Despite pressure from several lawmakers to declare the new coronavirus a U.S. public health emergency, Health and Human Services (HHS) Secretary Alex Azar said such a declaration isn’t needed, at least not yet.
As of Jan. 28, only five cases of 2019-nCoV infection had been confirmed in the U.S., and all five patients had been in Wuhan, China, which is ground zero for the outbreak that has sickened thousands in China and beyond. So far, there’s been no person-to-person transmission in the U.S., Azar said at a media briefing.
While Azar wouldn’t go so far as to call the new coronavirus an emergency in the U.S., he said it “is a potentially very serious public health threat, but, at this point, Americans should not worry for their own safety.”
Adding that “this is a very fast moving, constantly changing situation,” Azar said he would declare an emergency if it’s recommended by public health officials. Currently, officials at the CDC characterize the risk of 2019-nCoV infection in the U.S. as low.
Meanwhile, U.S. health officials continue to prepare for an outbreak at a historic pace. Within one week of China making the genetic sequence of the virus available, the CDC had developed a rapid diagnostic that can determine, after the fact, if a person actually was infected with 2019-nCoV. “This is really an historic accomplishment,” Azar said.
He credited the swift development of the diagnostic to the transparency and collaboration brought about by international health regulations that require the sharing of genetic sequences and isolates.
The NIH and CDC are now working on a next-generation diagnostic that can be used at the point of care, said Tony Fauci, director of the NIH's National Institute of Allergy and Infectious Diseases (NIAID).
On the treatment side, U.S. researchers are waiting for live isolates from the U.S. patients and others so they can clone their B cells to develop monoclonal antibodies specifically targeting 2019-nCoV, Fauci said.
In the absence of approved coronavirus therapies, antiviral drugs approved or being developed for other uses are being tested in the field in China. Abbvie Inc.’s HIV drug, Kaletra (lopinavir/ritonavir), is one of those being put to the test, Fauci added.
NIAID also is partnering on several vaccines to protect against 2019-nCoV, drawing from its experience in previous coronavirus outbreaks. One vaccine, being developed with Moderna Inc. using its messenger RNA platform, is expected to go into a phase I trial within three months, Fauci said. He said he expects it would then take three months to get safety and immunogenicity data. Whether the vaccine advances to phase II will depend not only on those data but also on whether the outbreak is ongoing later this year.
Fauci noted that investigational vaccines being developed during the 2003 SARS outbreak didn’t make it to phase II because the outbreak had ended, making continued clinical development a challenge.
In addition to the NIH’s collaborations, the FDA is leveraging its expertise to facilitate the development and availability of investigational medical countermeasures (MCMs) to help address the new coronavirus, FDA Commissioner Stephen Hahn said. That means collaborating – with interagency partners, drug and device developers, international partners and global regulators – to expedite the development and availability of MCMs to diagnose, treat and mitigate 2019-nCoV infections.
One of the FDA’s top priorities is advancing and sharing the reference materials necessary for the development and availability of diagnostics. Sponsors interested in potential emergency use authorization (EUA) for such tests should contact CDRH-EUA-Templates@fda.hhs.gov for more information and templates. Sponsors interested in developing 2019-nCoV therapies should submit information and questions via the FDA’s Pre-IND Consultation program.
There could be a hitch, though. Under the Pandemic and All-Hazards Preparedness Reauthorization Act, the HHS secretary has to declare an emergency or threat justifying an EUA before the FDA can authorize the emergency use of an unapproved medical product or an off-label use of an approved product.