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The FDA and the White House also announced new initiatives to combat the novel coronavirus.
The World Health Organization (WHO) has declined to declare the novel coronavirus (COVID-19) a pandemic,1 however the CDC is preparing for potential pandemic conditions.2 In addition to the agency's preparations, the FDA and the White House also announced new initiatives Tuesday to combat the spreading virus.
Cases in the United States have risen to 54, including 3 patients repatriated from Wuhan, China, and 36 repatriated from the Diamond Princess cruise ship.3
“We are still at the stage of containment, but we are already starting to plan for mitigation,” said Nancy Messonnier, MD, director of the National Center for Immunization and Respiratory Diseases.2
In a CDC press conference Tuesday, Messonnier said she expects to eventually see community spread in the US, meaning cases will begin appearing without a known source of exposure.2 Community spread is already being observed in several other countries outside of China.1
The virus meets 2 of the 3 criteria for a pandemic, Messonnier said. It has caused illness resulting in death, and sustained person-to-person spread, but has not yet qualified as a pandemic because it lacks the definition for “worldwide spread.”2
The CDC’s goal is to continue detecting, tracking, and isolating all cases, as well as minimizing the impact on communities. Messonnier said the recommendations for a potential pandemic situation have been adapted from community guidelines to prevent an influenza pandemic. While it is not considered a pandemic yet, individuals and communities should begin planning ahead, Messonnier said.2
Nonpharmaceutical interventions (NPIs) are at the core of the recommendations, including personal protective measures, community NPIs, and environmental interventions.2
Personal protective measures under pandemic conditions would include a voluntary home quarantine of people with sick family members, Messonnier said. Other personal interventions have already been encouraged, including hand hygiene, and cough etiquette.2
Community interventions would include measures such as closing schools and businesses. While this would be highly disruptive, Messonnier said, people should consider options such as teleschooling, expanding options for employees to work from home, and replacing in-person meetings with video or phone conferences.2 Before taking the step of closure, schools may consider dividing students into smaller groups, Messonnier said.2
Finally, environmental NPIs include cleaning surfaces, including those in offices, schools, and homes.2
The maximum benefit occurs when all of these approaches are combined, Messonnier said. She added that preparing communities is 1 of the CDC’s main goals, and that different communities may need to implement different approaches, based on their individual needs.2
“I understand this whole situation may seem overwhelming, and that disruption to everyday life may be severe, but these are things people need to start thinking about now,” Messonnier said.2
For now, the CDC is continuing to focus on individuals that have traveled to China or have been in close contact with a patient with COVID-19. By planning for community spread, however, Messonnier said this focus may shift to a more broad population.2
“If that happens, it will be more and more important that the clinicians have a full tool kit,” she said.2
To that aim, the CDC also is working on the diagnostic tests for COVID-19, which had previously been malfunctioning. While Messonnier did not give a specific timeline for the release of new tests, she said they are hoping to roll the tests out “soon.”2
Currently, 12 locations around the country can test samples, as well as the CDC. The CDC has no backlog or delay, Messonnier said.2
In order to address the novel virus, a clinical trial was launched by the National Institute of Health to investigate the treatment potential of remdesivir in COVID-19. The first participant is an American who was repatriated after being quarantined on the Diamond Princess cruise ship.4 As an investigational broad-spectrum antiviral treatment, researchers are hopeful that it could provide a much-needed treatment for COVID-19.4
The FDA also is tackling concerns that COVID-19 could affect the safety and quality of foreign products. In order to mitigate the lack of access to some manufacturers in China, the agency is utilizing import screening, examinations, sampling, and import alerts to maintain the quality of products from China.5
“While we are not able to conduct inspections in China right now, this is not hindering our efforts to monitor medical products and food safety,” the Administration said in a statement.5
In addition, the White House has requested appropriation of $1.25 billion in emergency funding to continue supporting critical response and preparedness activities, as well as $535 million in emergency supplemental funding to be transferred from Ebola response efforts to the COVID-19 preparedness effort.6
“This funding would support all aspects of the US response, including: public health preparedness and response efforts; public health surveillance, epidemiology, laboratory testing, and quarantining costs; advanced research and development of new vaccines, therapeutics, and diagnostics; advanced manufacturing enhancements; and the Strategic National Stockpile,” said Russell T. Vought, acting director of the Office of Management and Budget, in a letter to.6
In a tweet, House Speaker Nancy Pelosi (D-CA) said the requested funding is overdue and “completely inadequate” to tackle COVID-19.7
Messonnier concluded that while the situation is concerning, legislators, health care professionals, and the public should focus on preparedness and prevention.
“I’m concerned about the situation, [the] CDC is confirmed about the situation, but we are putting our concerns to work preparing,” she said.2
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