Emergency Use Authorization

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U.S. Ambassador Visits UAE Phase 3 Clinical Trial Site & Learns First Doses of Sinopharm COVID-19 Vaccine Administered to Healthcare Professionals

U.S. Ambassador to the UAE, John Rakolta Jr., and others paid a visit to the Abu Dhabi Health Service company known as SEHA to learn more about the latest developments concerning the progress of their COVID-19 vaccine trials in this Persian Gulf country. There,...

Lilly on the Verge of COVID-19 Monoclonal Antibody EUA Approval First for High Risk Patients with Recent Mild-to-Moderate COVID-19 Diagnosis

TrialSite shared that Eli Lilly’s (Lilly) monoclonal antibody program targeting COVID-19 appeared to be working, at least according to some trial site reports. Now Lilly is moving to secure an emergency use authorization for its monotherapy (LY-CoV555) to the U.S....

Will China Supply Much of the World’s Vaccine for COVID-19? WHO In Discussions to do Just That

The World Health Organization (WHO) now purportedly considers China as its strategic COVID-19 vaccine supplier as the world’s most populous nation—representing the second largest GDP rapidly gaining on the United States—makes its moves to become the world’s primary...

“Operation Warp Speed” Moves to Warp 2: AstraZeneca Begins Phase 3, Experts Skeptical as Trump Administration Prepares for November 1 Vaccine Delivery, and Speed-Up May Involve an EUA

Monday, AstraZeneca said it has begun Phase 3 trials of AZD1222, its COVID-19 vaccine candidate. This makes them the third firm to be in Phase 3 for the virus. As chronicled by CNN August 31 and updated September 1, the vaccine is developed with Oxford University and...

Why Didn’t the HHS Consult with Mayo Clinic National Convalescent Plasma Officials in Moving to Halt the EUA?

Mayo Clinic investigators and supporting team members were “puzzled” by federal actions this week involved with at least the temporary halting of the convalescent plasma program. TrialSite summarized a New York Times article announcing that key federal research...

National Convalescent Plasma EUA Results: Not Sufficient Evidence for Claim that Convalescent Plasma Reduces COVID-19 Death Rate

National Convalescent Plasma EUA Results: Not Sufficient Evidence for Claim that Convalescent Plasma Reduces COVID-19 Death Rate TrialSite initially covered the National Convalescent Plasma Study, led by Mayo Clinic, with great enthusiasm. In fact, many...

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