Biopharma Update on the Novel Coronavirus: August 21
News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays.
FDA Actions
Third EUA for Antigen Test: The FDA issued a EUA for a third COVID-19 antigen test. The EUA was given to LumiraDX UK Ltd. for its LumiraDx SARS-CoV-2 Ag Test.
UV Lights and Lamps: The FDA posted FAQs for consumers that may be interested to purchase UVC lamps to disinfect in the home during the COVID-19 pandemic.
Temporary Industry Guidance: The FDA released temporary guidance entitled, “Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers.”
Warning Letter: The FDA and the FTC issued a warning letter to Living Senior, LLC for selling fraudulent COVID-19 products.
Warning Letter: The FDA issued a warning letter to Predictive Biotech, Inc. for CoreCyte. CoreCyte is an unapproved umbilical cord-derived product that claims to treat or cure COVID-19.
Diagnostics Update: To-date the FDA has authorized 218 individual EUAs, which include 176 molecular tests, 39 antibody tests and 3 antigen tests.
Testing Therapies, Antivirals and Vaccines
One of the leading groups in developing a COVID-19 vaccine, U.S.-based Pfizer and Germany’s BioNTech, released additional Phase I data from their ongoing U.S. trial of BNT162b2 (B2), their mRNA-based vaccine against COVID-19. The vaccine has otherwise advanced into a Phase II/III trial. The companies had released preliminary data on the vaccine on July 1, but that was for a different vaccine than the one they are taking into a 30,000-patient Phase III trial. The companies were originally testing four variations of their vaccine, each with a different combination of mRNA format and target antigen. The preliminary data announced on July 1 were for BNT1621b1 (B1). But on July 28, they announced they had selected BNT162b2 to take into larger studies.
Following approval of its coronavirus vaccine, the first in the world, Russia plans to initiate a new study involving 40,000 people as the country looks to boost production and distribute the drug to patients in that country, as well as to patients in countries it has struck deals with.
Johnson & Johnson announced plans to test a coronavirus vaccine candidate in September. The Phase III clinical trial would enroll up to 60,000 healthy adults across the U.S. and in other countries.
SAB Biotherapeutics announced the dosing of the first patient in its Phase Ib clinical trial evaluating the safety and pharmacological activity of SAB-185, a COVID-19 therapeutic. SAB-185, developed from SAB’s novel technology platform that leverages the native human immune response to offer a differentiated high-potency therapeutic option that potentially addresses virus mutations, is currently being tested in an ongoing Phase I trial in healthy volunteers for the treatment of COVID-19.
The FDA cleared Appili Therapeutics to proceed with an expanded Phase II trial in the U.S. to evaluate favipiravir against COVID-19 outbreaks in long-term care facilities. Favipiravir is a Japan-based therapy developed and regulated for the prevention of pandemic influenza outbreak under the brand name Avigan.
Company Actions/Announcements
Reported by the Boston Business Journal, CureVac is in discussions with European countries to provide up to 405 million doses of its experimental COVID-19 vaccine.
Hercules Pharmaceuticals published promising preclinical in vivo studies demonstrating the efficacy of its Aryl Hydrocarbon Receptor (AhR) inhibitor HP163 against Zika virus infection and potentially against coronavirus infection, such as SARS-CoV-2. The studies showed HP163 reduced viral replication in animals infected with Zika-virus and reduced microcephaly. In vitro studies demonstrated the efficacy of AhR inhibitors against Dengue. They also believe it can be effective against COVID-19 and other coronaviruses by way of a similar mechanism.
Other Industry News
As reported by Reuters, Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research has vowed to resign if the Trump administration approves a vaccine before it is shown to be safe and effective.
Scientists in Singapore discovered a new variant of COVID-19 that causes milder infections. The study was published in The Lancet journal this week.
In May, Fitbit, a company that manufactures and markets health-tracking watches, announced it had launched a study with a goal of creating an algorithm that could detect COVID-19 before symptoms appeared. In about a two-month period, 100,000 Fitbit wearers in the U.S. and Canada enrolled and more than 1,000 positive COVID-19 cases were reported. The company released early findings from the study and has uploaded the data to the Medrxiv preprint server. The study concludes that they can detect almost 50% of COVID-19 cases a day before enrollees in the study reported the onset of symptoms, and they do so with 70% specificity.
A new study published in the Journal of Pediatrics shows children can have a significantly higher level of virus in their airways than adults who were hospitalized with COVID-19. This could impact the spread of COVID-19.
According to a research letter published in the journal of Physics of Fluids, a team of researchers simulated virus-laden particle movement from urinal flushing. The results indicate that particles can manifest external spread and masks should be mandatory in public restrooms.
The University of Waterloo released a study using a mathematical model to explore class sizes and student-to-teacher ratios on number of COVID-19 infections and student-days of closed classrooms in Canada. The model suggested the optimal student-to-teacher ratio to maximize in-person instruction opportunities to be well below planned ratios in many jurisdictions, which are as high as 15:2 in childcare centers and 30:1 in schools. The model found that total student-days lost to classroom closure were between five and eight times higher in the 15:2 ratios than for 8:2 or 7:3.