There was no clear bombshell in the first meeting of an FDA advisory committee dedicated to COVID-19 vaccines. There were, however, several conclusions. Known as the Vaccines and Related Biological Products Advisory Committee (VRBAC), the meeting yesterday provided an overview of the steps medical and government authorities are taking to approve COVID-19 vaccines. Go to […]
vaccines
Sanofi to launch COVID-19 vaccine trial in Q4
Sanofi (NYSE:SNY) and Translate Bio (NSDQ:TBIO) announced today that a Phase 1/2 clinical trial for its COVID-19 vaccine candidate is set for the fourth quarter of 2020. Preclinical results for MRT5500, the COVID-19 vaccine candidate under development by the two companies, demonstrated a favorable immune response profile against SARS-CoV-2, the virus causing coronavirus, which supports the selection […]
J&J exec denies pressure to rush COVID-19 vaccine
Johnson & Johnson’s (NYSE:JNJ) chief scientific officer said today that the first doses of his company’s COVID-19 vaccine could be available for frontline healthcare workers in January or February, but added the company isn’t rushing it. If granted an emergency use authorization by the FDA, that’s the earliest Dr. Paul Stoffels said the single-dose vaccine developed […]
FDA defies Trump on vaccine approval timeline
The FDA today told COVID-19 vaccine developers that it needs two months’ worth of safety data before it will consider emergency approvals. The agency’s move cast further doubt on a vaccine against SARS-COV-2 being ready by election day, November 3 — a notion mentioned repeatedly by President Trump in attempts to pressure the agency to […]
U.S. should have enough COVID-19 vaccine by Q3 2021, CDC head tells Senate panel
CDC director Dr. Robert Redfield told a Senate panel today that the federal government should have enough coronavirus vaccine for Americans to resume “regular life” by the third quarter of 2021, according to a report by CNBC. Redfield said vaccinations could begin November or December of 2020 and that it could take 6 to 9 months to […]
Moderna touts preclinical study results for COVID-19 vaccine candidate
Moderna (NSDQ:MRNA) announced today that the preclinical study of its COVID-19 vaccine candidate observed immune response and protection against the virus in non-human primates. Cambridge, Mass.-based Moderna’s study, published in The New England Journal of Medicine, showed that a two-dose vaccination schedule of the mRNA-1273 vaccine candidate led to a “robust immune response and protection” against SARS-CoV-2 infection […]
Small study yields ‘really good news’ for COVID-19 vaccine odds
Scientists at the La Jolla Institute for Immunology have documented a robust antiviral immune response to SARS-CoV-2 in a group of 20 adults who had recovered from COVID-19. Their work, published in today’s online edition of Cell, show that the body’s immune system is able to recognize SARS-CoV-2 in many ways, dispelling fears that the virus may elude […]
The top 10 medical disruptors of 2018
Each year the Cleveland Clinic determines what the top 10 disruptors in healthcare will be for the following year. The criteria to be considered a disruptor or innovation is that it has to be innovative and could change care in a significant way in the next year. Approximately 150 to 200 Cleveland Clinic physicians from […]
