As the number of cases of the novel coronavirus climbs, government leaders, healthcare systems, biopharmaceutical companies, and other stakeholders are looking for methods to contain the epidemic. Avalere analysis found that at least 80 vaccine developers and academic institutions¹ have publicly stated they are rapidly working on vaccine candidates for COVID-19. As the nation anticipates a vaccine to prevent the virus, history underscores the variability in development timelines for developing a safe and effective vaccine for emerging infectious disease vaccines.

Orange denotes a vaccine specific to the infectious disease came to market.

This chart excludes Influenza A (H1N1) 2009 monovalent vaccines FDA-approved in 2003, 2006, 2007. There is no FDA-approved H7N9 vaccine. Total confirmed coronavirus cases based on data from Johns Hopkins COVID-19 global cases.

*Total cases denoted represents total number of cases recognized by CDC between April 12, 2009 to April 10, 2010.

***The influenza A (H5N1) monovalent vaccine FDA-approved in 2007, was included in the Strategic National Stockpile.

Historically, development of vaccines can take months to years after the initial outbreak to ensure no serious, yet rare, side effects exist. While the phases of clinical development are similar for therapeutics and vaccines, vaccine development can be more complex and lengthy due to the design and manufacturing of vaccines as well as the size and length of clinical trials required to prove the safety and efficacy of a product that will be administered to healthy individuals.

While vaccine development involves a high risk of failure, potential opportunities to expedite the development of a COVID-19 vaccine may include:

• Expedited and streamlined regulatory review processes through continual correspondence with US Food and Drug Administration (FDA) reviewers
• Innovative clinical trial design which could include real-world evidence or decentralized approaches
• Additional contracts through the Biomedical Advanced Research and Development Authority under the US Department of Health and Human Services to support costly advanced research and development of vaccine candidates and other sustained public-private partnerships
• Coordination and communication of global research efforts with international partners and stakeholders, including epidemiological analysis and forecasting, sharing of technical expertise and guidance for laboratory protocols, and leveraging existing immunological studies of pathogens with similar genetic profiles
• Consideration of alternative and novel vaccine manufacturing methods and production platforms to reduce cost and production time
• Use of modeling techniques such as immunoinformatics to increase the likelihood of success for vaccine candidates by narrowing down the search for potent targets

On March 19, President Trump stated that he has directed the FDA to consider additional ways to expedite review and availability of COVID-19 vaccines, but details have not yet been released. Earlier this month, the President signed legislation authorizing $8.3 billion in funding to bolster initiatives for vaccine and drug development as well as domestic and international response efforts.

“Given the urgent public health need and the complexity of conducting clinical trials in the middle of the current outbreak, a multi-stakeholder effort as well as sustained public-private partnerships will help see a vaccine candidate through to deployment and licensure,” said Kelly Cappio, associate principal at Avalere.

To receive Avalere updates, connect with us.

Check out our COVID-19 content page.

Notes

1. At least 61 biotechnology companies, 18 academic institutions, and 4 global pharmaceutical companies globally as of March 23, 2020