Neutralizing antibodies in milk and blood of lactating women vaccinated for SARS-CoV-2: a systematic review.

Objective: To compare the presence of neutralizing antibodies against SARS-CoV-2 found in the breast milk and blood of vaccinated lactating women with those not vaccinated.

Data Source: The study was registered in the International Prospective Register of Systematic Reviews (PROSPERO) under CRD42021287554 and followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Cohort, case-control, and cross-sectional studies that evaluated antibodies against SARS-CoV-2 in the milk and blood of vaccinated mothers and had as control group unvaccinated mothers were eligible.

Paediatric Medicines - Regulatory Drivers, Restraints, Opportunities and Challenges.

The investment in the pharmaceutical development of medicines for paediatric use represents a minority when compared to that one made for adult population. Which reasons lie behind this status quo? Which policies have been implemented to reverse such asymmetry? Is there room to new regulatory initiatives? The creation of regulations establishing the obligation to conduct paediatric trials was deemed necessary as a means of producing products of proven quality, safety and efficacy and, in addition, to set forth financial incentives for the pharmaceutical industry reduce this delay. The first regulatory initiatives were carried out by the Food and Drug Administration (FDA) at the end of the 20 century.