Biopharma Update on the Novel Coronavirus: August 24
News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays.
FDA Actions
Convalescent Plasma: The FDA issued a EUA for investigational convalescent plasma for the treatment of COVID-19.
EUA: The FDA issued a EUA to NovaSterilis for Nova2200 to be used to decontaminate compatible N95 respirators for single-user reuse by health care personnel.
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
The U.S. Food and Drug Administration (FDA) reversed itself Sunday following pressure from the White House and announced an Emergency Use Authorization for convalescent plasma as a treatment for patients who have contracted COVID-19, the disease caused by the novel coronavirus.
AstraZeneca stock jumped more than 3% this morning after rumors broke that President Trump was considering fast-tracking the company’s COVID-19 vaccine candidate. According to a Financial Times report, three people briefed on the plan indicated Trump wants to give AstraZeneca and the University of Oxford’s experimental COVID-19 vaccine emergency use authorization (EUA) ahead of the U.S. presidential election on November 3.
Novavax announced the first volunteers have been enrolled in a Phase II clinical trial to evaluate immunogenicity and safety of NVX-CoV2373, and investigational COVID-19 vaccine candidate.
Tiziana Life Sciences was granted a patent for a potential coronavirus treatment. The patent is for methods that use a fully human monoclonal antibody, TZLS-501 which recognizes both IL-6 receptor and IL-6 receptor complex.
Beckman Coulter Diagnostics launched its SARS-CoV-2 Immunoglobulin M (IgM) antibody test, with plans to begin shipping 15+ million tests each month. The assay demonstrated 99.9% specificity and 98.3% sensitivity and detects an individual’s immune status with a positive predictive value of 95.5%. IgM antibodies are those produced in the early days of infection, and an IgM test may play a critical role in helping us slow the spread of the virus in the face of PCR test shortages and delays in test results as long as two weeks.
Company Actions/Announcements
Russia claimed the world’s first approved COVID-19 vaccine, but over the weekend, the Chinese government said it has been providing experimental coronavirus vaccines to high-risk populations in that country since July. No vaccine has yet to be approved in China, but a state health official said during a televised interview over the weekend that the government sought to jump-start broad immunity by providing some vaccinations against the novel coronavirus to medical workers and those who work at food markets and in the transportation and service sector, Reuters reported.
Australia-based Cynata Therapeutics is enrolling patients in the MEND (MEseNchymal coviD-19) Trial. The MEND Trial will investigate the early efficacy of Cynata’s proprietary Cymerus mesenchymal stem cells (MSCs) in adults admitted to intensive care with COVID-19.
Other Industry News
Operation Warp Speed wants its partners to establish a COVID-19 vaccine distribution system by Nov. 1, 2020. UPS and other partners plan to conduct test delivery runs in September.