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USFDA panel recommends emergency use of Moderna COVID-19 vaccine
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on December 17, following a day-long discussion and presentations, decided to back the vaccine by a vote of 20 in favor and one abstention.
Source: Reuters
The panel of independent experts that advise the USFDA has recommended the emergency use of Moderna s COVID-19 vaccine. The panel s recommendation on December 17 in favour of the Moderna vaccine will set a stage for the rollout of the second COVID-19 vaccine in the US. Last week, the USFDA approved the emergency use of the vaccine by Pfizer and its German partner BioNTech.
[December 17, 2020]
Mesoblast Update on COVID-19 ARDS Trial
NEW YORK, Dec. 17, 2020 (GLOBE NEWSWIRE) Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today provided an update on the randomized controlled trial of remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection after the Data Safety Monitoring Board (DSMB) performed a third interim analysis on the trialâs first 180 patients. The trial was powered to achieve a primary endpoint of 43% reduction in mortality at 30 days for treatment with remestemcel-L on top of maximal care in a trial of 300 patients. This projected mortality reduction was based on pilot data observed during the initial stages of the pandemic when control mortality rates were exceedingly high and prior to new evolving treatment regimens that have reduced disease mortality in ventilated patients. The DSMB reported that there were no safety concerns and noted that the trial is not
Phase I/II trial initiated to study VLA2001, potential COVID-19 vaccine
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Valneva has initiated its Phase I/II trial for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.
Valneva has announced the initiation of a Phase I/II clinical study for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.
VLA2001-201 is the first-in-human study that will evaluate three dose levels of VLA2001 (low, medium, high) for safety, tolerability and immunogenicity in a two-dose schedule with intra muscular vaccinations three weeks apart. Overall, approximately 150 healthy young adults aged 18 to 55 years will be recruited. The study will start with an open-label dose-escalation phase. Following review of safety data by an independent Data Safety Monitoring Board (DSMB), the study will be conducted as a randomised, double-blind, multi-centre study. The trial will be conducted in study sites across the UK and is supported by the UK National Institute for Health Research (NIH
Written by Eric He
As Santa Clara County received its first shipment of COVID-19 vaccines from Pfizer this week, the seven-day average of new COVID-19 cases crossed 1,000 for the first time since the pandemic began.
Courtesy Santa Clara County
Public Health Pharmacy Pharmacist in Charge Quelan To (left) and Pharmacy Technician Jenifer Villanueva receive the first shipment of the Pfizer-BioNTech COVID-19 vaccine in Santa Clara County this week.
The post-Thanksgiving surge is a stark indication that even as help appears on the horizon, the county is in the midst of its darkest phase of the pandemic yet, and experts believe that the general public won’t have access to the vaccine until the spring.