LONDON – A new national consortium of virologists has been set up to systematically assess how mutations in SARS-CoV-2 affect key outcomes such as effectiveness of vaccines and therapies, transmissibility of the virus and the severity of COVID-19 infections. Now is the critical time to do this, as the level of both natural and vaccine-conferred immunity that might drive natural selection is increasing, said Wendy Barclay, head of the department of infectious disease at Imperial College London, who is leading the G2P-UK (Genotype to Phenotype-UK) project.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS examines device classification process at FDA; NIH offers NGS system for SARS-CoV-2; FDA issues pandemic policy for coagulation systems.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hyperfine Research, Novaerus, Perkinelmer, Perspectum.
Moncef Slaoui, chief advisor to Operation Warp Speed, the public-private partnership to hurry along a vaccine for COVID-19, cited tough going in the early days of development, as researchers met “a real challenge to engage the population.” During a panel discussion at the virtual 39th J.P. Morgan Healthcare Conference, he pointed to “a double-edged sword, to talk about what a vaccine can do, when we don’t know – and then once you know, you’re going to have to change your message.”
Reports of multiple new variants of the SARS-CoV-2 virus have emerged, raising questions about the efficacy of vaccines, but also regarding the utility of diagnostic and other tests. The U.S. FDA’s Tim Stenzel said single-target tests are thus at a greater risk of returning a false negative result, adding that these developers “should consider this carefully” in surveillance of their tests.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: New test beats biopsy for transplant rejection; NICE eyes digital health HTAs; MHRA moves on the hazards of bedrails; TGA zeroes in on tests for COVID-19; HHS posts rule for agency enforcement action.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Excalibur Healthcare Services, Siemens Healthineers, Vestibular First.
CAJICA, Colombia – Authorities in Brazil released new efficacy data for Sinovac Biotech Ltd.'s COVID-19 vaccine Coronavac that surprised on the downside, suggesting the vaccine could be much less effective than initially indicated for preventing symptomatic infections.