The Food and Drug Administration (FDA)
is taking steps to modify an existing FDA Ebola research contract
with Public Health England (PHE) to include a near-term analysis of
2019 Novel Coronavirus (2019-nCoV), according to contract documents
released March 3.
On Jan. 31, the Secretary of Health and
Human Services (HHS) issued a Public Health Emergency Declaration
pursuant to section 319 of the Public Health Service (PHS) Act “as
a result of confirmed cases of 2019 Novel Coronavirus (2019-nCoV)”.
The emergency gives HHS authorization to take appropriate actions in
response to the emergency including providing grants, entering into
contracts; and conducting and supporting investigations into the
cause, treatment, or prevention of the disease or disorder.
“An urgent requirement now exists for
additional research in order to aid in the development of effective
medical countermeasures (MCMs) to combat this emerging threat,” FDA
said in contract documents. “PHE has a demonstrated and unique
expertise in performing research with similar viruses and is the only
known source that can undertake required research in a timely, safe
and effective manner. This contractor is known to have sufficient
facilities to safely experiment and develop synthetic viruses, and
the capability to document and deliver all research objectives within
a compressed timeline.”
The purpose of this acquisition is to
rapidly leverage current expertise, facilities, agreements, and other
resources currently under contract for Ebola study, in order to
execute urgent research to address near term knowledge gaps for the
emerging 2019 novel coronavirus.
“Presently, there are limited MCMs
due to several factors including a paucity of information on
infection in humans, the absence of diverse animal models to ensure
licencing, the difficulty in accessing samples from human patients
with disease and the frequency of outbreaks,” FDA officials said in
the contract.
PHE was awarded contract number
HHSF223201510104C in 2015 for the total amount of $3.2 million
through the FDA for the study of Ebola virus. Over the course of the
contract, PHE has demonstrated not only their ability to successfully
execute their technical approach, but also to respond in an effective
and timely manner to the Ebola outbreak at that time. In 2016, the
contract was extended through Sept. 13, 2020 at no additional cost to
the government.
“The current outbreak of novel
coronavirus constitutes a public health emergency in part due to the
unknown aspects of the virus,” contract documents state.
“Presently, the U.S. government is engaged in a multilateral effort
to source and characterize viral isolates, however, it is unclear
when (or if) these efforts will be successful.”
