COVID-19: Trump Presents Guidelines for Opening Economy; NIH to Partner With Industry on Vaccines, Treatments

President Donald Trump yesterday released broad guidelines to drive a re-opening of the US economy in the wake of the coronavirus disease 2019 (COVID-19) pandemic, outlining conditions that should be in place while leaving final decisions to the nation’s governors.

The 18-page document, “Opening Up America Again,” could put pressure on some states to send people back to work but acknowledges that conditions vary across the country. Governors are not legally required to follow the guidelines, and both health and business leaders have acknowledged that the ability to test for COVID-19 will be essential.

“We must have a working economy. And we want to get it back. Very, very quickly. And that’s what’s going to happen,” Trump said during a White House press briefing on the guidance, which was unveiled the same day US Labor Department figures showed that 22 million Americans have filed for unemployment since Trump declared a national emergency March 13.

The “gating criteria” in the report cover:

• Symptoms: there should be downward trajectories in both “influenza-like illnesses” in the previous 14 days and of COVID-like symptoms in cases reported over the same period
• Cases: there needs to be a downward trajectory of total diagnosed cases or of positive tests, compared with total tests given over the previous 14 days.
• Hospitals: these should be able to treat all patients without crisis care and have testing in place for at-risk healthcare workers, including antibody testing.

The task of managing re-entry would fall to the states, which would be responsible for developing robust testing programs to ensure the safety of healthcare workers and citizens alike. The report calls on states to have a testing system in place that can trace contacts of people who test positive for COVID-19 and quickly produce results. Sentinel screening would be used for some high-risk asymptomatic groups, such as older adults (especially those in congregate care settings), the poor, racial minorities, and Native Americans.

Healthcare systems also must be able to “quickly and independently” make sure staff have adequate personal protective equipment and enough medical equipment, such as ventilators, in case renewed surges occur.

The plan outlines 3 distinct phases of re-entry for individuals and for employers, including instructions for personal hygiene and re-engagement steps for specific types of employers. In phase 1, for example, visits to senior living facilities and hospitals would still be prohibited and strict hygiene protocols would be followed for all who interact with patients. Elective surgeries could resume this phase, on an outpatient basis, “at facilities that adhere to CMS guidelines.”

If a state or region clears the gating criteria after a second 14-day period, the area could reach phase 2. Additional “opening” would be permitted for individuals and in workplaces, with elective surgeries permitted on both an inpatient and outpatient basis. However, visits to senior care centers and hospitals would still be prohibited.

Once a state or region clears the 14-day period a third time with no signs of a COVID-19 rebound, the area would begin phase 3. This phase would bring unrestricted staffing at worksites, and visits to senior care facilities and hospitals would resume.

During this phase, vulnerable populations should still adopt physical distancing. This would include the elderly and those with certain chronic conditions such as diabetes, obesity, or asthma, or those undergoing chemotherapy. Even low-risk individuals are encouraged to avoid large crowds.

NIH to Create Public-Private Partnerships. The National Institutes of Health (NIH) and the Foundation for NIH announced a plan among leading pharmaceutical manufacturers, the HHS Office of Assistant Secretary for Preparedness and Response, the CDC, the FDA, and the European Medicines Agency to coordinate research for vaccines and treatments for COVID-19.

The Accelerating COVID-19 Therapeutic Interventions and Vaccines partnership will work on streamlining clinical trials, coordinating regulatory responses, and “leveraging assets among all partners” in a model to address both COVID-19 and future pandemics. More than 100 potential vaccines and treatments are being studied, the NIH said in its statement.

“We need to bring the full power of the biomedical research enterprise to bear on this crisis,” NIH Director Francis S. Collins, MD, PhD, said in a statement. “Now is the time to come together with unassailable objectivity to swiftly advance the development of the most promising vaccine and therapeutic candidates that can help end the COVID-19 global pandemic.”

A steering committee that includes NIH and FDA leadership, along with private-sector leaders, will direct the effort. “COVID-19 is the most significant global health challenge of our lifetime, and it will take all of us working together as a global community to put an end to this pandemic,” Paul Stoffels, MD, vice chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said in the NIH statement.

“Battling the COVID-19 pandemic is far too great a challenge for any one company or institution to solve alone,” added Mikael Dolsten, MD, PhD, chief scientific officer and president, Worldwide Research, Development and Medical, Pfizer. “We are seeing an unprecedented level of collaboration across the innovation ecosystem to address this global health crisis, and this potentially powerful NIH initiative may allow us to further accelerate the delivery of much needed therapies to patients around the world.”

The initiative will leverage several existing efforts within the NIH and FDA, including the Coronavirus Treatment Acceleration Program. More than a dozen existing NIH research networks will take part, including several associated with global HIV trials.