NIH launches study looking at effectiveness of COVID-19 vaccines in pregnant women

The U.S. National Institutes of Health (NIH) has launched a study looking at the immune responses generated by COVID-19 vaccines in pregnant or postpartum women.

Called MOMI-VAX, the study will measure the development and longevity of antibodies in women vaccinated during pregnancy or the first two months after giving birth.

The researchers will also analyze the safety of the vaccines and whether or not vaccinated pregnant women can along protection to their babies via the placenta or breast milk. 

The findings will be especially important, considering the increased risk of severe disease and death that expecting mothers face from COVID-19 and the risk that newborns will face, considering there is no vaccine approved for their age.   

A new NIH study will enroll 750 pregnant women and 250 mothers who have given birth within the last two months to measure the development and longevity of antibodies generated by COVID-19 vaccines. Pictured: Nurse Rita Rojas inoculates a pregnant woman with a dose of the Moderna COVID-19 vaccine, June 2021

Pregnant women were not included in the clinical trials for any of the COVID-19 vaccines that have been approved in the U.S. despite their increased risk.

This practice is common in clinical trials because researchers do not want to risk the health of mothers-to-be. 

Pregnant women are at higher risk of complications from COVID-19 including premature birth, high blood pressure with organ failure risk, need for intensive care and possible death, according to the NIH.  

Federal regulators said there no were no safety concerns about COVID-19 vaccines, but that they could no make guarantees to pregnant women without sufficient data.

In January, the World Health Organization (WHO) warned that COVID-19 vaccines should not be used on pregnant women – and then walked back its advice and said vaccines can be administered in expectant mothers safely.

A research study conducted in February in Israel showed that antibodies were detected in all 20 women administered with both the doses of the Pfizer-BioNTech vaccine during their third trimester of pregnancy and also in their newborns.

Pfizer and BioNTech in February started a separate trial, with 4,000 international volunteers, evaluating safety and effectiveness of their COVID-19 vaccine in healthy pregnant women. 

The CDC currently recommends that women consult with their doctors to make a choices and make a risk-benefit analysis of the risk of severe COVID-19 compared to the unknowns of a new vaccine. 

Recent CDC data found that by May, just 16 percent of mothers-to-be in the U.S. had received at least one dose of a coronavirus vaccine. 

‘Tens of thousands of pregnant and breastfeeding people in the United States have chosen to receive the COVID-19 vaccines available under emergency use authorization,’ Dr Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, said in a press release.  

‘However, we lack robust, prospective clinical data on vaccination in these populations.

‘The results of this study will fill gaps in our knowledge and help inform policy recommendations and personal decision-making on COVID-19 vaccination during pregnancy and in the postpartum period.’

The trial will enroll up to 750 pregnant and 250 postpartum women within two months of delivery, who have already received or will receive a COVID-19 vaccine authorized by the U.S. Food and Drug Administration (FDA)

Women and babies will be followed through their first birthday to see  how well vaccines generated antibodies and if there is a vaccine type that works best.

Pregnant mothers will have their blood drawn at the start of the study and one month after vaccination as well as samples drawn every two months after giving birth.

Infants will be analyzed through samples of umbilical cord blood drawn at delivery and through samples taken at two months old and six months old.

Currently just three COVID-19 vaccines are authorized for emergency use under the FDA – from Moderna, Pfizer-BioNTech and Johnson & Johnson – but the study is designed to allow up to five vaccines to be analyzed.