Biopharma Update on the Novel Coronavirus: October 20
News information is not all-inclusive and updates are published once a week on Tuesdays.
Warning Letter: The FDA and the FTC issued a warning letter to For Our Vets LLC dba Patriot Supreme for selling products with fraudulent COVID-19 claims.
New Guidance: The FDA issued and implemented new guidance, Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
Diagnostics Update: To-date the FDA has authorized 282 individual EUAs, which include 220 molecular tests, 56 antibody tests and 6 antigen tests.
Centogene NV received EUA from the FDA for CentoSure, its latest SARS-CoV-2 RT-PCR test. It allows the test to be used for people without any symptoms or suspicion of COVID-19, supporting widespread population testing.
DB (Becton, Dickinson and Company) received a CE mark for its BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes for assessing immune function in COVID-19 patients. The test enables clinicians to go beyond the complete blood count to better understand the underlying mechanisms for severity in COVID-19 patients, especially those with co-morbidities.
Australia’s Beroni Group announced the successful completion of SARS-CoV-2 pseudovirus neutralization assay in collaboration with GenScript Biotech Corporation. The assay targets on coronavirus-specific nanobodies and tests affinity and efficacy to prevent the virus infection.
Beckman Coulter will be using a BARDA grant to validate the ability of their Monocyte Distribution Width (MDW) hematology biomarker to aid in the rapid detection of a rare but serious complication of COVID-19 affecting children.
Testing Therapies, Antivirals and Vaccines
There has been some discussion of running challenge trials for COVID-19 vaccines. In a challenge trial, people are given a vaccine then intentionally dosed with the virus or bacteria that causes the disease. For diseases that are very deadly without reliable therapies, it is considered unethical and very dangerous. But the UK is going to go ahead and try it anyway. Please read more here.
The U.S. Army Medical Research and Development (USAMRDC) initiated a Phase I clinical trial of its novel vaccine against COVID-19. The vaccine candidate is called “spike ferritin nanoparticle” (SpFN) and uses ferritin— “attaching a certain type of spike protein to a polymerized version of ferritin,” according to the organization.
The UK government’s COVID-19 Vaccine Taskforce and a contract research company called Open Orphan announced a $13 million (£10 million) plan to test investigational COVID-19 vaccines in volunteers who are then intentionally exposed to SARS-CoV-2, the virus that causes COVID-19. The trials won’t begin until early 2021 and are expected to finish in May 2021. They will require regulatory and ethical approval.
In several studies, Gilead Sciences’ remdesivir has shown that it can decrease the hospital stays of COVID-19 patients. A new clinical trial by the World Health Organization (WHO), however, reports that the drug does not have any particular effect on a patient’s survival. Please read more here.
Moderna is working with international regulators to accelerate approval of the company’s coronavirus disease 2019 (COVID-19) vaccine candidate, mRNA-1273, which is currently leading the global COVID-19 vaccine race alongside vaccine candidates from AstraZeneca, Pfizer and Johnson & Johnson. Please read more here.
The race for a COVID-19 vaccine continues to heat up as case numbers rise. Please read more here.
Pfizer received approval from the U.S. Food and Drug Administration (FDA) to enroll children as young as 12 years of age in its COVID-19 vaccine trial.
Last week Relief Therapeutics and NeuroRx released results on Tuesday from their open-label prospective study looking into RLF-100 (aviptadil) as a potential treatment for COVID-19 and respiratory failure. Please read more here.
Pfizer will not seek Emergency Use Authorization (EUA) for its COVID-19 vaccine until the end of November even if the readout from a Phase III study expected later this month is positive. Please read more here.
Two months ago, Russia planted its flag as the first coronavirus vaccine. This week, they rolled out their second vaccine, still leaps and bounds ahead of the rest of the world who’s currently engaged in rigorous testing to prove their candidate’s safety and efficacy. Russia has apparently bypassed the Phase III portion and granted regulatory approval to the peptide-based drug, EpiVacCorona, which was developed by the Vector Institute in Siberia. Please read more here.
Other Industry News
Researchers at Johns Hopkins Medicine identified a protein, known as factor D, that appears essential to the inflammatory process of SARS-CoV-2, the virus that causes COVID-19. They believe that by inhibiting factor D, it would reduce the inflammatory reactions that make COVID-19 so deadly. They published their research in the journal Blood. Please read more here.
Virginia Tech researchers received a $1 million grant from the USDA National Institute of Food and Agriculture to study ways to ensure people do not catch COVID-19 from handling packaging and ways to properly sanitize food at all levels of distribution and production. Reza Ovissipour is the primary investigator and an assistant professor in food science and technology and the Virginia Seafood Agricultural Research and Experiment Center and a Virginia Cooperative Extension specialist.
Dr. Monica Gandhi, MD, an infectious diseases doctor and professor of medicine at UC San Francisco, poses the hypothesis that masks and other social distancing measures may reduce the viral inoculum – or amount – of the SARS-CoV-2 we contract. Please read more here.
The coronavirus disease 2019 (COVID-19) pandemic has placed the world in a tailspin, which the healthcare industry has responded to in kind with the development and rapid deployment of tests designed to detect infection. Here's a look at the pros and cons of the most common COVID-19 tests.
With multiple COVID-19 vaccines in development, the Centers for Disease Control and Prevention (CDC) is confident that any vaccines the FDA authorizes or approves will be safe because they are based on the FDA’s usual stringent protocols. The greater question, after a vaccine is approved, is how it will be distributed. Please read more here.