Biopharma Update on the Novel Coronavirus: December 8

CV Update_December 8

News information is not all-inclusive and updates are published once a week on Tuesdays. 

FDA Actions

Warning Letters: The FDA issued warning letters to the following for unapproved and misbranded products related to COVID-19.

Diagnostics Update: To-date the FDA has authorized 295 individual EUAs, which include 227 molecular tests, 61 antibody tests and seven antigen tests.



Nucleic-acid-based assays are the gold standard for detecting the presence of the SARS-CoV-2 virus, but they eventually will be replaced with simpler and more advanced techniques, such as CRISPR-Cas, LAMP, and other faster and less-expensive methods, according to a paper published in APL Bioengineering (a publication of the American Institute of Physics). Please click here for more information

On November 26, Swiss medtech company Abionic announced that they have developed the first COVID-19 severity test, the cSOFA (Covid Sequential Organ Failure Assessment) score, to help doctors quickly and accurately triage cases that come into emergency rooms. The cSOFA Score evolved from a test Abionic developed for sepsis. Please click here for more information

The  U.S. Food and Drug Administration (FDA) has given Emergency Use Authorization (EUA) to a COVID-19 test developed by Roche that measures antibodies within the blood. The test appears to be geared toward measuring the antibody response produced by the vaccines currently under review. 


Testing Therapies, Antivirals and Vaccines

Researchers with the U.S. National Institute of Allergy & Infectious Diseases (NIAID) published a letter in The New England Journal of Medicine describing the three-month immunogenicity levels in Moderna’s mRNA-1273 vaccine.

Once touted as promising treatments and by some even a cure, the World Health Organization dashes those claims, finding no benefit in the use of four popular COVID-19 treatments (remdesivir, hydroxychloroquine, lopinavir, or interferon-beta-1a) on hospitalized patients.  

Children, who have not been widely tested in clinical trials for the vaccine, are typically less severely affected and are much further down the priority list for receiving the vaccines. But the vaccine has not been tested at all in younger children. Please read more here

Please read more about the timeline of the development of a COVID-19 vaccine.

Auris Medical rose by as much as 480% last week after it announced lab test results, which appeared to show that its nasal spray could potentially protect users against COVID-19, according to Business Insider.

Sweden-based Cyxone received approval from Poland’s regulatory authority to launch a Phase II clinical trial with Rabeximod in moderate Covid-19 patients. The oral treatment is intended to prevent the progression to acute respiratory distress symptoms. Preliminary results are expected in the third quarter of 2021.

Organizational Actions/Announcements 

Last week, the United Kingdom’s Medicines & Healthcare Products Regulatory Agency (MHRA) granted temporary authorization for emergency use to Pfizer and BioNTech for their COVID-19 mRNA vaccine. It didn’t take long for the decision to generate criticism and questions.


Other Industry News

The pharmaceutical industry has battled COVID-19 since the moment members learned of it. The U.S. declared war on COVID and sacrificed large swathes of its economy to prevent the spread of this dreaded disease. Yet, despite the push, the UK is set to administer the first Western vaccine before the FDA’s vaccine review committee even meets, leaving an increasingly skeptical public wondering why. Please read here for more information

Numerous companies who have COVID-19 vaccines in development, have astonished skeptics by the speed with which they have developed vaccines that appear to be safe and effective. But now comes an even more daunting challenge—scaling up manufacturing and distribution to deliver the vaccine to populations around the world in a timely and effective manner. Please click here for more information

Governments across the globe have flexed their financial muscles to secure promises of as many doses of COVID-19 vaccines as possible when they become available. By in large, most of the doses of vaccines that have already been spoken for are going to countries with significant resources. Last week, NPR provided a chart that highlighted where vaccine doses will go as manufacturing demands are met.

When a vaccine against COVID-19 is authorized, frontline healthcare workers and residents of long-term care facilities should be the first to receive the medication, an independent advisory panel for the U.S. Centers for Disease Control and Prevention recommends. Last week, the CDC Advisory Committee on Immunization Practices voted 13-1 in support of this recommendation.

President Donald Trump has repeatedly assured U.S. citizens that his administration would secure enough COVID-19 vaccine doses to protect the nation. However, a new report shows his government failed to act in securing additional doses of Pfizer and BioNTech’s vaccine this summer.

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