In This Article
- At Mass General's virtual medical grand rounds, former FDA Commissioner Scott Gottlieb, MD, spoke about how the U.S. should prepare for a probable second peak of the COVID-19 outbreak in Autumn 2020
- One or more point-of-care diagnostics may be approved by the FDA in the coming weeks, but the chance of having widespread community testing by August is slim because there is no comprehensive federal government strategy
- For the development of SARS-CoV-2 vaccines and COVID-19 therapeutics, the FDA and industry should collaborate to choose the one or two most promising candidates in the near term and put all resources behind them
- As it has done for certain orphan drugs, the FDA should serve as a consultant to companies developing leading therapeutics by advising on clinical trial endpoints, reviewing data from ongoing trials and giving interim feedback
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Scott Gottlieb, MD, former chief of the FDA and partner at New Enterprise Associates, was a featured speaker at Massachusetts General Hospital's virtual medical grand rounds held on April 9, 2020. He called on the FDA to partner with pharmaceutical companies to accelerate the development of diagnostics, vaccines and therapeutics to manage the COVID-19 pandemic. Below is a summary of takeaways on the timeline and challenges in developing, manufacturing and distributing these technologies to manage the pandemic.
By the end of April the U.S. will probably be able to offer two million PCR-based SARS-CoV-2 tests per week, Dr. Gottlieb said. To scale beyond that will require the deployment of additional systems, especially point-of-care diagnostics. These would ideally be available by August or September when the second peak of SARS-CoV-2 infections could occur after people return to work and school.
A number of diagnostics are in development and may be approved by the FDA in the coming weeks, but it will take time to ramp up the supply, Dr. Gottlieb noted. The chance of having widespread community testing by August is growing increasingly slim. There is no comprehensive federal government strategy yet, and Congress still needs to appropriate funds for components such as paying physicians to do the tests and subsidizing insurance companies for the mandated coverage.
A conservative estimate is that a vaccine against SARS-CoV-2 is a couple of years away, Dr. Gottlieb said. The four main possibilities are an mRNA vaccine, a protein-based vaccine, an adenoviral vector or application of the vector used in the Ebola vaccine.
Dr. Gottlieb is urging the FDA and industry to identify the one or two strongest vaccine contenders and focus all clinical trials on those. Be transparent and allow companies to petition the agency, he said, but concentrate on the best possibilities in the near term.
One or two highly effective therapeutics are needed to rescue patients with severe COVID-19, or, more likely, prevent patients from progressing to severe disease. A small number of agents are promising enough to be ready by fall if the government and private industry work together, Dr. Gottlieb said.
As with vaccines, the FDA should focus its activity on drugs that show the greatest near-term promise, he said. The agency should play the same "consultant" role it has offered to companies developing drugs for rare diseases: help companies choose the clinical trial endpoints that will support regulatory approval, review trial data in real-time and give fast interim feedback.
The challenge is that the supply of any therapeutic will be constrained in the short term. Dr. Gottlieb gave the example that at best, Regeneron could probably produce one million doses of sarilumab per day in its U.S. facility by August—if it moves production of all its other drugs to its manufacturing facility in Ireland.
Producing COVID-19 drugs outside the U.S. isn't feasible because of the prospect of import restrictions, so the nation will need to invest in creating manufacturing capacity, Dr. Gottlieb concluded.
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Learn more about COVID-19 Medical Grand Rounds at Mass General