Abstract
The COVID-19 pandemic is a stark reminder of the heavy toll that emerging infectious diseases (EIDs) with epidemic and pandemic potential can inflict. Vaccine development, scale-up, and commercialization is a long, expensive, and risky enterprise that requires substantial upfront planning and offers no guarantee of success. EIDs are a particularly challenging target for global health preparedness, including for vaccine development. Insufficient attention has been given to challenges, lessons learned, and potential solutions to support and sustain vaccine industry engagement in vaccine development for EIDs. Drawing from lessons from the most recent Ebola epidemic in the Democratic Republic of the Congo, as well as the 2009 H1N1 influenza, 2014-2016 Ebola, and 2015-16 Zika outbreaks preceding it, we offer our perspective on challenges facing EID vaccine development and recommend additional solutions to prioritize in the near term. The 6 recommendations focus on reducing vaccine development timelines and increasing business certainty to reduce risks for companies. The global health security community has an opportunity to build on the current momentum to design a sustainable model for EID vaccines.
Highlights
The COVID-19 pandemic is a stark reminder of the heavy toll that emerging infectious diseases (EIDs) with epidemic and pandemic potential can inflict
Drawing from lessons from the most recent Ebola epidemic in the Democratic Republic of the Congo, as well as the 2009 H1N1 influenza, 2014-2016 Ebola, and 2015-16 Zika outbreaks preceding it, we offer our perspective on challenges facing EID vaccine development and recommend additional solutions to prioritize in the near term
The COVID-19 pandemic caused by the SARS-CoV-2 inflict heavy human and economic costs and can endanger virus is a stark reminder that emerging infectious lives, disrupt societies, and damage economies.[1,2]
Summary
We draw on prior experience to show how 2 critical factors work against vaccine development in an emergency: time and risk. Companies that respond to an outbreak have had to divert resources from core business lines, often for many years, to develop a vaccine that tends to lack a commercial market and may only be needed in limited supply and during limited periods of time This diversion can cripple all but the largest and most well-supported efforts and creates a major disincentive. Opportunity costs that result from delayed commercially viable programs, diverted manufacturing lines, and diversion of scientists, regulatory team members, and other resources can quickly outweigh direct costs.[26] funding tends to be short-term or redirected after the emergency is over These decisions are made without consideration for the ongoing costs companies will incur in completing development, securing licensure, fulfilling post-market regulatory obligations, and scaling manufacturing appropriately to meet uncertain demand. These factors negatively affect company risk/ benefit assessments for engagement and increase uncertainty for managers and investors, potentially discouraging companies from responding to the EID
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