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Coronavirus News

FDA Approves First Treatment for COVID-19

“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic. As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”

NIH: Two Studies Show COVID-19 Antibodies Persist for Months

The new findings show that people who survive a COVID-19 infection continue to produce protective antibodies against key parts of the virus for at least three to four months after developing their first symptoms. In contrast, some other antibody types decline more quickly. The findings offer hope that people infected with the virus will have some lasting antibody protection against re-infection, though for how long still remains to be determined.

Coronavirus Interview with Sec. Alex Azar, Surgeon General Jerome Adams, Dr. Deborah Birx

“Our strategy is clear, which is we want to reduce the number of cases, we want to reduce the number of hospitalizations and we want to reduce the number of fatalities that result from coronavirus because we as the Surgeon General said, are weeks to months away from monoclonal antibodies allow us to treat and prevent the disease, as well as vaccines will enable us to as the President said, move beyond COVID, eventually, and we need to bridge to that. We need the American people to hang in there with us and our message about what they need to do is very clear, it’s wash your hands, watch your distance, wear your face covering when you can’t watch your distance, out of settings and you can’t do those things, and especially right now.” – Sec. Alex Azar

COVID-19 Vaccines: Ensuring Regulatory and Scientific Integrity During the Approval Process

Duke Margolis Center for Health Policy
In recent weeks, career officials at the FDA have repeatedly made clear that they will not authorize or approve a COVID-19 vaccine without strong data showing that it is safe, effective, and manufactured to a high-quality standard. The process by which the FDA’s expert review staff and independent advisors will make this determination is based in decades of well-established regulatory processes, including multiple public-facing steps to ensure transparency. All of these steps will take place regardless of whether a vaccine is under review for full approval under a traditional BLA or for authorization under an EUA.

Updates for Children, Teens, and Young Adults

Updated guidelines include a Decision Making Tool to help parents and caregivers weigh the risks and benefits of their options as well as a Checklist for Families to help weigh the risks and benefits of their options.

COVID-19 Vaccines: Planning for Equitable Distribution and Access

Duke Margolis Center for Health Policy
As part of Operation Warp Speed, initial planning is already underway for a staged distribution of an eventual vaccine. Under the leadership of the Centers for Disease Control (CDC) and the Department of Defense (DOD), the Federal government has outlined a process by which a centralized distribution system will support allocation of vaccines to critical and high-risk populations across all states and territories. As with any routine or seasonal vaccine, states and territories have responsibility for the “last mile” of vaccine distribution and administration— managing state systems for vaccine allocation, ordering, distribution, and inventory management, as well as working with providers across the state to deliver vaccines to the public across a wide variety of settings.

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White House

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COVID-19 vaccine in record time
Coronavirus testing expansion

President Trump has unveiled Guidelines for Opening Up America Again, a three-phased approach based on the advice of public health experts. These steps will help state and local officials when reopening their economies, getting people back to work, and continuing to protect American lives.

  • CDC Activities and Initiatives Supporting the COVID-19 Response and the President’s Plan for Opening America Up Again (HERE)

 

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