The World Health Organization (WHO) reports that $675 million is needed for a coronavirus global preparedness and response plan and the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) provided updates to the actions these agencies are taking, including the facilitation of the development of products to address the virus.

WHO outlines global preparedness and response plan

WHO reported that to further address the spread of the new coronavirus (2019-nCoV) outbreak in China and globally and to protect states with weaker health systems, the international community has launched a $675-million preparedness and response plan covering the months of February through to April 2020.

The Strategic Preparedness and Response Plan (SPRP) for the new coronavirus lays out activities and resources needed by international health organizations globally, including WHO, to implement priority public health measures in support of countries to prepare and respond to nCoV-2019 for a period February to April 2020. The objectives of the plan are to  limit human-to-human transmission of the virus, particularly in countries most vulnerable if they were to face an outbreak; identify, isolate and care for patients early; communicate critical risk and event information; minimize social and economic impact; reduce virus spread from animal sources; and address crucial unknowns.

The plan focuses on: rapidly establishing international coordination and operational support; scaling up country readiness and response operations; and accelerating priority research and innovation.

As of February 5, 2020, WHO reports that 25 countries have reported confirmed cases of the new coronavirus, including China, where 24,363 people had contracted the virus, or over 99% of all cases. In all other countries, 191 cases have contracted the virus.

The EMA launches its plan

To contribute to the global response to the outbreak of the novel coronavirus (2019-nCoV) infections, the European Medicines Agency (EMA) says it is taking concrete actions to accelerate the development and availability of medicinal products for the treatment and prevention of the new coronavirus.

“EMA has activated its plan for managing emerging health threats,” says Guido Rasi, the agency’s Executive Director, in a February 4, 2020 statement. “The new coronavirus has been declared a public health emergency of international concern by the World Health Organization, and we are drawing on the strong expertise of the European medicines network to provide fast-track scientific advice and give prompt feedback on any proposed medicine developments.”

The agency said it is surveying the landscape for potential antivirals or vaccines to treat or prevent novel coronavirus infections. EMA is also analyzing all available information on developers’ drug pipelines. As with any emerging public health threat, EMA collaborates and exchanges information with EU public health authorities, notably the European Commission, the Health Security Committee and the European Centre for Disease Prevention and Control (ECDC), the WHO and other international regulators, in particular through the International Coalition of Regulatory Authorities (ICMRA).

There are currently no commercially available medicinal products that are authorized to detect, treat or prevent infections with the novel coronavirus, according to the EMA. The agency said it is ready to support medicine developers with all available regulatory tools to advance and expedite the development of effective measures to fight and prevent the spread of this virus.

The EMA said that developers working on medicinal products or vaccines that could be used for treatment or prevention of novel coronavirus 2019-nCoV infections are encouraged to contact the agency and discuss their strategy for evidence generation as soon as possible.

The 2019-nCoV identified in Wuhan, China in December 2019, is a new strain of coronavirus that has not been previously seen in humans. Although the most likely primary source of this outbreak is of animal origin, human-to-human transmission is confirmed and investigations are ongoing to determine all sources and modes of transmission of the 2019-nCoV virus. Cases have now been detected in several countries in Asia, Australia, Europe and North America. Further global spread is likely, according to the EMA, which says EU authorities will provide further updates as more information becomes available.

FDA takes further action

Late last month (January 2020), the FDA outlined its actions to advance development of novel coronavirus medical countermeasures to expedite the development and availability of medical products to prevent, diagnose and treat 2019-nCoV and earlier this month (February 2020)  issued an emergency use authorization (EUA) to enable emergency use of the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, this test has been limited to use at CDC laboratories; the authorization allows the use of the test at any CDC-qualified lab across the country. Under this EUA, the use of 2019-nCoV Real-Time RT-PCR Diagnostic Panel is authorized for patients who meet the CDC criteria for 2019-nCoV testing. Testing is limited to qualified laboratories designated by the CDC and, in the US, those certified to perform high complexity tests. The diagnostic is a reverse transcriptase polymerase chain reaction (PCR) test that provides presumptive detection of 2019-nCoV from respiratory secretions, such as nasal or oral swabs. As there are no commercially available diagnostic tests cleared or approved by the FDA for the detection of 2019-nCoV, the US Department of Health and Human Services determined that an EUA is crucial to ensure timely access to diagnostics.

Source: World Health Organization, the European Medicines Agency, US Food and Drug Administration