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.”