With COVID-19, questions about how infections cause lasting immunity, or don’t, and how you know and what it all means for vaccines have become a matter of public focus. But some immunologists have been pondering those questions for years. “The immune system has a very good memory,” Bali Pulendran told BioWorld. “Clearly, some viruses and some pathogens can enter the body and stimulate the immune system, and the immune system can remember that encounter for decades.”
LONDON – The U.K. is funding a national program of research to investigate the major unanswered questions related to the immune response to COVID-19. The aim of the research, involving teams of immunologists in 17 research institutions, is to unpick the immunological backdrop of one of the most notable aspects of COVID-19 infection, which is the huge spectrum of severity of symptoms.
A number of controversies have swirled around the U.S. FDA’s handling of the COVID-19 pandemic, including the question of the emergency use authorization (EUA) program for testing. The FDA’s Tim Stenzel said on an Aug. 26 testing town hall that he would not answer questions about the rescission order for FDA regulation of lab-developed tests (LDTs), but also said, “we are simply overwhelmed” with EUA filings for testing.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acessa Health, Altair, Avellino, Avero Diagnostics, Baril, Cerebain Biotech, Edap, Enwave, Essilorluxottica, Grandvision, Hal Optical Investments, Hologic, Maravai Lifesciences, Mediwound, Otsuka America Pharmaceutical, Pct, Pkg, Premier Medical Laboratory Services, Proscia, Proteus Digital Health, Sonde Health, Sugentech, Team Technologies, Trilink Biotechnologies, Valencia Technologies, Vericel.
Despite two significant coronavirus outbreaks in the last two decades that killed hundreds of people, dominated international headlines, and grabbed millions in research dollars, SARS-CoV-2 still caught researchers, national scientific advisors, pharmaceutical companies flatfooted when it emerged in late 2019. Why?
The U.S. Department of Health and Human Services (HHS) has ordered the FDA to cease requiring developers of lab-developed tests (LDTs) to go through the agency’s premarket review mechanisms before offering an LDT. The context of the order might at first blush be interpreted as limiting the scope of the order to the public health emergency (PHE) to the COVID-19 pandemic, but the statement expands the temporal scope by referencing a need for rulemaking on the FDA’s part, one of several indications that this order is intended to outlast the PHE.
The U.S. FDA has granted emergency use authorization (EUA) to Lumiradx UK Ltd. for its point-of-care SARS-CoV-2 antigen test, which aims to speed the diagnosis of people suspected of having the virus that causes COVID-19. The test detects antigen nucleocapsid protein from a nasal swab taken from symptomatic patients and delivers results in less than 12 minutes.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Curetis, Lumiradx, Opgen, Pelvital, Zymo Research.
