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Volume 44, Issue 2
Bio/pharma researchers mobilize to diagnose and treat patients in pandemic threat.
An outbreak of viral pneumonia cases in Wuhan, China at the end of 2019 sparked concerns of another coronavirus (CoV) jumping species from animals to humans, causing a global pandemic. Fears of a repeat of the severe acute respiratory syndrome (SARS) outbreak in 2002 or the Middle East respiratory syndrome (MERS) in 2012 rattled financial markets, led to the lockdown for millions of people, and mobilized R&D efforts around the world.
Chinese officials announced the identification of a novel CoV-2019-nCoV-on Dec. 31, 2019; one month later, the number of confirmed and suspected cases exceeded 10,000 and more than 100 deaths were reported. While nearly all of the cases were in China, other countries, including the United States had small numbers of suspected or confirmed cases. Authorities in China implemented public health measures, enforcing aggressive travel restrictions and screening programs. Other nations employed screening and travel restrictions.
Meanwhile, the medical research and pharmaceutical communities scrambled to answer basic questions about how the virus is transmitted, stages of contagion, incubation period, and the types-or lack-of symptoms in infected patients. Lessons learned from the SARS and MERS outbreaks are guiding researchers in these efforts.
Following previous outbreaks, the World Health Organization (WHO) placed the SARS-CoV and MERS-CoV on its Priority Pathogen list to encourage the development of countermeasures. Researchers are adapting platform diagnostic modalities used in the previous outbreaks for early recognition and isolation of 2019-nCoV infections and to assess the potential use of broad-spectrum antivirals and vaccines (1). A genomic sequence of 2019-nCoV has been released to public databases, enabling researchers around the world to find clues to detection of the virus and potential treatment options.
The urgency for sharing data and biological material was emphasized in a January 2020 meeting between Tedros Adhanom Ghebreyesus, the director-general of the WHO, and President Xi Jinping of the People’s Republic of China (2). WHO also is launching a clinical data platform where anonymized clinical data can be shared to support the public health response to the outbreak.
FDA Commissioner Stephen M. Hahn said in a statement that the agency is “employing the full range of our public health authorities to facilitate the development and availability of investigational medical products to help address this urgent public health situation.” These efforts include explanations of the development pathways, including Emergency Use Authorization, sharing reference materials for diagnostic development, and directing sponsors of therapeutics to the agency’s Pre-Investigational New Drug Application Consultation Program (3).
A number of drug companies are investigating the potential for the use of existing therapies as treatment against the virus. Others-backed by the Coalition for Epidemic Preparedness Innovations-are using platform technologies to expedite the development of new treatments. Inovio Pharmaceuticals will use its DNA-based platform development and testing of a coronavirus vaccine matched to the outbreak strain. The University of Queensland in Australia will use its molecular clamp rapid-response technology to develop a new vaccine. And, Moderna will manufacture an mRNA vaccine against 2019-nCoV; the National Institute of Allergy and Infectious Diseases, which collaborated on the vaccine design with Moderna, will conduct investigational new drug and Phase I studies (4).
For an industry accustomed to a slow, methodical development pace, the urgency presented by this health emergency will put R&D skills and resources to the test.
1. C. I. Paules, H. D. Marston, A.S. Fauci, JAMA online, doi:10.1001/jama.2020.0757 (Jan. 23, 2020).
2. WHO, “WHO, China Leaders Discuss Next Steps in Battle Against Coronavirus Outbreak,” Press Release, Jan. 28, 2020.
3. FDA, “FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures,” Press Release, Jan. 27, 2020.
4. CEPI, “CEPI to Fund Three Programmes to Develop Vaccines Against the Novel Coronavirus, nCoV-2019,” Press Release, Jan. 23, 2020.
Vol. 44, No. 2
When referring to this article, please cite it as R. Peters, “The Call for a Rapid Response," Pharmaceutical Technology 44 (2) 2020.