Accelerating the Development of Measles and Rubella Microarray Patches to Eliminate Measles and Rubella: Recent Progress, Remaining Challenges.

David N Durrheim,Christopher J Gregory,Jessica J Mistilis,Natasha Crowcroft,Courtney Jarrahian,Kristen Earle,Jean-Pierre Amorij,Birgitte Giersing,Robin Biellik,Mateusz Hasso-Agopsowicz,Collrane Frivold,Philippe-Alexandre Gilbert,Marion Menozzi-Arnaud,Mercy Mvundura

doi:10.3389/fpubh.2022.809675

Abstract

Measles and rubella microarray patches (MR-MAPs) are critical in achieving measles and rubella eradication, a goal highly unlikely to meet with current vaccines presentations. With low commercial incentive to MAP developers, limited and uncertain funding, the need for investment in a novel manufacturing facility, and remaining questions about the source of antigen, product demand, and regulatory pathway, MR-MAPs are unlikely to be prequalified by WHO and ready for use before 2033. This article describes the current progress of MR-MAPs, highlights challenges and opportunities pertinent to MR-MAPs manufacturing, regulatory approval, creating demand, and timelines to licensure. It also describes activities that are being undertaken by multiple partners to incentivise investment in and accelerate the development of MR-MAPs.

Highlights

Reviewed by: Peter McIntyre, University of Otago, New Zealand Shobha Broor, Shree Guru Gobind Singh Tricentenary University, India Michael Bennish, Mpilonhle, South Africa
Measles and rubella microarray patches (MR-Microarray patches (MAPs)) are critical in achieving measles and rubella eradication, a goal highly unlikely to meet with current vaccines presentations
With low commercial incentive to MAP developers, limited and uncertain funding, the need for investment in a novel manufacturing facility, and remaining questions about the source of antigen, product demand, and regulatory pathway, MR-MAPs are unlikely to be prequalified by World Health Organization (WHO) and ready for use before 2033

Summary

SECTION 2: OVERVIEW OF THE CLINICAL DEVELOPMENT OF MR-MAPs

Two MR-MAP candidates, one with vaccine-coated and one with dissolving microneedles, are currently in early-stage clinical development. The coated MAP is being evaluated in a single centre, placebo controlled, partially blind, randomized phase I trial to examine the safety and tolerability of different doses of MR delivered by MAP in healthy young adults, aged 18–50 years, in Australia (ACTRN12621000820808). Both studies will compare responses to subcutaneous MR immunization with N&S (standard of care) after a single vaccination, and will be evaluated by assessing measles and rubella specific IgG and virus neutralizing antibody titres. Produced clinical trial material that is representative of the final manufacturing process (assumed fully automated, compliant with current good manufacturing practices)

SECTION 3: MR-MAP MANUFACTURING CONSIDERATIONS

Findings

SECTION 6: CLARITY AND CONSIDERATIONS FOR THE MR-MAP REGULATORY STRATEGY