AstraZeneca Coronavirus vaccine trial remains on hold in the U.S., HHS chief Azar says

CNBC ^ | 09/25/2020 | Noah Higgins-Dunn

[SeekAndFind]

AstraZeneca’s late-stage coronavirus vaccine trial in the U.S. remains on hold as federal investigators seek “answers to important questions” over its safety for patients, Health and Human Services Secretary Alex Azar told CNBC on Wednesday.

Global clinical trials for AstraZeneca’s Covid-19 vaccine, called AZD1222, were placed on hold Sept. 6 after one of the participants in the U.K. reported a serious adverse reaction. Following an investigation, AstraZeneca said on Sept. 12 that it had resumed trials in the U.K., though the U.S. trial has since remained on hold.

“Look at the AstraZeneca program, phase three clinical trial, a lot of hope. Single serious adverse event report in the United Kingdom, global shutdown and hold of the clinical trials,” Azar told CNBC’s “Squawk Box” in defense of the Trump administration’s quick development of a Covid-19 vaccine amid safety concerns.

“Still on hold here in the United States as the (U.S. Food and Drug Administration) seeks answers to important questions to verify safety information around those vaccines. Plan is by the book, we’re keeping patient safety at the center of everything we do,” he said.

AstraZeneca spokeswoman Michele Meixell confirmed that the vaccine’s trial in the U.S. remains on hold.

“Regulators in each individual country determine when trials can start and they do this in their own time frame,” she said in a statement to CNBC. “On the current U.S. trial status specifically, we are continuing to work with the FDA to facilitate review of the information and the agency will decide when the U.S. trial can resume.”

The United States has been racing to develop, manufacture and distribute a coronavirus vaccine in record time as part of the Trump administration’s Operation Warp Speed, a partnership between federal agencies, including HHS, the FDA, the U.S. Centers for Disease Control

[FreeReign]

Still on hold here in the United States as the (U.S. Food and Drug Administration) seeks answers....

If the FDA is Deep State, then what chance do we have that the vaccine trials will start up in the appropriate timely manner.

[Georgia Girl 2]

Here's my shocked face. 😱

[A Navy Vet]

"The United States has been racing to develop, manufacture and distribute a coronavirus vaccine in record time as part of the Trump administration’s Operation Warp Speed, a partnership between federal agencies, including HHS, the FDA, the U.S. Centers for Disease Control"

And yet the politicians and MSM say Trump is doing nothing. Hell, once he knew of the China virus, he stopped flights coming in from China in late January. About a week later he stopped all in-bound flights from Italy with their huge China textile population in the north. Lies, lies, and more damned lies by the MSM. Then he creates Operation Warp Speed for a vaccine that are just months away from success.

[corkoman]

Poor reporting - the study is not on hold but the ENROLLMENT of new patients is suspended until cause is determined of that bad event.

All treated patients continue to be evaluated according to the study protocol.

It is an important distinction - should another, similar adverse event occur that would deep six the rest of the study.

If 1) all treated patients go another few weeks without (similar) another event and 2) some underlying patient factor is established as the cause of the event...then the enrollment of new patients will resume.