Is breastfeeding post COVID-19 vaccination is safe?

COVID-19 mRNA vaccines play a vital role in the fight against SARS-CoV-2 infection. However, lactating women have been largely excluded from most vaccine clinical trials. 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). Researchers from NYU Langone Hospital evaluated if COVID-19 vaccine mRNA is detectable in BM after maternal vaccination and determined its potential translational activity.

The researchers collected BM samples from 13 lactating, healthy, post-partum women before and after COVID-19 mRNA vaccination. Vaccine mRNA in whole BM and BM extracellular vesicles (EVs) was assayed using quantitative Droplet Digital PCR, and its integrity and translational activity were evaluated.

Of 13 lactating women receiving the vaccine (20 exposures), trace mRNA amounts were detected in 10 exposures up to 45 h post-vaccination. The mRNA was concentrated in the BM EVs; however, these EVs neither expressed SARS-COV-2 spike protein nor induced its expression in the HT-29 cell line. Linkage analysis suggests vaccine mRNA integrity was reduced to 12–25% in BM.

These findings demonstrate that the COVID-19 vaccine mRNA is not confined to the injection site but spreads systemically and is packaged into BM EVs. However, as only trace quantities are present and a clear translational activity is absent, the researchers believe breastfeeding post-vaccination is safe, especially 48 h after vaccination. Nevertheless, since the minimum mRNA vaccine dose to elicit an immune reaction in infants <6 months is unknown, a dialogue between a breastfeeding mother and her healthcare provider should address the benefit/risk considerations of breastfeeding in the first two days after maternal vaccination.

Proposed model of biodistribution of vaccine mRNA to breast milk (BM)

Following intramuscular administration, the vaccine mRNA enclosed in lipid nanoparticles (LNPs) is transported to the mammary glands through either hematogenous or lymphatic pathways. Within the mammary cell cytosol, a portion of the released vaccine mRNA is recruited and packaged into developing extracellular vesicles (EVs). The vaccine mRNA can be packaged into multivesicular bodies as intraluminal vesicles that will fuse with the mammary cell’s plasma membrane, resulting in the release of mRNA-containing exosomes/EVs into breast milk. Some vaccine mRNA can also be packaged into microvesicles (MVs) formed by the outward budding of the mammary cell’s plasma membrane and released into BM. 

Hanna N, Manzano De Mejia C, Heffes-Doon A, Lin X, Botros B, Gurzenda E, Clauss-Pascarelli C, Nayak A. (2023) Biodistribution of mRNA COVID-19 vaccines in human breast milk. Lancet 96(1), 104800. [article]