The latest mutation to the coronavirus, dubbed COVID-19, has sparked a reaction by many national governments, but the expense associated with development of vaccines and diagnostics is considerable. Ron Klain, who served as the Obama administration’s coordinator for the response to the Ebola virus, said during an Aspen Institute seminar that drug makers took a hit in their efforts to develop a vaccine for the Ebola virus, and thus there is a need to de-risk these and other development efforts in the private sector.
Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, said in a Feb. 12, 2020, press briefing that the agency expects to see the virus spread in community settings in the U.S. and in other nations. The pathogen has killed more than 1,100 people to date and has been diagnosed in more than 45,000 people across the globe. Messonier said the demand for N95 masks and respirators has spiked in popular reaction to the outbreak, which could lead to shortages among health care personnel.
Sustained federal investment needed
Klain argued for a sustained investment in U.S. federal government capacity for response to outbreaks of communicable diseases rather than the boom-and-bust of responses to outbreaks such as the Ebola virus and the anthrax attacks following the attacks on the World Trade Center in 2001. He said a public/private partnership can ease some of the risks for drug makers, several of which lost substantial sums in their efforts to provide a vaccine for the Ebola virus. “We should be doing something as a public entity to take that risk down” for drug makers, he said, adding that there are also concerns about liability in the U.S. and other nations. Consequently, the day may come when lives are lost not only because of the development timeline for therapies and diagnostics, but also because of legal and policy questions.
Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, said the decision to impose travel restrictions was not made lightly. Messonier seconded that position, and they both noted that while the restrictions provide no hermetic seal against COVID-19, they gave the U.S. federal response much-needed breathing room to prepare for the worst.
Messonier said CDC has a series of guidances for all sectors of the health care industry, noting that the N95 masks are quite important. “We need to make sure we’re not misusing masks now” so they will be available later when and where needed.
Fauci said he believes it is “highly likely that the number of cases of people who are minimally symptomatic or asymptomatic” is much larger than is currently recognized. One of the concerns is the degree of transmissibility by asymptomatic patients, although this is “generally not the major driver of an outbreak.” However, awareness of that transmissibility does inform policy for screening and diagnosis.
Fauci said that Ebola was typically transmitted only by direct contact with an obviously sick person, and thus there was a good sense of the prospects for spread. The effort to contain the COVID-19 will change when there is evidence of large-scale community spread, and while the risk to those in the U.S. is low, the prospect of a pandemic is “still very real,” he said.
Messonier said 11 of the 13 cases in the U.S. were diagnosed in those who had traveled to Wuhan, China, the epicenter of the outbreak, while the other two diagnoses were in those who had been in direct contact with one of the other 11 individuals. At present, the federal strategy is to contain the outbreak via “social distancing,” but Fauci said a vaccine is at least a year off under optimistic assumptions, by which time the threat may have passed.
Fauci said vaccines may take several years to develop under ordinary circumstances, but noted that first-in-human trials for a COVID-19 vaccine may commence sometime in the next three months. That study may require another three months to complete, following which would be a phase II trial that would consume another six to eight months. Scaling up production of a successful candidate might require several more months, and the net result is that at least a year will pass before a vaccine is available, assuming all goes well.
Drug makers have to address the opportunity cost as well as the cost of ramping up production for a vaccine, and Fauci said industry is unlikely to provide a manufacturing site that would be readily switched to vaccine production due to the implicit opportunity cost. He was reluctant to provide a mortality rate estimate for COVID-19, in part because the widely quoted estimate of 2% fails to factor in the prevalence of undiagnosed cases.
The mortality rate for the 2003 outbreak of severe acute respiratory syndrome (SARS) was 9% to 10%, but the pathogen behind SARS did not transmit vigorously. Seasonal influenzas often exhibit mortality rates of 0.1%, Fauci said, while pandemic influenzas of 1957 and 1968 registered fatality rates of roughly 1%.
“When you talk about the catastrophe of 1918, that was close to 2%” mortality, Fauci said of the Spanish flu pandemic, adding that there is some prospect that the mortality rate for COVID-19 will settle in at roughly 1%, which would mimic a severe seasonal influenza season. “You can surmise what its’ going to be, but we don’t know what it’s going to be,” he emphasized, particularly given the lack of experience with the behavior of this pathogen.
Moody’s Investor Service of New York said in a Feb. 12, 2020, investor note that an extended outbreak of COVID-19 could boost demand for several products, but that there is at present no indication that supply chains for products shipped from China are in any immediate danger. Moody’s said that the province in China in which most active pharmaceutical ingredients are manufactured is some distance from Wuhan’s home province of Hubei, although a rapid proliferation of the virus could affect operations at these sites and thus disrupt shipments of APIs to drug manufacturing sites in the U.S. The picture for devices and device components made in China is similar, and demand for finished drugs and devices shipped to China could be affected if Beijing continues to struggle to contain the outbreak.