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Rita C. Peters is editorial director of BioPharm International, Pharmaceutical Technology, and Pharmaceutical Technology Europe.
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 fears 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 at medical and bio/pharmaceutical research organizations 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-reported small numbers of suspected or confirmed cases. Authorities in China implemented public health measures, enforcing aggressive travel restrictions and screening programs. Other countries screened travelers arriving from China or banned travel entirely.
Meanwhile, the medical research and pharmaceutical communities scrambled to answer basic questions about the virus using lessons learned from the SARS and MERS outbreaks. Following the previous outbreaks, the World Health Organization (WHO) placed the SARS-CoV and MERS-CoV on its Priority Pathogen list, encouraging research and the development of countermeasures against CoVs.
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 antivirals and vaccines for treatment (1). A genomic sequence of 2019-nCoV has been released to public databases, enabling researchers around the world to help find clues to detection of the virus and potential treatment options. 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 (2).
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 (3).
For an industry accustomed to a slow, methodical development pace, the urgency presented by the public health emergency will put R&D 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. FDA, “FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures,” Press Release, Jan. 27, 2020.
3. CEPI, “CEPI to Fund Three Programmes to Develop Vaccines Against the Novel Coronavirus, nCoV-2019,” Press Release, Jan. 23, 2020.
Vol. 33, No. 2
When referring to this article, please cite it as: R. Peters, “The Call for a Rapid Response,” BioPharm International, 33 (2) 2020.