The United States leads the world in biotech innovation, but does it also lead the world in the development of COVID-19 diagnostics, vaccines and therapeutics?
The United States leads the world in biotech innovation, but does it also lead the world in the development of COVID-19 diagnostics, vaccines and therapeutics?
Based upon the number of clinical trials listed with ClinicalTrials.gov, the answer, so far, is “no.” But, if the number of potential solutions in development are considered, “no” may become “yes.”
Clinical Trials by the Numbers
In sheer numbers of therapeutic trials at all stages, China has the most, with 62. Europe has 53 and the U.S. has 32, according to ClinicalTrials.gov. Other countries or regions have only a handful. Canada, for example has 12, the Middle East has six, Southeast Asia has five, Australia has four, Africa and Mexico two each and India one. For some trials, locations were not listed. A total of 230 trials were reported.
When we look at vaccine trials, Europe leads with seven, followed by China with six and the U.S. with four. A total of 23 trials were reported. Of those, only one – in Wuhan, China – was active, and nine were recruiting.
In terms of clinical trials involving diagnostics tests, ClinicalTrials.gov reports 118. Europe leads with 36, followed by China with 25, and the U.S. with 19. Canada is in fourth position, with six.
The numbers of therapeutics, vaccines and diagnostics in clinical trials don’t show the complete picture, though. Many biopharma companies and academic labs are actively engaged in the COVID-19 battle but are not yet ready for clinical trials.
United States
The FDA is working with more than 240 diagnostic test developers who have said they plan to submit emergency use authorization (EUA) requests.
As of April 2, the FDA had issued 25 EUAs, including one to Cellex to detect the presence of coronavirus antibodies. It is designed as an adjunct to laboratory results rather than as a definitive diagnostic. More than 125 labs now provide COVID-19 testing.
Currently, the FDA is allowing four developer-validated diagnostic tests to be distributed while awaiting FDA validation or issuance of an EUA. They are:
- BD BioGx SARS-CoV-2 Reagents for BD MAX System
- BGI Genomics Co. Ltd
- Co-Diagnostics, Inc.
- OSANG Healthcare Co., Ltd, GeneFinder COVID-19 Plus RealAmp Kit
Additionally, the FDA is leading a national effort to facilitate development of two antibody-rich platforms (convalescent plasma and hyperimmune globulin) derived from the blood of recovered COVID-19 patients “as fast as possible,” HHS Secretary Alex Azar said in a statement.
The FDA also is looking at new ways to bring efficacious products through the regulatory process faster. Initially, that meant using the emergency investigational new drug application (eIND) process. The agency also is expanding access to clinical trials to institutions, such as rural hospitals, that currently lack such access.
Europe
The EMA is working with the developers of approximately 40 therapeutics that may have potential against COVID-19. Some of the most promising candidates and their current authorized uses are:
• remdesivir (investigational)
• lopinavir/ritonavir (for HIV)
• chloroquine and hydroxychloroquine (for malaria and autoimmune diseases)
• systemic interferons and, in particular interferon beta (for multiple sclerosis)
• monoclonal antibodies with activity against components of the immune system
The EMA also is talking with developers of a dozen or so potential COVID-19 vaccines, but cautions that it may take a year or more before a vaccine is ready for approval.
As of Friday, April 3, the EMA maintained, “There are currently no authorized vaccines or treatments in the EU to prevent or treat novel coronavirus disease (COVID-19) specifically or any other coronaviruses.” Chloroquine and hydroxychloroquine, it instructed, were to be used only in clinical trials or emergency programs.
The EMA did, however, outline compassionate use recommendations for the investigational antiviral medicine remdesivir in the context of COVID-19. Laboratory studies indicate remdesivir, a viral RNA polymerase inhibitor, prevents SARS-CoV-1 and 2 (SARS and COVID-19) and MERS-CoV from replicating.
The United Kingdom
What the U.K. billed as “the world’s largest randomized clinical trial of potential coronavirus treatments,” was announced last Thursday, but actually began in mid-March. As part of the U.K.’s prioritization of COVID-19 research, some 1,000 patients from 132 hospitals were recruited in the first 15 days, and thousands more are joining the trials.
The trial tests:
- lopinavir-litonavir, an HIV treatment
- dexamethasone, a steroid to reduce inflammation
- hydroxychloroquine, a malaria treatment
Additional medicine may be added as they are identified.
This trial, called “Recovery” received £2.1 million in funding from UK Research and Innovation and the Department of Health and Social Care. It is part of a wider £20 million rapid research response investment by the government to identify ways to tackle the coronavirus outbreak. COVID-19 trials will be fast-tracked.
Additionally, the BioIndustry Association (BIA) is working with the Coalition for Epidemic Preparedness Innovations (CEPI) and the British government to coordinate manufacturing capacity and ideas to support the research, development and scale-up of life sciences sector responses to the pandemic.
China
China admits COVID-19 infections are continuing. April 3, the National Health Commission of the PRC reported, “31 new cases of confirmed infections, 12 new cases of suspected infections (all are imported cases), and 4 deaths (all in Hubei province)” based on data from China’s 31 providences and the Xinjiang Production and Construction Corps. The report cited 870 cases of “imported infections” and 60 asymptomatic cases (a new data point). It started the day with “81,620 reports of confirmed cases and 3,322 deaths.” Of those cases, 76,571 had been discharged from the hospital.
“China will overcome difficulties to give priority to restoring and raising the output of medicine and disease prevention materials, strengthen supervision over product quality, and provide more materials for the global fight against the disease,” China’s President, Xi Jinping, told Belgian King Philippe and Indonesian President Joko Widodo during an April 2 phone call.
That pledge to improve quality came after a Reuters report that Spain and Slovakia complained that results from diagnostic kits produced in China and supplied to 11 countries were inaccurate. Soon afterward, the National Medical Products Administration (NMPA) – formerly the China FDA – began requiring certification before medical products (including assays, kits, and masks) could be exported.
