COVID-19 Resources and Services from WCG:
COVID-19 Webinar Series
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Join thousands of your peers in WCG’s online panels, where clinical trial and public health experts provide the latest insights on COVID-19 and discuss the biggest questions and topics you submit.
COVID-19 Clinical Trial Tracker
Monitor the progress of clinical trials for COVID-19 treatments and vaccines, leveraging data from the WCG Knowledge Base™.
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
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Watch Recent COVID-19 Webinars
Recent news on COVID-19 and clinical trials
News provided by WCG FDAnews and WCG CenterWatch
Biden Administration Spending $3 Billion to Develop COVID-19 Medicines
The Biden administration yesterday launched a $3 billion program to develop antiviral medicines for treating COVID-19 and confronting future pandemics.
U.S., EU Pledge to Lower Export Barriers for COVID-19 Products
The U.S. and EU reached an agreement to reduce export restrictions for COVID-19 vaccines and therapeutics at a Tuesday summit meeting in Brussels.
FDA Authorizes Third Drug Substance Batch From Emergent Facility
The FDA has approved a third batch of Johnson & Johnson (J&J) COVID-19 vaccine drug substance for release from the embattled Emergent plant in Baltimore, Maryland — but still hasn’t authorized the Bayview facility to resume production.
AstraZeneca Antibody Therapy for COVID-19 Fails in Late-Stage Trial
AstraZeneca’s monoclonal antibody cocktail, AZD7442, failed to prevent symptomatic COVID-19 infection in a late-stage study of individuals recently exposed to the SARS-CoV-2 virus.
FDA Details GMP Issues at Emergent’s Bayview Plant; Tells J&J to Destroy 60 Million Doses
Emergent BioSolutions’ troubled Bayview, Md., plant, a manufacturing site for Johnson & Johnson’s COVID-19 vaccine, repeatedly failed to seal off a preparation area for vaccine ingredients and allowed production garbage to be carried through the area, leading to contamination, explains Peter Marks, director of FDA’s Center for Biologics Evaluation and…
Novavax to Seek EUA in Q3 for Its COVID-19 Vaccine
Novavax said it plans to file for FDA Emergency Use Authorization (EUA) of its two-dose COVID-19 vaccine in the third quarter, supported by the strong efficacy data from its late-stage trial in which the recombinant DNA-based vaccine proved 100 percent effective in preventing moderate and severe disease, and more than…
FDA Denies Emergency Authorization for Bharat Biotech’s COVID-19 Vaccine
The FDA has declined to authorize Bharat Biotech’s COVID-19 vaccine, Covaxin, for emergency use, prompting the Indian drugmaker’s U.S. partner, Ocugen, to instead seek a full approval of the shot through a Biologics License Application (BLA).
Innova Medical Group Gets FDA Warning for Unapproved COVID-19 Test
The warning letter stemmed from an inspection of the company’s Pasadena, Calif., manufacturing facility.
EMA Approves New Manufacturing Facility for Moderna’s Vaccine
The new CHMP recommendations are expected to enable the production of an additional “one to two million vials” of vaccine for the EU market each month, the committee said.
FDA Outlines Safety Data Needed for COVID-19 Vaccine EUAs for Children and Adolescents
The FDA would need to see safety data from at least 3,000 trial participants to grant Emergency Use Authorization or approval for a COVID-19 vaccine for children under age 12, an agency official told members of its vaccine advisory panel yesterday.
FDA Awards Amazon Subsidiary EUA for Direct-to-Consumer COVID-19 Test
The test can be used for patients who do not have any symptoms or suspected COVID-19 infection. A nondirect-to-consumer version of the test was authorized earlier this year.
Merck Secures $1.2 Billion Government Contract for Experimental COVID-19 Treatment
The U.S. government will pay Merck an estimated $1.2 billion for 1.7 million courses of its experimental COVID-19 antiviral, molnupiravir, if the drug is authorized by the FDA.
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.