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The State of COVID-19 Vaccine Candidate Development

Summary

The novel coronavirus (COVID-19) was first reported in Wuhan, China, on December 31, 2019, and within a month was declared a public health emergency of international concern (PHEIC) by the World Health Organization (WHO).

To date, over 78,000 cases of COVID-19 have been confirmed across 29 countries (the vast majority in China), and more than 2,400 deaths have been reported. COVID-19 is a health security threat, and it is receiving worldwide attention, yet it is just one more on a growing list of infectious diseases—SARS, MERS, Ebola, Zika—that have emerged over the past 2 decades.

With each new outbreak, governments and healthcare systems have rushed to contain the epidemic and respond to public health needs. Leaders have called upon the biopharmaceutical industry to quickly develop vaccines to prevent further spread of these emerging infectious diseases (EIDs). The risks and opportunity costs associated with EID vaccine development programs are high, and the market value of medical countermeasures is often low. While public-private partnerships (PPPs) have typically supported medical countermeasure R&D in the initial phases of the outbreaks, supporting vaccine candidates from the preclinical phase through licensure requires sustained funding.

In the current crisis, at least 13 biotechnology companies, 5 academic institutions, and 3 global pharmaceutical companies have announced COVID-19 vaccine development programs or partnerships. Several of these companies have support from global funders and US government agencies. The Coalition for Epidemic Preparedness Innovations (CEPI), created to catalyze vaccine candidate development, has announced funding for 4 different vaccine candidates and a partnership with GSK to utilize their adjuvant technology. The National Institutes of Health, including the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA), have also announced partnerships with companies developing COVID-19 vaccines. Sustained funding and support will be necessary to carry candidates from the preclinical phase through licensure. Vaccine development faces substantial hurdles, with an average likelihood of approval from phase 1 to licensure of only 16.2% and an estimated average cost of US $319–$469 million ($137 million–$1.1 billion range) from the pre-clinical stage though phase 2 for an epidemic infectious disease.

Despite the number of companies dedicating resources to COVID-19 vaccine development and US agency partnerships, administration action in support of the response has been mixed. Immediately following the WHO PHEIC declaration and the CDC’s confirmation of the first human-to-human transmission of COVID-19 in the US, Secretary Azar declared the novel coronavirus a national public health emergency. The White House has also formed the President’s Coronavirus Task Force to lead and coordinate the US government’s response. However, the President’s FY 2021 budget does not include funding explicitly dedicated to COVID-19 response, and the agencies directly involved in the PPPs that support vaccine and drug development had proposed cuts to their budgets, including a $25 million cut to BARDA’s Advanced Research and Development program and a $136 million cut to extramural research at NIAID for Biodefense and Emerging Infectious Diseases. The White House may submit an emergency funding request to Congress as soon as today to support the COVID-19 response.

Policymakers seeking to increase the likelihood that a vaccine makes it to the finish line could consider policies and funding streams that better support R&D from end to end and from bench to bedside, and create market certainty for the resulting products through stockpiles, market entry rewards, or other mechanisms. The global preparedness community can also use the emergence of COVID-19 as another indicator of the importance of proactively investing in EID vaccine research, rather than relying on reactionary measures to ensure the global vaccine ecosystem is poised for success for future novel infectious diseases.

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