The State of COVID-19 Vaccine Candidate Development

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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).
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Note: This insight was originally posted on February 24, 2020. It was updated on June 6, 2020, to reflect the most recent information.

On March 11, the World Health Organization (WHO) officially declared COVID-19 a global pandemic, and cases have climbed into the millions. COVID-19 joins a growing list of infectious diseases—SARS, MERS, Zika—that have emerged over the past 20 years, yet its scale has greatly surpassed that of the others.

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). Generally, the risks and opportunity costs associated with EID vaccine development programs are high, and the market value of medical countermeasures may be 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.

Vaccine development faces substantial hurdles, with an average likelihood of approval from phase I to licensure of only 16.2 %, and an estimated average cost of US$319–$469 million ($137 million–$1.1 billion range) from the preclinical stage though phase 2 for an epidemic infectious disease. Given the urgent need for a COVID-19 vaccine, the Coalition for Epidemic Preparedness Innovations (CEPI), a global partnership between public, private, philanthropic, and civil society organizations, made an urgent call for funding in March, estimating that it will need $2 billion to support the rapid development of COVID-19 vaccines with the goal of submitting at least 3 vaccine candidates for licensure with regulatory authorities. Amid the current crisis, 10 vaccine candidates have entered clinical trials, and at least 123 candidates are in the preclinical stages of development as of June 2, according to the WHO.

Several of these candidates have support from global funders and US government agencies. The CEPI has announced funding for 9 different vaccine candidates as well as a partnership to utilize a company’s adjuvant technology. The National Institutes of Health (NIH) has formed an interagency, international PPP called Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) to enhance coordination between regulatory, clinical, and industry stakeholders. One focus of ACTIV is to engage with regulators on surrogate clinical endpoints for evaluation to accelerate clinical advancement of vaccine candidates. The Biomedical Advanced Research and Development Authority (BARDA) within the US Department of Health and Human Services has also announced partnerships with companies developing COVID-19 vaccines, with five major contracts worth over $2.1 billion thus far. The US government, under legislation enacted in March (H.R. 6074 and H.R. 678) has provided over $6 billion in emergency funding for the development and purchase of COVID-19 diagnostics, vaccines, and therapeutics through the NIH (early-stage research only) and BARDA. The administration also launched Operation Warp Speed on May 15 to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, with an aim to have the first set of doses available to Americans by early 2021.

It remains to be seen how many COVID-19 vaccine candidates will reach licensure and whether COVID-19 will become an endemic global disease requiring annual routine vaccination. Policymakers seeking to increase the likelihood that multiple COVID-19 vaccine candidates and future EID vaccines make it to the finish line could consider policies and funding streams that provide sustained funding for R&D and create market certainty for the resulting products through stockpiles, market entry rewards, or other mechanisms should routine vaccination not be required. 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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