The United States leads the world in biotech innovation, but does it also lead the world in developing diagnostic, vaccines and COVID-19 therapies?
Based on the number of clinical trials registered with ClinicalTrials.gov, the answer, so far, is “no.” However, if the number of potential solutions in development are considered, “no” can be “yes.”
Clinical Trials with Numbers
In mere amounts therapeutic trial at all stages, China has the most, with 62. Europe has 53 and the US 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, the location is not registered. A total of 230 trials were reported.
When we look at vaccine trials, Europe leads with seven, followed by China with six and the US with four. A total of 23 trials were reported. Of them, only one – in Wuhan, China – was active, and nine recruited.
In terms of clinical trials involving diagnostic tests, ClinicalTrials.gov reports 118. Europe leads with 36, followed by China with 25, and the US with 19. Canada ranks fourth, with six.
However, the number of therapies, vaccines, and diagnostics in clinical trials does not show a complete picture. Many biopharma companies and academic laboratories are actively involved in the battle of COVID-19 but are not ready for clinical trials.
United States of America
The FDA works with more than 240 diagnostic test developers who say they plan to submit requests for authorization for emergency use (EUA).
On April 2, the FDA issued 25 EUA, including one to Cellex to detect the presence of coronavirus antibodies. It was designed as an adjunct to laboratory results rather than as a definitive diagnostic. More than 125 laboratories now provide COVID-19 testing.
At present, the FDA allows four diagnostic tests validated by the developer to be distributed pending FDA validation or EUA issuance. They:
- BD BioGx SARS-CoV-2 Reagent for BD MAX Systems
- BGI Genomics Co. Ltd.
- Co-Diagnostics, Inc.
- OSANG Healthcare Co., Ltd., GeneFinder COVID-19 Plus RealAmp Kit
In addition, the FDA is leading a national effort to facilitate the development of two antibody-rich platforms (plasma recovery and hyperimmune globulin) derived from the blood of COVID-19 patients who recover “as quickly as possible,” HHS Secretary Alex Azar said in a statement. .
The FDA is also looking for new ways to deliver efficacious products through the regulatory process more quickly. Initially, it meant using an emergency New investigative drug application (eIND) process. The agency also expanded access to clinical trials to institutions, such as rural hospitals, which currently lack such access.
EMA works with the developers of about 40 therapies that may have the potential to fight COVID-19. Some of the most promising candidates and their current official uses are:
• remdesivir (investigation)
• lopinavir / ritonavir (for HIV)
• chloroquine and chloroquine hydroxy (for malaria and autoimmune)
• systemic interferon and, specifically beta interferon (for multiple sclerosis)
• monoclonal antibodies with activity against components of the immune system
EMA also spoke with a dozen potential COVID-19 vaccine developers, but warned that it might take a year or more before the vaccine is ready for approval.
On Friday, April 3, EMA stated, “There are currently no official vaccines or treatments in the EU to specifically prevent or treat coronavirus (COVID-19) or other coronaviruses. “Chloroquine and hydroxychloroquine, as instructed, should be used only in clinical trials or emergency programs.
EMA, however, elaborates recommendation for loving use for the antiviral drug remdesivir studied in the context of COVID-19. Laboratory studies show remdesivir, an inhibitor of viral RNA polymerase, preventing SARS-CoV-1 and 2 (SARS and COVID-19) and MERS-CoV from replication.
What the UK calls “the world’s largest randomized clinical trial with the potential for corona virus treatment,” was announced last Thursday, but actually began in mid-March. As part of the COVID-19 research priority in the UK, around 1,000 patients from 132 hospitals were recruited in the first 15 days, and thousands more joined the trial.
- lopinavir-litonavir, HIV treatment
- dexamethasone, a steroid to reduce inflammation
- hydroxychloroquine, malaria treatment
Additional drugs can be added when they are identified.
This trial, called “Recovery” received £ 2.1 million in funding from the UK Research and Innovation and the Department of Health and Social Care. This is part of the government’s rapid research response investment of more than £ 20 million to identify ways to deal with the coronavirus outbreak. COVID-19 trials will be tracked quickly.
In addition, the Bio Industry Association (BIA) works with the Coalition for Epidemic Innovation Preparedness (CEPI) and the UK government to coordinate manufacturing capacity and ideas to support research, development and improvement of the response of the science sector to the pandemic.
China recognizes COVID-19 infection continues. April 3, PRC National Health Commission reported, “31 new cases of confirmed infection, 12 new cases of suspected infection (all are imported cases), and 4 deaths (all in Hubei province)” based on data from 31 Chinese maintenance and the Xinjiang Production and Construction Corps. The report cites 870 cases of “imported infection” and 60 cases without symptoms (new data points). It began the day with “81,620 confirmed case reports and 3,322 deaths.” Of these cases, 76,571 had been discharged from the hospital.
“China will overcome the difficulty of prioritizing restoring and increasing output of medicines and disease prevention materials, strengthening supervision of product quality, and providing more material for the global war on disease,” Chinese President Xi Jinping told King Philippe of Belgium. and Indonesian President Joko Widodo during a telephone call on April 2.
The promise to improve quality comes after a Reuters report that Spain and Slovakia complain that the results of diagnostic kits produced in China and supplied to 11 countries are inaccurate. Soon after, the National Medical Product Administration (NMPA) – formerly the Chinese FDA – began requiring certification before medical products (including testing, equipment, and masks) could be exported.
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