Recommendations for acceleration of vaccine development and emergency use filings for COVID-19 leveraging lessons from the novel oral polio vaccine

Abstract

A new oral polio vaccine, nOPV2, has become the first vaccine to pursue a WHO Emergency Use Listing. Many lessons were learned as part of the accelerated development plan and submission, which have been categorized under the following sections: regulatory, clinical development, chemistry manufacturing and controls, and post-deployment monitoring. Efforts were made to adapt findings from these studies to COVID-19 vaccine candidates. Specific concepts for accelerating COVID-19 vaccine development across multiple functional domains were also included. The goals of this effort were twofold: (1) to help familiarize vaccine developers with the EUL process; and (2) to provide general guidance for faster development and preparations for launch during the COVID-19 pandemic.

Dual Corneal-Graft Rejection after mRNA Vaccine (BNT162b2) for COVID-19 during the First Six Months of Follow-Up: Case Report, State of the Art and Ethical Concerns

“…More than fifteen months after the outbreak of Coronavirus Disease-19 (COVID- 19) pandemic, vaccines appear to be a promising approach for the resolution of the infection [1,2]. However, after the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) granted the "emergency use authorization" of the COVID-19 vaccines developed by BioNTech/Pfizer and Moderna, numerous debates sprung up within the scientific community regarding the safety of the post-marketing phase, and side effects not described during the experimental stages [3][4][5].…”

From Bench to the Clinic: The Path to Translation of Nanotechnology-Enabled mRNA SARS-CoV-2 Vaccines

“…The accelerated development of vaccines, combined with the novelty of the technologies adopted for their production may result on several concerns, including technical manufacturing problems and ethical matters regarding global access and availability of vaccines [ 98 ]. The unprecedented speed in the development of vaccines provides many lessons for the future such as insights on regulations, global access, clinical development, chemistry manufacturing and controls, and post-deployment monitoring [ 99 ].…”

International Efforts and Next Steps to Advance COVID-19 Vaccines Research and Production in Low- and Middle-Income Countries

“…By collecting and analyzing current biosafety requirements in LMICs with vaccine manufacturing capacities, SAGE could identify gaps between the ability of these countries to control biosafety risks and the current international standards and develop targeted recommendations for improvement. Moreover, similarly to the WHO strategy in the novel oral polio vaccine approval, a WHO-led expert panel with highly trained and experienced GMP auditors could help vaccine manufacturers in LMICs improve their biosafety risk management and obtain WHO EUL for vaccines [29].…”