Dr. Anthony Fauci of the National institutes of Health (NIH) today updated the U.S. Senate on the status of the COVID-19 pandemic in the nation. Although progress is being made on multiple fronts the United States finds itself at the epicenter of a global pandemic. As of this writing, nearly 1.4 million cases are known with over 82,000 dead. Although it would appear in many locations the curve is moving in a better direction the U.S. and many other nations are not out of the woods. Dr. Fauci in his ongoing attempt at representing and positioning the situation to balance multiple interests did his best to deliver a clear and coherent update. He cautioned that if appropriate measures such as testing, contact tracing and social distancing as well as other precautions weren’t taken by the Fall the American people could experience another dangerous spike in the COVID-19 epidemic. He emphasized at the NIH a four-fold strategy to help America (and by extension the world) transcend the crisis including 1) improve the nation’s fundamental knowledge of the disease 2) develop new point of care diagnostics 3) characterize and test therapeutics and 4) develop safe and effective vaccines
The NIH has recently introduced a program to accelerate the development of efficient and effective diagnostic products called “Rising to the COVID-19 Challenge: Rapid Acceleration of Diagnostics” or “RADx).
As the nation is in the midst of trying to contain this devastating pandemic, biomedical technology will play a key role and hence the importance of this government-sponsored initiative. Fueled by a bold $1.5 billion investment made possible by federal stimulus funding, RADx represents an urgent call for science and engineering’s most inventive and visionary minds to come together and put forth compelling ideas. Ideas will be evaluated in a in a “Shark Tank” like selection process to get to success or failure rapidly.
Dr. Fauci emphasized that the government was monitoring a number of broad spectrum anti-viral therapies in various stages of testing. Of course, remdesivir, a recent “success” story, was controversial in that the sponsors changed the outcome measures two weeks prior to the study’s conclusion. The Dr. failed to mention that but did go one to declare that the international trial, with over 1,000 hospitalized participants in multiple sites did produce a significantly significant yet “modest” outcome. The study revealed that at least within this population those that were ill with COVID-19 showed a 31% faster time to recovery. The NIH hopes to build on again what he describes as modest success.
Other therapeutic classes of drugs in various clinical research phases include the following categories:
· Hyperimmune globulin therapy
· Repurposed drugs
· Immune based therapies
· Host modifiers
· Monoclonal Antibodies
The nation’s lead doctor reported that least eight vaccines are in clinical development. He reminded the audience that the NIH has been collaborating with a number of biotech and drug companies at various stages in development. The one he identified was Moderna, the advanced mRNA-based vaccine recently granted $483 million by BARDA.
He reminded the audience that from the start he made the prediction that the development of a safe and efficacious vaccine, assuming one would even be developed, would take 12 to 18 months. He reminded the audience that the government-supported vaccine efforts are moving at a swift pace and that at least with the Moderna vaccine candidate known as mRNA-1273, currently in Phase I clinical trials, that the effort would seamlessly move to a Phase II/III study hopefully toward late Spring (end of May) to early summer (June). If all goes according to plan, with no hiccups or bottlenecks, the first actionable vaccine data could be ready by late fall to early winter 2020.
Dr. Fauci emphasized that there were multiple companies developing multiple vaccines in the clinical trial state and that it is in the best interests of all if there are “multiple shorts” at the goal. More than one successful vaccine certainly helps with global distribution. He emphasized that vaccines did carry risks—for example, in some cases they can include negative consequences where the patient taking the vaccine actually becomes sicker.
Accelerating COVID-19 Therapeutic Interventions and Vaccines
Finally, the NIH launched public private partnership accelerating COVID-19 therapeutic interventions and vaccines.
In this arrangement, the NIH and the Foundation of the NIH organized a coalition of more than a dozen leading biopharmaceutical companies, the Health and Human Services Office of the Assistant Secretary for Preparedness and Response, the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration and the European Medicines Agency to develop and execute an international strategy for a coordinated response to the COVID-19 pandemic.
Part of this effort involves the U.S. Food and Drug Administration’s Coronavirus Treatment Acceleration Program to speed development of safe and effective countermeasures.