While most of America is locked down at home, in almost every case, pharmaceutical, medical device and equipment, and biotechnology companies (including operations, research and development, manufacture, and supply chain) organizations are considered essential workers and are facing this global challenge head on.

Even with diminished staff and resources, the pharmaceutical and life sciences industry continues to work toward the development of diagnostics, vaccines and therapies for respiratory infection.

The FDA (Food & Drug Administration) has taken action to streamline discovery, while many diagnostic tools and drug targets are starting to find their way into the greater conversation about how to handle SARS-CoV-2 and the COVID-19 disease itself.

FDA Activity

  • More Regulatory Relief: The FDA will provide regulatory relief during the outbreak.
  • Foreign Inspections: In response to the COVID-19 outbreak, the FDA is postponing most foreign inspections.
  • Authorization of Emergency Use: On the basis of this determination, the FDA Secretary declared that circumstances exist justifying the authorization of emergency use of personal respiratory protective devices during the COVID-19 outbreak.

While regulatory issues are being managed, some companies are starting to make progress on diagnostic tools. Testing has been a significant challenge for the US and is essential for identifying people who have been infected and for understanding the true scope of the outbreak. A few companies are making strides in this space.

  • Abbott: The FDA approved Abbott’s molecular test for the novel coronavirus that causes COVID-19 under an Emergency Use Authorization (EUA). The company indicates it is immediately shipping 150,000 Abbott RealTime SARS-CoV-2 EUA tests to current customers in the U.S.
  • Biomerica has begun shipping samples of this COVID-19 test to multiple Ministries of Health and government agencies that have requested the product through the company’s distributors in the Middle East, throughout Europe, and other countries

In the end, what will help get the global population back to life as we knew it will be healing and preventive measures. Here, companies are attempting to find therapies to treat the illness and eventually prevent infection.

Failed clinical studies

  • In adults with severe COVID-19 hospitalized in Wuhan, China, treatment using a combination of antiviral drugs – lopinavirritonavir (HIV/AIDS therapies) – provided no benefit.

Vaccine candidates

Two Phase I safety clinical trials on vaccine candidates were initiated:

  • mRNA-1273: The US National Institute of Allergy and Infectious Disease (NIAID) collaborated with Moderna to develop an RNA vaccine matching a spike of the coronavirus surface.
  • Ad5-nCoV: A Phase I safety trial of a recombinant adenovirus vaccine candidate manufactured by CanSino Biologics Inc. (Tianjin, China), called Ad5-nCoV, began recruiting 108 healthy adults in Wuhan, China in March.
  • Several other vaccine candidates were being fast-tracked to begin first-in-human studies, as of March 2020.

Post-exposure prevention

Based on experience with antimicrobials, pre-exposure prophylaxis and post-exposure prophylaxis (PEP) with antiviral drugs may be effective procedures to minimize infection which causes COVID-19.  PEP using the antibiotic, rifampicin, is recommended by WHO for people at high risk of infection before or after exposure to pandemic influenza. Some experts speculate that antiviral drugs administered shortly after the onset of COVID-19 infection symptoms may reduce illness and lower the risk of infecting other people by reducing viral shedding in respiratory secretions.

Repurposing approved drugs

During the COVID-19 outbreak, drug repurposing (or “repositioning”) is the clinical research process of rapidly screening and defining the safety and efficacy of existing drugs already approved for other diseases to be used for people with COVID-19.

Clinical trials using repurposed, generally safe, existing drugs for hospitalized COVID-19 patients may take less time and have lower overall costs to obtain endpoints proving safety (absence of serious side effects) and post-infection efficacy, and can rapidly access existing drug supply chains for manufacturing and worldwide distribution.

Phase III trials

  • Favipiravir: In people with COVID-19, favipiravir (marketed as Avigan and approved for use in Japan in 2014 for several viral diseases) was found to be safe and had preliminary efficacy in an early-stage trial in Shenzhen, China.
  • Remdesivir: the Gilead Sciences antivirus drug candidate is in multiple clinical trials, with preliminary results expected in May 2020
  • ASC-09 + ritonavir (oral tablet): ASC-09 (product of the Chinese firm, Ascletis Pharma Inc.), a HIV-1 protease inhibitor in combination with ritonavir, was initiated in a Phase III trial in China during February 2020 to assess efficacy against COVID-19.
  • Tocilizumab: a monoclonal antibody with activity against the interleukin-6 receptor involved in inflammation, tocilizumab is already marketed under the trade name, Actemra, to treat arthritis. It is under clinical development to determine safety and efficacy against pneumonia in hospitalized people with COVID-19. The manufacturer, Genentech, announced the April start of a Phase III trial across several countries.

There is no need to reiterate that these are unprecedented times. Recently released drone footage video of Boston tells a clear story about how seriously many communities are taking the COVID-19 Stay-At-Home declarations across America. In these times, ClinLab wishes the labs and companies working on the COVID-19 challenge the best of luck and applauds and supports their efforts.

Source data: Wikipedia & The Food & Drug Administration 3.31.20