COVID-19 Resources and Services from WCG:
COVID-19 Webinar Series
Watch the WCG COVID-19 Webinar Series On-Demand
Join thousands of your peers in watching WCG’s webinar series, where clinical trial and public health experts provide the insights on COVID-19 and discuss the biggest questions and topics you submit.
COVID-19 Trial Insights from the WCG Knowledge Base™
About WCG Trial Insights
The WCG Trial Insights series brings you weekly insights on trial activity throughout the COVID-19 crisis, based on the extensive services we provide to life science clients and supported by our proprietary and powerful WCG Knowledge Base™.
WCG COVID-19 Advisory Services
Need help interpreting critical data to navigate the impact of COVID-19 on trials and sites? We leverage insights and benchmark data from the WCG Knowledge Base to guide best practices for trial performance during this unprecedented time.
Insights from June 11, 2021
Recent Insights from WCG
Watch Recent COVID-19 Webinars
Recent news on COVID-19 and clinical trials
News provided by WCG FDAnews and WCG CenterWatch
MHRA Grants Conditional Authorization to Moderna’s Bivalent COVID-19 Booster Vaccine
The bivalent vaccine also elicited potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to the Spikevax booster, Moderna said.
Novavax Submits EUA Application to FDA for COVID-19 Vaccine Booster
The FDA granted Novavax’s COVID-19 vaccine emergency authorization in July as a two-dose primary series.
EC Gives Full Marketing Authorization to Gilead Sciences’ Veklury
The drug will continue to be closely monitored to assess its effectiveness against emerging SARS-CoV-2 variants.
Imspex Gets CE Mark for BreathSpec Device
The company aims to further develop breath-based testing as a “non-invasive way to address major healthcare challenges.”
FDA Provides Update on Haimen Shengbang Laboratory’s Recall of Its Viral Transport Media Containers
The agency said that the products pose a risk of false results.
Hyris T-Cell Test Gains CE-IVD Mark
The test has not yet been approved, cleared or authorized for use in the U.S.
Qorvo Received EUA for Rapid COVID-19 Antigen Test
The test is authorized for detection of antigens from the SARS-CoV-2 virus in nasal swab specimens.
FDA Grants EUA to Helix Diagnostics SARS nCOV-2019 Multiplexed Assay Test
Under the EUA, the agency limits analysis of the test samples to Helix Diagnostics’ laboratory in Waterford, Mich.
FDA Expands EUA for Twist Bioscience SARS-CoV-2 NGS Assay
Emergency use of the test is limited to laboratories that meet requirements to perform high complexity tests.
Eli Lilly to Make Bebtelovimab Commercially Available
Lilly said the drug will be available in the week of Aug.15, before the anticipated depletion of the U.S. government’s currently available supply.
FDA Provides Update on North American Diagnostics’ Recall of SARS-CoV-2 Test Kits
So far, no complaints or reports of injuries or deaths have been linked to the test kits, the FDA said.
Axcella’s Investigational Drug Shows Promise in Long COVID Clinical Trial
People who took AXA1125 had statistically significant improvements in their level of mental and physical fatigue.
Expert insights on clinical trials and COVID-19
As we navigate COVID-19 together, our clinical trial experts are engaged to address the biggest questions. To submit a topic or question, use the form at the bottom of the page.
Submit a COVID-19 question or topic to be considered in future webinars
Please note: protocol-specific questions for studies under the oversight of a WCG IRB should be submitted through your IRB contact person, not through this form.
Disclaimer: All information available on this site is intended for your general knowledge and is not for the purpose of providing regulatory advice, medical advice, or a substitute for institutional review board review. You should not use this information to determine compliance with any applicable laws or regulations governing institutional review boards and human subjects research.