are waiting to see if the women in the studies became pregnant as an early indicator. Pictured: An ampoule of the Modern COVID-19 vaccine is seen at a local clinic
In the UK, the Medicines and Health Products Regulatory Agency (MHRA) issued guidelines last month stating that pregnant women should not be inoculated until after they have given birth.
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 might be pregnant are urged to delay vaccination until they are sure they are not, and those trying a baby should not be immunized either.
“There is currently insufficient evidence to recommend vaccination of 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 no current evidence of safety, as pregnant women have been, as usual, excluded from all vaccination studies.”