MOMI-VAX is conducted by the NIAID-funded Infectious Diseases Clinical Research Consortium (IDCRC). Researchers will measure the development and durability of antibodies against SARS-CoV-2, the virus that causes COVID-19, in people vaccinated during pregnancy or the first two postpartum months. Researchers also will assess vaccine safety and evaluate the transfer of vaccine-induced antibodies to infants across the placenta and through breast milk.
"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. However, we lack robust, prospective clinical data on vaccination in these populations," said NIAID Director Anthony S. Fauci, M.D., "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."
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Pregnant people with COVID-19 are more likely to be hospitalized, be admitted to the intensive care unit, require mechanical ventilation, and die from the illness than their non-pregnant peers. Severe COVID-19 during pregnancy also may put the infant at risk for complications such as preterm birth. Individuals who are pregnant or breastfeeding can choose to receive authorized COVID-19 vaccines, and studies to gather safety data in these populations are ongoing. So far, COVID-19 vaccines appear to be safe in these populations. The NIAID study will build on these studies by improving the understanding of antibody responses to COVID-19 vaccines among pregnant and postpartum people and the transfer of antibodies to their infants during pregnancy or through breast milk.
Investigators will enroll up to 750 pregnant individuals and 250 postpartum individuals within two months of delivery who have received or will receive any COVID-19 vaccine authorized or licensed by the U.S. Food and Drug Administration. Their infants also will be enrolled in the study. Vaccines are not provided to participants as part of the study protocol. Currently, three COVID-19 vaccines are available in the United States under emergency use authorization: the Moderna and Pfizer-BioNTech mRNA vaccines and the Johnson & Johnson adenoviral vector vaccine. The study is designed to assess up to five types of FDA-licensed or authorized COVID-19 vaccines, should additional options become available.
The investigators will evaluate breast milk antibodies to assess the potential for protection against COVID-19 in breastfed infants. Study staff also will gather information on COVID-19 illnesses in pregnant and postpartum participants, birth and neonatal outcomes, and COVID-19 illnesses in infant participants.
