The National Institutes of Health (NIH) of the US has started a new clinical study, MOMI-VAX, to assess immune responses induced by Covid-19 vaccines in pregnant or postpartum individuals.
During the study, the development and durability of antibodies against the Covid-19 virus will be measured in participants who get inoculated during pregnancy or the initial two months of postpartum.
It will also monitor the safety of the vaccines, along with the transfer of vaccine-generated antibodies to infants across the placenta and via breast milk.
The study is funded by the NIH unit National Institute of Allergy and Infectious Diseases (NIAID) and carried out by the NIAID-backed Infectious Diseases Clinical Research Consortium (IDCRC).
Pregnant individuals who contract Covid-19 are at more risk of hospitalisation, admission to the intensive care unit, mechanical ventilation, and death from the infection compared to non-pregnant people.
Severe Covid-19 in pregnant individuals may cause complications such as preterm birth for infants.
Studies are being conducted to assess Covid-19 vaccines in this population and data so far indicate safety, noted NIH.
The latest study will build on these studies and will offer better insights into antibody responses to Covid-19 vaccines among pregnant and postpartum individuals. It will also help understand the transfer of antibodies to their infants.
NIAID director Anthony Fauci 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.”
Up to 750 pregnant subjects and 250 postpartum subjects within two months of delivery will be enrolled. Participants must have received or will get any US Food and Drug Administration authorised or licenced Covid-19 vaccine.
Their infants will also be part of the study.
Vaccines will not be administered as part of the study protocol. Participants will be followed up through the first year post-delivery.
While the study is designed to evaluate up to five types of Covid-19 vaccines, only Moderna and Pfizer-BioNTech mRNA vaccines and the Johnson & Johnson adenoviral vector vaccine are currently available in the US.
Earlier this month, NIH initiated a Phase I/II trial to evaluate the safety and immunogenicity of mixed Covid-19 vaccine regimens.