The World Health Organization (WHO) warns that Moderna’s coronavirus vaccine should not be used on pregnant women – affecting more than three million mothers in the US.
To date, there have been no vaccine trials that have included pregnant women – and this is expected to be only after the first quarter of 2021 – which means there are no safety data, the WHO says.
Researchers want to establish that the 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 higher 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,” the WHO statement released on Tuesday read. .
High-risk pregnant women include those who are front-line health care workers or have underlying conditions.
This is the same guideline that the WHO issued just three weeks ago on the Pfizer vaccine.
But doctors in the US have opposed the exclusion of pregnant women from vaccination recommendations because of their high risk of serious COVID-19 diseases, and say patients should decide for themselves whether they want the shot or not.
The World Health Organization has recommended that pregnant women not receive Moderna’s coronavirus vaccine due to a lack of safety data and should only be vaccinated if they are at high risk. Pictured: A healthcare worker donates a dose of Pfizer-BioNTech COVID-19 at Clalit Health Services in Tel Aviv on January 23
The WHO recommendation would affect more than three million pregnant women in the US, as the country still vaccinates around 1.25 million people every day (above)
In a virtual information session, Kate O’Brien, Director of Vaccination of the WHO, emphasized the need for clinical trials on the Moderna vaccine on pregnant women.
‘There is no reason to think that there may be a problem during pregnancy. We just acknowledge that the data is not currently there, ‘she said.
However, the American College of Obstetrics and Gynecology strongly opposed the exclusion of pregnant women from vaccination trials and guidance.
In a statement, the organization writes that pregnant women should choose for themselves whether they want to be vaccinated, and that they should be informed of any risks.
“Pregnant individuals 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 said.
‘Furthermore, more than half of pregnant individuals also fall into another high priority category, including frontline workers and those with underlying conditions.
“ACOG insists that the decision to vaccinate pregnant women should be left to each patient in consultation with their trusted clinician.”
There is currently no data on how many women became pregnant during Moderna’s trial against coronavirus.
During the advisory committee of the Food and Drug Administration (FDA)’s advisory committee to recommend whether Pfizer’s vaccine should be approved – the only other shot approved in the US – researchers revealed that 23 pregnancies during the trial on November 14 took place.
Of the pregnancies, 12 were among the vaccine group and 11 among the placebo group.
In the vaccine group, four were vaccinated before their last menstrual period, four within 30 days after their last menstrual period and four more than 30 days thereafter.
In the placebo group, two routes were vaccinated before their last menstrual period, six within 30 days after their last menstrual period and two more than 30 days thereafter.
No outcomes are known yet, except for one woman in the placebo group who was less than 20 weeks pregnant.
It is not uncommon for pregnant women not to include in vaccine trials.
Many gynecologists have opposed the exclusion of pregnant women from vaccination recommendations because pregnant COVID-19 patients are twice as likely to be included in treatment needs and three times more likely to require mechanical ventilation (above).
Expecting mothers, for example, was never included in flu shots, but was encouraged by doctors to get it after years of data showing that the jab behaves normally in healthy participants.
Doctors say they are concerned about pregnant women not receiving the coronavirus vaccine because the workforce is millions of pregnant women or breastfeeding women.
According to the Centers for Disease Control & Prevention (CDC), 75 percent of healthcare workers are female and approximately 330,000 healthcare workers may be pregnant or recently postpartum during the implementation of the vaccine. ‘
What’s more, the CDC data show that pregnant COVID-19 patients are twice as likely to have ICUs, and three times more likely to require mechanical ventilation than non-pregnant women with the disease.
Recently, the Association for Maternal-Fetal Medicine called on the federal government to include pregnant and lactating women in vaccine trials.
In a report in STAT News, three Johns Hopkins professors asked the FDA to allow pregnant or postpartum health workers to get the chance.
“We do not agree with the position of the British authorities that make it possible for pregnant or lactating health workers to get the vaccine, regardless of their circumstances,” they wrote.
‘If we are not able to offer vaccines to pregnant or lactating health workers, it is health care systems that must provide them with alternative protection strategies, such as protection, reimbursement or paid leave.
“Yet it may not be a viable strategy for most healthcare facilities that cannot afford to work without a significant portion of their staff.”
Expected women were not included in clinical trials and researchers are waiting to see if any women in studies became pregnant as an early indicator. Pictured: a vial of the Moderna COVID-19 vaccine is seen in a local clinic
In the UK, the Regulatory Agency (MHRA) of the Medicines and Healthcare Products issued guidelines last month making it clear that pregnant women should not be vaccinated before giving birth.
The government said this applies to vaccines that are or can be approved, including those made by Pfizer, Moderna and AstraZeneca Plc.
Women who think they may be pregnant are asked to delay the vaccination until they are sure they are not, and those who are trying a baby should not be vaccinated either.
“There is currently not enough evidence to vaccinate pregnant women against COVID-19,” said Dr. Mary Ross Davie of the UK’s College of Midwives at the time said.
“There is no evidence of harm, but there is also no current evidence of safety, as pregnant women are, as usual, excluded from all vaccination trials.”