Applying lessons from the Ebola vaccine experience for SARS-CoV-2 and other epidemic pathogens

Abstract

The world is experiencing an unprecedented global pandemic of coronavirus disease 2019 (COVID-19) caused by a novel coronavirus, Severe Acute Respiratory Syndrome-coronavirus-2 (SARS-CoV-2). Development of new vaccines and therapeutics are important to achieve long-term prevention and control of the virus. Experience gained in the development of vaccines for Ebola virus disease provide important lessons in the regulatory, clinical, and manufacturing process that can be applied to SARS-CoV-2 and other epidemic pathogens. This report outlines the main lessons learned by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (MSD) during development of an Ebola Zaire vaccine (ERVEBO®) and looks ahead to critical lessons beyond vaccine development. It highlights focus areas for public-private partnership and regulatory harmonization that can be directly applied to current vaccine development efforts for SARS-CoV-2, while drawing attention to the need for parallel consideration of issues beyond development that are equally important to achieve global preparedness and response goals.

Assessing the Safety of COVID-19 Vaccines: A Primer

“…The desperate need for an Ebola vaccine galvanised us, and in less than 12 months, 12 clinical trials ran the gamut from a "first in man" dosing study to a phase III efficacy trial [3]. This was achieved through successful collaborations and running these stages in parallel [4,5]. However, while the pre-licensure clinical programme was executed in record time, fragile settings are often ill equipped for post-licensure safety surveillance.…”

Exploring uncertainty and risk in the accelerated response to a COVID-19 vaccine: Perspective from the pharmaceutical industry

“…Conducting clinical trials during a pandemic poses important challenges [28] . Not only is it difficult to predict where and when outbreaks will occur and to prepare trial sites to match vaccine readiness for testing, but also the burden of the outbreak on the healthcare system may not allow for dedicated trial resources and will likely impact enrolment, site visits and data collection.…”

Expert Forecasts of COVID-19 Vaccine Development Timelines

“…First, our sample is predominantly Canadian, though it is worth noting Canada has a productive vaccine development enterprise. 5 Second, our elicitation approach was relatively simple to minimize survey burden for vaccine developers. Nevertheless, our estimates provide a more complete picture of expert belief than single point estimates or media quotes from individuals.…”