The National Institute of Health (NIH) has initiated a study, called MOMI-VAX, to assess the development and durability of antibodies against SARS-CoV-2, in women who were vaccinated during pregnancy or during the first two postpartum months. The study will also undertake to examine vaccine safety and transfer of vaccine-induced antibodies to infants through the placenta and breast milk.

Up to 750 pregnant women and 250 postpartum women within two months of delivery who have received or will receive any currently US FDA approved COVID-19 vaccine (Moderna, Pfizer-BioNTech or Johnson & Johnson), will be recruited for the trial; up to five types of Covid vaccines can be assessed. The study will also enrol the infants born to the participants. Vaccines are not provided to participants as part of the study protocol. Blood samples would be collected at the time of entry into the trial; at delivery for participants who enroled during pregnancy and two, six, and 12 months after delivery for analysis. For pregnant women who enrolled in the study before taking the vaccine, samples would be collected at enrolment and one month after vaccination. Participants and their infants would be followed through the first year after delivery. Antibody testing would be done on samples drawn from umbilical cord blood collected at delivery and from infants two and six months after delivery.

The potential effects on maternal immune responses and transfer of antibodies across the placenta according to the mother’s age, the trimester of pregnancy during which the vaccine was received, the mother’s health, and the mother’s COVID-19 risk status would also be evaluated. Mothers will have the option of providing breast milk samples at approximately two weeks, two months, six months, and 12 months after delivery. Evaluation of breast milk antibodies will help assess the potential for protection against COVID-19 in breastfed infants.

Pregnant women are a vulnerable group and are at increased risk for severe illness from Covid-19. 

The CDC says that pregnant women can receive a COVID-19 vaccine, although data on the safety of COVID-19 vaccines in pregnant people is limited. WHO recommends that for pregnant women the use of the COVID-19 vaccine be considered on the basis of a benefit vs risk assessment. It recommends vaccinating pregnant women if they are at high risk of exposure to Covid, and if they have co-morbid conditions

However, in India, vaccination of pregnant women is not yet allowed due to lack of clinical trial data, even though the National Technical Advisory Group on Immunisation in India (NTAGI) has recommended that “pregnant women should not be excluded from vaccination because exposure probability is very high and therefore the benefit far outweighs the risk. However, before vaccination, pregnant women should be fully informed that the long-term adverse reactions, and the safety of the vaccine for fetus and child is not yet established.”

Dr Anthony S. Fauci, NIAID Director said, “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.”

(Source: NIH, June 23, 2021)