23rd September 2023
Several vulnerable groups, such as pregnant and lactating women, have been excluded from the initial vaccine clinical trials.
The possible passage of the vaccine mRNA to breast milk (BM), resulting in neonatal exposure, was not investigated.
As a result, limited research has been conducted on the systemic distribution of vaccine mRNA during lactation,
and whether it is excreted in human breast milk (BM).
We evaluated if COVID-19 vaccine mRNA is detectable in breast milk after maternal vaccination,
and determined its potential translational activity.
Methods
We collected breast milk samples from 13 lactating, healthy, post-partum women before and after COVID-19 mRNA vaccination.
Vaccine mRNA in whole breast milk and BM extracellular vesicles (EVs) assayed using quantitative Droplet Digital PCR,
and its integrity and translational activity were evaluated.
Findings
Of 13 lactating women receiving the vaccine (20 exposures),
trace mRNA amounts were detected in 10 exposures,
up to 45 hours post-vaccination.
The mRNA was concentrated in the breast milk extracellular vesicles (EVs);
This can be significant as the breast milk extracellular vesicles act as natural LNPs, protecting the mRNA from degradation.
Milk-derived EVs are resistant to proteolysis by gastric and pancreatic secretions and can be readily absorbed by intestinal epithelial cells
However, these EVs neither expressed SARS-COV-2 spike protein,
nor induced its expression in the HT-29 cell line.
However, positive control samples used in concentrations similar to those of BM EVs also failed to induce S protein expression.
Vaccine mRNA integrity was reduced to 12-25% in BM.