The World Health Organization (WHO) warns that Moderna’s coronavirus vaccine should not be used in pregnant women – affecting more than three million pregnant women in the United States
No vaccine trial to date has included pregnant women – and they are not expected to do so before the first quarter of 2021 – which means that there is no safety data, says the WHO.
The researchers want to determine whether vaccines are safe and effective in healthy, non-pregnant people, before testing them on future mothers and their future children.
“Although pregnancy puts women at greater risk for severe COVID-19, the use of this vaccine in pregnant women is currently not recommended unless they are at risk of high exposure,” says the WHO statement released on Tuesday.
High-risk pregnant women include those who are frontline health professionals or with underlying diseases.
This is the same guidance that the WHO released about the Pfizer vaccine just three weeks earlier.
But doctors in the United States are opposed to excluding pregnant women from vaccine recommendations due to the high risk of serious illnesses with COVID-19 and say that patients must decide for themselves whether or not they want the vaccine.
The World Health Organization recommended that pregnant women not receive the coronavirus vaccine from Moderna due to a lack of safety data and should only be immunized if they were at high risk. Pictured: A healthcare professional administers a dose of Pfizer-BioNTech COVID-19 at the Clalit Health Services in Tel Aviv, January 23
The WHO recommendation will affect more than three million pregnant women in the United States, as the country continues to vaccinate about 1.25 million people every day (above)
In a virtual briefing on Tuesday, WHO director of immunization Kate O’Brien emphasized that clinical trials of the Modern vaccine are needed in pregnant women.
“There is no reason to think there could be a problem with pregnancy, we are just recognizing that the data is not there at the moment,” she said.
However, the American College of Obstetrics and Gynecology has been vehemently against the exclusion of pregnant women from vaccination trials and guidelines.
In a note, the organization wrote that pregnant women must decide 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 illnesses associated with COVID-19 infection, such as admission to the ICU, mechanical ventilation and death,” says the statement.
In addition, more than half of pregnant women also fall into another high priority category, including frontline workers and those with underlying diseases.
‘ACOG continues to urge that, for pregnant women, the decision to vaccinate should be left to each patient, in consultation with their trusted doctor.’
Currently, there is no data on how many women became pregnant during the trial of the vaccine against Cormorant virus from Moderna.
However, during the Food and Drug Administration (FDA) advisory committee meeting on the recommendation of whether or not to approve the Pfizer vaccine – the only other injection approved in the United States – the researchers revealed that 23 pregnancies occurred during the study in 14 from November.
Of the pregnancies, 12 were in the vaccine group and 11 were in the placebo group.
In the vaccine group, four were immunized before the last menstrual period, four within 30 days after the last menstrual period and four more than 30 days later.
In the placebo group, two were inoculated before the last menstrual period, six within 30 days after the last menstrual 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 not to include pregnant women in vaccine trials.
Many gynecologists are opposed to excluding pregnant women from vaccine recommendations because pregnant patients with COVID-19 are twice as likely to be admitted to ICUs and three times as likely to require mechanical ventilation (above)
For example, pregnant women were never included in the flu vaccine studies, but they were encouraged by doctors to obtain it after years of data showing that the vaccine behaved normally in healthy participants.
Doctors say they are concerned that pregnant women do not receive 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 the health workforce is female and about 330,000 health workers’ may be pregnant or recently postpartum at the time vaccine implementation ‘.
Furthermore, CDC data show that pregnant patients with COVID-19 are twice as likely to be admitted to ICUs and three times as likely to need mechanical ventilation as non-pregnant women with the disease.
The Society for Maternal-Fetal Medicine recently called on the federal government to include pregnant and lactating women in vaccine trials.
And, in an opinion article in STAT News, three Johns Hopkins professors urged the FDA to allow pregnant or postpartum health workers to receive the injection.
“We disagree with the UK authorities’ position that it may make it impossible for pregnant or nursing mothers to receive the vaccine, regardless of their circumstances,” they wrote.
‘If we are unable to offer vaccines to pregnant or lactating health professionals, it is the responsibility of health systems to offer them alternative protection strategies, such as protection, transfer or paid leave.
‘However, this may not be a viable strategy for most healthcare facilities, which cannot operate without a significant portion of their workforce.’
Pregnant women were not included in the clinical trials and the researchers are waiting to see if any women in the studies became pregnant as an early indicator. In the photo: a vial of the vaccine Moderna COVID-19 is seen at a local clinic
In the United Kingdom, the Medicines and Health Products Regulatory Agency (MHRA) issued guidelines last month, making it clear that pregnant women should not be vaccinated before delivery.
The government said that this applies to vaccines that have been or may be approved, including those made by Pfizer, Moderna and AstraZeneca Plc.
Women who think they may be pregnant should postpone vaccination until they are sure they are not, and those who are trying to have a baby should also not be immunized.
“There is currently insufficient evidence to recommend vaccination of pregnant women against COVID-19,” said Dr. Mary Ross Davie of the UK’s Royal College of Midwives at the time.
“There is no evidence of harm, but there is also no current safety evidence, as pregnant women were, as is normal, excluded from all vaccination tests.”