BioBiz: Johnson & Johnson single-dose vaccine considered for emergency use authorization


Johnson & Johnson’s single-dose vaccine has been endorsed for consideration for emergency use authorization. According to an analysis by U.S. regulators that sets the stage for a final decision on a new and easier-to-use shot to help tame the pandemic.

The US Food and Drug Administration’s scientists confirmed the vaccine is about 66% effective at preventing moderate to severe COVID-19. The agency also said J&J’s vaccine — one that could help speed vaccinations by requiring just one dose instead of two — is safe to use.

On Friday, the agency’s independent advisers will debate if the evidence is strong enough to recommend the long-anticipated vaccine. Armed with that advice, FDA is expected to make a final decision within days.

Pfizer Inc. announced that the FDA accepted for Priority Review the company’s Biologics License Application (BLA) for TicoVac™, its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE in individuals 1 year of age and older. If approved, TicoVac would be the first vaccine in the U.S. to help protect adults and children who are visiting or living in TBE endemic areas.

Nascent Biotech, Inc. published strong In-Vitro study results from its research collaboration with Syracuse University. The data show that Pritumumab successfully blocked 80% of viral entry into cells. Based on these results, PTB will be advanced to laboratory-based animal studies.

Syracuse University researchers, Alison Patteson, assistant professor of physics, and Jennifer Schwarz, associate professor of physics, recently published the study outcomes featuring the viability of certain antibodies to block SARS2 from entering cells by way of cell-surface vimentin, a pathway for the virus to enter the body. 

Can-Fite BioPharma’s new data from the Phase II advanced liver cancer study including overall survival of nearly 4 years in two patients who are under namodenoson treatment. Additional findings show the disappearance of ascites, normal liver function and good quality of life. In one patient stable disease has been recorded with the disappearance of peritoneal carcinomatosis. Namodenoson continues to demonstrate a good safety profile and is well tolerated with no severe adverse events reported.