Coronavirus is believed to have originated in a live animal market in Wuhan, China. The rapid spread of this virus, partly due to the level of contagion in individuals before they show any symptoms of infection, and even with a low fatality rate, has energized public and private organizations.
The outbreak was declared a public health emergency of international concern (PHEIC) by the World Health Organization (WHO) on January 30, 2020. Declaring an outbreak as a PHEIC is a way of stressing the urgent need for international coordination of research and development efforts. It is the sixth such emergency since 2005:
- 2009 H1N1 Influenza Virus (swine flu)
- 2014 Wild poliovirus resurgence
- 2014 West Africa Ebola virus
- 2015 Zika virus
- 2019 Kivu Ebola virus
Lessons Learned from Ebola
A small Canadian laboratory had been working on a vaccine for Ebola for years. The outbreak of 2014 with mortality rates of 90% added a level of urgency to their task that made it clear they needed a larger pharmaceutical partner to accelerate the development and manufacture of a vaccine. Merck became that partner and initiated a clinical trial at unprecedented speed. The resulting Ebola vaccine was offered in a compassionate use protocol in the outbreak of 2018. In 2019 the Ervebo vaccine was granted EMA and FDA approval. Research Partnership reported, “Getting Ervebo to market has been widely hailed as a phenomenal achievement on the part of all organizations involved, given the criticism pharmaceutical companies have traditionally come under for neglecting infectious diseases in low income regions due to lack of incentives from global market forces alone.”
Lessons Learned from Zika
The Biomedical Advanced Research and Development Authority (BARDA), an office of the U.S. Department of Health and Human Services, was a key player in forming public-private partnerships to incentivize drug and vaccine development in response to ZIKA. Sustaining the urgency and momentum started by BARDA when the outbreak subsided is a lesson learned from confronting ZIKA.
Since the virus originated in a densely populated area that is a major transportation hub, unlike Ebola and ZIKA, it has taken weeks instead of months to identify and characterize the strain. This is the first major test for the Coalition for Epidemic Preparedness Innovations (CEPI), a public-private coalition that was set up in 2017 with the aim of derailing epidemics by speeding up the development of vaccines. CEPI has given a $9M grant to Inovio Pharma and Beijing Advaccine Biotechnology for the development of INO-4800. They have already created 3000 doses for human clinical trials beginning in April with results expected in September 2020, and have plans in place for large scale manufacturing. APN-01 that was developed by the University of British Columbia and APEIRON Biologics for the treatment of the SARS virus is being analyzed to treat coronavirus. MRNA-1273 vaccine has had the first vials manufactured by Moderna and shipped to the Vaccine Research Center, a division of NIAID, for clinical trials in April.
Thirty therapies are being tested or planned to be tested including a few traditional Chinese medicines for the treatment of the symptoms of coronavirus. Remdesivir by Gilead Sciences was originally developed to treat Ebola patients and is now in two phase II clinical trials in Wuhan for coronavirous with the results available in the next few weeks. Biocryst Pharma’s Galidesivir, an antiviral drug, has shown broad spectrum activity against a wide variety of pathogens including coronavirus. NIAID is sponsoring a 48 patient human clinical trial of Regeneron’s REGN 3048-3051drug for the treatment of coronavirus. Pfizer, Mateon Therapeutics, Hong Kong University of Science and Technology are a few of the organizations developing treatment options. Columbia University is the recipient of a $2.1M grant from the Jack Ma Foundation to develop a coronavirus cure.
Research Partnership reports, “Cynical commentators suggest that pharma has been more ready to get involved in developing vaccines and therapeutics for coronavirus because it poses a more direct threat to mature markets with economies who can afford to pay for prevention and treatment.” It could still be a flash in the pan, but the highly transmissible nature of coronavirus and the soaring number of afflicted would argue for continued close collaboration between public and private stakeholders to maximize our changes of beating this virus.