AstraZeneca COVID-19 vaccine trial in U.S. on hold until at least midweek - Reuters sources

Exclusive: AstraZeneca COVID-19 vaccine trial in U.S. on hold until at least midweek - sources AstraZeneca's COVID-19 vaccine trial remains on hold in the United States pending a U.S. investigation into a serious side effect in Britain even as other trials of the vaccine resume, sources familiar with the details told Reuters. Julie Steenhuysen, Marisa Taylor U.S.

CHICAGO (Reuters) - AstraZeneca’s COVID-19 vaccine trial remains on hold in the United States pending a U.S. investigation into a serious side effect in Britain even as other trials of the vaccine resume, sources familiar with the details told Reuters.

AstraZeneca on Saturday said it had restarted its trial in Britain after regulators completed their review of a serious side effect in one trial participant there.

This was the first indication that the U.S. trial will remain on hold until the U.S. Food and Drug Administration and a safety panel investigate the case.

Enrollment in the company’s global trials of the vaccine, which it is developing with researchers at Oxford University, was put on pause on Sept. 6.

Sources told Reuters that enrollment of new patients and other trial procedures for the pivotal U.S. trial were being rescheduled until at least midweek and that it was not clear how long it would take for the FDA to complete its probe.

Governments around the world are desperate for a vaccine to help end the pandemic, which has caused more than 900,000 deaths and global economic turmoil. The World Health Organization (WHO) had flagged AstraZeneca’s as the most promising. A prolonged delay in the U.S. trial could slow access to the vaccine in the United States.

The British adverse event involved a study patient thought to be suffering a rare spinal inflammatory disorder called transverse myelitis. ...

--- WHO praises decision

WHO praises AstraZeneca COVID-19 vaccine trial pause A World Health Organization official on Tuesday said that the decision by AstraZeneca to pause global trials of its experimental coronavirus vaccine after an unexplained illness showed the firm was prioritising safety. Reuters Staff U.S.

Meanwhile:

Adar Poonawalla, the chief executive officer of the world’s largest vaccine manufacturer, said in an interview Monday that the world will likely have to wait until the end of 2024 for total inoculation from the coronavirus-- at best.

Poonawalla, the head of the Serum Institute of India, told the Financial Times that he understands that the world is looking for optimism in the fight against the virus, but pharmaceutical companies are nowhere close to producing a vaccine on the massive scale required. He said his company has committed to producing a billion doses, but he said the world could need 15 billion.