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Product Development

COVID-19 Quick Takes: FDA authorizes 15-minute, $5 antigen test from Abbott; plus  updates from IDSA, CEPI, Novavax, VBI, Verndari, AZ, Fluidigm, Tyme

Aug 27, 2020 | 1:28 AM GMT

Abbott test cleared for rapid point-of-care
Abbott Laboratories (NYSE:ABT) said FDA granted Emergency Use Authorization (EUA) to a 15-minute point-of-care COVID-19 antigen test that costs $5 and detects SARS-CoV-2 nucleocapsid protein from nasal swabs. In patients suspected of having COVID-19 given the test within seven days of symptom onset, BinaxNOW had a sensitivity of 97.1% and a specificity of 98.5%. Abbott expects to ship tens of millions of tests next month, and 50 million tests a month beginning in October. The company plans to launch a companion mobile app that will display whether a tester was positive or negative. Antigen tests are considered a key technology for asymptomatic screening (see “Asymptomatic Testing Pushes Forward”).

IDSA recommends against EUA path for vaccines
The Infectious Diseases Society of America and the HIV Medicine Association sent a letter Wednesday to FDA Commissioner Stephen Hahn and CBER Director Peter Marks calling on FDA to seek full approval of a COVID-19 vaccine rather than grant an EUA “in light of public distrust of vaccines.” At a minimum, the groups recommended approval or authorization not be issued until Phase III testing is complete. The letter comes after ex-FDA officials criticized an EUA granted Sunday for convalescent plasma as putting politics ahead of science (see “EUA May Be Merited”).

CEPI seeking proposals for single-dose vaccines
The Coalition for Epidemic Preparedness Innovations extended its call for COVID-19 vaccine development proposals to Sept. 28 to meet its goal of delivering 2 billion vaccines doses by YE21. The organization said it is interested in proposals for single-dose vaccines from developers with proven technology and a track record of vaccine development, approval and manufacturing. CEPI has already allotted $890 million in commitments across nine vaccine candidates. 

Novavax enrolling elderly in Phase II
Novavax Inc. (NASDAQ:NVAX) said it has begun enrolling volunteers in the Phase II portion of its Phase I/II COVID-19 vaccine clinical trial. The biotech said half the trial’s population will be adults ages 60-84. Novavax expects interim data for NVX-CoV2373 next quarter.

VBI chooses two vaccine candidates
VBI Vaccines Inc. (NASDAQ:VBIV) said it has selected two COVID-19 vaccine candidates developed with its enveloped virus-like particle technology to enter the clinic by year-end. VBI-2901 is a trivalent vaccine that expresses spike proteins of SARS-CoV-2, SARS-CoV-1 and MERS-CoV; VBI-2902 is a monovalent vaccine that solely expresses SARS-CoV-2 spike. In mice, both a single dose of each vaccine elicited geometric mean titers of neutralizing antibodies that were four times higher than convalescent sera.

BARDA funding vaccine patch tech
Verndari Inc. said it has entered a $1 million cost-sharing agreement with HHS’s Biomedical Advanced Research and Development Authority to develop the biotech’s microneedle dermal patch vaccine delivery technology for COVID-19. BARDA will provide 68% of the funding, and Verndari will provide the remainder.

Vaccine adcomm on the calendar
FDA’s Hahn tweeted Wednesday that on Oct. 22, the agency will hold a virtual advisory committee meeting for COVID-19 vaccines that will be open for the public to view.

AZ starts clinical testing of antiviral antibody combo
AstraZeneca plc (LSE:AZN; NYSE:AZN) said it has begun dosing healthy volunteers in a Phase I trial of its SARS-CoV-2 neutralizing antibody therapeutic. The cocktail, dubbed AZD7442, combines two mAbs licensed from Vanderbilt University, which derived the antibodies from infected patients. The therapy is at least the ninth in the class to enter the clinic (see “Regeneron Leads Antiviral Antibody Pack”).

EUA for Fluidigm’s saliva test
Fluidigm Corp. (NASDAQ:FLDM) said FDA granted EUA to Advanta Dx, a saliva-based COVID-19 test. The product was selected to participate in NIH’s Rapid Acceleration of Diagnostics program and has a proposed budget of up to $37 million. RADx was launched in April with $1.5 billion to fuel development of rapid and easy-to-use diagnostics for SARS-CoV-2 infection with the goal of expanding testing capacity so that by December, 6 million people — or 2% of the U.S. population — can be tested per day, with additional tests in reserve (see “NIH, HHS Fast-tracking Point-of-care”).

Tyme plans clinical trial of bile acid therapy
Tyme Technologies Inc. (NASDAQ:TYME) said it is collaborating with Massachusetts General Hospital and the Weill Cornell Medical Center to start a placebo-controlled trial of TYME-19, an oral synthetic bile acid, in high-risk, recently diagnosed COVID-19 patients. 

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