No vaccine trials to date have included pregnant women – and they are not expected to until after the first quarter of 2021 – meaning there is no safety data, the WHO says.
Researchers want to determine the vaccines are safe and effective in healthy, non-pregnant people before testing them in mothers-to-be 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 currently not recommended, unless they are at risk of high exposure,’ the WHO’s statement released on Tuesday read.
Pregnant women at high risk include those who are frontline healthcare workers or having underlying conditions.
This is the same guidance that the WHO issued about the Pfizer vaccine just three weeks earlier.
But doctors in the U.S. have opposed pregnant women being excluded from vaccine recommendations due to their high risk of severe illness from COVID-19 and say the patients should decide themselves whether or not they want the shot.
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 immunized if they are at high risk. Pictured: A health worker administers a dose of the Pfizer-BioNTech COVID-19 at Clalit Health Services, in Tel Aviv, January 23
The WHO’s recommendation will affect more than three million pregnant women in the U.S. 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 that clinical trials of the Moderna vaccine are needed on pregnant women.
‘There is no reason to think there could be a problem in pregnancy, we are just acknowledging the data is not there at the moment,’ she said.
However, the American College of Obstetrics and Gynecology has been staunchly against the exclusion of pregnant women from vaccination trials and guidance.
In a statement, the organization wrote that pregnant women should choose themselves whether or not they want to be vaccinated and be informed of any risks.
‘Pregnant individuals are more likely to have certain manifestations of severe illness associated with COVID-19 infection such as ICU admission, mechanical ventilation, and death,’ the statement reads.
‘Further, upwards of half of pregnant individuals also fall into another high-priority category, including frontline workers and those with underlying conditions.
‘ACOG continues to urge that for pregnant individuals, the decision to vaccinate must be left to each patient in consult with their trusted clinician.’
There is currently no data on how many women became pregnant during Moderna’s coroanvirus vaccine trial.
However, during the Food and Drug Administration’s (FDA) advisory committee meeting on recommending whether or not approve Pfizer’s vaccine – the only other shot approved in the U.S. – researchers revealed 23 pregnancies occurred during the trial as of November 14.
Of the pregnancies, 12 were among the vaccine group and 11 were among the placebo group.
In the vaccine group, four were immunized prior to their last menstrual period, four within 30 days after their last menstrual period and four more than 30 days after.
In the placebo group, two wee inoculated prior to their last menstrual period, six within 30 days after their last menstrual period and two more than 30 days after.
No outcomes are known yet aside from one woman in the placebo group who had a miscarriage at less than 20 weeks’ gestation.
It is not uncommon to not include pregnant women in vaccine trials.
Many gynecologists have opposed pregnant women being excluded from vaccine recommendations because pregnant COVID-19 patients are twice as likely to be admitted to ICUs and three times more likely to need mechanical ventilation (above)
For example, expecting mothers have never been included in flu shot studies, but have been encouraged by doctors to get it after years of data showing the jab behaved normally in healthy participants.
Doctors say they are concerned about pregnant women not receiving 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-care workforce are female and about 330,000 healthcare workers ‘could be pregnant or recently postpartum at time of vaccine implementation.’
What’s more, data from the CDC show pregnant COVID-19 patients are twice as likely to be admitted to ICUs and three times more likely to need mechanical ventilation than non-pregnant women with the disease.
Recently, the Society for Maternal-Fetal Medicine called on the federal government to include pregnant and lactating women in vaccine trials.
And, in an op-ed in STAT News, three professors from Johns Hopkins urged the FDA to allow pregnant or postpartum healthcare workers to be allowed to receive the shot.
‘We disagree with the position of the UK authorities that may make it impossible for pregnant or lactating health workers to get the vaccine regardless of their circumstances,’ they wrote.
‘If we are unable to offer vaccines to pregnant or lactating frontline health workers, it is incumbent upon health care systems to offer them alternative protection strategies such as shielding, reassignment, or paid leave.
‘Yet this may not be a viable strategy for most health care facilities, which cannot afford to operate without a significant portion of their workforce.’
Expectant women have not been 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 at a local clinic
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) issued guidelines last month making it clear pregnant women should not be inoculated until after they have given birth.
The government said this applies for 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 certain they are not, and those trying for a baby should not be immunized either.
‘Currently there is not enough evidence to recommend vaccinating pregnant women against COVID-19,’ Dr Mary Ross Davie from the UK’s Royal College of Midwives said at the time.
‘There is no evidence of harm, but there is also no current evidence of safety as pregnant women were, as is normal, excluded from all of the vaccination trials.’
WHAT ARE PREGNANCY GUIDELINES FOR OTHER VACCINES?
Vaccinations during pregnancy are done for some illnesses but not for others, and it can depend on the type of jab being used and the balance of risk. Women should always consult a pharmacist or doctor about vaccines before, during or shortly after pregnancy for proper advice.
The NHS generally doesn’t advise that women have ‘live’ vaccines while they’re pregnant. These are jabs that have functioning, but weakened, viruses inside them to stimulate the immune system.
Doctors may choose not to give these because there is a small risk that the virus, although it is usually damaged enough not to make it past an adult’s immune system and cause illness, could infect the baby.
These vaccines may be used, however, if there is a greater risk posed to the baby by the mother catching the illness for real, depending on how likely this is and how dangerous the illness is.
Live vaccines that may not be recommended include:
- Tuberculosis BCG jab
- Measles, mumps and rubella (MMR)
- Yellow fever
On the other hand, some vaccines are actively recommended to women who are pregnant.
The flu jab, for example, is offered for free to pregnant women because the virus becomes so widespread during the winter, making the mother likely to catch it, and the possibility that it can cause serious complications in the mum, such as pneumonia.
Mothers-to-be are also encouraged to get vaccinated against whooping cough (pertussis) because the illness can be very severe for babies.
Both the flu and whooping cough vaccines given to pregnant women would be ‘inactivated’ vaccines, which means the fragments of virus and bacteria they contain are dead, which eliminates the risk of the baby or mother getting infected.
Pregnant women are advised not to go to parts of the world where travel vaccines might be needed.