Measles and rubella microarray patches (MR-MAPs) are critical to achieving measles and rubella eradication, and the need for their expedited product development was recommended by WHO’s SAGE in 2016. Since then, two MR-MAP candidates have entered clinical development ( Vaxxas; Micron Biomedical), and recently Micron Biomedical announced the first proof-of-concept data in infants from a Phase 1/2 study in the Gambia. Vaccination by MR-MAP was safe and well tolerated. At day 42, MR-MAP demonstrated equivalent measles and rubella seroprotection rates as MR administered to infants via the sub-cutaneous route, who were MR-vaccine naïve at the start of the trial. In the wake of this highly anticipated and exciting clinical data, MR programme and MAP stakeholders are eager to understand how to expedite the MR-MAP pathway to licensure and use.
As we and others have discussed previously (here), investment in and establishment of a pilot manufacturing facility for MR-MAPs will be needed to scale-up and manufacture clinical trial material for the phase III pivotal licensure study. Since the decision to invest in vaccine manufacture has been deferred until after clinical proof-of-concept, there could now be approx. 2.5 years before the start of the pivotal licensure study of MR-MAP. While partners are actively working on acceleration and de-risking strategies (including engaging an additional antigen supplier) there is – in the meantime - an opportunity to address pertinent clinical, pre-implementation and operational research questions in the next 2 years to better design the phase III licensure study and prepare for timely introduction. As such, this PDVAC meeting focused primarily on these questions, and not on the late-stage product development aspects, which are rapidly evolving.